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Veterinary Medicines Authorised/Transfer Pending Products

This list was last updated on Thursday, November 12, 2020


Please Note
The contents of the table are believed to be correct at the time of compilation. The HPRA makes no representations or warranties about and disclaim all liability for the content,
accuracy, completeness or suitability of the information contained in the table for any purpose whatsoever and the information is made available to the public for information purposes
only.

Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
4XLA Post- Ecolab VPA10795/002/ 0.64, 2.64 Teat dip solution - QG52A LM: Licensed - Sodium chlorite Full application - Topical use
Milking Deutschland 001 percent Merchant as - Lactic acid (Article 12(3) of
Germicidal Teat GmbH weight/volume defined in Directive No
Dip Solution relevant national 2001/82/EC)
legislation

Abacare 1% w/v J. & M. VPA10954/010/ 1 percent Pour-on solution - QP54AA02 LM: Licensed - Abamectin Informed - Topical use
Pour-On Solutio Veterinary 001 weight/volume Merchant as consent
Services Ltd defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Abinex Forte 1 % Bimeda Animal VPA22033/035/ 1 percent Pour-on solution - QP54AA02 LM: Licensed - Abamectin Informed - Topical use
w/v Pour On Health Limited 001 weight/volume Merchant as consent
Solution defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Acecare 2 mg/ml Ecuphar NV VPA10491/009/ 2 Solution for - QN05AA04 VPO: Veterinary - Acepromazine Generic - Intramuscular
Solution for 001 milligram(s)/millil injection Practitioner Only application use
Injection for itre as defined in (Article 13(1) of - Intravenous
Dogs and Cats relevant national Directive No use
legislation 2001/82/EC) - Subcutaneous
use

ACEGON 50 Laboratorios VPA10495/004/ 50 Solution for - QH01CA01 POM: - Gonadorelin Generic - Intramuscular
micrograms/ml SYVA, S.A.U 001 microgram(s)/mil injection Prescription Only application use
solution for lilitre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle relevant national 2001/82/EC)
legislation

Acidum Silicicum Galway HOVR10537/01 . Oral solution LM: Licensed Simplified - Oral use
Homoeopathics 8/001 Merchant as Registration of a
(Manufacturing) defined in Veterinary
Limited relevant national Homeopathic
legislation Medicinal
Product (Article
16, Directive
2001/82/EC)
Acomec 10 ECO Animal VPA22693/024/ 10.0 Solution for - QP54AA01 LM: Licensed - Ivermectin Informed - Subcutaneous
mg/ml Solution Health Europe 001 milligram(s)/millil injection Merchant as consent use
for Injection Limited itre defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Acomec 5 mg/ml ECO Animal VPA22693/023/ 5 Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Informed - Topical use
Pour-On Solution Health Europe 001 milligram(s)/millil Merchant as consent
for Cattle Limited itre defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Adaxio Shampoo Ceva Santé VPA10815/042/ 20, 20 Shampoo - QD08AC52 POM: - Chlorhexidine Hybrid - Topical use
for dogs Animale 001 milligram(s)/millil Prescription Only digluconate application
itre Medicine as - Miconazole (Article 13(3) of
defined in nitrate Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 1 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Adequan 100 Daiichi Sankyo VPA10404/001/ 100 Solution for - QM01AX12 POM: - Polysulphated Full application - Intramuscular
mg/ml Solution Altkirch SARL 001 milligram(s)/millil injection Prescription Only glycosaminoglyc (Article 12(3) of use
for Injection itre Medicine as an Directive No
defined in 2001/82/EC)
relevant national
legislation

Adequan 250 Daiichi Sankyo VPA10404/001/ 250 Solution for - QM01AX12 POM: - Polysulphated Full application - Intraarticular
mg/ml Solution Altkirch SARL 002 milligram(s)/millil injection Prescription Only glycosaminoglyc (Article 12(3) of use
for Injection itre Medicine as an Directive No
defined in 2001/82/EC)
relevant national
legislation

Aderexa 12.5 Krka, d.d., Novo VPA10774/063/ 12.5, 125.0 Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/125 mg mesto 002 mg/tablet Prescription Only oxime application
chewable tablets Medicine as - Praziquantel (Article 13(1) of
for dogs defined in Directive No
weighing at least relevant national 2001/82/EC)
5 kg legislation

Aderexa 2.5 Krka, d.d., Novo VPA10774/063/ 2.5, 25.0 Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/25 mg mesto 001 mg/tablet Prescription Only oxime application
chewable tablets Medicine as - Praziquantel (Article 13(1) of
for small dogs defined in Directive No
and puppies relevant national 2001/82/EC)
weighing at least legislation
0.5 kg

Adocam 1.5 aniMedica VPA10826/020/ 1.5 Oral suspension - QM01AC06 POM: - Meloxicam Generic - Oral use
mg/ml oral GmbH 001 milligram(s)/millil Prescription Only application
suspension for itre Medicine as (Article 13(1) of
dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Adrenacaine Norbrook VPA22664/087/ 50, 0.02 Solution for - QN01BA52 POM: - Procaine Generic - Subcutaneous
Solution for Laboratories 001 milligram(s)/millil injection Prescription Only hydrochloride application use
Injection for (Ireland) Limited itre Medicine as - Adrenaline (Article 13(1) of
Cattle defined in Directive No
relevant national 2001/82/EC)
legislation

Adrestan 10 mg Dechra VPA22622/003/ 10 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Informed - Oral use
hard capsules for Regulatory B.V. 001 capsule Prescription Only consent
dogs Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Adrestan 30 mg Dechra VPA22622/003/ 30 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Informed - Oral use
hard capsules Regulatory B.V. 002 capsule Prescription Only consent
Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Adrestan 60 mg Dechra VPA22622/003/ 60 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Informed - Oral use
hard capsules Regulatory B.V. 003 capsule Prescription Only consent
Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Advantage 100 Elanco GmbH VPA22020/046/ 100 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid - Cutaneous use
Spot-on solution 002 Prescription Only
for Dogs Medicine as
defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 2 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Advantage 250 Elanco GmbH VPA22020/046/ 250 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid - Cutaneous use
Spot-on solution 003 Prescription Only
for Dogs Medicine as
defined in
relevant national
legislation

Advantage 40 Elanco GmbH VPA22020/052/ 40 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Generic - Cutaneous use
mg Spot-on 001 Prescription Only application
solution for Small Medicine as (Article 13(1) of
Cats and Small defined in Directive No
Pet Rabbits relevant national 2001/82/EC)
legislation

Advantage 40 Elanco GmbH VPA22020/045/ 40 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid - Cutaneous use
Spot-on solution 001 Prescription Only
for Cats Medicine as
defined in
relevant national
legislation

Advantage 40 Elanco GmbH VPA22020/046/ 40 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid - Cutaneous use
Spot-on solution 001 Prescription Only
for Dogs Medicine as
defined in
relevant national
legislation

Advantage 400 Elanco GmbH VPA22020/047/ 400 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid - Cutaneous use
Spot-on solution 001 Prescription Only
for Dogs Medicine as
defined in
relevant national
legislation

Advantage 80 Elanco GmbH VPA22020/052/ 80 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Generic - Cutaneous use
mg Spot-on 002 Prescription Only application
solution for Medicine as (Article 13(1) of
Large Cats and defined in Directive No
Large Pet relevant national 2001/82/EC)
Rabbits legislation

Advantage 80 Elanco GmbH VPA22020/045/ 80 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid - Cutaneous use
Spot-on solution 002 Prescription Only
for Cats Medicine as
defined in
relevant national
legislation

Advantix Spot-on Elanco GmbH VPA22020/048/ 250.0/1250.0 Spot-on solution - QP53AC54 POM: - Imidacloprid Full application - Topical use
solution for dogs 003 mg/pipette Prescription Only - Permethrin (Article 12(3) of
over 10 kg up to Medicine as Directive No
25 kg defined in 2001/82/EC)
relevant national
legislation

Advantix Spot-on Elanco GmbH VPA22020/048/ 400.0/2000.0 Spot-on solution - QP53AC54 POM: - Imidacloprid Full application - Topical use
solution for dogs 004 mg/pipette Prescription Only - Permethrin (Article 12(3) of
over 25 kg up to Medicine as Directive No
40 kg defined in 2001/82/EC)
relevant national
legislation

Advantix Spot-on Elanco GmbH VPA22020/048/ 100.0/500.0 Spot-on solution - QP53AC54 POM: - Imidacloprid Full application - Topical use
solution for dogs 002 mg/pipette Prescription Only - Permethrin (Article 12(3) of
over 4 kg up to Medicine as Directive No
10 kg. defined in 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 3 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Advantix Spot-on Elanco GmbH VPA22020/048/ 600/3000 Spot-on solution - QP53AC54 POM: - Imidacloprid Fixed - Topical
solution for dogs 005 mg/pipette Prescription Only - Permethrin combination
over 40 kg up to Medicine as (40/60) application
60 kg defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Advantix Spot-on Elanco GmbH VPA22020/048/ 40.0/200.0 Spot-on solution - QP53AC54 POM: - Imidacloprid Full application - Topical use
solution for dogs 001 mg/pipette Prescription Only - Permethrin (Article 12(3) of
up to 4 kg Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Agrisept MC Medentech Ltd. VPA10928/001/ 2.5 gram/tablet Tablet - QG52A LM: Licensed - Sodium - Topical use
Tabs 2.5 g 001 Merchant as didichloroioscya
effervescent defined in nurate
tablet for teat relevant national (anhydrous)
dip/spray legislation
solution
Alamycin 100 Norbrook VPA22664/015/ 100 Solution for - QJ01AA06 POM: - Oxytetracycline Full application - Intramuscular
mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only hydrochloride (Article 12(3) of use
for Injection (Ireland) Limited itre Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national
legislation

Alamycin Norbrook VPA22664/014/ 3.2 percent Cutaneous - QD06AA03 POM: - Oxytetracycline Full application - Topical use
Aerosol 3.2 Laboratories 001 weight/volume spray, solution Prescription Only (Article 12(3) of
%w/v Cutaneous (Ireland) Limited Medicine as Directive No
Spray, solution defined in 2001/82/EC)
relevant national
legislation

Alamycin LA 200 Norbrook VPA22664/016/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Full application - Intramuscular
mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
for Injection (Ireland) Limited itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Alamycin LA 300 Norbrook VPA22664/039/ 300 Solution for - QJ01AA06 POM: - Oxytetracycline Full application - Intramuscular
mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
for Injection (Ireland) Limited itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Albencare with Ancare Ireland VPA10915/006/ 150 Oral suspension - QP52AC11 LM: Licensed - Albendazole - Oral use
Selenium Oral Ltd. 001 milligram(s)/millil Merchant as
Suspension itre defined in
relevant national
legislation

Albex 10 % Oral Chanelle VPA10987/142/ 10 percent Oral suspension - QP52AC11 LM: Licensed - Albendazole - Oral use
Suspension Pharmaceuticals 002 weight/volume Merchant as
Manufacturing defined in
Limited relevant national
legislation

Albex 2.5 % Oral Chanelle VPA10987/142/ 2.5 percent Oral suspension - QP52AC11 LM: Licensed - Albendazole - Oral use
Suspension Pharmaceuticals 001 weight/volume Merchant as
Manufacturing defined in
Limited relevant national
legislation

Albex Gold 200 Chanelle VPA10987/123/ 200 Oral suspension - QP52AC11 LM: Licensed - Albendazole Hybrid - Oral use
mg/ml oral Pharmaceuticals 001 milligram(s)/millil Merchant as application
suspension for Manufacturing itre defined in (Article 13(3) of
cattle Limited relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 4 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Albiotic 330 Huvepharma NV VPA10782/028/ 330, 100 Intramammary - QJ51RF03 POM: - Lincomycin Full application - Intramammary
mg/100 mg 001 mg/syringe solution Prescription Only - Neomycin (Article 12(3) of use
Intramammary Medicine as Directive No
Solution defined in 2001/82/EC)
relevant national
legislation

Alcide Ecolab VPA10795/003/ 26.4/6.4 Teat dip - QG52A LM: Licensed - Lactic acid Full application - Topical use
UDDERgold Deutschland 001 milligram(s)/millil Merchant as - Sodium chlorite (Article 12(3) of
Platinum GmbH itre defined in Directive No
relevant national 2001/82/EC)
legislation

Alfacef RTU, 50 Alfasan VPA10980/013/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular
mg/ml, Nederland B.V 001 milligram(s)/millil injection Prescription Only application use
suspension for itre Medicine as (Article 13(1) of - Subcutaneous
injection for defined in Directive No use
cattle and pigs relevant national 2001/82/EC)
legislation

Alfacycline LA Alfa Med Limited VPA10894/002/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Informed - Intramuscular
Solution for 001 milligram(s)/millil injection Prescription Only (as consent use
Injection itre Medicine as oxytetracycline application
defined in dihydrate) (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

ALFAGLANDIN Alfasan VPA10980/012/ 0.250 Solution for - QG02AD90 POM: - Cloprostenol Generic - Intramuscular
C 0.250 mg/ml Nederland B.V 001 milligram(s)/millil injection Prescription Only application use
solution for itre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle relevant national 2001/82/EC)
legislation

Alfamox LA 150 Alfa Med Limited VPA10894/004/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin (as Informed - Intramuscular
mg/ml 001 milligram(s)/millil injection Prescription Only amoxicillin consent use
Suspension for itre Medicine as trihydrate) application
Injection defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Alfapen-Strep Alfa Med Limited VPA10894/003/ 200, 200 Suspension for - QJ01RA01 POM: - Benzylpenicillin Informed - Intramuscular
Suspension for 001 milligram(s)/millil injection Prescription Only procaine consent use
Injection itre Medicine as - application
defined in Dihydrostreptom (Article 13c of
relevant national ycin (as the Directive No
legislation sulfate) 2001/82/EC)

Alfatrim 40/200 Alfa Med Limited VPA10894/005/ 40, 200 Solution for - QJ01EW10 POM: - Trimethoprim Informed - Intramuscular
Solution for 001 milligram(s)/millil injection Prescription Only - Sulfadiazine consent use
Injection itre Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

ALFAXAN 10 Jurox (Ireland) VPA22751/001/ 10 Solution for - QN01AX05 VPO: Veterinary - Alfaxalone Full application - Intravenous
mg/ml solution Limited 001 milligram(s)/millil injection Practitioner Only (Article 12(3) of use
for injection for itre as defined in Directive No
dogs and cats relevant national 2001/82/EC)
legislation

Alfaxan Jurox (Ireland) VPA22751/003/ 10 Solution for - QN01AX05 VPO: Veterinary - Alfaxalone Generic - Intravenous
Multidose 10 Limited 001 milligram(s)/millil injection Practitioner Only application use
mg/ml solution itre as defined in (Article 13(1) of
for injection for relevant national Directive No
dogs and cats legislation 2001/82/EC)

Alfaxan Jurox (Ireland) VPA22751/002/ 10 Solution for - QN01AX05 VPO: Veterinary - Alfaxalone Hybrid - Intravenous
Multidose 10 Limited 001 milligram(s)/millil injection Practitioner Only application use
mg/ml solution itre as defined in (Article 13(3) of
for injection for relevant national Directive No
dogs, cats and legislation 2001/82/EC)
pet rabbits

Veterinary Medicines Authorised/Transfer Pending Products Page 5 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Alizin 30 mg/ml Virbac S.A. VPA10988/066/ 30 Solution for - QG03XB90 POM: - Aglepristone - Subcutaneous
Solution for 001 milligram(s)/millil injection Prescription Only use
Injection itre Medicine as
defined in
relevant national
legislation

ALPHA JECT PHARMAQ AS VPA10804/001/ . Emulsion for - QI10AB02 POM: - Aeromonas Full application - Intraperitoneal
3000 Emulsion 001 injection Prescription Only salmonicida (Article 12(3) of use
for injection for Medicine as subspecies Directive No
Atlantic salmon defined in Salmonicida; AL 2001/82/EC)
relevant national 2017
legislation - Listonella
anguillarum
serotype O1; AL
112
- Listonella
anguillarum
serotype O2a;
AL 104
ALPHA JECT PHARMAQ AS VPA10804/003/ . Emulsion for - QI10AA01 POM: - Formaldehyde Full application - Intraperitoneal
micro 1 PD 001 injection Prescription Only inactivated (Article 12(3) of use
Emulsion for Medicine as culture of salmon Directive No
injection, vaccine defined in pancreas 2001/82/EC)
for Atlantic relevant national disease virus
salmon legislation inactivated strain
al v405

ALPHA JECT PHARMAQ AS VPA10804/005/ . Emulsion for - QI10AL02 POM: - infectious Full application - Intraperitoneal
micro 6 emulsion 001 injection Prescription Only pancreatic (Article 12(3) of use
for injection for Medicine as necrosis virus, Directive No
atlantic salmon defined in inactivated 2001/82/EC)
relevant national - Listonella
legislation anguillarum
serotype o2a; al
104
- Listonella
anguillarum
serotype o1; al
112
- Aeromonas
salmonicida
subsp.
salmonicida, al
2017
- Moritella
viscosa, al 266
- Vibrio
salmonicida al
1134
Alphalben 100 ALPHA-VET VPA10391/001/ 100 Oral suspension - QP52AC11 LM: Licensed - Albendazole Generic - Oral use
mg/ml Oral Állatgyógyászati 001 milligram(s)/millil Merchant as application
Suspension for Kft. itre defined in (Article 13(1) of
Cattle and relevant national Directive No
Sheep legislation 2001/82/EC)

Altidox 500 mg/g Eurovet Animal VPA10989/068/ 500 Powder for use - QJ01AA02 POM: - Doxycycline Hybrid - Oral use
powder for use in Health B.V. 001 milligram(s)/gra in drinking water Prescription Only hyclate application
drinking water for m Medicine as (Article 13(3) of
pigs, chickens defined in Directive No
and turkeys relevant national 2001/82/EC)
legislation

Altresyn 4 mg/ml Ceva Santé VPA10815/010/ 4 Oral solution - QG03DX90 POM: - Altrenogest Generic - Oral use
oral solution for Animale 001 milligram(s)/millil Prescription Only application
pigs itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 6 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Aludex 50 g/l Intervet Ireland VPA10996/101/ 50 gram(s)/litre Concentrate for - QP53AD01 POM: - Amitraz Full application - Topical use
Concentrate for Limited 001 cutaneous Prescription Only (Article 12(3) of
cutaneous solution Medicine as Directive No
solution defined in 2001/82/EC)
relevant national
legislation

Aluspray 4% w/w Vetoquinol VPA10983/020/ 4 percent Cutaneous - QD08AB LM: Licensed - Aluminium Full application - Topical use
Cutaneous Ireland Limited 001 weight/weight spray, powder Merchant as powder (Article 12(3) of
Spray, Powder defined in Directive No
relevant national 2001/82/EC)
legislation

Alvebuton 100 V.M.D. n.v. VPA16142/003/ 100 Solution for - QA05AX90 POM: - Menbutone - Intramuscular
mg/ml Solution 001 milligram(s)/millil injection Prescription Only use
for injection for itre Medicine as - Intravenous
cattle, pigs, defined in use
horses, sheep, relevant national
goats legislation

Alvegesic vet. 10 V.M.D. n.v. VPA16142/002/ 10 Solution for - QN02AF01 POM: - Butorphanol Generic - Intramuscular
mg/ml Solution 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
Horses, Dogs defined in Directive No use
and Cats relevant national 2001/82/EC) - Subcutaneous
legislation use

Alzane 5 mg/ml, Laboratorios VPA10495/001/ 5 Solution for - QV03AB90 POM: - Atipamezole Generic - Intramuscular
solution for SYVA, S.A.U 001 milligram(s)/millil injection Prescription Only hydrochloride application use
injection for dogs itre Medicine as (Article 13(1) of
and cats defined in Directive No
relevant national 2001/82/EC)
legislation

Amatib 800 mg/g Krka, d.d., Novo VPA10774/045/ 800 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - Oral use
oral powder for mesto 001 milligram(s)/gra in drinking water Prescription Only trihydrate application
pigs and m Medicine as (equivalent to (Article 13(1) of
chickens defined in 697 mg Directive No
relevant national amoxicllin) 2001/82/EC)
legislation

Amcofen Krka, d.d., Novo VPA10774/059/ 12.5, 125 Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
12.5/125.0 mg mesto 002 mg/tablet Prescription Only oxime application
chewable tablets Medicine as - Praziquantel (Article 13(1) of
for dogs defined in Directive No
weighing at least relevant national 2001/82/EC)
5 kg legislation

Amcofen 16 Krka, d.d., Novo VPA10774/060/ 16, 40 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/40 mg mesto 002 Prescription Only oxime application
chewable tablets Medicine as - Praziquantel (Article 13(1) of
for cats weighing defined in Directive No
at least 2 kg relevant national 2001/82/EC)
legislation

Amcofen 2.5 Krka, d.d., Novo VPA10774/059/ 2.5, 12.5 Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/25 mg mesto 001 mg/tablet Prescription Only oxime application
chewable tablets Medicine as - Praziquantel (Article 13(1) of
for small dogs defined in Directive No
and puppies relevant national 2001/82/EC)
weighing at least legislation
0.5 kg

Amcofen 4 Krka, d.d., Novo VPA10774/060/ 4, 10 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/10 mg mesto 001 Prescription Only oxime application
chewable tablets Medicine as - Praziquantel (Article 13(1) of
for small cats defined in Directive No
and kittens relevant national 2001/82/EC)
weighing at least legislation
0.5 kg

Veterinary Medicines Authorised/Transfer Pending Products Page 7 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Amflee 2.5 Krka, d.d., Novo VPA10774/022/ 2.5 Cutaneous - QP53AX15 POM: - Fipronil Generic, hybrid - Cutaneous use
mg/ml cutaneous mesto 001 milligram(s)/millil spray, solution Prescription Only or similar
spray, solution itre Medicine as biological
for cats and dog defined in application
relevant national (Article 13 of
legislation Directive No
2001/82/EC)
Amflee Combo Krka, d.d., Novo VPA10774/051/ 134, 120.6 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Spot-on use
134 mg/120.6 mesto 002 mg/pipette Merchant as - (S)-methoprene application
mg spot-on defined in (Article 13(1) of
solution for relevant national Directive No
medium dogs legislation 2001/82/EC)

Amflee Combo Krka, d.d., Novo VPA10774/051/ 268, 241.2 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Spot-on use
268 mg/241.2 mesto 003 mg/pipette Merchant as - (S)-methoprene application
mg spot-on defined in (Article 13(1) of
solution for large relevant national Directive No
dogs legislation 2001/82/EC)

Amflee Combo Krka, d.d., Novo VPA10774/051/ 402, 361.8 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Spot-on use
402 mg/361.8 mesto 004 mg/pipette Merchant as - (S)-methoprene application
mg spot-on defined in (Article 13(1) of
solution for extra relevant national Directive No
large dogs legislation 2001/82/EC)

Amflee Combo Krka, d.d., Novo VPA10774/050/ 50, 60 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Spot-on use
50 mg/60 mg mesto 001 mg/pipette Merchant as - (S)-methoprene application
spot-on solution defined in (Article 13(1) of
for cats relevant national Directive No
legislation 2001/82/EC)

Amflee Combo Krka, d.d., Novo VPA10774/051/ 67, 60.3 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Spot-on use
67 mg/60.3 mg mesto 001 mg/pipette Merchant as - (S)-methoprene application
spot-on solution defined in (Article 13(1) of
for small dogs relevant national Directive No
legislation 2001/82/EC)

Amodip 1.25 mg Ceva Santé VPA10815/048/ 1.25 mg/tablet Chewable tablet - QC08CA01 POM: - Amlodipine Full application - Oral use
chewable tablets Animale 001 Prescription Only (Article 12(3) of
for cats Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Amoxibactin 250 Le Vet Beheer VPA10475/013/ 250 mg/tablet Tablet - QJ01CA04 POM: - Amoxicillin (as - Oral use
mg tablets for B.V. 002 Prescription Only amoxicillin
dogs Medicine as trihydrate)
defined in
relevant national
legislation

Amoxibactin 50 Le Vet Beheer VPA10475/013/ 50 mg/tablet Tablet - QJ01CA04 POM: - Amoxicillin (as - Oral use
mg tablets for B.V. 001 Prescription Only amoxicillin
dogs and cats Medicine as trihydrate)
defined in
relevant national
legislation

Amoxibactin 500 Le Vet Beheer VPA10475/013/ 500 mg/tablet Tablet - QJ01CA04 POM: - Amoxicillin (as - Oral use
mg tablets for B.V. 003 Prescription Only amoxicillin
dogs Medicine as trihydrate)
defined in
relevant national
legislation

AMOXICILLIN GLOBAL VET VPA10477/002/ 500 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - In drinking
GLOBAL VET HEALTH SL 001 milligram(s)/gra in drinking water Prescription Only application water use
HEALTH 500 m Medicine as (Article 13(1) of - Oral use
mg/g, powder for defined in Directive No
use in drinking relevant national 2001/82/EC)
water for legislation
chickens,
turkeys, ducks
and pigs

Veterinary Medicines Authorised/Transfer Pending Products Page 8 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Amoxinsol 50 % Vetoquinol VPA10983/041/ 50 percent Powder for oral - QJ01CA04 POM: - Amoxicillin - Oral use
w/w powder for Ireland Limited 001 weight/weight solution Prescription Only trihydrate
oral solution Medicine as
defined in
relevant national
legislation

AMOXY Dopharma VPA10791/005/ 697 Oral powder - QJ01CA04 POM: - Amoxicillin Generic - Oral use
ACTIVE, 697 Research B.V. 001 milligram(s)/gra Prescription Only application
mg/g, oral m Medicine as (Article 13(1) of
powder for pigs defined in Directive No
and chickens relevant national 2001/82/EC)
legislation

Amphen 200 Huvepharma NV VPA10782/034/ 200 Granules for use - QJ01BA90 POM: - Florfenicol Hybrid - In drinking
mg/g granules 001 milligram(s)/gra in drinking water Prescription Only application water use
for use in m Medicine as (Article 13(3) of
drinking water for defined in Directive No
pigs relevant national 2001/82/EC)
legislation

Ampisol 2g Franklin VPA10976/013/ 2 gram(s) Powder for - QJ01CA01 POM: - Ampicillin (as - Intramuscular
Pharmaceuticals 001 solution for Prescription Only ampicillin sodium use
Ltd. injection Medicine as ph.eur.) - Intravenous
defined in use
relevant national
legislation

Ampitras 20% Kela n.v. VPA10981/006/ 20 percent Suspension for - QJ01CA01 POM: - Ampicillin - Intramuscular
w/v, suspension 001 weight/volume injection Prescription Only use
for injection Medicine as
defined in
relevant national
legislation

AMPROLINE HUVEPHARMA VPA10453/002/ 400 Solution for use - QP51AX09 POM: - Amprolium (as Hybrid - In drinking
400 mg/mL SA 001 milligram(s)/millil in drinking water Prescription Only hydrochloride) application water use
solution for use itre Medicine as (Article 13(3) of
in drinking water defined in Directive No
for chickens and relevant national 2001/82/EC)
turkeys legislation

AMX 10 mg/ml PHARMAQ AS VPA10804/002/ 10 Concentrate for - QP53AC11 POM: - Deltamethrin Full application - Topical use
concentrate for 001 milligram(s)/millil solution for fish Prescription Only (Article 12(3) of - Water-borne
solution for fish itre treatment Medicine as Directive No use
treatment defined in 2001/82/EC)
relevant national
legislation

Anaemex 200 Ark Animal Care VPA10900/010/ 200 Solution for - QB03AC90 LM: Licensed - Iron Well-established - Intramuscular
mg/ml Solution Ltd 001 milligram(s)/millil injection Merchant as use application use
for Injection itre defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

Anaestamine Le Vet Beheer VPA10475/010/ 100 Solution for - QN01AX03 VPO: Veterinary - Ketamine Generic - Intramuscular
100 mg/ml B.V. 001 milligram(s)/millil injection Practitioner Only application use
solution for itre as defined in (Article 13(1) of - Intravenous
injection relevant national Directive No use
legislation 2001/82/EC)

Animec 0.8 Chanelle VPA10987/070/ 0.8 Oral solution - QP54AA01 LM: Licensed - Ivermectin Hybrid - Oral use
mg/ml Oral Pharmaceuticals 001 milligram(s)/millil Merchant as application
Solution for Manufacturing itre defined in (Article 13(3) of
Sheep Limited relevant national Directive No
legislation 2001/82/EC)

Animec 1 % Chanelle VPA10987/147/ 1 percent Solution for - QP54AA01 LM: Licensed - Ivermectin - Subcutaneous
Solution for Pharmaceuticals 001 weight/volume injection Merchant as use
Injection Manufacturing defined in
Limited relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 9 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Animec 18.7 ECO Animal VPA22693/008/ 18.7 Oral paste - QP54AA01 LM: Licensed - Ivermectin Well-established - Oral use
mg/g Oral Paste Health Europe 001 milligram(s)/gra Merchant as use application
for Horses Limited m defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

Animec 5 mg/ml Chanelle VPA10987/152/ 5 Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Generic - Topical use
Pour-on Solution Pharmaceuticals 001 milligram(s)/millil Merchant as application
for Cattle Manufacturing itre defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Animec Super Chanelle VPA10987/068/ 10 Solution for - QP54AA51 LM: Licensed - Ivermectin Generic - Subcutaneous
Solution for Pharmaceuticals 001 milligram(s)/millil injection Merchant as - Clorsulon application use
Injection Manufacturing itre defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Animedazon aniMedica VPA10826/005/ 3.21 gram/spray Cutaneous - QD06AA02 POM: - Generic - Cutaneous use
Spray, 2.45 % GmbH 001 container spray, Prescription Only Chlortetracycline application
w/w cutaneous suspension Medicine as hydrochloride (Article 13(1) of
spray defined in Directive No
suspension for relevant national 2001/82/EC)
cattle, sheep and legislation
pigs
Animeloxan, 20 aniMedica VPA10826/025/ 20 Solution for - QM01AC06 POM: - Meloxicam Generic - Intramuscular
mg/ml, solution GmbH 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle, pigs and defined in Directive No use
horses relevant national 2001/82/EC) - Subcutaneous
legislation use

Anisec 0.5 % w/v Chanelle VPA10987/158/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin - Topical use
Pour-on Solution Pharmaceuticals 001 weight/volume Merchant as
Manufacturing defined in
Limited relevant national
legislation

Anivac VHD Pharmagal Bio VPA10556/001/ minimum 1 PD9 Suspension for - QI08AA01 POM: - Rabbit Full application - Subcutaneous
Suspension for s.r.o 001 injection Prescription Only haemorrhagic (Article 12(3) of use
injection for Medicine as disease, strain Directive No
rabbits defined in RHDV PHB 98 2001/82/EC)
relevant national
legislation

Anthelmin 230 Krka, d.d., Novo VPA10774/049/ 230/20 mg/tablet Film-coated - QP52AA51 CAM: - Pyrantel Generic - Oral use
mg/20 mg film- mesto 001 tablet Companion embonate application
coated tablets for Animal Medicine - Praziquantel (Article 13(1) of
cats as defined in Directive No
relevant national 2001/82/EC)
legislation

Anthelmin Plus Krka, d.d., Novo VPA10774/033/ 150, 144, 50 Tablet - QP52AC55 CAM: - Febantel Generic - Oral use
Flavour Tablets mesto 001 mg/tablet Companion - Pyrantel application
for dogs Animal Medicine embonate (Article 13(1) of
as defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Anthelmin Plus Krka, d.d., Novo VPA10774/033/ 525, 504, 175 Tablet - QP52AC55 CAM: - Febantel Generic - Oral use
XL Tablets for mesto 002 mg/tablet Companion - Pyrantel application
dogs Animal Medicine embonate (Article 13(1) of
as defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Antisedan 5 Orion VPA10664/003/ 5 Solution for - QV03AB90 POM: - Atipamezole Full application - Intramuscular
mg/ml solution Corporation 001 milligram(s)/millil injection Prescription Only hydrochloride (Article 12(3) of use
for injection itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 10 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Anxt-F Complements of HOVR10489/00 Oral solution CAM: - Aconite - Oral use
Scotland Ltd 1/001 Companion (aconitum
Animal Medicine napellus)
as defined in - Avena sativa
relevant national - Belladonna
legislation (atropa
belladonna)
- Borax (natrium
tetraboracicum)
- Calcium
phosphoricum
- Gelsemium
sempervirens
- Lycopodium
clavatum
- Natrium
carbonicum
- Natrium
chloratum
(natrium mur)
- Passiflora
incarnata
- Phosphorus
- Rhododendron
- Scutellaria
lateriflora
- Silicea (acidum
silicicum)
- Staphisagria
(delphinium)
- Stramonium
(datura
stramonium)
- Valeriana
officinalis

API-Bioxal, 886 Chemicals Laif VPA10388/001/ 886.0 Powder for syrup - QP53AG03 LM: Licensed - Oxalic acid Full application - Topical use
mg/g powder for S.P.A 001 milligram(s)/gra Merchant as dihydrate (Article 12(3) of
in-hive use m defined in Directive No
relevant national 2001/82/EC)
legislation

APIGUARD gel Vita Bee Health VPA22752/001/ 25 percent Gel - QP53AX22 LM: Licensed - Thymol - Inhalation use
(25% thymol) for Limited 001 Merchant as - Topical use
beehive use defined in
relevant national
legislation

Apivar 500 mg Veto-Pharma VPA22827/001/ 500 milligram(s) Bee-hive strip - QP53AD01 LM: Licensed - Amitraz Well-established
Bee-hive strips SAS 001 Merchant as use application
for honey bees defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

Apivar 500 mg Duggan PVPA10400/001 500 Bee-hive strip - QP53AD01 LM: Licensed - Amitraz
Bee-hive strips Veterinary /001 milligram/strip Merchant as
for honey bees Supplies Ltd. defined in
relevant national
legislation

Apovomin 3 Dechra VPA22622/002/ 3 Solution for - QN04BC07 VPO: Veterinary - Apomorphine Generic - Subcutaneous
mg/ml solution Regulatory B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection for itre as defined in (Article 13(1) of
dogs relevant national Directive No
legislation 2001/82/EC)

Apralan G200 Elanco GmbH VPA22020/013/ 200 Premix for - QA07AA92 POM: - Apramycin - Oral use
Premix for 002 gram(s)/kilogra medicated Prescription Only
medicated m(s) feeding stuff Medicine as
feeding stuff defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 11 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Apralan Soluble Elanco GmbH VPA22020/010/ 552,000 Powder for use - QA07AA92 POM: - Apramycin Full application - Oral use
Powder for use 001 international in drinking Prescription Only (Article 12(3) of
in drinking unit(s)/gram water/milk Medicine as Directive No
water/milk replacer defined in 2001/82/EC)
replacer for pigs, relevant national
calves, chickens legislation
and rabbits

Apravet 100 g/kg Huvepharma NV VPA10782/013/ 100 Premix for - QJ01GB POM: - Apramycin 13(1) generic - Per Oral
premix for 001 gram(s)/kilogra medicated Prescription Only sulphate
medicated m(s) feeding stuff Medicine as
feeding stuff for defined in
pigs relevant national
legislation

Apravet 552 Huvepharma NV VPA10782/024/ 552 international Powder for use - QA07AA92 POM: - Apramycin Generic - In drinking
IU/mg powder for 001 unit(s)/milligram in drinking Prescription Only application water/milk use
use in drinking water/milk Medicine as (Article 13(1) of
water/milk for defined in Directive No
pigs, calves, relevant national 2001/82/EC)
chickens and legislation
rabbits

Aquaprim Univet Limited VPA10990/024/ 200, 40 Solution for - QJ01EW10 POM: - Trimethoprim - Intramuscular
Solution for 001 milligram(s)/millil injection Prescription Only - Sulfadiazine use
Injection itre Medicine as
defined in
relevant national
legislation

AquaVac ERM Intervet Ireland VPA10996/218/ . Oral emulsion - QI10BB03 POM: - Yersinia ruckeri Full application - Per Oral
Oral. Oral Limited 001 Prescription Only cells inactivated (Article 12(3) of
emulsion for Medicine as (Hagerman type Directive No
rainbow trout defined in 1 stain) 2001/82/EC)
relevant national
legislation

AquaVac ERM. Intervet Ireland VPA10996/214/ . Concentrate for - QI10BB03 POM: - Yersinia ruckeri - ZZZ Immersion
Concentrate for Limited 001 dip suspension Prescription Only cells inactivated
dip suspension Medicine as (Hagerman type
for Rainbow trou defined in 1 stain)
relevant national
legislation

AQUAVAC PD Intervet Ireland VPA10996/281/ . Emulsion for - QI10AA01 POM: - Salmon Full application - Intraperitoneal
emulsion for Limited 001 injection - QI10BA Prescription Only pancreas (Article 12(3) of use
injection for Medicine as disease virus Directive No
Atlantic salmon defined in (strain F93-125) 2001/82/EC)
relevant national inactivated
legislation

AQUAVAC PD Intervet Ireland VPA10996/281/ . Emulsion for - QI10AA01 POM: - Salmon Full application - Intraperitoneal
emulsion for Limited 001 injection - QI10BA Prescription Only pancreas (Article 12(3) of use
injection for Medicine as disease virus Directive No
Atlantic salmon defined in (strain F93-125) 2001/82/EC)
relevant national inactivated
legislation

AquaVac PD3 Intervet Ireland VPA10996/274/ . Emulsion for - QI10AL POM: - Inactivated Full application - Intraperitoneal
emulsion for Limited 001 injection Prescription Only salmon pancreas (Article 12(3) of use
injection for Medicine as disease virus Directive No
Atlantic salmon defined in - Inactivated 2001/82/EC)
relevant national infectious
legislation pancreatic
necrosis virus
- Inactivated
aeromonas
salmonicida
subsp.
salmonicida

Veterinary Medicines Authorised/Transfer Pending Products Page 12 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Aqupharm 1 (9 Ecuphar NV VPA10491/010/ 9 Solution for - QB05BB01 POM: - Sodium Generic - Intraperitoneal
mg/ml) solution 001 milligram(s)/millil injection/infusion Prescription Only chloride application use
for itre Medicine as (Article 13(1) of - Intravenous
injection/infusion defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Aqupharm 11 Ecuphar NV VPA10491/011/ . Powder for - QB05BB01 POM: - Sodium Generic - Intravenous
(Hartmann's) 001 suspension for Prescription Only chloride application use
Solution for fish treatment Medicine as - Potassium (Article 13(1) of
Infusion. defined in chloride Directive No
relevant national - Calcium 2001/82/EC)
legislation chloride
dihydrate
- Sodium lactate

Arentor DC 250 Univet Limited VPA10990/050/ 250 mg/syringe Intramammary - QJ51DB90 POM: - Cefalonium Hybrid - Intramammary
mg 001 suspension Prescription Only application use
Intramammary Medicine as (Article 13(3) of
Suspension for defined in Directive No
Dry Cows relevant national 2001/82/EC)
legislation

ARIXIL vet 20 Vetpharma VPA10516/020/ 20 mg/tablet Film-coated - QC09AA07 POM: - Benazepril Generic - Oral use
mg film-coated Animal Health, 002 tablet Prescription Only hydochloride application
tablet for dogs S.L. Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

ARIXIL vet 5 mg Vetpharma VPA10516/020/ 5 mg/tablet Film-coated - QC09AA07 POM: - Benazepril Generic - Oral use
film-coated tablet Animal Health, 001 tablet Prescription Only hydochloride application
for dogs and cat S.L. Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Arrest Oral Ancare Ireland VPA10915/003/ 2.50/3.75 Oral suspension - QP52AC13 LM: Licensed - Fenbendazole - Oral use
Suspension Ltd. 001 percent - QP52AE01 Merchant as - Levamisole
weight/volume defined in hydrochloride
relevant national
legislation

Arrest Oral Ancare Ireland VPA10915/003/ 2.50/3.75 Oral suspension - QP52AC13 LM: Licensed - Fenbendazole - Oral use
Suspension Ltd. 001 percent - QP52AE01 Merchant as - Levamisole
weight/volume defined in hydrochloride
relevant national
legislation

Ataxxa 1250 Krka, d.d., Novo VPA10774/034/ 1250, 250 Spot-on solution - QP53AC54 POM: - Permethrin Hybrid - Topical use
mg/250 mg spot- mesto 003 mg/pipette Prescription Only - Imidacloprid application
on solution for Medicine as (Article 13(3) of
dogs over 10 kg defined in Directive No
up to 25 kg relevant national 2001/82/EC)
legislation

Ataxxa 200 Krka, d.d., Novo VPA10774/034/ 200, 40 Spot-on solution - QP53AC54 POM: - Permethrin Hybrid - Topical use
mg/40 mg spot- mesto 001 mg/pipette Prescription Only - Imidacloprid application
on solution for Medicine as (Article 13(3) of
dogs up to 4 kg defined in Directive No
relevant national 2001/82/EC)
legislation

Ataxxa 2000 Krka, d.d., Novo VPA10774/034/ 2000, 400 Spot-on solution - QP53AC54 POM: - Permethrin Hybrid - Topical use
mg/400 mg spot- mesto 004 mg/pipette Prescription Only - Imidacloprid application
on solution for Medicine as (Article 13(3) of
dogs over 25 kg defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 13 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Ataxxa 500 Krka, d.d., Novo VPA10774/034/ 500, 100 Spot-on solution - QP53AC54 POM: - Permethrin Hybrid - Topical use
mg/100 mg spot- mesto 002 mg/pipette Prescription Only - Imidacloprid application
on solution for Medicine as (Article 13(3) of
dogs over 4 kg defined in Directive No
up to 10 kg relevant national 2001/82/EC)
legislation

Atipam, 5.0 Eurovet Animal VPA10989/055/ 5.0 Solution for - QV03AB90 POM: - Atipamezole Generic - Intramuscular
mg/ml, solution Health B.V. 001 milligram(s)/millil injection Prescription Only hydrochloride application use
for injection for itre Medicine as (Article 13(1) of
cats and dogs defined in Directive No
relevant national 2001/82/EC)
legislation

ATOPICA 10 mg Elanco GmbH VPA22020/016/ 10 Milligrams per Capsule, soft - QL04AA01 POM: - Ciclosporin Full application - Oral use
soft capsules for 001 capsule Prescription Only (Article 12(3) of
dogs Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

ATOPICA 100 Elanco GmbH VPA22020/016/ 100.00 Capsule, soft - QL04AA01 POM: - Ciclosporin Full application - Oral use
mg soft capsules 004 Milligrams per Prescription Only (Article 12(3) of
for dogs capsule Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Atopica 100 Elanco GmbH VPA22020/013/ 100 Oral solution - QL04A POM: - Ciclosporin Full application - Oral use
mg/ml oral 001 milligram(s)/millil Prescription Only (Article 12(3) of
solution for cats itre Medicine as Directive No
and dogs defined in 2001/82/EC)
relevant national
legislation

ATOPICA 25 mg Elanco GmbH VPA22020/016/ 25 Milligrams per Capsule, soft - QL04AA01 POM: - Ciclosporin Full application - Oral use
soft capsules for 002 capsule Prescription Only (Article 12(3) of
dogs Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

ATOPICA 50 mg Elanco GmbH VPA22020/016/ 50 Milligrams per Capsule, soft - QL04AA01 POM: - Ciclosporin Full application - Oral use
soft capsules for 003 capsule Prescription Only (Article 12(3) of
dogs Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Aurimic ear Richter Pharma VPA10801/007/ 23.0, 5.0, 0.5293 Ear drops, - QS02CA01 POM: - Miconazole Generic - Auricular use
drops and AG 001 milligram(s)/millil suspension Prescription Only nitrate application - Cutaneous use
cutaneous itre Medicine as - Prednisolone (Article 13(1) of
suspension for defined in acetate Directive No
dogs and cats relevant national - Polymyxin B 2001/82/EC)
legislation sulfate

AURIZON ear Vetoquinol VPA10983/042/ 3/10/0.9 Ear drops, - QS02CA06 POM: - Marbofloxacin - Auricular use
drops, Ireland Limited 001 milligram(s)/millil suspension Prescription Only - Clotrimazole
suspension itre Medicine as -
defined in Dexamethasone
relevant national
legislation

Aurofac Granular Zoetis Belgium VPA10387/001/ 250 Premix for - QJ01AA03 POM: - Generic - Oral use
250 mg/g Premix S.A. 001 milligram(s)/gra medicated Prescription Only Chlortetracycline application
for medicated m feeding stuff Medicine as hydrochloride (Article 13(1) of
feedingstuff for defined in Directive No
pigs and relevant national 2001/82/EC)
chickens legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 14 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Austiofen 100 Chanelle VPA10987/065/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
mg Tablets for Pharmaceuticals 003 Prescription Only application
dogs Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Austiofen 20 mg Chanelle VPA10987/065/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for dogs Pharmaceuticals 001 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Austiofen 50 mg Chanelle VPA10987/065/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for dogs Pharmaceuticals 002 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

AVINEW NEO Boehringer VPA10454/027/ . Effervescent - QI01AD06 POM: - Live newcastle Full application - Ocular use
effervescent Ingelheim 001 tablet Prescription Only disease virus (Article 12(3) of - Oculonasal use
tablet for Vetmedica Medicine as (VG/GA) Directive No - Oral use
chickens and GmbH defined in component 2001/82/EC)
turkeys relevant national
legislation

AviPro Lohmann Animal VPA10977/009/ . Oral lyophilisate - QI01AD04 POM: - Live chicken Full application - Oral use
Thymovac Health GmbH 001 Prescription Only anaemia virus (Article 12(3) of
Lyophilisate for Medicine as (CAV), strain Directive No
use in drinking defined in cux-1 2001/82/EC)
water relevant national
legislation

Avishield IB GI- GENERA Inc VPA10405/005/ . Lyophilisate for - QI01AD07 POM: - Avian infectious Full application - In drinking
13, lyophilisate 001 oculonasal Prescription Only bronchitis virus, (Article 12(3) of water use
for oculonasal suspension/use Medicine as live Directive No - Oculonasal use
suspension/use in drinking water defined in 2001/82/EC) - Oral use
in drinking water relevant national
for chickens legislation

Avishield IB GENERA Inc VPA10405/002/ . Lyophilisate for - QI01AD07 POM: - Avian infectious Full application - Oculonasal use
H120, 001 suspension for Prescription Only brochitis virus (Article 12(3) of - Oral use
lyophilisate for oculonasal or Medicine as massachusetts Directive No
oculonasal spray app defined in serotype strain 2001/82/EC)
suspension/use relevant national h-120
in drinking water, legislation
for chickens

Avishield IBD GENERA Inc VPA10405/004/ . - QI01AD09 POM: - Avian infectious Full application - Oculonasal use
INT, lyophilisate 001 Prescription Only bursal disease (Article 12(3) of - Oral use
for oculonasal Medicine as virus, live Directive No
suspension/use defined in 2001/82/EC)
in drinking water, relevant national
for chickens legislation

Avishield IBD GENERA Inc VPA10405/006/ . Lyophilisate for - QI01AD09 POM: - Avian infectious Full application - In drinking
Plus, 001 use in drinking Prescription Only bursal disease (Article 12(3) of water use
lyophilisate for water Medicine as virus, live Directive No
use in drinking defined in 2001/82/EC)
water, for relevant national
chickens legislation

Avishield ND B1, GENERA Inc VPA10405/003/ . Lyophilisate for - QI01AD06 POM: - Newcastle Full application - Oculonasal use
lyophilisate for 001 oculonasal Prescription Only disease virus, (Article 12(3) of - Oral use
oculonasal suspension, use Medicine as live Directive No
suspension/use in drinking water defined in 2001/82/EC)
in drinking water relevant national
for chickens. legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 15 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
B. Braun Vet B. Braun VPA10465/003/ 0.600/0.040/0.0 Solution for - QB05BB01 POM: - Sodium Well-established - Intravenous
Care Hartmann's Melsungen AG 001 27/0.312 infusion Prescription Only chloride use application use
Lactated Ringers grams/100 Medicine as - Potassium (Article 13a of
Solution for millilitres defined in chloride Directive No
infusion for relevant national - Calcium 2001/82/EC)
cattle, horses, legislation Chloride 2 H2O
sheep, goats, - Sodium (S) -
pigs, dogs and lactate
cats

B. Braun Vet B. Braun VPA10465/002/ 7.5 grams/100 Solution for - QB05BB01 POM: - Sodium Well-established - Intravenous
Care hypertonic Melsungen AG 001 millilitres infusion Prescription Only chloride use application use
NaCl solution Medicine as (Article 13a of
(7.5 g/100 ml) defined in Directive No
Solution for relevant national 2001/82/EC)
infusion for legislation
horses, cattle,
sheep, goats,
pigs, dogs and
cats
B.V.P. COPPER Ballinskelligs VPA10956/007/ 20, 1 Suspension for - QA12CX POM: - Copper - Intramuscular
WITH VITAMIN Vet. Products Lt 001 milligram(s)/millil injection Prescription Only methionate use
B12 INJECTION itre Medicine as - Vitamin b12
defined in
relevant national
legislation

B.V.P. COPPER Ballinskelligs VPA10956/007/ 20, 1 Suspension for - QA12CX LM: Licensed - Copper - Intramuscular
WITH VITAMIN Vet. Products Lt 002 milligram(s)/millil injection Merchant as methionate use
B12 INJECTION itre defined in - Vitamin b12
relevant national
legislation

Bactidiaryl Oral Vetoquinol VPA10983/006/ . Oral powder - QJ01RA90 POM: - Neomycin - Oral use
Powder Ireland Limited 001 Prescription Only sulfate
Medicine as - Tetracycline
defined in hydrochloride
relevant national
legislation

Baycox 25 Elanco GmbH VPA22020/054/ 25 Solution for use - QP51AJ01 POM: - Toltrazuril Generic - Oral use
mg/ml, solution 001 milligram(s)/millil in drinking water Prescription Only application
for use in itre Medicine as (Article 13(1) of
drinking water for defined in Directive No
chickens and relevant national 2001/82/EC)
turkeys legislation

Baycox 50 mg/ml Elanco GmbH VPA22020/059/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Full application - Oral use
oral suspension, 001 milligram(s)/millil Prescription Only (Article 12(3) of
pig itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Baycox Bovis Elanco GmbH VPA22020/042/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Full application - Oral use
50mg/ml oral 001 milligram(s)/millil Prescription Only (Article 12(3) of
suspension itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Baycox Multi 50 Elanco GmbH VPA22020/055/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use
mg/ml oral 001 milligram(s)/millil Prescription Only application
suspension for itre Medicine as (Article 13(1) of
Cattle, Pigs and defined in Directive No
Sheep relevant national 2001/82/EC)
legislation

Baycox Sheep, Elanco GmbH VPA22020/050/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Full application - Oral use
50 mg/ml oral 001 milligram(s)/millil Prescription Only (Article 12(3) of
suspension. itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 16 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Bayer Dog Tasty Vetoquinol SA VPA10521/013/ 150,144,50 Tablet - QP52AC55 CAM: - Febantel Generic - Oral use
Bone 150/144/50 001 mg/tablet Companion - Pyrantel application
mg tablets Animal Medicine embonate (Article 13(1) of
as defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Bayer Dog Tasty Vetoquinol SA VPA10521/013/ 525,504,175 Tablet - QP52AA51 CAM: - Febantel Generic - Oral use
Bone XL 002 mg/tablet Companion - Pyrantel application
525/504/175 mg Animal Medicine embonate (Article 13(1) of
tablets as defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Bayticol 10 Elanco GmbH VPA22020/060/ 10 Pour-on solution - QP53AC05 LM: Licensed - Flumethrin Full application - Topical use
mg/ml Pour-On 001 milligram(s)/millil Merchant as (Article 12(3) of
Solution itre defined in Directive No
relevant national 2001/82/EC)
legislation

Baytril 10% Oral Elanco GmbH VPA22020/063/ 10 Oral solution - QJ01MA90 POM: - Enrofloxacin Full application - Oral use
Solution 001 milligram(s)/millil Prescription Only (Article 12(3) of
itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Baytril 100 Elanco GmbH VPA22020/043/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Full application - Intramuscular
mg/ml Solution 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
for Injection itre Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national - Subcutaneous
legislation use

Baytril 2.5% Oral Elanco GmbH VPA22020/062/ 2.5 percent Oral solution - QJ01MA90 POM: - Enrofloxacin Full application - Oral use
Solution 001 weight/volume Prescription Only (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Baytril 25 mg/ml Elanco GmbH VPA22020/044/ 25 Solution for - QJ01MA90 POM: - Enrofloxacin Full application - Intramuscular
solution for 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
injection itre Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national - Subcutaneous
legislation use

Baytril 50 mg/ml Elanco GmbH VPA22020/061/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin - Intramuscular
Solution for 001 milligram(s)/millil injection Prescription Only use
Injection itre Medicine as - Intravenous
defined in use
relevant national - Subcutaneous
legislation use

Baytril Flavour Elanco GmbH VPA22020/065/ 15 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin - Oral use
Tablets 15 mg 001 Prescription Only
Medicine as
defined in
relevant national
legislation

Baytril Flavour Elanco GmbH VPA22020/065/ 150 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin - Oral use
Tablets 150 mg 003 Prescription Only
Medicine as
defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 17 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Baytril Flavour Elanco GmbH VPA22020/065/ 50 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin - Oral use
Tablets 50 mg 002 Prescription Only
Medicine as
defined in
relevant national
legislation

Baytril Max 100 Elanco GmbH VPA22020/053/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml Solution 001 milligram(s)/millil injection Prescription Only application use
for Injection for itre Medicine as (Article 13(1) of - Intravenous
Cattle and Pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Baytril Piglet Elanco GmbH VPA22020/064/ 5.0 Oral solution - QJ01MA90 POM: - Enrofloxacin - Oral use
Doser 0.5% Oral 001 milligram(s)/millil Prescription Only
Solution itre Medicine as
defined in
relevant national
legislation

Bayvarol 3.6 mg Elanco GmbH VPA22020/066/ 3.6 Bee-hive strip - QP53AC05 LM: Licensed - Flumethrin Full application - Cutaneous use
Bee-Hive Strips 001 milligram/strip Merchant as (85%) (Article 12(3) of
for honey bees defined in Directive No
relevant national 2001/82/EC)
legislation

Beaphar Flea Beaphar B.V. VPA10455/002/ 3.9 Collar - QP53AF03 CAM: - Dimpylate Full application - Topical use
Tick Collar for 001 gram(s)/collar Companion (Article 12(3) of
Dogs Animal Medicine Directive No
as defined in 2001/82/EC)
relevant national
legislation

Beaphar Flea Beaphar B.V. VPA10455/001/ 2.1 Collar - QP53AF03 CAM: - Dimpylate Full application - Topical use
Collar for Cats 001 gram(s)/collar Companion (Article 12(3) of
Animal Medicine Directive No
as defined in 2001/82/EC)
relevant national
legislation

Beaphar Beaphar B.V. VPA10455/004/ 0.2 percent Shampoo - QP53AC04 CAM: - Permethrin Full application - Topical use
Insecticidal Dog 001 weight/weight Companion (40/60) (Article 12(3) of
Shampoo, 0.2% Animal Medicine Directive No
w/w as defined in 2001/82/EC)
relevant national
legislation

Beaphar Pump Beaphar B.V. VPA10455/005/ 1.027, 1.284 Cutaneous - QP53AC51 CAM: - Pyrethrum Full application - Topical use
Action Flea 001 percent spray, solution Companion extract (Article 12(3) of
Spray, weight/volume Animal Medicine - Piperonyl Directive No
Cutaneous as defined in butoxide 2001/82/EC)
Spray Solution relevant national
legislation

Belavit AD3E, Bela-Pharm VPA10445/006/ 176.47,50.00,10 Solution for - QA11JA LM: Licensed - Retinol Generic - Intramuscular
solution for GmbH & Co. KG 001 0.00 injection Merchant as palmitate application use
injection for milligram(s)/millil defined in - all-rac-alpha- (Article 13(1) of - Subcutaneous
horses, cattle, itre relevant national Tocopheryl Directive No use
pigs, and dogs legislation acetate 2001/82/EC)
- Cholecalciferol
concentrate

Benakor 20 mg Le Vet BV VPA10816/005/ 20 mg/tablet Tablet - QC09AA07 POM: - Benazepril - Oral use
tablets for dogs 003 Prescription Only hydrochloride
Medicine as
defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 18 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Benakor 5 mg Le Vet BV VPA10816/005/ 5 mg/tablet Tablet - QC09AA07 POM: - Benazepril - Oral use
tablets for dogs 002 Prescription Only hydrochloride
Medicine as
defined in
relevant national
legislation

Benazecare Ecuphar NV VPA10491/006/ 20 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use
Flavour 20 mg 002 Prescription Only hydrochloride application
Tablets for Dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Benazecare Ecuphar NV VPA10491/006/ 5 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use
Flavour 5 mg 001 Prescription Only hydochloride application
Tablets for Dogs Medicine as (Article 13(1) of
and Cats defined in Directive No
relevant national 2001/82/EC)
legislation

Benefortin LAVET VPA10482/001/ 2.5 mg/tablet Tablet - QC09AA07 POM: - Benazepril - Oral use
Flavour 2.5 mg Pharmaceuticals 001 Prescription Only hydrochloride
tablets for cats Ltd Medicine as
and dogs defined in
relevant national
legislation

Benefortin LAVET VPA10482/001/ 20 mg/tablet Tablet - QC09AA07 POM: - Benazepril - Oral use
Flavour 20 mg Pharmaceuticals 003 Prescription Only hydrochloride
tablets for dogs Ltd Medicine as
defined in
relevant national
legislation

Benefortin LAVET VPA10482/001/ 5 mg/tablet Tablet - QC09AA07 POM: - Benazepril - Oral use
Flavour 5 mg Pharmaceuticals 002 Prescription Only hydrochloride
tablets for cats Ltd Medicine as
and dogs defined in
relevant national
legislation

Betafuse 1 mg/g Norbrook VPA22664/129/ 1, 5 Gel - QD07CC01 POM: - Betamethasone Hybrid - Topical use
+ 5 mg/g gel for Laboratories 001 milligram(s)/gra Prescription Only - Fusidic acid application
dogs (Ireland) Limited m Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Betamox 150 Norbrook VPA22664/004/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin Full application - Intramuscular
mg/ml Laboratories 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
Suspension for (Ireland) Limited itre Medicine as Directive No - Subcutaneous
Injection defined in 2001/82/EC) use
relevant national
legislation

Betamox LA 150 Norbrook VPA22664/010/ 150 Suspension for - QJ01CA01 POM: - Amoxicillin Full application - Intramuscular
mg/ml Laboratories 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
Suspension for (Ireland) Limited itre Medicine as Directive No - Subcutaneous
Injection defined in 2001/82/EC) use
relevant national
legislation

Bexepril 2.5 mg Chanelle VPA10987/074/ 2.5 mg/tablet Film-coated - QC09AA07 POM: - Benazepril Generic - Oral use
Film-coated Pharmaceuticals 001 tablet Prescription Only application
tablet for dogs Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 19 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Bexepril 20 mg Chanelle VPA10987/074/ 20 mg/tablet Film-coated - QC09AA07 POM: - Benazepril Generic - Oral use
Film-coated Pharmaceuticals 003 tablet Prescription Only application
tablet for dogs Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Bexepril 5 mg Chanelle VPA10987/074/ 5 mg/tablet Film-coated - QC09AA07 POM: - Benazepril - Oral use
Film-coated Pharmaceuticals 002 tablet Prescription Only
tablet for dogs Manufacturing Medicine as
Limited defined in
relevant national
legislation

Big Cat Wormer Vetoquinol SA VPA10521/010/ 30.0/345.0 Tablet - QP52AA51 CAM: - Praziquantel Informed - Oral use
Film-Coated 001 mg/tablet Companion - Pyrantel consent
Tablets Animal Medicine embonate application
as defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Bilosin 200 Bimeda Animal VPA22033/036/ 200 Solution for - QJ01FA90 POM: - Tylosin - Intramuscular
mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only use
for Injection itre Medicine as
defined in
relevant national
legislation

Bilovet 200 Bimeda Animal VPA22033/055/ 200 Solution for - QJ01FA90 POM: - Tylosin Generic - Intramuscular
mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only application use
for Injection for itre Medicine as (Article 13(1) of
cattle and pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Bimadine Bimeda Animal VPA22033/037/ 25 g/sachet Powder for oral - QJ01EQ03 POM: - Sulfadimidine Well-established - Oral use
Powder for Oral Health Limited 001 suspension Prescription Only use application
Suspension Medicine as (Article 13a of
defined in Directive No
relevant national 2001/82/EC)
legislation

Bimastat Oral Bimeda Animal VPA22033/001/ 25/150/105 Oral suspension - QJ01RA02 POM: - Neomycin Full application - Oral use
Suspension Health Limited 001 milligram(s)/millil Prescription Only - Sulfadiazine (Article 12(3) of
itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Bimectin 0.5% ECO Animal VPA22693/019/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Informed - Topical use
Cattle Pour-on Health Europe 001 Merchant as consent
Solution Limited defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Bimectin 1% w/v Bimeda Animal VPA22033/056/ 1.0 percent Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
Solution for Health Limited 001 weight/volume injection Merchant as application use
Injection defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Bimectin Horse Bimeda Animal VPA22033/049/ 18.7 Oral paste - QP54AA01 LM: Licensed - Ivermectin Generic - Oral use
Oral Paste 18.7 Health Limited 001 milligram(s)/gra Merchant as application
mg/g m defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Bimectin Plus Bimeda Animal VPA22033/002/ 10/100 Solution for - QP54AA51 LM: Licensed - Ivermectin Generic - Subcutaneous
Solution for Health Limited 001 milligram(s)/millil injection Merchant as - Clorsulon application use
Injection itre defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 20 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Bimeprine 5 Bimeda Animal VPA22033/057/ 5 Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Generic - Pour-on use
mg/ml pour-on Health Limited 001 milligram(s)/millil Merchant as application
solution for cattle itre defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Bimotrim Co Bimeda Animal VPA22033/038/ 200, 40 Solution for - QJ01EW13 POM: - Sulfadoxine ZZZ --Unknown- - Intramuscular
Injection Health Limited 001 milligram(s)/millil injection Prescription Only - Trimethoprim use
itre Medicine as - Intravenous
defined in use
relevant national
legislation

Bimoxyl LA 150 Bimeda Animal VPA22033/039/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin - Intramuscular
mg/ml Health Limited 001 milligram(s)/millil injection Prescription Only use
Suspension for itre Medicine as - Subcutaneous
Injection defined in use
relevant national
legislation

Bimoxyvet LA Laboratorios VPA10436/002/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin Generic - Intramuscular
150 mg/ml, Maymó, S.A. 001 milligram(s)/millil injection Prescription Only application use
Suspension for itre Medicine as (Article 13(1) of
Injection for defined in Directive No
cattle, sheep and relevant national 2001/82/EC)
pigs legislation

Bioamoxi 500 V.M.D. n.v/s.a. VPA10817/001/ 500 Powder for oral - QJ01CA04 POM: - Amoxicillin Well-established - Oral use
mg/g powder for 001 milligram(s)/gra solution Prescription Only use application
oral solution for m Medicine as (Article 13a of
chicken defined in Directive No
relevant national 2001/82/EC)
legislation

Biocillin 1000 Bela-Pharm VPA10445/002/ 1000 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - Oral use
mg/g Powder for GmbH & Co. KG 001 milligram(s)/gra in drinking water Prescription Only trihydrate application
use in drinking m Medicine as (Article 13(1) of
water for defined in Directive No
chickens, ducks relevant national 2001/82/EC)
and turkeys legislation

Bioestrovet Vetoquinol VPA10983/043/ 0.250 Solution for - QG02AD90 POM: - Cloprostenol Generic - Intramuscular
0.250 mg/ml Ireland Limited 001 milligram(s)/millil injection Prescription Only application use
solution for itre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle relevant national 2001/82/EC)
legislation

BIOSUIS Salm Bioveta, a.s. VPA22028/001/ . Emulsion for - QI09AB14 POM: - Salmonella Full application - Intramuscular
emulsion for 001 injection Prescription Only enterica subsp. (Article 12(3) of use
injection for pigs Medicine as enterica sv. Directive No
defined in Typhimurium 2001/82/EC)
relevant national (wild type,
legislation fagotype:
DT104)
- Salmonella
enterica subsp.
enterica sv.
Derby (wild type,
PFGE type: De1)
- Salmonella
enterica subsp.
enterica sv.
Infantis (wild
type)

Bisolvon 10mg/g Boehringer VPA10454/002/ 10 Oral powder - QR05CB02 POM: - Bromhexine - Oral use
Oral Powder Ingelheim 001 milligram(s)/gra Prescription Only hydrochloride
Vetmedica m Medicine as
GmbH defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 21 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Blackleg Vaccin Zoetis Belgium VPA10387/002/ . Suspension for - QI02AB01 LM: Licensed - Clostridium Full application - Subcutaneous
S.A. 001 injection - QI04AB01 Merchant as chauvoei whole (Article 12(3) of use
defined in culture, Directive No
relevant national inactivated 2001/82/EC)
legislation

Blackleg Vaccin Zoetis Belgium VPA10387/002/ . Suspension for - QI02AB01 LM: Licensed - Clostridium Full application - Subcutaneous
S.A. 001 injection - QI04AB01 Merchant as chauvoei whole (Article 12(3) of use
defined in culture, Directive No
relevant national inactivated 2001/82/EC)
legislation

BLACKLEG Intervet Ireland VPA10996/142/ . Suspension for - QI02AB01 LM: Licensed - Clostridium Full application - Subcutaneous
VACCINE Limited 001 injection - QI04AB01 Merchant as chauvoei cells (Article 12(3) of use
defined in and equivalent Directive No
relevant national toxoid of strain 2001/82/EC)
legislation 655
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
656
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
657
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
658
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
1048
BLACKLEG Intervet Ireland VPA10996/142/ . Suspension for - QI02AB01 LM: Licensed - Clostridium Full application - Subcutaneous
VACCINE Limited 001 injection - QI04AB01 Merchant as chauvoei cells (Article 12(3) of use
defined in and equivalent Directive No
relevant national toxoid of strain 2001/82/EC)
legislation 655
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
656
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
657
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
658
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
1048
Blast LHV Bonapp HOVR10466/00 . Oral solution LM: Licensed - Calcarea Simplified - Oral use
3/001 Merchant as carbonica Registration of a
defined in - Silica Veterinary
relevant national - Carbo Homeopathic
legislation vegetabilis Medicinal
- Phytolacca Product (Article
decandra 16, Directive
- Solidago 2001/82/EC)
BLOCKADE 0.25 DeLaval NV VPA10827/002/ 0.25 percent Powder and - QG52A LM: Licensed - Iodine available Full application - Topical use
% w/w iodine 001 weight/weight suspension for Merchant as (as (Article 12(3) of
teat dip solution suspension for defined in iodine/poloxome Directive No
injection relevant national r/sodium 2001/82/EC)
legislation iodine/povidone
complex)*

Veterinary Medicines Authorised/Transfer Pending Products Page 22 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Bob Martin Clear The Bob Martin VPA10881/008/ 1.9/4.9 Shampoo - QP53AC CAM: - Pyrethrum pale - Topical use
Flea Shampoo Company 001 milligram(s)/gra Companion extract 25%
for Dogs & m Animal Medicine - Piperonyl
Puppies 1.9 as defined in butoxide
mg/g / 4.9 mg/g relevant national
legislation

Bob Martin Clear The Bob Martin VPA10881/001/ 100 mg/tablet Coated tablet - QP52AX01 CAM: - Nitroscanate - Oral use
Wormer 100 mg Company 001 Companion
Film Coated Animal Medicine
Tablets for Small as defined in
Dogs and relevant national
Puppies legislation

Bob Martin Clear The Bob Martin VPA10881/002/ 500 mg/tablet Coated tablet - QP52AX01 CAM: - Nitroscanate - Oral use
Wormer 500 mg Company 001 Companion
Film Coated Animal Medicine
Tablets for Dogs as defined in
relevant national
legislation

Bob Martin Easy The Bob Martin VPA10881/006/ 222.2 Granules - QP52AC13 CAM: - Fenbendazole 13c informed - Per Oral
to Use Wormer Company 001 milligram(s)/gra Companion consent
Granules for m Animal Medicine
Cats as defined in
relevant national
legislation

Bob Martin Easy Chanelle VPA10987/116/ 222.2 Granules - QP52AC13 CAM: - Fenbendazole 13c informed - Per Oral
to Use Wormer Pharmaceuticals 002 milligram(s)/gra Companion consent
Granules for Manufacturing m Animal Medicine
Large Dogs Limited as defined in
relevant national
legislation

Bob Martin Easy Chanelle VPA10987/116/ 222.2 Granules - QP52AC13 CAM: - Fenbendazole 13c informed - Per Oral
to Use Wormer Pharmaceuticals 001 milligram(s)/gra Companion consent
Granules for Manufacturing m Animal Medicine
Small Dogs Limited as defined in
relevant national
legislation

Bob Martin Flea The Bob Martin VPA10881/010/ 2 Cutaneous - QP53AC51 CAM: - Pyrethrum pale - Topical use
Spray cutaneous Company 001 spray, solution Companion extract 25%
spray solution Animal Medicine - Piperonyl
as defined in butoxide
relevant national
legislation

Boflox flavour 20 LIVISTO Int'l, VPA10425/004/ 20 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use
mg tablets for S.L. 001 Prescription Only application
dogs and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Boflox flavour 80 LIVISTO Int'l, VPA10425/004/ 80 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use
mg tablets for S.L. 002 Prescription Only application
dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 23 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Boflox, 100 Industrial VPA10509/003/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular
mg/ml solution Veterinaria, S.A. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

BONHAREN IVN Contipro a.s. VPA22837/001/ 10 Solution for - QM09AX01 VPO: Veterinary - Sodium Generic - Intravenous
10 mg/ml 001 milligram(s)/millil injection Practitioner Only hyaluronate application use
solution for itre as defined in (Article 13(1) of
injection for relevant national Directive No
horses and dogs legislation 2001/82/EC)

Borgal 24% Virbac S.A. VPA10988/082/ 200, 40 Solution for - QJ01EW13 POM: - Sulfadoxine Full application - Intramuscular
Solution for 001 milligram(s)/millil injection Prescription Only - Trimethoprim (Article 12(3) of use
Injection itre Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national - Subcutaneous
legislation use

Bovaclox DC Norbrook VPA22664/005/ 500, 250 Intramammary - QJ51RC POM: - Cloxacillin Full application - Intramammary
Intramammary Laboratories 001 mg/syringe suspension Prescription Only - Ampicillin (Article 12(3) of use
Suspension (Ireland) Limited Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Bovaclox DC Norbrook VPA22664/038/ 600, 300 Intramammary - QJ51CR50 POM: - Cloxacillin Full application - Intramammary
Xtra Laboratories 001 mg/syringe suspension Prescription Only - Ampicillin (Article 12(3) of use
(Ireland) Limited Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

BOVALTO Boehringer VPA10454/028/ . Suspension for - QI02AB04 POM (E): - Mannheimia Full application - Intramuscular
PASTOBOV Ingelheim 001 injection Prescription Only haemolytica type (Article 12(3) of use
Vetmedica Exempt as 1a antigen Directive No - Subcutaneous
GmbH defined in leucotoxin 2001/82/EC) use
relevant national
legislation

BOVALTO Respi Boehringer VPA10454/029/ . Suspension for - QI02AL POM (E): - Inactivated Full application - Subcutaneous
3 suspension for Ingelheim 001 injection Prescription Only bovine (Article 12(3) of use
injection Vetmedica Exempt as respiratory Directive No
GmbH defined in syncytial virus, 2001/82/EC)
relevant national strain bio-24
legislation - Inactivated
bovine
parainfluenza 3
virus, strain bio-
23
- Inactivated
mannheimia
(pasteurella)
haemolyica, a1
strain dsm 5283
BOVALTO Respi Boehringer VPA10454/029/ . Suspension for - QI02AL POM (E): - Inactivated Full application - Subcutaneous
4 suspension for Ingelheim 002 injection Prescription Only bovine (Article 12(3) of use
injection Vetmedica Exempt as respiratory Directive No
GmbH defined in syncytial virus, 2001/82/EC)
relevant national strain bio-24
legislation - Inactivated
bovine
parainfluenza 3
virus, strain bio-
23
- Inactivated
mannheimia
haemolytica
serotype a1
strain dsm 5283
- Inactivated
bovine viral
diarrhoea virus,
strain bio-25

Veterinary Medicines Authorised/Transfer Pending Products Page 24 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
BOVALTO Boehringer VPA10454/029/ . Nasal spray, - QI02AD07 POM (E): - Bovine Full application - Intra-nasal
RESPI Ingelheim 003 lyophilisate and Prescription Only respiratory (Article 12(3) of
INTRANASAL, Vetmedica solvent for Exempt as syncytial virus, Directive No
nasal spray, GmbH suspension defined in live 2001/82/EC)
lyophilisate and relevant national - Bovine
solvent for legislation parainfluenza
suspension virus 3
attenuated
Bovex 2.265% Chanelle VPA10987/039/ 2.265 percent Oral suspension - QP52AC02 LM: Licensed - Oxfendazole - Oral use
Pharmaceuticals 001 weight/volume Merchant as
Manufacturing defined in
Limited relevant national
legislation

Bovi.BLI.Compl Galway HOVR10537/00 . Oral solution LM: Licensed Simplified - Oral use
ex Homoeopathics 5/001 Merchant as Registration of a
(Manufacturing) defined in Veterinary
Limited relevant national Homeopathic
legislation Medicinal
Product (Article
16, Directive
2001/82/EC)
Bovi.BLS.Compl Galway HOVR10537/00 . Oral solution LM: Licensed Simplified - Oral use
ex Homoeopathics 4/001 Merchant as Registration of a
(Manufacturing) defined in Veterinary
Limited relevant national Homeopathic
legislation Medicinal
Product (Article
16, Directive
2001/82/EC)
BOVICEF DC Zoetis Belgium VPA10387/003/ 250 mg/syringe Intramammary - QJ51DB90 POM: - Cefalonium Hybrid - Intramammary
250 mg S.A. 001 suspension Prescription Only application use
Intramammary Medicine as (Article 13(3) of
Suspension for defined in Directive No
Cattle relevant national 2001/82/EC)
legislation

Bovicox 50 J. & M. VPA10954/011/ 50 Oral suspension - QP51AJ01 LM: Licensed - Toltrazuril Generic - Oral use
mg/ml oral Veterinary 001 milligram(s)/millil Merchant as application
suspension for Services Ltd itre defined in (Article 13(1) of
cattle and sheep relevant national Directive No
legislation 2001/82/EC)

BOVIDEC Benchmark VPA22980/001/ . Suspension for - QI02AA01 POM (E): - Bovine viral - Subcutaneous
Animal Health 001 injection Prescription Only diarrhoea (bvd) use
Norway AS Exempt as virus strain
(trading as defined in ky1203nc
Benchmark relevant national (inactivated):
Animal Health) legislation

Bovidip 2 %w/v DeLaval NV VPA10827/003/ 2 percent Teat dip/spray - QG52A LM: Licensed - Iodine 13a - Topical
Concentrate for 001 weight/volume solution Merchant as bibliographical
Teat Dip or defined in
Spray Solution relevant national
for bovine legislation

BOVIGEN FORTE VPA10806/004/ . Emulsion for - QI02AL01 POM: - Bovine Full application - Intramuscular
SCOUR Healthcare Ltd 001 injection Prescription Only coronavirus (Article 12(3) of use
Emulsion for Medicine as strain c-197 Directive No
injection for defined in (inactivated) 2001/82/EC)
cattle relevant national - Bovine
legislation rotavirus strain
TM-91, serotype
G6P1
(inactivated).
- Escherichia coli
strain EC/17,
(inactivated)
expressing
F5(K99) adhesin

Veterinary Medicines Authorised/Transfer Pending Products Page 25 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Bovilis Bovipast Intervet Ireland VPA10996/152/ . Suspension for - QI02AL04 POM (E): - Inactivated Full application - Subcutaneous
RSP suspension Limited 001 injection Prescription Only bovine (Article 12(3) of use
for injection for Exempt as respiratory Directive No
cattle defined in syncytial virus 2001/82/EC)
relevant national strain ev908
legislation - Inactivated
Parainfluenza-3-
virus, strain SF-4
Reisinger
- Inactivated
mannheimia
(pasteurella)
haemolyticaA1,
strain M4/1
Bovilis BVD Intervet Ireland VPA10996/271/ . Suspension for - QI02AA01 POM (E): - Inactivated Full application - Intramuscular
Suspension for Limited 001 injection Prescription Only antigen of (Article 12(3) of use
injection for Exempt as cytopathogenic Directive No
cattle defined in BVDV strain C- 2001/82/EC)
relevant national 86
legislation

Bovilis Huskvac Intervet Ireland VPA10996/081/ . Oral suspension - QI02AN01 POM (E): - Inactivated Full application - Oral use
Limited 001 Prescription Only cells and (Article 12(3) of
Exempt as equivalent toxoid Directive No
defined in of irradiated 3rd 2001/82/EC)
relevant national stage of
legislation dictyocaulus
vivipatrous

Bovilis IBR Intervet Ireland VPA10996/200/ 60 enzyme- Suspension for - QI02AA03 POM (E): - Inactivated Immunological - Intramuscular
marker inac Limited 001 linked injection Prescription Only antigen of BHV-1 veterinary use
Suspension for immunosorbent Exempt as (gE) strain GK/D medicinal
injection for assay unit defined in product
cattle relevant national application
legislation (Article 13d of
Directive No
2001/82/EC)
Bovilis IBR Intervet Ireland VPA10996/172/ . Lyophilisate and - QI02AD01 POM (E): - Glycoprotein E Full application - Intramuscular
marker live, Limited 001 solvent for Prescription Only deficient (gE-) (Article 12(3) of use
lyophilisate and suspension for Exempt as Bovine Herpes Directive No - ZZZ Intranasal
solvent for injection defined in Virus Type 1 2001/82/EC) use
suspension for relevant national (BHV-1), strain
cattle legislation GK/D (gE-)1

Bovilis Intervet Ireland VPA10996/276/ . Lyophilisate and - QI02AD07 POM (E): - Bovine Full application - Nasal use
INtranasal RSP Limited 001 solvent for Prescription Only respiratory (Article 12(3) of
Live, nasal suspension for Exempt as syncytial virus Directive No
spray, nasal defined in (live) strain 2001/82/EC)
lyophilisate and administration relevant national Jencine-2013
solvent for legislation - Bovine
suspension for parainfluenza
cattle virus type 3 (live)
strain INT2-2013

Bovilis Ringvac Intervet Ireland VPA10996/284/ . Lyophilisate and - QI02AP01 POM: - Attenuated Full application - Intramuscular
lyophilisate and Limited 001 solvent for Prescription Only micronidia of (Article 12(3) of use
solvent for suspension for Medicine as trichophyton Directive No
suspension for injection defined in verrucosum 2001/82/EC)
injection for relevant national strain ltf-130
cattle legislation - Attenuated
micronidia of
trichophyton
verrucosum
strain ltf-130
- Attenuated
micronidia of
trichophyton
verrucosum
strain ltf-130

Veterinary Medicines Authorised/Transfer Pending Products Page 26 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Bovilis Rotavec Intervet Ireland VPA10996/216/ . Emulsion for - QI02AL01 POM: - Bovine Full application - Intramuscular
Corona emulsion Limited 001 injection Prescription Only rotavirus, strain (Article 12(3) of use
for injection for Medicine as UK-Compton, Directive No
cattle defined in serotype G6 P5 2001/82/EC)
relevant national (inactivated)
legislation - Bovine
coronavirus
- E.coli, f5
adhesin (k99)
Bovimast DC, Bimeda Animal VPA22033/003/ 500 mg/syringe Intramammary - QJ51CF POM: - Cloxacillin Informed - Intramammary
500 mg Health Limited 001 suspension Prescription Only consent use
cloxacillin/syring Medicine as application
e, Intramammary defined in (Article 13c of
suspension relevant national Directive No
legislation 2001/82/EC)

Bovimec 10 Bimeda Animal VPA22033/050/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
mg/ml solution Health Limited 001 milligram(s)/millil injection Merchant as application use
for injection for itre defined in (Article 13(1) of
cattle relevant national Directive No
legislation 2001/82/EC)

Bovimectin 1 % Bimeda Animal VPA22033/051/ 1.0 percent Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
solution for Health Limited 001 weight/volume injection Merchant as application use
injection for defined in (Article 13(1) of
cattle relevant national Directive No
legislation 2001/82/EC)

Bovipour 5 Chanelle VPA10987/162/ 5 Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Generic - Topical use
mg/ml Pour-on Pharmaceuticals 001 milligram(s)/millil Merchant as application
Solution for Manufacturing itre defined in (Article 13(1) of
Cattle Limited relevant national Directive No
legislation 2001/82/EC)

Bovis LHV Bonapp HOVR10466/00 . Oral solution LM: Licensed - Calcarea Simplified - Oral use
2/001 Merchant as carbonica Registration of a
defined in - Atropa Veterinary
relevant national belladonna Homeopathic
legislation - Allium cepa oil Medicinal
- Euphrasia Product (Article
officinalis 16, Directive
- Carbo 2001/82/EC)
vegetabilis
- Solidago
virgaurea
Boviseal Dry Zoetis Belgium VPA10387/096/ 2.6 g/syringe Intramammary - QJ51X LM: Licensed - Bismuth Full application - Intramammary
Cow S.A. 001 Infusion Merchant as subnitrate (Article 12(3) of use
Intramammary defined in Directive No
Infusion relevant national 2001/82/EC)
legislation

Bovitec Plus Oral J. & M. VPA10954/009/ 150 Oral suspension - QP52AC11 LM: Licensed - Albendazole Informed - Oral use
Suspension Veterinary 001 milligram(s)/millil Merchant as consent
Services Ltd itre defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Bovivac S Intervet Ireland VPA10996/165/ . Suspension for - QI02AB POM (E): - Salmonella Full application - Subcutaneous
Limited 001 injection Prescription Only dublin strain (Article 12(3) of use
Exempt as s342/70 formalin Directive No
defined in inactivated 2001/82/EC)
relevant national - Salmonella
legislation typhimurium
strain s341/70
formalin
inactivated

Veterinary Medicines Authorised/Transfer Pending Products Page 27 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Britt LHV Bonapp HOVR10466/00 Oral solution LM: Licensed - Bellis perennis - Oral use
8/001 Merchant as - Calcarea
defined in carbonica
relevant national - Calendula
legislation officinalis
- Solidago
- Atropa
belladonna
- Carbo
vegetabilis
BRONCHI- Zoetis Belgium VPA10387/004/ 2.1x 10^6 - 5.5 x Lyophilisate and - QI07AE01 POM: - Bordetella Full application - ZZZ Intranasal
SHIELD, S.A. 001 10^ 8 colony solvent for nasal Prescription Only bronchiseptica, (Article 12(3) of use
lyophilisate and forming drops, Medicine as live, attenuated Directive No
solvent for unit(s)/millilitre suspension defined in strain 92b 2001/82/EC)
suspension for relevant national
nasal drops for legislation
dogs
Bupaq Multidose Richter Pharma VPA10801/005/ 0.3 Solution for - QN02AE01 VPO: Veterinary - Buprenorphine Generic - Intramuscular
0.3 mg/ml AG 001 milligram(s)/millil injection Practitioner Only application use
Solution for itre as defined in (Article 13(1) of - Intravenous
Injection for relevant national Directive No use
Dogs and Cats legislation 2001/82/EC)

Buprecare 0.3 Ecuphar NV VPA10491/004/ 0.3 Solution for - QN02AE01 VPO: Veterinary - Buprenorphine Generic - Intramuscular
mg/ml Solution 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for Injection for itre as defined in (Article 13(1) of
Dogs and Cats relevant national Directive No
legislation 2001/82/EC)

Buprecare Ecuphar NV VPA10491/004/ 0.3 Solution for - QN02AE01 VPO: Veterinary - Buprenorphine Generic - Intramuscular
Multidose 0.3 002 milligram(s)/millil injection Practitioner Only application use
mg/ml Solution itre as defined in (Article 13(1) of - Intravenous
for Injection for relevant national Directive No use
Dogs and Cats legislation 2001/82/EC)

Buprefelican Le Vet Beheer VPA10475/021/ 0.3 Solution for - QN02AE01 VPO: Veterinary - Buprenorphine Generic - Intramuscular
Multidose 0.3 B.V. 001 milligram(s)/millil injection Practitioner Only application use
mg/ml solution itre as defined in (Article 13(1) of - Intravenous
for injection for relevant national Directive No use
dogs and cats legislation 2001/82/EC)

Buprenodale Dechra VPA22622/004/ 0.3 Solution for - QN02AE01 VPO: Veterinary - Buprenorphine Generic - Intramuscular
Multidose, 0.3 Regulatory B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
mg/ml solution itre as defined in (Article 13(1) of - Intravenous
for injection for relevant national Directive No use
dogs, cats and legislation 2001/82/EC)
horses

Buscopan Boehringer VPA10454/004/ 4/500 Solution for - QA03DB04 POM: - - Intramuscular


Compositum Ingelheim 001 milligram(s)/millil injection Prescription Only Butylscopolamin use
Solution for Vetmedica itre Medicine as e bromide - Intravenous
Injection GmbH defined in - Metamizole use
relevant national
legislation

Buscopanvet 20 Boehringer VPA10454/003/ 20 Solution for - QA03BB01 POM: - Hyoscine - Intramuscular


mg/ml solution Ingelheim 001 milligram(s)/millil injection Prescription Only butylbromide use
for injection Vetmedica itre Medicine as - Intravenous
GmbH defined in use
relevant national
legislation

Busol 0.004 T.P. Whelehan VPA10953/003/ 0.004 Solution for - QH01CA90 POM: - Buserelin Well-established - Intramuscular
mg/ml solution Son & Co. Ltd., 001 milligram(s)/millil injection Prescription Only use application use
for injection for itre Medicine as (Article 13a of - Intravenous
cattle, horses, defined in Directive No use
rabbits relevant national 2001/82/EC) - Subcutaneous
legislation use

Veterinary Medicines Authorised/Transfer Pending Products Page 28 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Butador 10 Richter Pharma VPA10801/004/ 10 Solution for - QN02AF01 POM: - Butorphanol Generic - Intramuscular
mg/ml solution AG 001 milligram(s)/millil injection Prescription Only (equivalent to application use
for injection for itre Medicine as butorphanol (Article 13(1) of - Intravenous
horses, dogs and defined in tartrate usp 14.6 Directive No use
cats relevant national mg) 2001/82/EC) - Subcutaneous
legislation - Butorphanol use
(equivalent to
14.58 mg
Butorphanol
tartrate)
Butox 7.5 mg/ml Intervet Ireland VPA10996/103/ 7.5 Pour-on - QP53AC11 LM: Licensed - Deltamethrin - Topical use
Pour On Limited 001 milligram(s)/millil suspension Merchant as
Suspension itre defined in
relevant national
legislation

ByeMite 500 Elanco GmbH VPA22020/049/ 500 Concentrate for - QP53AF01 POM: - Phoxim Generic - ZZZ Spray
mg/ml 001 milligram(s)/millil cutaneous spray, Prescription Only application
concentrate for itre emulsion Medicine as (Article 13(1) of
spraying defined in Directive No
emulsion for relevant national 2001/82/EC)
laying hens legislation

Cadorex 300 LIVISTO Int'l, VPA10425/002/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular
mg/ml solution S.L. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
cattle, sheep and defined in Directive No use
pigs relevant national 2001/82/EC)
legislation

Calcibel Bela-Pharm VPA10445/003/ 240/60/60 Solution for - QA12AX LM: Licensed - Calcium Hybrid - Intravenous
240/60/60 mg/ml GmbH & Co. KG 001 milligram(s)/millil infusion Merchant as gluconate for application use
solution for itre defined in injection (Article 13(3) of
infusion for relevant national - Magnesium Directive No
horses, cattle, legislation chloride 2001/82/EC)
sheep, goats and hexahydrate
pigs - Boric acid
Calciject 40 + 3 Norbrook VPA22664/032/ 332, 30, 68 Solution for - QA12 LM: Licensed - Calcium - Intravenous
Solution for Laboratories 001 milligram(s)/millil injection Merchant as gluconate use
Injection (Ireland) Limited itre defined in - Magnesium - Subcutaneous
relevant national hypophosphite use
legislation hexahydrate
- Boric acid
Calciject 40 Norbrook VPA22664/031/ 332.0, 68.0 Solution for - QA12A LM: Licensed - Calcium - Intravenous
Solution for Laboratories 001 milligram(s)/millil injection Merchant as gluconate use
Injection (Ireland) Limited itre defined in - Boric acid - Subcutaneous
relevant national use
legislation

Calciject LV Norbrook VPA22664/044/ 388.5, 73.4, Solution for - QA12 LM: Licensed - Calcium - Intravenous
Solution for Laboratories 001 65.0, 13.2 injection Merchant as gluconate use
Injection (Ireland) Limited milligram(s)/millil defined in - Boric acid - Subcutaneous
itre relevant national - Magnesium use
legislation chloride
hexahydrate
- Calcium
hydroxide
Calciject PMD Norbrook VPA22664/029/ 166, 34, 200, 50 Solution for - QA12AA20 LM: Licensed - Calcium - Intravenous
Solution for Laboratories 001 milligram(s)/millil injection Merchant as gluconate use
Injection (Ireland) Limited itre defined in - Boric acid - Subcutaneous
relevant national - Dextrose use
legislation Monohydrate
- Magnesium
hypophosphite
Calcipharm 40 Chem-Pharm VPA10823/015/ 332, 68 <br/> Solution for - QA12AA LM: Licensed - Calcium Informed - Intravenous
Solution for 001 milligram(s)/millil injection Merchant as gluconate consent use
Injection itre defined in - Boric acid application - Subcutaneous
relevant national (Article 13c of use
legislation Directive No
2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 29 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Calcipharm PMD Chem-Pharm VPA10823/014/ 166, 50, 200, 34 Solution for - QA12 LM: Licensed - Calcium Informed - Intravenous
Solution for 001 milligram(s)/millil injection Merchant as gluconate consent use
Injection itre defined in - Magnesium application - Subcutaneous
relevant national hypophosphite (Article 13c of use
legislation - Dextrose Directive No
monohydrate 2001/82/EC)
- Boric acid
Calcitat 25, aniMedica VPA10826/001/ 1.55, 21.45, Solution for - QA12AA LM: Licensed - Calcium Well-established - Intravenous
solution for GmbH 001 0.66, 3.25 injection/infusion Merchant as gluconate use application use
infusion and grams/100 defined in monohydrate (Article 13a of - Subcutaneous
injection in cattle millilitres relevant national - Calcium Directive No use
legislation borogluconate 2001/82/EC)
- Calcium
hydroxide
- Magnesium
chloride
hexahydrate
Calcitat 50, aniMedica VPA10826/001/ 3.10, 42.960, Solution for - QA12AA LM: Licensed - Calcium - Intravenous
solution for GmbH 002 1.32, 6.50 injection/infusion Merchant as gluconate use
infusion and grams/100 defined in monohydrate - Subcutaneous
injection in cattle millilitres relevant national - Calcium use
legislation borogluconate
- Calcium
hydroxide
- Magnesium
chloride
hexahydrate
Calcivet Solution Norbrook VPA22664/054/ 332, 68, 30 Solution for - QA12A LM: Licensed - Calcium Informed - Intravenous
for Injection for Laboratories 001 milligram(s)/millil injection Merchant as gluconate consent use
Cattle (Ireland) Limited itre defined in - Boric acid application - Subcutaneous
relevant national - Magnesium (Article 13c of use
legislation hypophosphite Directive No
hexahydrate 2001/82/EC)
Calicide, Trouw VPA10862/001/ 1000 Premix for - QP53BC03 POM (E): - Technical Full application - Oral use
Teflubenzuron Aquaculture Ltd 001 gram(s)/kilogra medicated Prescription Only teflubenzuron (Article 12(3) of
1000 g/kg (T/A Skretting) m(s) feeding stuff Exempt as Directive No
Premix for defined in 2001/82/EC)
medicated relevant national
feeding stuff legislation

Calmafusion, Interchemie VPA22812/001/ 380.0, 60.0, 50.0 Solution for - QA12AX POM: - Calcium Generic - Intravenous
380mg/60mg/50 Werken De 001 milligram(s)/millil infusion Prescription Only gluconate for application use
mg, solution for Adelaar Eesti AS itre Medicine as injection (Article 13(1) of
infusion for defined in - Magnesium Directive No
cattle, sheep and relevant national chloride 2001/82/EC)
pigs legislation hexahydrate
- Boric acid
Canaural ear Dechra VPA10803/003/ . Ear drops, - QS02CA01 POM: - Diethanolamine ZZZ --Unknown- - Auricular use
drops, Veterinary 001 suspension Prescription Only Fusidate
suspension for Products A/S Medicine as - Framycetin
dogs and cats defined in sulphate
relevant national - Nystatin
legislation - Prednisolone

Canergy 100 mg Le Vet Beheer VPA10475/016/ 100 mg/tablet Tablet - QC04AD90 POM: - Propentofylline Generic - Oral use
tablets for dogs B.V. 001 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Canidryl 100 mg Chanelle VPA10987/064/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for dogs Pharmaceuticals 003 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Canidryl 20 mg Chanelle VPA10987/064/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for dogs Pharmaceuticals 001 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 30 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Canidryl 50 mg Chanelle VPA10987/064/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for dogs Pharmaceuticals 002 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Caninsulin 40 Intervet Ireland VPA10996/048/ 40 international Suspension for - QA10AC03 POM: - Insulin - Subcutaneous
IU/ml Limited 001 unit(s)/millilitre injection Prescription Only use
Suspension for Medicine as
Injection defined in
relevant national
legislation

Canishield 0.77 Beaphar B.V. VPA10455/003/ 0.77 Medicated collar - QP53AC11 POM: - Deltamethrin Hybrid - Cutaneous use
g medicated 002 gram(s)/collar Prescription Only application
collar for small Medicine as (Article 13(3) of
and medium defined in Directive No
sized dogs relevant national 2001/82/EC)
legislation

Canishield 1.04 Beaphar B.V. VPA10455/003/ 1.04 gram(s) Collar - QP53AC11 POM: - Deltamethrin Hybrid - Cutaneous use
g medicated 001 Prescription Only application
collar for large Medicine as (Article 13(3) of
sized dogs defined in Directive No
relevant national 2001/82/EC)
legislation

CANIXIN DHPPi Virbac S.A. VPA10988/101/ 0 cell culture Lyophilisate and - QI07AD04 POM: - Canine Full application - Subcutaneous
lyophilisate and 001 infective dose 50 solvent for Prescription Only distemper virus (Article 12(3) of use
solvent for suspension for Medicine as (lederle strain) Directive No
suspension for injection defined in - Canine 2001/82/EC)
injection for dogs relevant national parvovirus (cpv
legislation 780916 strain)
- Canine
adenovirus type
2 (manhattan
strain)
- Canine
parainfluenza
(manhattan
strain)
CANIXIN Virbac S.A. VPA10988/101/ . Lyophilisate and - QI07AI02 POM: - Canine Full application - Subcutaneous
DHPPi/L 002 suspension for Prescription Only distemper virus (Article 12(3) of use
lyophilisate suspension for Medicine as - Canine Directive No
suspension for injection defined in adenovirus type 2001/82/EC)
injection for dogs relevant national 2
legislation - Canine
parvovirus
- Canine
parainfluenza
- L.canicola
- L.
icterohaemorrha
giae
Canixin L Virbac S.A. VPA10988/102/ . Suspension for - QI07AB01 POM: - Leptospira Full application - Subcutaneous
suspension for 001 injection Prescription Only interrogans (Article 12(3) of use
injection for dogs Medicine as serogroup Directive No
defined in icterohaemorrag 2001/82/EC)
relevant national iae, inactivated
legislation - Leptospira
interrogans
serogroup
canicola,
inactivated

Veterinary Medicines Authorised/Transfer Pending Products Page 31 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
CANIXIN Pi/L Virbac S.A. VPA10988/103/ . Lyophilisate and - QI07AI08 POM: - Canine Full application - Subcutaneous
lyophilisate and 001 suspension for Prescription Only Parainfluenza, (Article 12(3) of use
suspension for suspension for Medicine as live Directive No
suspension for injection defined in - Leptospira 2001/82/EC)
injection for dogs relevant national interrogans
legislation serogroup
canicola,
inactivated
- Leptospira
interrogans
serogroup
icterohaemorrag
iae, inactivated

Cardisure Eurovet Animal VPA10989/059/ 5 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Generic - Oral use
flavoured 5 mg Health B.V. 003 Prescription Only application
Tablets For dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cardisure 3.5 Dechra VPA22622/026/ 3.5 Oral solution - QC01CE90 POM: - Pimobendan Hybrid - Oral use
mg/ml Oral Regulatory B.V. 001 milligram(s)/millil Prescription Only application
Solution for Dog itre Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cardisure Eurovet Animal VPA10989/059/ 1.25 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Generic - Oral use
flavoured 1.25 Health B.V. 001 Prescription Only application
mg Tablets For Medicine as (Article 13(1) of
dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Cardisure Eurovet Animal VPA10989/059/ 10 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Generic - Oral use
flavoured 10 mg Health B.V. 004 Prescription Only application
Tablets For dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cardisure Eurovet Animal VPA10989/059/ 2.5 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Generic - Oral use
flavoured 2.5 mg Health B.V. 002 Prescription Only application
Tablets For dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Carofertin 10 Alvetra u. Werfft VPA10661/002/ 10 Emulsion for - QA11CA02 POM: - Betacarotene Generic - Intramuscular
mg/ml Emulsion GmbH 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of
cattle and pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Carporal 160 mg Le Vet Beheer VPA10475/019/ 160 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
tablets for dogs B.V. 002 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Carporal 40 mg Le Vet Beheer VPA10475/019/ 40 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
tablets for dogs B.V. 001 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 32 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Carprieve 100 Norbrook VPA22664/091/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
mg Flavoured Laboratories 003 Prescription Only application
Tablets for Dogs (Ireland) Limited Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Carprieve 100 Norbrook VPA22664/071/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
mg Tablets for Laboratories 003 Prescription Only application
Dogs (Ireland) Limited Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Carprieve 20 mg Norbrook VPA22664/091/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Flavoured Laboratories 001 Prescription Only application
Tablets for Dogs (Ireland) Limited Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Carprieve 20 mg Norbrook VPA22664/071/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for Dogs Laboratories 001 Prescription Only application
(Ireland) Limited Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Carprieve 5 Norbrook VPA22664/069/ 50 Solution for - QM01AE91 POM: - Carprofen Generic - Intravenous
%w/v Small Laboratories 001 milligram(s)/millil injection Prescription Only application use
Animal Solution (Ireland) Limited itre Medicine as (Article 13(1) of - Subcutaneous
for Injection defined in Directive No use
relevant national 2001/82/EC)
legislation

Carprieve 50 mg Norbrook VPA22664/091/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Flavoured Laboratories 002 Prescription Only application
Tablets for Dogs (Ireland) Limited Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Carprieve 50 mg Norbrook VPA22664/071/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for Dogs Laboratories 002 Prescription Only application
(Ireland) Limited Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Carprieve 50 Norbrook VPA22664/080/ 50 Solution for - QM01AE91 POM: - Carprofen Well-established - Intravenous
mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only use application use
for Injection for (Ireland) Limited itre Medicine as (Article 13a of - Subcutaneous
Cattle defined in Directive No use
relevant national 2001/82/EC)
legislation

Carprodolor 50 Le Vet Beheer VPA10475/003/ 50 Solution for - QM01AE91 POM: - Carprofen Generic - Intravenous
mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
cattle defined in Directive No use
relevant national 2001/82/EC)
legislation

Carprodyl F 100 Ceva Santé VPA10815/003/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
mg, tablets for Animale 003 Prescription Only application
dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 33 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Carprodyl F 20 Ceva Santé VPA10815/003/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
mg, tablets for Animale 001 Prescription Only application
dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Carprodyl F 50 Ceva Santé VPA10815/003/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
mg, tablets for Animale 002 Prescription Only application
dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Carprodyl Quadri Ceva Santé VPA10815/045/ 120 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
120 mg Animale 002 Prescription Only application
chewable tablets Medicine as (Article 13(1) of
for dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Carprodyl Quadri Ceva Santé VPA10815/045/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
50 mg tablets for Animale 001 Prescription Only application
dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Carprofelican 50 Le Vet Beheer VPA10475/007/ 50 Solution for - QM01AE91 POM: - Carprofen Generic - Intravenous
mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
dogs and cats defined in Directive No use
relevant national 2001/82/EC)
legislation

Carprofen KRKA Krka, d.d., Novo VPA10774/019/ 50 Solution for - QM01AE91 POM: - Carprofen for Generic - Intravenous
50 mg/ml mesto 001 milligram(s)/millil injection Prescription Only veterinary use application use
solution for itre Medicine as (Article 13(1) of - Subcutaneous
injection for dogs defined in Directive No use
and cats relevant national 2001/82/EC)
legislation

Carprogesic 20 Norbrook VPA22664/079/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use
mg Tablets for Laboratories 001 Prescription Only
dogs (Ireland) Limited Medicine as
defined in
relevant national
legislation

Carprogesic 50 Norbrook VPA22664/079/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use
mg Tablets for Laboratories 002 Prescription Only
dogs (Ireland) Limited Medicine as
defined in
relevant national
legislation

Carprox vet 100 Krka, d.d., Novo VPA10774/006/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use
mg tablets for mesto 003 Prescription Only
dogs Medicine as
defined in
relevant national
legislation

Carprox vet 20 Krka, d.d., Novo VPA10774/006/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use
mg tablets for mesto 001 Prescription Only
dogs Medicine as
defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 34 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Carprox vet 50 Krka, d.d., Novo VPA10774/006/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use
mg tablets for mesto 002 Prescription Only
dogs Medicine as
defined in
relevant national
legislation

Carprox vet 50 Krka, d.d., Novo VPA10774/005/ 50 Solution for - QM01AE91 POM: - Carprofen Generic - Intravenous
mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
dogs and cats defined in Directive No use
relevant national 2001/82/EC)
legislation

Cartrophen Vet Maperath Herbal VPA22748/001/ 100 Solution for - QM01AX90 VPO: Veterinary - Pentosan Full application - Subcutaneous
100 mg/ml Limited 001 milligram(s)/millil injection Practitioner Only polysulphate (Article 12(3) of use
Solution for itre as defined in sodium Directive No
Injection. relevant national 2001/82/EC)
legislation

Catobevit 100 Krka, d.d., Novo VPA10774/052/ 100, 0.05 Solution for - QA12CX99 POM: - Butafosfan Generic, hybrid - Intramuscular
mg/ml + 0.05 mesto 001 milligram(s)/millil injection Prescription Only - or similar use
mg/ml solution itre Medicine as Cyanocobalamin biological - Intravenous
for injection for defined in application use
cattle, horses, relevant national (Article 13 of - Subcutaneous
dogs and cats legislation Directive No use
2001/82/EC)
Cazitel 230/20 Chanelle VPA10987/102/ 230, 20 Film-coated - QP52AA51 CAM: - Pyrantel Hybrid - Oral use
mg Flavoured Pharmaceuticals 001 mg/tablet tablet Companion embonate application
Film-Coated Manufacturing Animal Medicine - Praziquantel (Article 13(3) of
Tablets for Cats Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Cazitel Plus Chanelle VPA10987/077/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use
Tablets for Dogs Pharmaceuticals 001 mg/tablet Companion - Pyrantel application
Manufacturing Animal Medicine - Febantel (Article 10(3) of
Limited as defined in Directive No
relevant national 2001/83/EC)
legislation

Cazitel Plus XL Chanelle VPA10987/077/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Cazitel Plus XL Chanelle VPA10987/077/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Cazitel Plus XL Chanelle VPA10987/077/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

C-DIP Kilco VPA10948/002/ 0.5 percent Teat dip/spray - QD08AC02 LM: Licensed - Chlorhexidine - Topical use
(International) 001 weight/volume solution Merchant as gluconate
Ltd. defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 35 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
CEEMAST Dry Bimeda Animal VPA22033/004/ 500/500 Intramammary - QJ51RD01 POM: - Cefalexin Informed - Intramammary
Cow Health Limited 001 mg/syringe suspension Prescription Only - consent use
Intramammary Medicine as Dihydrostreptom application
Suspension defined in ycin (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Cefabactin 1000 Le Vet Beheer VPA10475/024/ 1000 milligram(s Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use
mg tablets for B.V. 004 Prescription Only monohydrate application
dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cefabactin 250 Le Vet Beheer VPA10475/024/ 250 milligram(s) Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use
mg tablets for B.V. 002 Prescription Only monohydrate application
dogs and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cefabactin 50 Le Vet Beheer VPA10475/024/ 50 milligram(s) Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use
mg tablets for B.V. 001 Prescription Only monohydrate application
dogs and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cefabactin 500 Le Vet Beheer VPA10475/024/ 500 milligram(s) Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use
mg tablets for B.V. 003 Prescription Only monohydrate application
dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cefaseptin 300 Vetoquinol VPA10983/044/ 300 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Hybrid - Oral use
mg tablets for Ireland Limited 002 Prescription Only application
dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cefaseptin 75 Vetoquinol VPA10983/044/ 75 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Hybrid - Oral use
mg tablets for Ireland Limited 001 Prescription Only application
dogs and cats Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cefaseptin 750 Vetoquinol VPA10983/044/ 750 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Hybrid - Oral use
mg tablets for Ireland Limited 003 Prescription Only application
dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

CEFAVEX 50 SP Veterinaria, VPA10790/005/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular
mg/ml, S.A. 001 milligram(s)/millil injection Prescription Only application use
suspension for itre Medicine as (Article 13(1) of - Subcutaneous
injection for pigs defined in Directive No use
and cattle relevant national 2001/82/EC)
legislation

Cefenil 50 mg/ml Norbrook VPA22664/086/ 50 Powder for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular
Powder and Laboratories 001 milligram(s)/millil solution for Prescription Only application use
Solvent for (Ireland) Limited itre injection Medicine as (Article 13(1) of
Solution for defined in Directive No
Injection for relevant national 2001/82/EC)
Cattle and Pigs legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 36 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Cefenil RTU, 50 Norbrook VPA22664/099/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular
mg/ml, Laboratories 001 milligram(s)/millil injection Prescription Only application use
Suspension for (Ireland) Limited itre Medicine as (Article 13(1) of - Subcutaneous
Injection for Pigs defined in Directive No use
and Cattle relevant national 2001/82/EC)
legislation

Ceffect 25 mg/ml Emdoka bvba VPA10534/003/ 25 Suspension for - QJ01DE90 POM: - Cefquinome Generic - Intramuscular
suspension for 001 milligram(s)/millil injection Prescription Only application use
injection for itre Medicine as (Article 13(1) of
cattle and pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Ceffect LC, 75 Emdoka bvba VPA10534/005/ 75 mg/syringe Intramammary - QJ01DE90 POM: - Cefquinome Generic - Intramammary
mg, 001 ointment Prescription Only application use
intramammary Medicine as (Article 13(1) of
ointment for defined in Directive No
lactating cows relevant national 2001/82/EC)
legislation

Cefimam DC, Norbrook VPA22664/123/ 150 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome (as Generic - Intramammary
150 mg Laboratories 001 ointment Prescription Only cefquinome application use
Intramammary (Ireland) Limited Medicine as sulfate) (Article 13(1) of
Ointment for Dry defined in Directive No
Cows relevant national 2001/82/EC)
legislation

Cefimam LC, 75 Norbrook VPA22664/120/ 75 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Generic - Intramammary
mg Laboratories 001 ointment Prescription Only application use
Intramammary (Ireland) Limited Medicine as (Article 13(1) of
Ointment for defined in Directive No
Lactating Cows relevant national 2001/82/EC)
legislation

CEFOKEL 50 Kela n.v. VPA10981/015/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular
mg/ml, 001 milligram(s)/millil injection Prescription Only application use
suspension for itre Medicine as (Article 13(1) of - Subcutaneous
injection for pigs defined in Directive No use
and cattle relevant national 2001/82/EC)
legislation

Cefquinome Norbrook VPA22664/122/ 150 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Generic - Intramammary
Norbrook DC, Laboratories 001 ointment Prescription Only application use
150 mg (Ireland) Limited Medicine as (Article 13(1) of
Intramammary defined in Directive No
Ointment for Dry relevant national 2001/82/EC)
Cows legislation

Cefquinome Norbrook VPA22664/121/ 75 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Generic - Intramammary
Norbrook LC, 75 Laboratories 001 ointment Prescription Only application use
mg (Ireland) Limited Medicine as (Article 13(1) of
Intramammary defined in Directive No
Ointment for relevant national 2001/82/EC)
Lactating Cows legislation

Ceftiocyl 50 Vetoquinol VPA10983/045/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular
mg/ml, Ireland Limited 001 milligram(s)/millil injection Prescription Only application use
suspension for itre Medicine as (Article 13(1) of - Subcutaneous
injection for defined in Directive No use
cattle and pigs relevant national 2001/82/EC)
legislation

Ceftiocyl Fluid 50 Vetoquinol VPA10983/046/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular
mg/ml, Ireland Limited 001 milligram(s)/millil injection Prescription Only application use
suspension for itre Medicine as (Article 13(1) of
injection for pigs defined in Directive No
and cattle relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 37 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Cemay 50 mg/ml Laboratorios VPA10436/001/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular
suspension for Maymó, S.A. 001 milligram(s)/millil injection Prescription Only application use
injection for pigs itre Medicine as (Article 13(1) of - Subcutaneous
and cattle defined in Directive No use
relevant national 2001/82/EC)
legislation

Cephacare Ecuphar NV VPA10491/005/ 1000 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use
Flavour 1000 mg 004 Prescription Only application
Tablets for Dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cephacare Ecuphar NV VPA10491/005/ 250 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use
flavour 250 mg 002 Prescription Only application
tablets for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cephacare Ecuphar NV VPA10491/005/ 50 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use
flavour 50 mg 001 Prescription Only application
tablets for cats Medicine as (Article 13(1) of
and dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Cephacare Ecuphar NV VPA10491/005/ 500 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use
flavour 500 mg 003 Prescription Only application
tablets for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cephaguard DC Virbac S.A. VPA10988/083/ 150 mg/syringe Intramammary - QJ51DA92 POM: - Cefquinome Full application - Intramammary
150 mg 001 ointment Prescription Only (Article 12(3) of use
intramammary Medicine as Directive No
ointment defined in 2001/82/EC)
relevant national
legislation

Ceporex 18 Intervet Ireland VPA10996/223/ 18 percent Suspension for - QJ01DB01 POM: - Cefalexin - Intramuscular
%w/v Limited 001 weight/volume injection Prescription Only use
Suspension for Medicine as - Subcutaneous
Injection defined in use
relevant national
legislation

Cepravin Dry Intervet Ireland VPA10996/224/ 250 mg/syringe Intramammary - QJ51DA90 POM: - Cefalonium Full application - Intramammary
Cow Limited 001 suspension Prescription Only (Article 12(3) of use
Intramammary Medicine as Directive No
Suspension defined in 2001/82/EC)
relevant national
legislation

Cepritect 250 mg Norbrook VPA22664/142/ 250 mg/syringe Intramammary - QJ51DB90 POM: - Cefalonium (as Hybrid - Intramammary
Intramammary Laboratories 001 suspension Prescription Only cefalonium application use
Suspension for (Ireland) Limited Medicine as dihydrate?) (Article 13(3) of
Dry Cows defined in Directive No
relevant national 2001/82/EC)
legislation

Cevac IBD 2512 Ceva Santé VPA10815/020/ . Lyophilisate for - QI01AD09 POM: - Live infectious 13(4)Similiar - Per Oral
L lyophilisate for Animale 001 suspension Prescription Only bursal disease Biological
oral suspension Medicine as (ibd) virus strain,
for chickens defined in winterfield 2512,
relevant national g-61
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 38 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
CEVAC IBird Ceva Santé VPA10815/022/ . Lyophilisate for - QI01AD07 POM: - Live attenuated Full application - In drinking
lyophilisate for Animale 001 suspension Prescription Only infectious (Article 12(3) of water use
suspension for Medicine as bronchitis (ib) Directive No - ZZZ Spray
chickens defined in virus, strain 1/96, 2001/82/EC)
relevant national variant subtype
legislation

CEVAC MASS L CEVA-Phylaxia VPA10463/004/ . Lyophilisate for - QI01AD07 POM: - Live attenuated Full application - Nebulisation
lyophilisate for Veterinary 001 suspension Prescription Only infectious (Article 12(3) of use
oculonasal Biologicals Co. Medicine as bronchitis Directive No
suspension for Ltd defined in disease virus, 2001/82/EC)
chicken relevant national Massachusetts
legislation type, strain B48

Cevac MD HVT CEVA-Phylaxia VPA10463/005/ . Suspension and - QI01AD03 POM: - Turkey Full application - In ovo
suspension and Veterinary 001 solvent for Prescription Only herpesirus, live (Article 12(3) of - Subcutaneous
solvent for Biologicals Co. suspension for Medicine as Directive No use
suspension for Ltd injection defined in 2001/82/EC)
injection for relevant national
chickens legislation

Cevac MD CEVA-Phylaxia VPA10463/007/ 800-5000 plaque Concentrate and - QI01AD03 POM: - Marek's Full application - Subcutaneous
Rispens Veterinary 001 forming unit solvent for Prescription Only disease virus (Article 12(3) of use
concentrate and Biologicals Co. suspension for Medicine as strain cvi 988 live Directive No
solvent for Ltd injection defined in 2001/82/EC)
suspension for relevant national
injection for legislation
chickens
Cevac Meta L CEVA-Phylaxia VPA10463/003/ . Lyophilisate for - QI01AD01 POM: - Avian Full application - Nebulisation
lyophilisate for Veterinary 001 suspension Prescription Only metapneumovir (Article 12(3) of use
suspension for Biologicals Co. Medicine as us, subtype B, Directive No - Ocular use
chickens Ltd defined in CRR126 strain 2001/82/EC)
relevant national
legislation

CEVAC Ceva Santé VPA10815/005/ . Lyophilisate and - QI01AD09 POM: - Live, Full application - In ovo
TRANSMUNE Animale 001 solvent for Prescription Only attenuated (Article 12(3) of - Subcutaneous
lyophilisate for suspension for Medicine as infectious bursal Directive No use
suspension for injection defined in disease (IBD) 2001/82/EC)
injection with relevant national virus, strain
solvent for legislation winterfield 2512,
chickens G-61

Cevaxel-RTU 50 Ceva Santé VPA10815/016/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur Generic - Intramuscular
mg/ml, Animale 001 milligram(s)/millil injection Prescription Only application use
suspension for itre Medicine as (Article 13(1) of - Subcutaneous
injection for defined in Directive No use
cattle and pigs relevant national 2001/82/EC)
legislation

Cevazuril 50 Ceva Santé VPA10815/007/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use
mg/ml, oral Animale 001 milligram(s)/millil Prescription Only application
suspension for itre Medicine as (Article 13(1) of
piglets and defined in Directive No
calves relevant national 2001/82/EC)
legislation

Chan Broad Chanelle VPA10987/010/ 22.5/15 Oral suspension - QP52AE01 LM: Licensed - Rafoxanide - Oral use
Spec Oral Pharmaceuticals 001 milligram(s)/millil - QP52AG05 Merchant as - Levamisole
Suspension Manufacturing itre defined in hydrochloride
Limited relevant national
legislation

Chan Broad Chanelle VPA10987/010/ 22.5/15 Oral suspension - QP52AE01 LM: Licensed - Rafoxanide - Oral use
Spec Oral Pharmaceuticals 001 milligram(s)/millil - QP52AG05 Merchant as - Levamisole
Suspension Manufacturing itre defined in hydrochloride
Limited relevant national
legislation

Chan Pen Strep Chanelle VPA10987/054/ 200, 200 Suspension for - QJ01RA01 POM: - Procaine Informed - Intramuscular
Suspension for Pharmaceuticals 001 milligram(s)/millil injection Prescription Only benzylpenicillin consent use
Injection Manufacturing itre Medicine as - application
Limited defined in Dihydrostreptom (Article 13c of
relevant national ycin Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 39 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Chanacycline LA Chanelle VPA10987/023/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline - Intramuscular
Solution for Pharmaceuticals 001 milligram(s)/millil injection Prescription Only use
Injection Manufacturing itre Medicine as
Limited defined in
relevant national
legislation

Chanatol Oral Chanelle VPA10987/033/ 0.099, 99 Oral solution - QA16QA LM: Licensed - Cobalt sulphate - Oral use
Solution Pharmaceuticals 001 percent Merchant as heptahydrate
Manufacturing weight/volume defined in - Propylene
Limited relevant national glycol
legislation

Chanaverm Plus Chanelle VPA10987/008/ 1.5 percent Oral solution - QP52AE51 LM: Licensed - Levamisole - Oral use
Oral Solution Pharmaceuticals 001 weight/volume Merchant as hydrochloride
Manufacturing defined in
Limited relevant national
legislation

Chanazine 10% Chanelle VPA10987/031/ 100 Solution for - QN05CM92 VPO: Veterinary - Xylazine base - Intramuscular
Solution for Pharmaceuticals 001 milligram(s)/millil injection Practitioner Only use
Injection Manufacturing itre as defined in - Intravenous
Limited relevant national use
legislation

Chanazine 2% Chanelle VPA10987/030/ 20 Solution for - QN05CM92 VPO: Veterinary - Xylazine base - Intramuscular
Solution for Pharmaceuticals 001 milligram(s)/millil injection Practitioner Only use
Injection Manufacturing itre as defined in - Intravenous
Limited relevant national use
legislation

Chanectin 0.5% Chanelle VPA10987/154/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin - Topical use
w/v Pour-on Pharmaceuticals 001 weight/volume Merchant as
Solution Manufacturing defined in
Limited relevant national
legislation

Chanectin 1 % Chanelle VPA10987/149/ 1.0 percent Solution for - QP54AA01 LM: Licensed - Ivermectin - Subcutaneous
Solution for Pharmaceuticals 001 weight/volume injection Merchant as use
Injection for Manufacturing defined in
Cattle Limited relevant national
legislation

Chanil 34 mg/ml Chanelle VPA10987/114/ 34 Oral suspension - QP52AG06 LM: Licensed - Oxyclozanide Generic - Oral use
oral suspension Pharmaceuticals 001 milligram(s)/millil Merchant as application
for cattle Manufacturing itre defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Chanimec 0.5% Chanelle VPA10987/155/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin - Topical use
w/v Pour-on Pharmaceuticals 001 weight/volume Merchant as
Solution Manufacturing defined in
Limited relevant national
legislation

CHANIMEC 0.8 Chanelle VPA10987/081/ 0.8 Oral solution - QP54AA01 LM: Licensed - Ivermectin Hybrid - Oral use
mg/ml Oral Pharmaceuticals 001 milligram(s)/millil Merchant as application
Solution for Manufacturing itre defined in (Article 13(3) of
Sheep Limited relevant national Directive No
legislation 2001/82/EC)

Chanimec 10 Chanelle VPA10987/145/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
mg/ml solution Pharmaceuticals 001 milligram(s)/millil injection Merchant as application use
for injection for Manufacturing itre defined in (Article 13(1) of
Cattle and Pigs Limited relevant national Directive No
legislation 2001/82/EC)

Chanimec Super Chanelle VPA10987/091/ 10 Solution for - QP54AA51 LM: Licensed - Ivermectin Generic - Subcutaneous
Solution for Pharmaceuticals 001 milligram(s)/millil injection Merchant as - Clorsulon application use
Injection Manufacturing itre defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 40 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Chanonil Combo Chanelle VPA10987/128/ 134, 120.6 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
134 mg/120.6 Pharmaceuticals 002 mg/pipette Prescription Only - (S)-methoprene application
mg Spot-on Manufacturing Medicine as (Article 13(3) of
Solution for Limited defined in Directive No
Medium Dogs relevant national 2001/82/EC)
legislation

Chanonil Combo Chanelle VPA10987/128/ 268, 241.2 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
268 mg/241.2 Pharmaceuticals 003 mg/pipette Prescription Only - (S)-methoprene application
mg Spot-on Manufacturing Medicine as (Article 13(3) of
Solution for Limited defined in Directive No
Large Dogs relevant national 2001/82/EC)
legislation

Chanonil Combo Chanelle VPA10987/128/ 402, 361.8 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
402 mg/361.8 Pharmaceuticals 004 mg/pipette Prescription Only - (S)-methoprene application
mg Spot-on Manufacturing Medicine as (Article 13(3) of
Solution for Extra Limited defined in Directive No
Large Dogs relevant national 2001/82/EC)
legislation

Chanonil Combo Chanelle VPA10987/127/ 50, 60 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
50 mg/60 mg Pharmaceuticals 001 mg/pipette Prescription Only - (S)-methoprene application
Spot-on Solution Manufacturing Medicine as (Article 13(3) of
for Cats and Limited defined in Directive No
Ferrets relevant national 2001/82/EC)
legislation

Chanonil Combo Chanelle VPA10987/128/ 67, 60.3 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
67 mg/60.3 mg Pharmaceuticals 001 mg/pipette Prescription Only - (S)-methoprene application
Spot-on Solution Manufacturing Medicine as (Article 13(3) of
for Small Dogs Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Chanoprim Chanelle VPA10987/029/ 40/200 Solution for - QJ01EW10 POM: - Trimethoprim Informed - Intramuscular
Solution for Pharmaceuticals 001 milligram(s)/millil injection Prescription Only - Sulfadiazine consent use
Injection Manufacturing itre Medicine as application
Limited defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Chanox Multi 50 Chanelle VPA10987/132/ 50 Oral suspension - QP51AJ01 LM: Licensed - Toltrazuril Generic - Oral use
mg/ml oral Pharmaceuticals 001 milligram(s)/millil Merchant as application
suspension for Manufacturing itre defined in (Article 13(1) of
Piglets, Calves Limited relevant national Directive No
and Lambs legislation 2001/82/EC)

Chloromed 150 Univet Limited VPA10990/041/ 150 Oral powder - QJ01AA03 POM: - Generic - Oral use
mg/g Oral 001 milligram(s)/gra Prescription Only Chlortetracycline application
Powder for m Medicine as hydrochloride (Article 13(1) of
Calves defined in Directive No
relevant national 2001/82/EC)
legislation

Chloromed 150 Univet Limited VPA10990/042/ 150 Oral powder - QJ01AA03 POM: - Generic - Oral use
mg/g Oral 001 milligram(s)/gra Prescription Only Chlortetracycline application
Powder for Pigs m Medicine as hydrochloride (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Chloromed 150 Univet Limited VPA10990/040/ 150 Premix for - QJ01AA03 POM: - Generic - Oral use
mg/g Premix for 001 milligram(s)/gra medicated Prescription Only Chlortetracycline application
medicated m feeding stuff Medicine as hydrochloride (Article 13(1) of
feeding stuff for defined in Directive No
calves relevant national 2001/82/EC)
legislation

Chloromed 150 Univet Limited VPA10990/043/ 150 Premix for - QJ01AA03 POM: - Generic - Oral use
mg/g premix for 001 milligram(s)/gra medicated Prescription Only Chlortetracycline application
medicated m feeding stuff Medicine as hydrochloride (Article 13(1) of
feeding stuff for defined in Directive No
pigs relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 41 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Chlorsol 50 % Vetoquinol VPA10983/047/ 50 percent Powder for oral - QJ01AA03 POM: - - Oral use
Powder for Oral Ireland Limited 001 weight/weight solution Prescription Only Chlortetracycline
Solution Medicine as
defined in
relevant national
legislation

Chorulon 1500 Intervet Ireland VPA10996/021/ 1500 Powder and - QG03GA01 POM: - Chorionic Full application - Intramuscular
IU Powder and Limited 001 international solvent for Prescription Only gonadotrophin (Article 12(3) of use
solvent for unit(s) solution for Medicine as Directive No - Intravenous
solution for injection defined in 2001/82/EC) use
injection relevant national
legislation

Chronogest CR Intervet Ireland VPA10996/011/ 20 mg/sponge Medicated - QG03D POM: - Flugestone Full application - Vaginal use
20 mg controlled Limited 001 sponge Prescription Only acetate (Article 12(3) of
release vaginal Medicine as Directive No
sponge for defined in 2001/82/EC)
sheep relevant national
legislation

CIDR 1.38 g Zoetis Belgium VPA10387/006/ 1.38 gram(s) Vaginal delivery - QG03DA04 VPO: Veterinary - Progesterone Hybrid - Vaginal use
Vaginal Delivery S.A. 001 system Practitioner Only - Progesterone application
System for Cattl as defined in (Article 13(3) of
relevant national Directive No
legislation 2001/82/EC)

Cirbloc emulsion CEVA-Phylaxia VPA10463/001/ . Emulsion for - QI09AA07 POM: - Inactivated Full application - Intramuscular
for injection for Veterinary 001 injection Prescription Only antigen of pcv (Article 12(3) of use
pigs Biologicals Co. Medicine as type 2b, strain Directive No
Ltd defined in rm 2001/82/EC)
relevant national
legislation

Citramox 1000 Laboratorios VPA10786/005/ 1000 Powder for use - QJ01CA04 POM: - Amoxicillin Hybrid - In drinking
mg/g powder for Karizoo S.A. 002 milligram(s)/gra in drinking water Prescription Only trihydrate application water use
use in drinking m Medicine as (Article 10(3) of
water for defined in Directive No
chickens, ducks, relevant national 2001/83/EC)
turkeys and pigs legislation

Citramox 500 Laboratorios VPA10786/005/ 500 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - Oral use
mg/g powder for Karizoo S.A. 001 milligram(s)/gra in drinking water Prescription Only application
use in drinking m Medicine as (Article 13(1) of
water for defined in Directive No
chickens, relevant national 2001/82/EC)
turkeys, ducks legislation
and pigs
CITRAMOX L.A. Laboratorios VPA10786/006/ 150 Solution for - QJ01CA04 POM: - Amoxicillin Generic - Intramuscular
150 mg/ml Karizoo S.A. 001 milligram(s)/millil injection Prescription Only trihydrate application use
suspension for itre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle and pigs relevant national 2001/82/EC)
legislation

Clavaseptin 250 Vetoquinol VPA10983/048/ 250 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin - Oral use
mg palatable Ireland Limited 002 Prescription Only - Clavulanic acid
tablets for dogs Medicine as
defined in
relevant national
legislation

Clavaseptin 50 Vetoquinol VPA10983/048/ 50 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin - Oral use
mg palatable Ireland Limited 001 Prescription Only - Clavulanic acid
tablets for dogs Medicine as
and cats defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 42 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Clavaseptin 500 Vetoquinol VPA10983/048/ 500 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin - Oral use
mg palatable Ireland Limited 003 Prescription Only - Clavulanic acid
tablets for dogs Medicine as
defined in
relevant national
legislation

Clavaseptin 62.5 Vetoquinol VPA10983/048/ 50, 12.5 Tablet - QJ01CR02 POM: - Amoxicillin Well-established - Oral use
mg Palatable Ireland Limited 004 mg/tablet Prescription Only - Clavulanic acid use application
tablets for dogs Medicine as (Article 13a of
and cats defined in Directive No
relevant national 2001/82/EC)
legislation

Clavubactin Le Vet Beheer VPA10475/014/ 250, 62.5 Tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Oral use
250/62.5 mg B.V. 002 mg/tablet Prescription Only - Clavulanic acid application
tablets for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Clavubactin Le Vet Beheer VPA10475/014/ 50, 12.5 Tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Oral use
50/12.5 mg B.V. 001 mg/tablet Prescription Only - Clavulanic acid application
tablets for cats Medicine as (Article 13(3) of
and dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Clavubactin Le Vet Beheer VPA10475/014/ 500, 125 Tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Oral use
500/125 mg B.V. 003 mg/tablet Prescription Only - Clavulanic acid application
tablets for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Clavucill V.M.D. n.v/s.a. VPA10817/002/ 200, 50 Tablet - QJ01CR02 POM: - Amoxicillin - Oral use
200mg/50mg, 002 mg/tablet Prescription Only - Clavulanic acid
tablets for dogs Medicine as
defined in
relevant national
legislation

Clavucill V.M.D. n.v/s.a. VPA10817/002/ 40, 10 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin - Oral use
40mg/10mg, 001 Prescription Only - Clavulanic acid
tablets for dogs Medicine as
and cats defined in
relevant national
legislation

Clavudale 200 Dechra VPA22622/005/ 200, 50 Tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use
mg/50 mg tablets Regulatory B.V. 002 mg/tablet Prescription Only - Clavulanic acid application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Clavudale 40 Dechra VPA22622/005/ 40, 10 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use
mg/10 mg tablets Regulatory B.V. 001 Prescription Only - Clavulanic acid application
for cats and dog Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Clavudale 400 Dechra VPA22622/005/ 400, 100 Tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use
mg/100 mg Regulatory B.V. 003 mg/tablet Prescription Only - Clavulanic acid application
tablets for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

CLIK 5% Pour- Elanco GmbH VPA22020/021/ 5 percent Pour-on - QP53AX LM: Licensed - Dicyclanil Full application - Topical use
on Suspension 001 weight/volume suspension Merchant as (Article 12(3) of
for Sheep defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 43 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
CLiK Extra 65 Elanco GmbH VPA22020/022/ 65 Pour-on - QP53AX24 LM: Licensed - Dicyclanil Full application - Topical use
mg/ml Pour-On 001 milligram(s)/millil suspension Merchant as (Article 12(3) of
Suspension for itre defined in Directive No
Sheep relevant national 2001/82/EC)
legislation

CLiKZiN 12.5 Elanco GmbH VPA22020/023/ 12.5 Pour-on - QP53AX24 LM: Licensed - Dicyclanil Full application - Topical use
mg/ml Pour-On 001 milligram(s)/millil suspension Merchant as (Article 12(3) of
Suspension for itre defined in Directive No
Sheep relevant national 2001/82/EC)
legislation

Clinacin 150 mg Chanelle VPA10987/144/ 150 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin - Oral use
Tablets for Dogs Pharmaceuticals 003 Prescription Only (as clindamycin
Manufacturing Medicine as hydrochloride)
Limited defined in
relevant national
legislation

Clinacin 25 mg Chanelle VPA10987/144/ 25 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin Well-established - Oral use
Tablets Pharmaceuticals 004 Prescription Only (as clindamycin use application
Manufacturing Medicine as hydrochloride) (Article 13a of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Clinacin 25 mg Chanelle VPA10987/144/ 25 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin - Oral use
Tablets for Dogs Pharmaceuticals 002 Prescription Only (as clindamycin
Manufacturing Medicine as hydrochloride)
Limited defined in
relevant national
legislation

Clinacin 300 mg Chanelle VPA10987/144/ 300 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin Well-established - Oral use
Tablets for Dogs Pharmaceuticals 005 Prescription Only (as clindamycin use application
Manufacturing Medicine as hydrochloride) (Article 13a of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Clinacin 75 mg Chanelle VPA10987/144/ 75 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin - Oral use
Tablets for Dogs Pharmaceuticals 001 Prescription Only (as clindamycin
Manufacturing Medicine as hydrochloride)
Limited defined in
relevant national
legislation

Clindabactin 220 Dechra VPA22622/028/ 220 mg/tablet Chewable tablet - QJ01FF01 POM: - Clindamycin Hybrid - Oral use
mg chewable Regulatory B.V. 001 Prescription Only application
tablets for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Clindabactin 440 Dechra VPA22622/028/ 440 mg/tablet Chewable tablet - QJ01FF01 POM: - Clindamycin Hybrid - Oral use
mg chewable Regulatory B.V. 002 Prescription Only application
tablets for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Clindabactin 55 Dechra VPA22622/027/ 55 mg/tablet Chewable tablet - QJ01FF01 POM: - Clindamycin Hybrid - Oral use
mg chewable Regulatory B.V. 001 Prescription Only application
tablets for dogs Medicine as (Article 13(3) of
and cats defined in Directive No
relevant national 2001/82/EC)
legislation

Clindacyl 150 mg Vetoquinol VPA10983/049/ 150 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin Informed - Oral use
Tablets for Dogs Ireland Limited 003 Prescription Only consent
Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 44 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Clindacyl 25 mg Vetoquinol VPA10983/049/ 25 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin Informed - Oral use
Tablets for dogs Ireland Limited 001 Prescription Only consent
and cats Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Clindacyl 300 mg Chanelle VPA10987/161/ 300 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin Well-established - Oral use
Tablets for Dogs Pharmaceuticals 001 Prescription Only (as clindamycin use application
Manufacturing Medicine as hydrochloride) (Article 13a of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Clindacyl 75 mg Vetoquinol VPA10983/049/ 75 mg/tablet Tablet - QJ01FF01 POM: - Clindamycin Informed - Oral use
Tablets for dogs Ireland Limited 002 Prescription Only consent
Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Clindaseptin 150 Chanelle VPA10987/163/ 150 Milligrams Capsule - QJ01FF01 POM: - Clindamycin Full application - Oral use
mg capsules for Pharmaceuticals 003 per capsule Prescription Only (as clindamycin (Article 12(3) of
dogs Manufacturing Medicine as hydrochloride) Directive No
Limited defined in 2001/82/EC)
relevant national
legislation

Clindaseptin 25 Chanelle VPA10987/163/ 25 Milligrams per Capsule - QJ01FF01 POM: - Clindamycin Full application - Oral use
mg capsules for Pharmaceuticals 001 capsule Prescription Only (as clindamycin (Article 12(3) of
dogs Manufacturing Medicine as hydrochloride) Directive No
Limited defined in 2001/82/EC)
relevant national
legislation

Clindaseptin 25 Chanelle VPA10987/097/ 25 Oral solution - QJ01FF01 POM: - Clindamycin Generic - Oral use
mg/ml oral Pharmaceuticals 001 milligram(s)/millil Prescription Only application
solution for cats Manufacturing itre Medicine as (Article 13(1) of
and dogs Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Clindaseptin 300 Chanelle VPA10987/163/ 300 Milligrams Capsule - QJ01FF01 POM: - Clindamycin Full application - Oral use
mg capsules for Pharmaceuticals 004 per capsule Prescription Only (as clindamycin (Article 12(3) of
dogs Manufacturing Medicine as hydrochloride) Directive No
Limited defined in 2001/82/EC)
relevant national
legislation

Clindaseptin 75 Chanelle VPA10987/163/ 75 Milligrams per Capsule - QJ01FF01 POM: - Clindamycin Full application - Oral use
mg capsules for Pharmaceuticals 002 capsule Prescription Only (as clindamycin (Article 12(3) of
dogs Manufacturing Medicine as hydrochloride) Directive No
Limited defined in 2001/82/EC)
relevant national
legislation

Closamectin 5 Norbrook VPA22664/088/ 5, 200 Pour-on solution - QP54AA51 LM: Licensed - Ivermectin Full application - Topical use
mg/ml + 200 Laboratories 001 milligram(s)/millil Merchant as - Closantel (Article 12(3) of
mg/ml Pour-On (Ireland) Limited itre defined in Directive No
Solution for relevant national 2001/82/EC)
Cattle legislation

Closamectin Norbrook VPA22664/083/ 5, 125 Solution for - QP54AA51 LM: Licensed - Ivermectin Fixed - Subcutaneous
Solution for Laboratories 001 milligram(s)/millil injection Merchant as - Closantel combination use
Injection for (Ireland) Limited itre defined in application
Cattle and relevant national (Article 13b of
Sheep legislation Directive No
2001/82/EC)
Closiver 5 Norbrook VPA22664/084/ 5, 125 Solution for - QP54AA51 LM: Licensed - Ivermectin Fixed - Subcutaneous
mg/ml/125 mg/ml Laboratories 001 milligram(s)/millil injection Merchant as - Closantel combination use
Solution for (Ireland) Limited itre defined in application
Injection for relevant national (Article 13b of
Cattle and legislation Directive No
Sheep 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 45 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Closivet 5 mg/ml Norbrook VPA22664/102/ 5, 200 Pour-on solution - QP54AA51 LM: Licensed - Ivermectin Informed - Topical use
+ 200 mg/ml Laboratories 001 milligram(s)/millil Merchant as - Closantel consent
Pour-On Solution (Ireland) Limited itre defined in application
for Cattle relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Cobactan 2.5% Intervet Ireland VPA10996/104/ 2.5 percent Suspension for - QJ01DE90 POM: - Cefquinome Full application - Intramuscular
w/v Suspension Limited 001 weight/volume injection Prescription Only (Article 12(3) of use
for Injection Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Cobactan LC, 75 Intervet Ireland VPA10996/105/ 75 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Full application - Intramammary
mg, Limited 001 ointment Prescription Only (Article 12(3) of use
intramammary Medicine as Directive No
ointment for defined in 2001/82/EC)
lactating cattle relevant national
legislation

Cobalt Super Chanelle VPA10987/032/ 2.1 Oral solution - QV06D LM: Licensed - Cobalt sulphate - Oral use
Oral Solution Pharmaceuticals 001 milligram(s)/millil Merchant as heptahydrate
2.1mg/ml Manufacturing itre defined in
Limited relevant national
legislation

Coccibal, 200 SP Veterinaria, VPA10790/012/ 200 Oral solution - QP51AX09 POM: - Amprolium (as Hybrid - Oral use
mg/ml solution S.A. 001 milligram(s)/millil Prescription Only hydrochloride) application
for use in itre Medicine as (Article 13(3) of
drinking water for defined in Directive No
chicken and relevant national 2001/82/EC)
turkeys legislation

Coglapix Ceva Santé VPA10815/030/ . Suspension for - QI09AB07 POM (E): - Actinobacillus Full application - Intramuscular
suspension for Animale 001 injection Prescription Only pleuropneumoni (Article 12(3) of use
injection for pigs. Exempt as ae strain nt3 Directive No
defined in - Actinobacillus 2001/82/EC)
relevant national pleurpneumonia
legislation e strain szii
- Actinobacillus
pleuropneumoni
ae strain po
- Actinobacillus
pleuropneumoni
ae strain u3
- Actinobacillus
pleuropneumoni
ae strain b4
Colfive LIVISTO Int'l, VPA10425/001/ 5,000,000 Oral solution - QA07AA10 POM: - Colistin sulfate Hybrid - Oral use
5,000,000 IU/ml S.L. 001 international Prescription Only application
concentrate for unit(s)/millilitre Medicine as (Article 13(3) of
oral solution for defined in Directive No
calves, pigs, relevant national 2001/82/EC)
lambs, chickens legislation
and turkeys
Coliscour 2 000 Ceva Santé VPA10815/006/ 2,000,000 Oral solution - QA07AA10 POM: - Colistin Generic - Oral use
000 IU/ml, Animale 001 international Prescription Only application
concentrate for unit(s)/millilitre Medicine as (Article 13(1) of
oral solution, defined in Directive No
pigs, poultry relevant national 2001/82/EC)
legislation

COLMYC 25 SP Veterinaria, VPA10790/003/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml ORAL S.A. 001 milligram(s)/millil Prescription Only application
SOLUTION for itre Medicine as (Article 13(1) of
calves defined in Directive No
relevant national 2001/82/EC)
legislation

Colombovac Zoetis Belgium VPA10387/007/ . Suspension for - QI01EA01 POM (E): - Inactivated Full application - Subcutaneous
PMV S.A. 001 injection Prescription Only newcastle (Article 12(3) of use
Exempt as disease virus Directive No
defined in strain la sota 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 46 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Colvasone 2 Norbrook VPA22664/028/ 2 Solution for - QH02AB02 POM: - Full application - Intramuscular
mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only Dexamethasone (Article 12(3) of use
for injection (Ireland) Limited itre Medicine as sodium Directive No - Intravenous
defined in phosphate 2001/82/EC) use
relevant national
legislation

Combiclav Norbrook VPA22664/143/ 200, 50, 10 Intramammary - QJ51RV01 POM: - Amoxicillin Hybrid - Intramammary
Intramammary Laboratories 001 mg/syringe suspension Prescription Only - Clavulanic acid application use
Suspension for (Ireland) Limited Medicine as - Prednisolone (Article 13(3) of
Lactating Cows defined in Directive No
relevant national 2001/82/EC)
legislation

Combizole Oral Bimeda Animal VPA22033/006/ 25.0/37.5 Oral suspension - QP52A LM: Licensed - Fenbendazole Informed - Oral use
Suspension Health Limited 001 milligram(s)/millil Merchant as - Levamisole consent
itre defined in hydrochloride application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Comfortan 10 Eurovet Animal VPA10989/069/ 10 Solution for - QN02AC90 VPO: Veterinary - Methadone Hybrid - Intramuscular
mg/ml solution Health B.V. 001 milligram(s)/millil injection Practitioner Only application use
for injection for itre as defined in (Article 13(3) of - Intravenous
dogs and cats relevant national Directive No use
legislation 2001/82/EC) - Subcutaneous
use

CONTINENCE FATRO S.p.A. VPA10836/008/ 40 Syrup - QG04BX91 POM: - Generic - Per Oral
40 mg/ml syrup 001 milligram(s)/millil Prescription Only Phenylpropanol application
for dogs itre Medicine as amine (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Co-op Teat Dip Kilco Chemicals VPA10929/001/ 20 Teat dip/spray - QD08AG03 LM: Licensed - Iodine Informed - Topical use
(Ire.) Limited 001 milligram(s)/millil solution Merchant as consent
itre defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Copasure 2 g Animax Limited VPA10834/001/ 2 gram(s) Capsule - QA12C LM: Licensed - Copper oxide - Oral use
capsules 001 Merchant as
defined in
relevant national
legislation

Copasure 27g Animax Limited VPA10834/001/ 27 gram(s) Capsule, hard - QA12C LM: Licensed - Copper oxide - Oral use
Capsules 003 Merchant as
defined in
relevant national
legislation

Copasure 4g Animax Limited VPA10834/001/ 4 g/capsule Capsule - QA12C LM: Licensed - Copper oxide - Oral use
Capsules 002 Merchant as
defined in
relevant national
legislation

Copinox 27g Animax Limited VPA10834/002/ 27 g/capsule Capsule, hard - QA12C LM: Licensed - Copper oxide - Oral use
Capsules 001 Merchant as
defined in
relevant national
legislation

Copper 20 mg/ml Ballinskelligs VPA10956/005/ 20 Suspension for - QA12CX LM: Licensed - Copper - Intramuscular
Suspension for Vet. Products Lt 002 milligram(s)/millil injection Merchant as use
Injection itre defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 47 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
CORTEXONAV Laboratorios VPA10495/005/ 2 Solution for - QH02AB02 POM: - Generic - Intraarticular
ET 2 mg/ml SYVA, S.A.U 001 milligram(s)/millil injection Prescription Only Dexamethasone application use
solution for itre Medicine as (Article 13(1) of - Intramuscular
injection for defined in Directive No use
cattle, horses, relevant national 2001/82/EC) - Intravenous
pigs, dogs and legislation use
cats
Cortico Veyxin Veyx-Pharma VPA10539/006/ 10.0 Suspension for - QH02AB06 POM: - Prednisolone Hybrid - Intramuscular
10 mg/ml GmbH 001 milligram(s)/millil injection Prescription Only acetate application use
suspension for itre Medicine as (Article 13(3) of
injection for defined in Directive No
cattle, horses, relevant national 2001/82/EC)
dogs and cats legislation

Cosacthen 0.25 Dechra VPA22622/001/ 0.25 Solution for - QH01AA02 VPO: Veterinary - Tetracosactide Well-established - Intramuscular
mg/ml solution Regulatory B.V. 001 milligram(s)/millil injection Practitioner Only use application use
for injection for itre as defined in (Article 13a of - Intravenous
dogs relevant national Directive No use
legislation 2001/82/EC)

Cosecure Cattle Bimeda Animal VPA22033/054/ 13.4, 0.5, 0.3 Bolus - QA12CE99 LM: Licensed - Copper Full application - Oral use
Bolus Health Limited 001 gram/100gram Merchant as - Cobalt (Article 12(3) of
Continuous defined in - Selenium Directive No
Release relevant national 2001/82/EC)
Intraruminal legislation
Device
Co-Trimoxazole Kela n.v. VPA10981/001/ 24 percent Solution for - QJ01EW POM: - - Intramuscular
24% w/v solution 001 weight/volume injection Prescription Only Sulfamethoxazo use
for injection Medicine as le
defined in - Trimethoprim
relevant national
legislation

Covexin 10 Zoetis Belgium VPA10387/008/ . Suspension for - QI02AB01 LM: Licensed - C. - Subcutaneous
Suspension for S.A. 001 injection - QI04AB01 Merchant as haemolyticum use
injection for defined in toxoid (strain cn
sheep and cattle relevant national 3629)
legislation - C. sordellii
toxoid (strain
831)
- C. tetani toxoid
(strain cn 3911)
- C. septicum
toxoid (strain cn
368)
- C. novyi type b
toxoid (strain cn
6120)
- C. chauvoei
whole culture
(strain cn 3796)
- C. perfringens
type d toxoid
(strain cn 3688)
- C. perfringens
type c toxoid
(strain cn 883)
- C. perfringens
type b toxoid
(strain cn 1240)
- C. perfringens
type a toxoid
(strain cn 1491)

Veterinary Medicines Authorised/Transfer Pending Products Page 48 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Covexin 10 Zoetis Belgium VPA10387/008/ . Suspension for - QI02AB01 LM: Licensed - C. - Subcutaneous
Suspension for S.A. 001 injection - QI04AB01 Merchant as haemolyticum use
injection for defined in toxoid (strain cn
sheep and cattle relevant national 3629)
legislation - C. sordellii
toxoid (strain
831)
- C. tetani toxoid
(strain cn 3911)
- C. septicum
toxoid (strain cn
368)
- C. novyi type b
toxoid (strain cn
6120)
- C. chauvoei
whole culture
(strain cn 3796)
- C. perfringens
type d toxoid
(strain cn 3688)
- C. perfringens
type c toxoid
(strain cn 883)
- C. perfringens
type b toxoid
(strain cn 1240)
- C. perfringens
type a toxoid
(strain cn 1491)

Covexin 8 Zoetis Belgium VPA10387/009/ . Suspension for - QI02AB01 LM: Licensed - C. perfringens Full application - Subcutaneous
Suspension for S.A. 001 injection - QI04AB01 Merchant as type b & c ß (Article 12(3) of use
injection for defined in toxoid Directive No
sheep and cattle relevant national - C. perfringens 2001/82/EC)
legislation type d (e) toxoid
- C. chauvoei
whole culture
- C. novyi type B
anaculture
- C. septicum
toxoid
- C. tetani toxoid
- C.
haemolyticum
anaculture

Covexin 8 Zoetis Belgium VPA10387/009/ . Suspension for - QI02AB01 LM: Licensed - C. perfringens Full application - Subcutaneous
Suspension for S.A. 001 injection - QI04AB01 Merchant as type b & c ß (Article 12(3) of use
injection for defined in toxoid Directive No
sheep and cattle relevant national - C. perfringens 2001/82/EC)
legislation type d (e) toxoid
- C. chauvoei
whole culture
- C. novyi type B
anaculture
- C. septicum
toxoid
- C. tetani toxoid
- C.
haemolyticum
anaculture

Coxaclear 50 Krka, d.d., Novo VPA10774/008/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use
mg/ml oral mesto 001 milligram(s)/millil Prescription Only application
suspension for itre Medicine as (Article 13(1) of
pigs, cattle and defined in Directive No
sheep relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 49 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Coxx-Kure 50 LAPROVET VPA10483/002/ 50 Oral suspension - QP51AJ01 LM: Licensed - Toltrazuril Generic - Oral use
mg/ml oral 001 milligram(s)/millil Merchant as application
suspension for itre defined in (Article 13(1) of
piglets and relevant national Directive No
calves legislation 2001/82/EC)

Cronyxin 50 Bimeda Animal VPA22033/034/ 50 Oral paste - QM01AG90 POM: - Flunixin Generic - Oral use
mg/g Oral paste Health Limited 001 milligram(s)/gra Prescription Only application
for horses m Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Cronyxin Bimeda Animal VPA22033/040/ 50 Solution for - QM01AG90 POM: - Flunixin - Intravenous
Injection 50 Health Limited 001 milligram(s)/millil injection Prescription Only use
mg/ml Solution itre Medicine as
for Injection defined in
relevant national
legislation

Cryomarex Boehringer VPA10454/030/ . Suspension for - QI01AD03 POM: - Marek disease Full application - Intramuscular
Rispens Ingelheim 001 injection Prescription Only virus (rispens (Article 12(3) of use
Vetmedica Medicine as strain) Directive No - Subcutaneous
GmbH defined in 2001/82/EC) use
relevant national
legislation

CTC 10 %w/w Univet Limited VPA10990/018/ 10 percent Oral powder - QJ01AA03 POM: - - Oral use
Oral Powder 001 weight/weight Prescription Only Chlortetracycline
Medicine as hydrochloride
defined in
relevant national
legislation

CTC 10 %w/w Univet Limited VPA10990/039/ 10<br/> percent Premix for - QJ01AA03 POM: - Full application - Oral use
Premix for 001 weight/weight medicated Prescription Only Chlortetracycline (Article 12(3) of
Medicated Feed feeding stuff Medicine as hydrochloride Directive No
defined in 2001/82/EC)
relevant national
legislation

CTC 15 %w/w Univet Limited VPA10990/039/ 15<br/> percent Premix for - QJ01AA03 POM: - Full application - Oral use
Premix for 002 weight/weight medicated Prescription Only Chlortetracycline (Article 12(3) of
Medicated Feed feeding stuff Medicine as hydrochloride Directive No
defined in 2001/82/EC)
relevant national
legislation

CTC 15% w/w Univet Limited VPA10990/034/ 15 percent Oral powder - QJ01AA03 POM: - Full application - Oral use
Oral Powder 001 weight/weight Prescription Only Chlortetracycline (Article 12(3) of
Medicine as hydrochloride Directive No
defined in 2001/82/EC)
relevant national
legislation

Curacef duo, 50 Virbac S.A. VPA10988/092/ 50,100 Suspension for - QJ01DD POM: - Ceftiofur Fixed - Intramuscular
mg/ml / 150 001 milligram(s)/millil injection Prescription Only - Ketoprofen combination use
mg/ml, itre Medicine as application
Suspension for defined in (Article 13b of
Injection for relevant national Directive No
Cattle legislation 2001/82/EC)

Curafluke 10% Univet Limited VPA10990/032/ 10 percent Oral suspension - QP52AC30 LM: Licensed - Fenbendazole Full application - Oral use
w/v Oral Drench 002 weight/volume Merchant as - Rafoxanide (Article 12(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Curafluke 5% Univet Limited VPA10990/032/ 50 / 50 Oral suspension - QP52AC30 LM: Licensed - Fenbendazole Full application - Oral use
w/v Oral Drench 001 milligram(s)/millil Merchant as - Rafoxanide (Article 12(3) of
itre defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 50 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Curazole 10 Univet Limited VPA10990/015/ 10 percent Oral suspension - QP52AC13 LM: Licensed - Fenbendazole - Oral use
%w/v Oral 001 weight/volume Merchant as
Drench defined in
relevant national
legislation

Curazole 2.5% Univet Limited VPA10990/015/ 2.5 percent Oral suspension - QP52AC13 LM: Licensed - Fenbendazole - Oral use
w/v Oral Drench 002 weight/volume Merchant as
defined in
relevant national
legislation

Curazole 5 %w/v Univet Limited VPA10990/015/ 5 percent Oral suspension - QP52AC13 LM: Licensed - Fenbendazole - Oral use
Oral Drench 003 weight/volume Merchant as
defined in
relevant national
legislation

Curazole 5% Univet Limited VPA10990/030/ 5 percent Premix for - QP52AC13 POM: - Fenbendazole - Oral use
w/w Premix for 001 weight/weight medicated Prescription Only
Medicated Feed feeding stuff Medicine as
defined in
relevant national
legislation

Curazole 50 Univet Limited VPA10990/044/ 50 Oral powder - QP52AC13 LM: Licensed - Fenbendazole Full application - Oral use
mg/g oral 001 milligram(s)/gra Merchant as (Article 12(3) of
powder for pigs m defined in Directive No
relevant national 2001/82/EC)
legislation

Curofen 50 mg/g Univet Limited VPA10990/045/ 50 Oral powder - QP52AC13 LM: Licensed - Fenbendazole Generic - Oral use
oral powder for 001 milligram(s)/gra Merchant as application
pigs m defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Curofen 50 mg/g Univet Limited VPA10990/046/ 50 Premix for - QP52AC13 POM: - Fenbendazole Generic - Oral use
Premix for 001 milligram(s)/gra medicated Prescription Only application
Medicated m feeding stuff Medicine as (Article 13(1) of
Feeding Stuff for defined in Directive No
Pigs relevant national 2001/82/EC)
legislation

Cyclavance 100 Virbac S.A. VPA10988/094/ 100 Oral solution - QL04A POM: - Ciclosporin Generic - Oral use
mg/ml oral 001 milligram(s)/millil Prescription Only application
solution for dogs itre Medicine as (Article 13(1) of
and cats defined in Directive No
relevant national 2001/82/EC)
legislation

Cyclio 12 mg Virbac S.A. VPA10988/061/ 12 mg/pipette Spot-on solution - QP53AX23 POM: - Pyriproxyfen - Topical use
Spot-on Solution 001 Prescription Only
For Small Dogs Medicine as
defined in
relevant national
legislation

Cyclio 30 mg Virbac S.A. VPA10988/061/ 30 mg/pipette Spot-on solution - QP53AX23 POM: - Pyriproxyfen - Topical use
Spot-on Solution 002 Prescription Only
for Medium Medicine as
Sized Dogs defined in
relevant national
legislation

Cyclio 60 mg Virbac S.A. VPA10988/060/ 60 mg/pipette Spot-on solution - QP53AX23 POM: - Pyriproxyfen - Topical use
Spot-on Solution 001 Prescription Only
for Cats Medicine as
defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 51 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Cyclio 60 mg Virbac S.A. VPA10988/061/ 60 mg/pipette Spot-on solution - QP53AX23 POM: - Pyriproxyfen - Topical use
Spot-on Solution 003 Prescription Only
for Large Dogs Medicine as
defined in
relevant national
legislation

Cyclix 250 Virbac S.A. VPA10988/079/ 250 Solution for - QG02AD90 POM: - Cloprostenol Generic - Intramuscular
microgram/ml 001 microgram(s)/mil injection Prescription Only sodium application use
solution for lilitre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle relevant national 2001/82/EC)
legislation

Cyclix porcine Virbac S.A. VPA10988/080/ 87.5 Solution for - QG02AD90 POM: - Cloprostenol Generic - Intramuscular
87.5 001 microgram(s)/mil injection Prescription Only sodium application use
microgram/ml lilitre Medicine as (Article 13(1) of
solution for defined in Directive No
injection relevant national 2001/82/EC)
legislation

Cyclo Spray, Eurovet Animal VPA10989/049/ 2.45 percent Cutaneous - QD06A POM: - - Topical use
2.45 % w/w for Health B.V. 001 weight/weight spray, Prescription Only Chlortetracycline
cattle, sheep and suspension Medicine as hydrochloride
pigs defined in
relevant national
legislation

Cyclosol LA 200 Eurovet Animal VPA10989/026/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline - Intramuscular
mg/ml Solution Health B.V. 001 milligram(s)/millil injection Prescription Only use
for Injection itre Medicine as
defined in
relevant national
legislation

Cydectin 0.1% Zoetis Belgium VPA10387/011/ 0.1 percent Oral solution - QP54AB02 LM: Licensed - Moxidectin Full application - Oral use
w/v oral solution S.A. 001 weight/volume Merchant as (Article 12(3) of
for sheep defined in Directive No
relevant national 2001/82/EC)
legislation

CYDECTIN 0.5% Zoetis Belgium VPA10387/012/ <p>5.00</p> Pour-on solution - QP54AB02 LM: Licensed - Moxidectin Full application - Topical use
w/v Pour-On for S.A. 001 milligram(s) Merchant as (Article 12(3) of
cattle defined in Directive No
relevant national 2001/82/EC)
legislation

Cydectin 1 % w/v Zoetis Belgium VPA10387/013/ 1 percent Solution for - QP54AB02 LM: Licensed - Moxidectin Full application - Subcutaneous
Solution for S.A. 001 weight/volume injection Merchant as (Article 12(3) of use
injection for defined in Directive No
cattle relevant national 2001/82/EC)
legislation

Cydectin 1% w/v Zoetis Belgium VPA10387/014/ 1 percent Solution for - QP54AB02 LM: Licensed - Moxidectin Full application - Subcutaneous
Injectable S.A. 001 weight/volume injection Merchant as (Article 12(3) of use
Solution for defined in Directive No
Sheep relevant national 2001/82/EC)
legislation

Cydectin 10 % Zoetis Belgium VPA10387/015/ 10 percent Solution for - QP54AB02 LM: Licensed - Moxidectin Full application - Subcutaneous
LA Solution for S.A. 001 weight/volume injection Merchant as (Article 12(3) of use
Injection for defined in Directive No
Cattle relevant national 2001/82/EC)
legislation

Cydectin 20 Zoetis Belgium VPA10387/095/ 20 Solution for - QP54AB02 LM: Licensed - Moxidectin Full application - Subcutaneous
mg/ml LA S.A. 001 milligram(s)/millil injection Merchant as (Article 12(3) of use
Solution for itre defined in Directive No
Injection for relevant national 2001/82/EC)
Sheep legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 52 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Cydectin Zoetis Belgium VPA10387/016/ 1/50 Oral solution - QP54AB52 LM: Licensed - Moxidectin Fixed - Oral use
TriclaMox S.A. 001 milligram(s)/millil Merchant as - Triclabendazole combination
1mg/ml + 50 itre defined in application
mg/ml Oral relevant national (Article 13b of
Solution for legislation Directive No
sheep 2001/82/EC)
Cydectin Zoetis Belgium VPA10387/017/ 5/200 Pour-on solution - QP54AB52 LM: Licensed - Moxidectin Fixed - Cutaneous use
TriclaMox 5 S.A. 001 milligram(s)/millil Merchant as - Triclabendazole combination
mg/ml + 200 itre defined in application
mg/ml Pour-on relevant national (Article 13b of
Solution for legislation Directive No
cattle 2001/82/EC)
Cypercare Medivet Limited VPA10887/002/ 2.5 percent Pour-on solution - QP53AC LM: Licensed - Cypermethrin - Topical use
2.5%w/v Pour-on 001 weight/volume Merchant as technical (93%)
Solution defined in (cis: trans 50:50)
relevant national
legislation

Cyperguard Bimeda Animal VPA22033/007/ 10 percent Concentrate for - QP53AC08 LM: Licensed - Cypermethrin Informed - Topical use
Concentrate for Health Limited 001 weight/weight dip suspension Merchant as high cis consent
Dip Emulsion defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
CZV Avian CZ Veterinaria, VPA10784/001/ 25000 Solution for - QI02AR02 VPO: Veterinary - Purified protein Full application - Intradermal use
Tuberculin PPD S.A. 001 international injection Practitioner Only derivative from (Article 12(3) of
unit(s)/millilitre as defined in culture of Directive No
relevant national Mycobacterium 2001/82/EC)
legislation avium, subsp.
avium strain D4
ER

CZV BOVINE CZ Veterinaria, VPA10784/002/ 2500 Solution for - QI02AR01 VPO: Veterinary - Purified protein Full application - Intradermal use
TUBERCULIN S.A. 001 International injection Practitioner Only derivative from (Article 12(3) of
PPD, solution for Units/dose as defined in culture of Directive No
injection relevant national mycobacterium 2001/82/EC)
legislation bovis, strain an-5

Dalmaprost FATRO S.p.A. VPA10836/009/ 0.075 Solution for - QG02AD90 POM: - d-Cloprostenol Generic - Intramuscular
0.075 mg/ml 001 milligram(s)/millil injection Prescription Only application use
solution for itre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle, pigs and relevant national 2001/82/EC)
horses legislation

DALMARELIN, FATRO S.p.A. VPA10836/002/ 25 Solution for - QH01CA92 POM: - Lecirelin Full application - Intramuscular
25 001 microgram(s)/mil injection Prescription Only (Article 12(3) of use
micrograms/ml, lilitre Medicine as Directive No
solution for defined in 2001/82/EC)
injection for relevant national
cattle and rabbit legislation

Dalmazin 75 FATRO S.p.A. VPA10836/001/ 75 Solution for - QG02AD90 POM: - d-Cloprostenol - Intramuscular
micrograms/ml 001 microgram(s)/mil injection Prescription Only use
solution for lilitre Medicine as
injection for cows defined in
and sows relevant national
legislation

Deccox 60.6 Zoetis Belgium VPA10387/018/ 60.6 Premix for - QP51AX14 POM: - Decoquinate - Oral use
g/kg Premix for S.A. 001 gram(s)/kilogra medicated Prescription Only
Medicated m(s) feeding stuff Medicine as
Feeding Stuff defined in
relevant national
legislation

DECTOMAX 10 Zoetis Belgium VPA10387/019/ 10 Solution for - QP54AA03 LM: Licensed - Doramectin Generic - Intramuscular
mg/ml Solution S.A. 001 milligram(s)/millil injection Merchant as application use
for Injection for itre defined in (Article 13(1) of - Subcutaneous
Cattle, Sheep relevant national Directive No use
and Pigs legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 53 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Dectomax 5 Zoetis Belgium VPA10387/020/ 5 Pour-on solution - QP54AA03 LM: Licensed - Doramectin Generic - Topical use
mg/ml Pour-On S.A. 001 milligram(s)/millil Merchant as application
Solution for itre defined in (Article 13(1) of
Cattle relevant national Directive No
legislation 2001/82/EC)

Dectospot 10 Bimeda Animal VPA22033/058/ 10 Pour-on solution - QP53AC11 LM: Licensed - Deltamethrin Generic - Topical use
mg/ml Pour-on Health Limited 001 milligram(s)/millil Merchant as application
Solution for itre defined in (Article 13(1) of
Cattle and relevant national Directive No
Sheep. legislation 2001/82/EC)

Defendog Virbac S.A. VPA10988/053/ 1.88 grams/100 Cutaneous - QP53AC04 CAM: - Permethrin - Topical use
Cutaneous 001 millilitres solution Companion technical (40:60)
solution Animal Medicine
as defined in
relevant national
legislation

Delta Acravet Ltd VPA10793/001/ 3 Solution for - QV03AB07 VPO: Veterinary - Apomorphine 12(3) full dossier - Subcutaneous
Apomorphine 001 milligram(s)/millil injection Practitioner Only hydrochloride
Hydrochloride itre as defined in
Solution for relevant national
Injection 3 mg/ml legislation

Deltadot 10 Bimeda Animal VPA22033/008/ 10 Pour-on solution - QP53AC11 LM: Licensed - Deltamethrin Generic - Topical use
mg/ml Pour-on Health Limited 001 milligram(s)/millil Merchant as application
Solution for itre defined in (Article 13(1) of
Cattle and relevant national Directive No
Sheep legislation 2001/82/EC)

Deltanil 10 Virbac S.A. VPA10988/087/ 10 Cutaneous - QP53AC11 LM: Licensed - Deltamethrin Hybrid - Topical use
mg/ml Pour-on 001 milligram(s)/millil solution Merchant as application
Solution for itre defined in (Article 13(3) of
cattle and sheep relevant national Directive No
legislation 2001/82/EC)

Delvosteron 100 Intervet Ireland VPA10996/065/ 100 Suspension for - QG03DA90 POM: - Proligestone Full application - Subcutaneous
mg/ml Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
Suspension for itre Medicine as Directive No
Injection defined in 2001/82/EC)
relevant national
legislation

Deosan Summer Diversey VPA10457/001/ 2.25 percent Teat dip - QD08AC02 LM: Licensed - Chlorhexidine - Topical use
Teatcare Plus Hygiene Sales 001 weight/weight Merchant as digluconate
Limited defined in solution
relevant national
legislation

Deosan Super Diversey VPA10457/002/ 2.0 percent Teat dip - QD08AG LM: Licensed - Iodine - Topical use
Iodip Hygiene Sales 001 weight/volume Merchant as
Limited defined in
relevant national
legislation

Deosan Teatcare Diversey VPA10457/003/ 0.45 percent Teat dip - QD08AC02 LM: Licensed - Chlorhexidine - Topical use
Plus Hygiene Sales 001 weight/weight Merchant as digluconate
Limited defined in solution
relevant national
legislation

Depocillin 300 Intervet Ireland VPA10996/068/ 300 Suspension for - QJ01CE09 POM: - Procaine - Intramuscular
mg/ml Limited 001 milligram(s)/millil injection Prescription Only benzylpenicillin use
Suspension for itre Medicine as - Subcutaneous
Injection defined in use
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 54 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Depo-Medrone V Zoetis Belgium VPA10387/021/ 40 Suspension for - QH02AB04 POM: - Full application - Intramuscular
40 mg/ml S.A. 001 milligram(s)/millil injection Prescription Only Methylprednisol (Article 12(3) of use
Suspension for itre Medicine as one acetate Directive No - ZZZ
Injection defined in 2001/82/EC) Intrasynovial
relevant national
legislation

Dermanolon 1.77 Le Vet Beheer VPA10475/026/ 1.77,17.7 Cutaneous - QD07XB02 POM: - Triamcinolone Generic - Cutaneous use
mg/ml + 17.7 B.V. 001 milligram(s)/millil spray, solution Prescription Only acetonide application
mg/ml cutaneous itre Medicine as - Salicylic acid (Article 13(1) of
spray, solution defined in Directive No
for dogs and cat relevant national 2001/82/EC)
legislation

Dermipred 10 Ceva Santé VPA10815/029/ 10 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Generic - Oral use
mg tablets for Animale 002 Prescription Only application
dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Dermipred 20 Ceva Santé VPA10815/029/ 20 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Hybrid - Oral use
mg tablets for Animale 003 Prescription Only application
dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Dermipred 5 mg Ceva Santé VPA10815/029/ 5 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Hybrid - Oral use
tablets for dogs Animale 001 Prescription Only application
Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Dermoline Battle Hayward VPA10921/002/ 0.084, 0.04 Shampoo - QP53AC51 LM: Licensed - Piperonyl Full application - Topical use
Insecticidal & Bower Ltd 001 percent Merchant as butoxide 100% (Article 12(3) of
Shampoo for weight/weight defined in - Pyrethrum Directive No
Horses relevant national extract 25% 2001/82/EC)
legislation

DETOGESIC 10 Vetcare Limited VPA10789/001/ 10 Solution for - QN05CM90 VPO: Veterinary - Detomidine Hybrid - Intravenous
mg/ml Solution 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for Injection for itre as defined in (Article 13(3) of
Horses relevant national Directive No
legislation 2001/82/EC)

Detonervin 10 Le Vet BV VPA10816/010/ 10 Solution for - QN05CM90 VPO: Veterinary - Detomidine Generic - Intramuscular
mg/ml, solution 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection for itre as defined in (Article 13(1) of - Intravenous
Horses and relevant national Directive No use
Cattle legislation 2001/82/EC)

Dexacortone 0.5 Le Vet Beheer VPA10475/035/ 0.5 mg/tablet Chewable tablet - QH02AB02 POM: - Generic - Oral use
mg chewable B.V. 001 Prescription Only Dexamethasone application
tablets for dogs Medicine as (Article 13(1) of
and cats defined in Directive No
relevant national 2001/82/EC)
legislation

Dexacortone 2.0 Le Vet Beheer VPA10475/035/ 2 mg/tablet Chewable tablet - QH02AB02 POM: - Generic - Oral use
mg chewable B.V. 002 Prescription Only Dexamethasone application
tablets for dogs Medicine as (Article 13(1) of
and cats defined in Directive No
relevant national 2001/82/EC)
legislation

Dexadreson 2 Intervet Ireland VPA10996/027/ 2 Solution for - QH02AB02 POM: - Full application - Intraarticular
mg/ml solution Limited 001 milligram(s)/millil injection Prescription Only Dexamethasone (Article 12(3) of use
for injection itre Medicine as Directive No - Intramuscular
defined in 2001/82/EC) use
relevant national - Intravenous
legislation use

Veterinary Medicines Authorised/Transfer Pending Products Page 55 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Dexafast 2 LIVISTO Int'l, VPA10425/008/ 2 Solution for - QH02AB02 POM: - Generic - Intraarticular
mg/ml solution S.L. 001 milligram(s)/millil injection Prescription Only Dexamethasone application use
for injection for itre Medicine as (Article 13(1) of - Intramuscular
horses, cattle, defined in Directive No use
pigs, dogs and relevant national 2001/82/EC) - Intravenous
cats legislation use

Dexafort Intervet Ireland VPA10996/028/ 1.32/2.67 Suspension for - QH02AB02 POM: - Full application - Intramuscular
Suspension for Limited 001 milligram(s)/millil injection Prescription Only Dexamethasone (Article 12(3) of use
Injection itre Medicine as sodium Directive No
defined in phosphate 2001/82/EC)
relevant national -
legislation Dexamethasone
phenylpropionate

Dexa-ject 2 Dopharma VPA10791/004/ 2 Solution for - QH02AB02 POM: - Generic - Intraarticular


mg/ml solution Research B.V. 001 milligram(s)/millil injection Prescription Only Dexamethasone application use
for injection for itre Medicine as (Article 13(1) of - Intramuscular
cattle, horses, defined in Directive No use
pigs, dogs and relevant national 2001/82/EC) - Intravenous
cats legislation use

Dexameth Chem-Pharm VPA10823/013/ 2<br/> Solution for - QH02AB02 POM: - Informed - Intramuscular
2mg/ml solution 001 milligram(s)/millil injection Prescription Only Dexamethasone consent use
for injection itre Medicine as sodium application - Intravenous
defined in phosphate (Article 13c of use
relevant national Directive No
legislation 2001/82/EC)

Dexamethasone Alfasan VPA10980/002/ 2 Solution for - QH02AB02 POM: - - Intramuscular


2 mg/ml solution Nederland B.V 001 milligram(s)/millil injection Prescription Only Dexamethasone use
for injection for itre Medicine as - Intravenous
dogs, cats, cattle defined in use
and horses relevant national
legislation

Dexashot 2 Vet-Agro Multi- VPA20742/003/ 2 Solution for - QH02AB02 POM: - Generic - Intraarticular
mg/ml solution trade company 001 milligram(s)/millil injection Prescription Only Dexamethasone application use
for injection for Sp z o.o. itre Medicine as (Article 13(1) of - Intramuscular
cattle, horses, defined in Directive No use
pigs, dogs and relevant national 2001/82/EC) - Intravenous
cats legislation use

Dexatat 2 mg/ml aniMedica VPA10826/002/ 2 Solution for - QH02AB02 POM: - Well-established - Intramuscular
solution for GmbH 001 milligram(s)/millil injection Prescription Only Dexamethasone use application use
Injection itre Medicine as (Article 13a of - Intravenous
defined in Directive No use
relevant national 2001/82/EC)
legislation

DEXMOPET 0.5 Vetpharma VPA10516/013/ 0.5 Solution for - QN05CM18 VPO: Veterinary - Generic - Intramuscular
mg/ml solution Animal Health, 001 milligram(s)/millil injection Practitioner Only Dexmedetomidi application use
for injection for S.L. itre as defined in ne (Article 13(1) of - Intravenous
dogs and cats relevant national Directive No use
legislation 2001/82/EC)

Dexrapid 2 Richter Pharma VPA10801/016/ 2.0 Solution for - QH02AB02 POM: - Generic - Intraarticular
mg/ml solution AG 001 milligram(s)/millil injection Prescription Only Dexamethasone application use
for injection itre Medicine as (as (Article 13(1) of - Intramuscular
defined in dexamethasone Directive No use
relevant national sodium 2001/82/EC) - Intravenous
legislation phosphate) use

DFV DOXIVET Divasa-Farmavic VPA10505/001/ 200 Solution for use - QJ01AA02 POM: - Doxycycline Hybrid - Oral use
200 mg/ml, S.A. 001 milligram(s)/millil in drinking water Prescription Only hyclate application
solution for use itre Medicine as (Article 13(3) of
in drinking water defined in Directive No
for pigs and relevant national 2001/82/EC)
chickens legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 56 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
DFV DOXIVET Divasa-Farmavic VPA10505/002/ 500 Powder for use - QJ01AA02 POM: - Doxycycline Generic - In drinking
500 mg/g, S.A. 001 milligram(s)/gra in drinking water Prescription Only hyclate application water use
powder for use in m Medicine as (Article 13(1) of
drinking water for defined in Directive No
pigs and relevant national 2001/82/EC)
chickens legislation

Diatrim 200 Eurovet Animal VPA10989/070/ 200, 40 Solution for - QJ01EW10 POM: - Sulfadiazine Generic - Intramuscular
mg/ml + 40 Health B.V. 001 milligram(s)/millil injection Prescription Only - Trimethoprim application use
mg/ml solution itre Medicine as (Article 13(1) of - Intravenous
for injection defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Diazedor 5 Richter Pharma VPA10801/011/ 5 Solution for - QN05BA01 VPO: Veterinary - Diazepam ph. Generic - Intravenous
mg/ml solution AG 001 milligram(s)/millil injection Practitioner Only eur. application use
for injection for itre as defined in (Article 13(1) of
dogs and cats relevant national Directive No
legislation 2001/82/EC)

Dihydrostreptom Alfasan VPA10980/004/ 25 percent Solution for - QJ01GA90 POM: - - Intramuscular


ycin 25% Nederland B.V 001 weight/volume injection Prescription Only Dihydrostreptom use
Solution for Medicine as ycin
Injection defined in
relevant national
legislation

Dilaterol 25 Le Vet Beheer VPA10475/002/ 25 Oral gel - QR03CC13 POM: - Clenbuterol- Generic - Oral use
micrograms/ml B.V. 001 microgram(s)/mil Prescription Only hydrochloride application
syrup for horses lilitre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

DILUMAREX Boehringer VPA10454/031/ . Solution for - QV07AB POM: Full application


Ingelheim 001 injection Prescription Only (Article 12(3) of
Vetmedica Medicine as Directive No
GmbH defined in 2001/82/EC)
relevant national
legislation

Dimazon 50 Intervet Ireland VPA10996/109/ 50 Solution for - QC03CA01 POM: - Furosemide Full application - Intramuscular
mg/ml Solution Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
for Injection itre Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national
legislation

DINALGEN 300 Ecuphar VPA10389/001/ 300 Oral solution - QM01AE03 POM: - Ketoprofen Well-established - Oral use
mg/ml oral Veterinaria 001 milligram(s)/millil Prescription Only use application
solution for use S.L.U. itre Medicine as (Article 13a of
in drinking water defined in Directive No
for cattle and relevant national 2001/82/EC)
pigs legislation

DINALGEN 150 Ecuphar VPA10389/002/ 150 Solution for - QM01AE03 POM: - Ketoprofen Well-established - Intramuscular
mg/ml solution Veterinaria 001 milligram(s)/millil injection Prescription Only use application use
for injection for S.L.U. itre Medicine as (Article 13a of - Intravenous
cattle, pigs and defined in Directive No use
horses relevant national 2001/82/EC)
legislation

Dipen 100ml Bimeda Animal VPA22033/009/ 200, 200 Suspension for - QJ01RA01 POM: - Procaine Informed - Intramuscular
Suspension for Health Limited 001 milligram(s)/millil injection Prescription Only benzylpenicillin consent use
Injection for itre Medicine as - application
cattle, sheep and defined in Dihydrostreptom (Article 13c of
pigs relevant national ycin (as the Directive No
legislation sulfate) 2001/82/EC)

Distocur 34 Dopharma VPA10791/013/ 34 Oral suspension - QP52AG06 LM: Licensed - Oxyclozanide Generic - Oral use
mg/ml Oral Research B.V. 001 milligram(s)/millil Merchant as application
suspension for itre defined in (Article 13(1) of
cattle and sheep relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 57 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Diurizone Vetoquinol VPA10983/011/ 50, 0.5 Solution for - QC03AX01 POM: - Full application - Intramuscular
Injectable Ireland Limited 001 milligram(s)/millil injection Prescription Only Hydrochlorothia (Article 12(3) of use
itre Medicine as zide Directive No - Intravenous
defined in - 2001/82/EC) use
relevant national Dexamethasone - Subcutaneous
legislation use

Diurizone Vetoquinol VPA10983/010/ 0.25, 75.0 Oral powder - QC03AX01 POM: - Full application - Oral use
Powder Ireland Limited 001 milligram(s)/gra Prescription Only Dexamethasone (Article 12(3) of
m Medicine as - Directive No
defined in Hydrochlorothia 2001/82/EC)
relevant national zide
legislation

Dolethal 200 Vetoquinol VPA10983/015/ 200 Solution for - QN51AA01 VPO: Veterinary - Pentobarbital - Intracardiac
mg/ml Solution Ireland Limited 001 milligram(s)/millil injection Practitioner Only sodium use
for Injection itre as defined in - Intravenous
relevant national use
legislation

Dolocarp flavour, aniMedica VPA10826/014/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
100 mg, GmbH 003 Prescription Only application
chewable tablet Medicine as (Article 13(1) of
for dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Dolocarp flavour, aniMedica VPA10826/014/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
20 mg, chewable GmbH 001 Prescription Only application
tablets for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Dolocarp flavour, aniMedica VPA10826/014/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
50 mg, chewable GmbH 002 Prescription Only application
tablet for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Dolorex 10 Intervet Ireland VPA10996/185/ 10 Solution for - QN02AF01 POM: - Butorphanol Well-established - Intramuscular
mg/ml Solution Limited 001 milligram(s)/millil injection Prescription Only use application use
for Injection for itre Medicine as (Article 13a of - Intravenous
horse, dog and defined in Directive No use
cat relevant national 2001/82/EC) - Subcutaneous
legislation use

Domidine 10 Eurovet Animal VPA10989/053/ 10 Solution for - QN05CM90 VPO: Veterinary - Detomindine Generic - Intramuscular
mg/ml solution Health B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection, for itre as defined in (Article 13(1) of - Intravenous
horses and cattl relevant national Directive No use
legislation 2001/82/EC)

Domitor 1 mg/ml Orion VPA10664/005/ 1 Solution for - QN05CM91 VPO: Veterinary - Medetomidine Full application - Intramuscular
solution for Corporation 001 milligram(s)/millil injection Practitioner Only hydrochloride (Article 12(3) of use
injection itre as defined in Directive No - Intravenous
relevant national 2001/82/EC) use
legislation

Domosedan 10 Orion VPA10664/004/ 10 Solution for - QN05CM90 VPO: Veterinary - Detomidine Full application - Intramuscular
mg/ml solution Corporation 001 milligram(s)/millil injection Practitioner Only hydrochloride (Article 12(3) of use
for injection itre as defined in Directive No - Intravenous
relevant national 2001/82/EC) use
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 58 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
DOMOSEDAN Orion VPA10664/001/ 7.6 Oromucosal gel - QN05CM90 VPO: Veterinary - Detomidine Full application - Sublingual use
GEL 7.6 mg/ml Corporation 001 milligram(s)/millil Practitioner Only hydrochloride (Article 12(3) of
oromucosal gel itre as defined in Directive No
relevant national 2001/82/EC)
legislation

DOPHEXINE 20 Dopharma VPA10791/011/ 20 Powder for use - QR05CB02 POM: - Bromhexine Hybrid - In drinking
mg/g powder for Research B.V. 001 milligram(s)/gra in drinking Prescription Only application water/milk use
use in drinking m water/milk Medicine as (Article 13(3) of
water/milk defined in Directive No
relevant national 2001/82/EC)
legislation

DORAFLOX 100 Dopharma VPA10791/009/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml solution Research B.V. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Dorbene vet 1 Laboratorios VPA10495/002/ 1 Solution for - QN05CM91 VPO: Veterinary - Medetomidine Generic - Intramuscular
mg/ml solution SYVA, S.A.U 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection for itre as defined in (Article 13(1) of - Intravenous
dogs and cats relevant national Directive No use
legislation 2001/82/EC) - Subcutaneous
use

Doxatib 500 Krka, d.d., Novo VPA10774/046/ 500 Powder for use - QJ01AA02 POM: - Doxycycline Generic - Oral use
mg/g powder for mesto 001 milligram(s)/gra in drinking water Prescription Only hyclate application
use in drinking m Medicine as (Article 13(1) of
water for pigs defined in Directive No
and chickens relevant national 2001/82/EC)
legislation

Doxipulvis 500 SP Veterinaria, VPA10790/008/ 500 Oral powder - QJ01AA02 POM: - Doxycycline Hybrid - Oral use
mg/g powder for S.A. 001 milligram(s)/gra Prescription Only application
use in drinking m Medicine as (Article 13(3) of
water / milk defined in Directive No
replacer relevant national 2001/82/EC)
legislation

Doxivex, 100 SP Veterinaria, VPA10790/001/ 100 Oral solution - QJ01AA02 POM: - Doxycycline Generic - Oral use
mg/ml S.A. 001 milligram(s)/millil Prescription Only application
concentrate for itre Medicine as (Article 13(1) of
oral solution for defined in Directive No
chickens and relevant national 2001/82/EC)
pigs legislation

Doxx-Sol 500 Huvepharma NV VPA10782/017/ 500 Powder for oral - QJ01AA02 POM: - Doxycycline Generic - Oral use
mg/g powder for 001 milligram(s)/gra solution Prescription Only hyclate application
use in drinking m Medicine as (Article 13(1) of
water/milk defined in Directive No
replacer for pre- relevant national 2001/82/EC)
ruminant calves, legislation
pigs and
chickens

Doxybactin 200 Le Vet Beheer VPA10475/031/ 200 mg/tablet Tablet - QJ01AA02 POM: - Doxycyline Hybrid - Oral use
mg tablets for B.V. 003 Prescription Only application
dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Doxybactin 400 Le Vet Beheer VPA10475/031/ 400 mg/tablet Tablet - QJ01AA02 POM: - Doxycyline Hybrid - Oral use
mg tablets for B.V. 004 Prescription Only application
dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 59 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Doxybactin 50 Le Vet Beheer VPA10475/031/ 50 mg/tablet Tablet - QJ01AA02 POM: - Doxycyline Hybrid - Oral use
mg tablets for B.V. 002 Prescription Only application
dogs and cats Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Doxycare Ecuphar NV VPA10491/013/ 200 mg/tablet Tablet - QJ01AA02 POM: - Doxycycline Hybrid - Per Oral
Flavour 200 mg 002 Prescription Only hyclate application
Tablets for Cats Medicine as (Article 13(3) of
and Dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Doxycare Ecuphar NV VPA10491/013/ 40 mg/tablet Tablet - QJ01AA02 POM: - Doxycycline Hybrid - Per Oral
Flavour 40 mg 001 Prescription Only hyclate application
Tablets for Cats Medicine as (Article 13(3) of
and Dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Doxylin, 433 Dopharma VPA10791/007/ 433 Powder for use - QJ01AA02 POM: - Doxycycline Hybrid - In drinking
mg/g, powder for Research B.V. 001 milligram(s)/gra in drinking water Prescription Only application water use
use in drinking m Medicine as (Article 13(3) of
water for defined in Directive No
chickens and relevant national 2001/82/EC)
turkeys legislation

Doxytab vet. 15 CP-Pharma VPA10810/020/ 15 milligram(s) Tablet - QJ01AA02 POM: - Doxycycline Generic - Oral use
mg Tablets for Handelsgesellsc 001 Prescription Only application
dogs and cats haft mbH Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Doxytab vet. 200 CP-Pharma VPA10810/020/ 200 milligram(s) Tablet - QJ01AA02 POM: - Doxycycline Hybrid - Oral use
mg Tablets for Handelsgesellsc 003 Prescription Only application
dogs haft mbH Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Doxytab vet. 400 CP-Pharma VPA10810/020/ 400 milligram(s) Tablet - QJ01AA02 POM: - Doxycycline Hybrid - Oral use
mg Tablets for Handelsgesellsc 004 Prescription Only application
dogs haft mbH Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Doxytab vet. 50 CP-Pharma VPA10810/020/ 50 milligram(s) Tablet - QJ01AA02 POM: - Doxycycline Hybrid - Oral use
mg Tablets for Handelsgesellsc 002 Prescription Only application
dogs and cats haft mbH Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Dozuril 25 mg/ml Dopharma VPA10791/002/ 25 Solution for use - QP51AJ01 POM: - Toltrazuril Generic - Oral use
solution for use Research B.V. 001 milligram(s)/millil in drinking water Prescription Only application
in drinking water itre Medicine as (Article 13(1) of
for chickens defined in Directive No
relevant national 2001/82/EC)
legislation

Draxxin Plus 100 Zoetis Belgium VPA10387/099/ 100, 120 Solution for - QJ01FA POM: - Tulathromycin Fixed - Subcutaneous
mg/ml + 120 S.A. 001 milligram(s)/millil injection Prescription Only - Ketoprofen combination use
mg/ml solution itre Medicine as application
for injection for defined in (Article 13b of
cattle relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 60 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Droncit Tablets Vetoquinol SA VPA10521/005/ 50.0 mg/tablet Tablet - QP52AA01 CAM: - Praziquantel - Oral use
50 mg 001 Companion
Animal Medicine
as defined in
relevant national
legislation

Drontal Cat Vetoquinol SA VPA10521/007/ 20/230 mg/tablet Tablet - QP52AA51 CAM: - Praziquantel - Oral use
Tablets 001 Companion - Pyrantel
Animal Medicine embonate
as defined in
relevant national
legislation

Drontal Cat XL Vetoquinol SA VPA10521/007/ 30/345 mg/tablet Tablet - QP52AA51 CAM: - Praziquantel Full application - Oral use
Film-coated 002 Companion - Pyrantel (Article 12(3) of
Tablets Animal Medicine embonate Directive No
as defined in 2001/82/EC)
relevant national
legislation

Drontal Dog Vetoquinol SA VPA10521/012/ 150,144,50 Tablet - QP52AC55 CAM: - Febantel Generic - Oral use
Tasty Bone 001 mg/tablet Companion - Pyrantel application
150/144/50 mg Animal Medicine embonate (Article 13(1) of
tablets as defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Drontal Dog Vetoquinol SA VPA10521/012/ 525,504,175 Tablet - QP52AA51 CAM: - Febantel Generic - Oral use
Tasty Bone XL 002 mg/tablet Companion - Pyrantel application
525/504/175 mg Animal Medicine embonate (Article 13(1) of
tablets as defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Drontal Oral Vetoquinol SA VPA10521/008/ 15 / 5 Oral suspension - QP52AF02 CAM: - Febantel Full application - Oral use
Suspension for 001 milligram(s)/millil Companion - Pyrantel (Article 12(3) of
Puppies itre Animal Medicine Directive No
as defined in 2001/82/EC)
relevant national
legislation

Drontal Plus Vetoquinol SA VPA10521/006/ 144, 50, 150 Tablet - QP52AC55 CAM: - Pyrantel Fixed - Oral use
Flavour Bone 003 mg/tablet Companion embonate combination
Shaped Tablets Animal Medicine - Praziquantel application
as defined in - Febantel (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Drontal Plus Vetoquinol SA VPA10521/011/ 150, 144, 50 Tablet - QP52AF30 CAM: - Febantel Informed - Oral use
Flavour Tablets 001 mg/tablet Companion - Pyrantel consent
for Dogs Animal Medicine embonate application
as defined in - Praziquantel (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Drontal Plus Vetoquinol SA VPA10521/006/ 150, 144, 50 Tablet - QP52AA51 CAM: - Febantel - Oral use
Tablets 001 mg/tablet Companion - Pyrantel
Animal Medicine embonate
as defined in - Praziquantel
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 61 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Drontal Plus XL Vetoquinol SA VPA10521/009/ 175, 504, 525 Tablet - QP52AF30 CAM: - Praziquantel Informed - Oral use
Flavour Tablets 001 mg/tablet Companion - Pyrantel consent
for Dogs Animal Medicine embonate application
as defined in - Febantel (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Drontal Plus XL Vetoquinol SA VPA10521/006/ 175, 504, 525 Tablet - QP52AC55 CAM: - Pyrantel - Oral use
Tablets 002 mg/tablet Companion embonate
Animal Medicine - Praziquantel
as defined in - Febantel
relevant national
legislation

Drontal Tasty Vetoquinol SA VPA10521/014/ 150,144,50 Tablet - QP52AC55 POM: - Febantel Generic - Oral use
Bone Multi-worm 001 mg/tablet Prescription Only - Pyrantel application
150/144/50 mg Medicine as embonate (Article 13(1) of
tablets defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Drontal Tasty Vetoquinol SA VPA10521/014/ 525,504,175 Tablet - QP52AA51 POM: - Febantel Generic - Oral use
Bone Multi-worm 002 mg/tablet Prescription Only - Pyrantel application
XL 525/504/175 Medicine as embonate (Article 13(1) of
mg tablets defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Drontal Tasty Vetoquinol SA VPA10521/015/ 150,144,50 Tablet - QP52AC55 POM: - Febantel Generic - Oral use
Bone Wormer 001 mg/tablet Prescription Only - Pyrantel application
150/144/50 mg Medicine as embonate (Article 13(1) of
tablets defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Drontal Tasty Vetoquinol SA VPA10521/015/ 525,504,175 Tablet - QP52AA51 POM: - Febantel Generic - Oral use
Bone Wormer XL 002 mg/tablet Prescription Only - Pyrantel application
525/504/175 mg Medicine as embonate (Article 13(1) of
tablets defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Dugmectin 18.7 ECO Animal VPA22693/010/ 18.7 Oral paste - QP54AA01 LM: Licensed - Ivermectin Informed - Oral use
mg/g Oral Paste Health Europe 001 milligram(s)/gra Merchant as consent
for Horses Limited m defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Dugnixon 50 GLOBAL VET VPA10477/004/ 50 Solution for - QM01AG90 POM: - Flunixin Generic - Intramuscular
mg/ml solution HEALTH SL 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle, pigs and defined in Directive No use
horses relevant national 2001/82/EC)
legislation

Duocycline 10% Univet Limited VPA10990/009/ 10 percent Solution for - QJ01AA06 POM: - Oxytetracycline - Intramuscular
Solution for 001 weight/volume injection Prescription Only hydrochloride use
Injection Medicine as
defined in
relevant national
legislation

Duocycline LA Univet Limited VPA10990/016/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline - Intramuscular
200 mg/ml 001 milligram(s)/millil injection Prescription Only use
Solution for itre Medicine as
Injection defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 62 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Duodip 3.1 %w/v Bimeda Animal VPA22033/011/ 3.1 percent Teat dip - QD08A LM: Licensed - Ammonium Informed - Topical use
Concentrated Health Limited 001 weight/volume Merchant as lauryl sulphate consent
Teat Dip defined in (as a application
relevant national concentrate 27- (Article 13c of
legislation 28% w/w) Directive No
2001/82/EC)
Duofast Norbrook VPA22664/003/ 40, 200 Intramammary - QJ51 POM: - Trimethoprim Informed - Intramammary
Intramammary Laboratories 001 milligram(s)/millil suspension Prescription Only - Sulphadiazine consent use
Suspension (Ireland) Limited itre Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Duotech Oral Norbrook VPA22664/057/ 25, 50 Oral suspension - QP52AC30 LM: Licensed - Oxfendazole - Oral use
Suspension for Laboratories 001 milligram(s)/millil Merchant as - Closantel
Sheep (Ireland) Limited itre defined in
relevant national
legislation

Duowin, Virbac S.A. VPA10988/054/ 1.88 / 0.2 Cutaneous - QP53AC POM: - Permethrin - Topical use
Cutaneous 001 grams/100 spray, solution Prescription Only (40/60)
spray, Solution millilitres Medicine as - Pyriproxyfen
defined in
relevant national
legislation

Duphalyte Zoetis Belgium VPA10387/023/ . Solution for - QB05BB POM: - Calcium Full application - Intraperitoneal
Solution for S.A. 001 injection Prescription Only chloride (Article 12(3) of use
Injection Medicine as hexahydrate Directive No - Intravenous
defined in - Magnesium 2001/82/EC) use
relevant national sulphate - Subcutaneous
legislation - Potassium use
chloride
- Thiamine
hydrochloride
- Riboflavine
sodium
phosphate
- Pyridoxine
Hydrochloride
-
Cyanocobalamin
- Nicotinamide
- Dexpanthenol
- Glucose
anhydrous
- Arginine
hydrochloride
- Cysteine
hydrochloride
monohydrate
- Histidine
hydrochloride
monohydrate
- Isoleucine
- Leucine
- Lysine
Hydrochloride
- Methionine
- dl-
Phenylalanine
- Threonine
- dl-Tryptophane
- dl-Valine
- Monosodium
glutamate
monohydrate

Dycoxan 2.5 Chanelle VPA10987/122/ 2.5 Oral suspension - QP51AJ03 LM: Licensed - Diclazuril Generic - Oral use
mg/ml Oral Pharmaceuticals 001 milligram(s)/millil Merchant as application
Suspension for Manufacturing itre defined in (Article 13(1) of
sheep and cattle Limited relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 63 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Ecofleece 10% Bimeda Animal VPA22033/012/ 10 percent Concentrate for - QP53AC LM: Licensed - Cypermethrin Informed - Topical use
w/w Sheep Dip Health Limited 001 weight/weight dip suspension Merchant as high cis consent
Concentrate defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Ecomectin 10 ECO Animal VPA22693/001/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin Well-established - Subcutaneous
mg/ml Solution Health Europe 001 milligram(s)/millil injection Merchant as use application use
for Injection Limited itre defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

Ecomectin 18.7 ECO Animal VPA22693/009/ 18.7 Oral paste - QP54AA01 LM: Licensed - Ivermectin Informed - Oral use
mg/g Oral Paste Health Europe 001 milligram(s)/gra Merchant as consent
for Horses Limited m defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Ecomectin 5 ECO Animal VPA22693/003/ 5 Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Well-established - Topical use
mg/ml Pour-on Health Europe 001 milligram(s)/millil Merchant as use application
Solution for Limited itre defined in (Article 13a of
Cattle relevant national Directive No
legislation 2001/82/EC)

Ecomectin 6 ECO Animal VPA22693/013/ 6 Oral powder - QP54AA01 POM: - Ivermectin Generic - Oral use
mg/g Oral Health Europe 001 milligram(s)/gra Prescription Only application
Powder for pigs Limited m Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Ecomectin 6 ECO Animal VPA22693/011/ 6 Premix for - QP54AA01 POM: - Ivermectin Generic - Oral use
mg/g Premix for Health Europe 001 milligram(s)/gra medicated Prescription Only application
medicated Limited m feeding stuff Medicine as (Article 13(1) of
feeding stuff for defined in Directive No
pigs relevant national 2001/82/EC)
legislation

Ectoflits Summer Bimeda Animal VPA22033/013/ 60 percent Concentrate for - QP53AF LM: Licensed - Dimpylate Informed - Topical use
and Winter Health Limited 001 weight/weight dip solution Merchant as (Diazinon consent
Sheep Dip, 60 defined in Stabilised application
%w/w relevant national Technical) (Article 13c of
Concentrate for legislation Directive No
Dip Solution 2001/82/EC)
Ectofly 12.5 Bimeda Animal VPA22033/059/ 12.5 Pour-on solution - QP53AC08 LM: Licensed - Cypermethrin Generic - Topical use
mg/ml Pour-On Health Limited 001 milligram(s)/millil Merchant as high:cis (80:20) application
Solution for itre defined in (Article 13(1) of
Sheep relevant national Directive No
legislation 2001/82/EC)

Ectospec 2.5% Bimeda Animal VPA22033/014/ 2.5 percent Pour-on solution - QP53AC LM: Licensed - Cypermethrin Informed - Topical use
w/v Pour-On Health Limited 001 weight/volume Merchant as technical (93%) consent
Solution defined in (cis: trans 50:50) application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Efex 10 mg Ceva Santé VPA10815/036/ 10 mg/tablet Chewable tablet - QJ01MA93 POM: - Marbofloxacin Hybrid - Oral use
chewable tablets Animale 001 Prescription Only application
for cats and dog Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Efex 100 mg Ceva Santé VPA10815/036/ 100 mg/tablet Chewable tablet - QJ01MA93 POM: - Marbofloxacin Hybrid - Oral use
chewable tablets Animale 003 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 64 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Efex 40 mg Ceva Santé VPA10815/036/ 40 mg/tablet Chewable tablet - QJ01MA93 POM: - Marbofloxacin Hybrid - Oral use
chewable tablets Animale 002 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

EFFIPRO 134 Virbac S.A. VPA10988/076/ 134 mg/pipette Cutaneous - QP53AX15 POM: - Fipronil Hybrid - Topical use
mg spot-on 002 solution Prescription Only application
solution for Medicine as (Article 13(3) of
medium dogs defined in Directive No
relevant national 2001/82/EC)
legislation

EFFIPRO 2.5 Virbac S.A. VPA10988/072/ 2.5 Cutaneous - QP53AX15 POM: - Fipronil Hybrid - Cutaneous use
mg/ml cutaneous 001 milligram(s)/millil spray, solution Prescription Only application
spray, solution itre Medicine as (Article 13(3) of
for cats and dog defined in Directive No
relevant national 2001/82/EC)
legislation

EFFIPRO 268 Virbac S.A. VPA10988/076/ 268 mg/pipette Cutaneous - QP53AX15 POM: - Fipronil Hybrid - Topical use
mg spot-on 003 solution Prescription Only application
solution for large Medicine as (Article 13(3) of
dogs defined in Directive No
relevant national 2001/82/EC)
legislation

EFFIPRO 402 Virbac S.A. VPA10988/076/ 402 mg/pipette Cutaneous - QP53AX15 POM: - Fipronil Hybrid - Topical use
mg spot-on 004 solution Prescription Only application
solution for very Medicine as (Article 13(3) of
large dogs defined in Directive No
relevant national 2001/82/EC)
legislation

EFFIPRO 50 mg Virbac S.A. VPA10988/075/ 50 mg/pipette Cutaneous - QP53AX15 POM: - Fipronil Hybrid - Cutaneous use
spot-on solution 001 solution Prescription Only application
for cats Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

EFFIPRO 67 mg Virbac S.A. VPA10988/076/ 67 mg/pipette Cutaneous - QP53AX15 POM: - Fipronil Hybrid - Topical use
spot-on solution 001 solution Prescription Only application
for small dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Effipro duo 100 Virbac S.A. VPA10988/100/ 100, 120 Spot-on solution - QP53AX65 POM: - Fipronil Fixed - Topical use
mg / 120 mg 006 mg/pipette Prescription Only - Pyriproxyfen combination
spot-on solution Medicine as application
for very large defined in (Article 13b of
cats relevant national Directive No
legislation 2001/82/EC)

Effipro duo 134 Virbac S.A. VPA10988/100/ 134,40 Spot-on solution - QP53AX65 POM: - Fipronil Fixed - Topical use
mg / 40 mg spot- 002 mg/pipette Prescription Only - Pyriproxyfen combination
on solution for Medicine as application
medium dogs defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Effipro duo 268 Virbac S.A. VPA10988/100/ 268,80 Spot-on solution - QP53AX65 POM: - Fipronil Fixed - Topical use
mg / 80 mg spot- 003 mg/pipette Prescription Only - Pyriproxyfen combination
on solution for Medicine as application
large dogs defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 65 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Effipro duo 402 Virbac S.A. VPA10988/100/ 402,120 Spot-on solution - QP53AX65 POM: - Fipronil Fixed - Topical use
mg / 120 mg 004 mg/pipette Prescription Only - Pyriproxyfen combination
spot-on solution Medicine as application
for very large defined in (Article 13b of
dogs relevant national Directive No
legislation 2001/82/EC)

Effipro duo 50 Virbac S.A. VPA10988/100/ 50,60 mg/pipette Spot-on solution - QP53AX65 POM: - Fipronil Fixed - Topical use
mg / 60 mg spot- 005 Prescription Only - Pyriproxyfen combination
on solution for Medicine as application
cats defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Effipro duo 67 Virbac S.A. VPA10988/100/ 67, 20 Spot-on solution - QP53AX65 POM: - Fipronil Fixed - Topical use
mg / 20 mg spot- 001 mg/pipette Prescription Only - Pyriproxyfen combination
on solution for Medicine as application
small dogs defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Effitix 134 Virbac S.A. VPA10988/097/ 134, 1200 Spot-on solution - QP53AC54 POM: - Fipronil Fixed - Cutaneous use
mg/1200 mg 003 mg/pipette Prescription Only - Permethrin combination
spot-on solution Medicine as application
for medium dogs defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Effitix 26.8 Virbac S.A. VPA10988/097/ 26.8, 240 Spot-on solution - QP53AC54 POM: - Fipronil Fixed - Cutaneous use
mg/240 mg spot- 001 mg/pipette Prescription Only - Permethrin combination
on solution for Medicine as application
very small dogs defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Effitix 268 Virbac S.A. VPA10988/097/ 268, 2400 Spot-on solution - QP53AC54 POM: - Fipronil Fixed - Cutaneous use
mg/2400 mg 004 mg/pipette Prescription Only - Permethrin combination
spot-on solution Medicine as application
for large dogs defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Effitix 402 Virbac S.A. VPA10988/097/ 402, 3600 Spot-on solution - QP53AC54 POM: - Fipronil Fixed - Cutaneous use
mg/3600 mg 005 mg/pipette Prescription Only - Permethrin combination
spot-on solution Medicine as application
for very large defined in (Article 13b of
dogs relevant national Directive No
legislation 2001/82/EC)

Effitix 67 mg/600 Virbac S.A. VPA10988/097/ 67, 600 Spot-on solution - QP53AC54 POM: - Fipronil Fixed - Cutaneous use
mg spot-on 002 mg/pipette Prescription Only - Permethrin combination
solution for small Medicine as application
dogs defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Effydral Tablets Zoetis Belgium VPA10387/024/ . gram/tablet Effervescent - QB05XA LM: Licensed - Anhydrous ZZZ --Unknown- - Oral use
S.A. 001 tablet Merchant as citric acid
defined in - Potassium
relevant national chloride
legislation - Sodium
chloride
- Sodium
hydrogen
carbonate
- Glycine
- Lactose
monohydrate
EFICUR 50 Laboratorios VPA10846/006/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur (as Generic - Intramuscular
mg/ml Hipra S.A. 001 milligram(s)/millil injection Prescription Only ceftiofur application use
suspension for itre Medicine as hydrochloride) (Article 13(1) of - Subcutaneous
injection for pigs defined in Directive No use
and cattle relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 66 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Eirpet Flea and P.B.S Sales VPA10878/001/ 15 percent Collar - QP53AF CAM: - Dimpylate Informed - Topical use
Tick Collar for Limited 001 weight/volume Companion consent
Dogs Animal Medicine application
as defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

EKYFLOGYL AUDEVARD VPA10481/002/ 1.80/8.65 Gel - QM02AX POM: - Prednisolone Generic - Cutaneous use
1.8mg/ml + 001 milligram(s)/millil Prescription Only - Lidocaine application
8.7mg/ml GEL itre Medicine as (Article 13(1) of
FOR HORSES defined in Directive No
relevant national 2001/82/EC)
legislation

Eliminall 134 mg Krka, d.d., Novo VPA10774/013/ 134 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
spot-on solution mesto 002 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Eliminall 2.5 Krka, d.d., Novo VPA10774/023/ 2.5 Cutaneous - QP53AX15 POM: - Fipronil Generic - Cutaneous use
mg/ml cutaneous mesto 001 milligram(s)/millil spray, solution Prescription Only application
spray, solution itre Medicine as (Article 13(1) of
for cats and dog defined in Directive No
relevant national 2001/82/EC)
legislation

Eliminall 268 mg Krka, d.d., Novo VPA10774/013/ 268 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
spot-on solution mesto 003 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Eliminall 402 mg Krka, d.d., Novo VPA10774/013/ 402 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
spot-on solution mesto 004 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Eliminall 50 mg Krka, d.d., Novo VPA10774/012/ 50 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
spot-on solution mesto 001 Prescription Only application
for cats Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Eliminall 67 mg Krka, d.d., Novo VPA10774/013/ 67 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
spot-on solution mesto 001 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Elivec 5 mg/ml LIVISTO Int'l, VPA10425/005/ 5 Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Generic - Pour-on use
pour-on solution S.L. 001 milligram(s)/millil Merchant as application
for cattle itre defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Embotape Oral Bimeda Animal VPA22033/015/ 400 Oral paste - QP52AF02 LM: Licensed - Pyrantel - Oral use
Paste 400 mg/g Health Limited 001 milligram(s)/gra Merchant as embonate
m defined in
relevant national
legislation

Emdofluxin 50 Emdoka bvba VPA10534/008/ 50 Solution for - QM01AG90 POM: - Flunixin Generic - Intramuscular
mg/ml solution 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle, pigs and defined in Directive No use
horses relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 67 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Emeprid 1 mg/ml Ceva Santé VPA10815/017/ 1 Oral solution - QA03FA01 POM: - Generic - Oral use
oral solution for Animale 001 milligram(s)/millil Prescription Only Metoclopramide application
dogs and cats itre Medicine as hydrochloride (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Emeprid 5 mg/ml Ceva Santé VPA10815/018/ 5 Solution for - QA03FA01 POM: - Generic - Intramuscular
solution for Animale 001 milligram(s)/millil injection Prescription Only Metoclopramide application use
injection for dogs itre Medicine as hydrochloride (Article 13(1) of - Intravenous
and cats defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Endex 19.5 % Elanco GmbH VPA22020/035/ 19.5 percent Oral suspension - QP52AC30 LM: Licensed - Triclabendazole - Oral use
w/v Oral 001 weight/volume Merchant as - Levamisole
Suspension for defined in hydrochloride
Cattle relevant national
legislation

Endex 8.75 % Elanco GmbH VPA22020/036/ 8.75 percent Oral suspension - QP52AC30 LM: Licensed - Triclabendazole - Oral use
w/v Oral 001 weight/volume Merchant as - Levamisole
Suspension for defined in hydrochloride
Sheep relevant national
legislation

Endofluke 100 Bimeda Animal VPA22033/060/ 100 Oral suspension - QP52AC01 LM: Licensed - Triclabendazole Generic - Oral use
mg/ml Oral Health Limited 001 milligram(s)/millil Merchant as application
Suspension itre defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Endogard Plus Krka, d.d., Novo VPA10774/004/ 150, 144, 50 Tablet - QP52AC55 CAM: - Febantel Generic - Oral use
Flavour Tablets mesto 001 mg/tablet Companion - Pyrantel application
for dogs Animal Medicine embonate (Article 13(1) of
as defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Endogard Plus Krka, d.d., Novo VPA10774/004/ 525, 504, 175 Tablet - QP52AC55 CAM: - Febantel Generic - Oral use
XL Tablets for mesto 002 mg/tablet Companion - Pyrantel application
dogs Animal Medicine embonate (Article 13(1) of
as defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Endospec 10% Bimeda Animal VPA22033/016/ 10 percent Oral suspension - QP52AC11 LM: Licensed - Albendazole ZZZ --Unknown- - Oral use
SC Health Limited 001 weight/volume Merchant as
defined in
relevant national
legislation

Endospec 2.5% Bimeda Animal VPA22033/017/ 2.5 percent Oral suspension - QP52AC11 LM: Licensed - Albendazole - Oral use
SC Health Limited 001 weight/volume Merchant as
defined in
relevant national
legislation

Engemycin 10 % Intervet Ireland VPA10996/071/ 10 percent Solution for - QJ01AA06 POM: - Oxytetracycline Full application - Intramuscular
DD Solution for Limited 001 weight/volume injection Prescription Only (Article 12(3) of use
injection Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national - Subcutaneous
legislation use

Engemycin Intervet Ireland VPA10996/212/ 25 Cutaneous - QD06AA03 POM: - Oxytetracycline Hybrid - Cutaneous use
Spray, 25 Limited 001 milligram(s)/millil spray, Prescription Only hydrochloride application
mg/mL, itre suspension Medicine as (Article 13(3) of
cutaneous spray, defined in Directive No
suspension for relevant national 2001/82/EC)
cattle, sheep and legislation
pigs

Veterinary Medicines Authorised/Transfer Pending Products Page 68 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Enovex 0.5 %w/v Norbrook VPA22664/056/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin - Topical use
Pour-On Solution Laboratories 001 weight/volume Merchant as
for Cattle (Ireland) Limited defined in
relevant national
legislation

Enovex 1% w/v Norbrook VPA22664/055/ 1.0 percent Solution for - QP54AA01 LM: Licensed - Ivermectin Informed - Subcutaneous
Solution for Laboratories 001 weight/volume injection Merchant as consent use
Injection for (Ireland) Limited defined in application
cattle, sheep and relevant national (Article 13c of
pigs legislation Directive No
2001/82/EC)
Enrobactin 25 Le Vet Beheer VPA10475/020/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml B.V. 001 milligram(s)/millil Prescription Only application
concentrate for itre Medicine as (Article 13(1) of
oral solution for defined in Directive No
pet rabbits, relevant national 2001/82/EC)
rodents, legislation
ornamental birds
and reptiles

Enrocare 100 Emdoka bvba VPA10534/007/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml Solution 003 milligram(s)/millil injection Prescription Only application use
for Injection for itre Medicine as (Article 13(1) of - Intravenous
Cattle and Pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Enrocare 25 Ecuphar NV VPA10491/007/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml Oral 004 milligram(s)/millil Prescription Only application
Solution for Pet itre Medicine as (Article 13(1) of
Rabbits, defined in Directive No
Rodents, relevant national 2001/82/EC)
Ornamental legislation
Birds and
Reptiles
Enrocare 25 Emdoka bvba VPA10534/007/ 25 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml Solution 001 milligram(s)/millil injection Prescription Only application use
for Injection for itre Medicine as (Article 13(1) of - Subcutaneous
Dogs, Cats, defined in Directive No use
Rabbits, relevant national 2001/82/EC)
Rodents, legislation
Reptiles and
Ornamental bird

Enrocare 50 Emdoka bvba VPA10534/007/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml Solution 002 milligram(s)/millil injection Prescription Only application use
for Injection for itre Medicine as (Article 13(1) of - Intravenous
Cattle, Pigs, defined in Directive No use
Dogs and Cats relevant national 2001/82/EC) - Subcutaneous
legislation use

Enrocat flavour LIVISTO Int'l, VPA10425/010/ 25 Oral suspension - QJ01MA90 POM: - Enrofloxacin Hybrid - Oral use
25 mg/ml oral S.L. 001 milligram(s)/millil Prescription Only application
suspension for itre Medicine as (Article 13(3) of
cats defined in Directive No
relevant national 2001/82/EC)
legislation

ENRODEXIL Industrial VPA10509/004/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
100 mg/ml Veterinaria, S.A. 001 milligram(s)/millil injection Prescription Only application use
solution for itre Medicine as (Article 13(1) of - Intravenous
injection for defined in Directive No use
cattle and pigs relevant national 2001/82/EC) - Subcutaneous
legislation use

ENRO-K 100 Laboratorios VPA10786/001/ 100 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml Solution Karizoo S.A. 001 milligram(s)/millil Prescription Only application
for use in itre Medicine as (Article 13(1) of
drinking water defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 69 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Enrotril Max 100 Norbrook VPA22664/089/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Subcutaneous
mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only application use
for Injection for (Ireland) Limited itre Medicine as (Article 13(1) of
Cattle defined in Directive No
relevant national 2001/82/EC)
legislation

Enrotron 100 aniMedica VPA10826/026/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml Solution GmbH 003 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Enrotron 100 aniMedica VPA10826/018/ 100 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml solution GmbH 001 milligram(s)/millil Prescription Only application
for use in itre Medicine as (Article 13(1) of
drinking water for defined in Directive No
chicken, turkeys relevant national 2001/82/EC)
and rabbits legislation

Enrotron 25 aniMedica VPA10826/017/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml oral GmbH 001 milligram(s)/millil Prescription Only application
solution for cattle itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Enrotron 25 aniMedica VPA10826/026/ 25 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml Solution GmbH 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
dogs, cats, defined in Directive No use
rodents, reptiles relevant national 2001/82/EC)
and ornamental legislation
birds
Enrotron 5 mg/ml aniMedica VPA10826/016/ 5 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
oral solution for GmbH 001 milligram(s)/millil Prescription Only application
pigs itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Enrotron 50 aniMedica VPA10826/026/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml Solution GmbH 002 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle, pigs, dogs defined in Directive No use
and cats relevant national 2001/82/EC) - Subcutaneous
legislation use

Enrotron Flavour aniMedica VPA10826/011/ 150 milligram(s) Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
150 mg Tablets GmbH 002 Prescription Only application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Enrotron Flavour aniMedica VPA10826/011/ 50 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
50 mg Tablets GmbH 001 Prescription Only application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Enrox Flavour 15 Krka, d.d., Novo VPA10774/001/ 15 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg Tablets for mesto 001 Prescription Only application
dogs and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 70 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Enrox Flavour Krka, d.d., Novo VPA10774/001/ 150 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
150 mg Tablets mesto 003 Prescription Only application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Enrox Flavour 50 Krka, d.d., Novo VPA10774/001/ 50 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg Tablets for mesto 002 Prescription Only application
dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Enroxil 100 Krka, d.d., Novo VPA10774/002/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml solution mesto 003 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

ENROXIL 50 Krka, d.d., Novo VPA10774/002/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml solution mesto 002 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
calves, pigs and defined in Directive No use
dogs relevant national 2001/82/EC) - Subcutaneous
legislation use

Enroxil Max 100 Krka, d.d., Novo VPA10774/002/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intravenous
mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
cattle defined in Directive No use
relevant national 2001/82/EC)
legislation

Entericolix, CZ Veterinaria, VPA10784/003/ . Emulsion for - QI09AB08 POM: - E.coli strain p4 Full application - Intramuscular
emulsion for S.A. 001 injection Prescription Only (f6 adhesins), (Article 12(3) of use
injection for pigs Medicine as inactivated Directive No
defined in - E.coli strain p5 2001/82/EC)
relevant national (f18 adhesins),
legislation inactivated
- E. coli strain p6
(f4ac adhesins),
inactivated
- E. coli strain P9
(F18ac
adhesins),
inactivated
- E.coli strain
p10 (f5 + f41
adhesins),
inactivated
- ß toxoid of C.
perfringens type
C

Enterisol Ileitis Boehringer VPA10454/005/ . tissue culture Lyophilisate + - QI09AE04 POM: - Attenuated live Full application - Oral use
lyophilisate and Ingelheim 001 infective dose solvent for Prescription Only bacteria (Article 12(3) of
solvent for oral Vetmedica 50/dose suspension Medicine as lawsonia Directive No
suspension for GmbH defined in intracellularis 2001/82/EC)
pigs relevant national (ms b3903)
legislation

Enteroporc AC IDT Biologika VPA10524/006/ . relative Lyophilisate and - QI09AB12 POM: - Clostridium Full application - Intramuscular
Lyophilisate and GmbH 001 unit/millilitre solvent for Prescription Only perfrigens type a (Article 12(3) of use
solvent for suspension for Medicine as alfa toxoid Directive No
suspension for injection defined in - Clostridium 2001/82/EC)
injection for pigs relevant national perfringens
legislation typea beta2
toxoid
- Clostridium
perfringens type
c beta1 toxoid

Veterinary Medicines Authorised/Transfer Pending Products Page 71 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Enzaprost 5 Ceva Santé VPA10815/002/ 5 Solution for - QG02AD01 POM: - Dinoprost Generic - Intramuscular
mg/ml Solution Animale 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of
cattle and pig defined in Directive No
relevant national 2001/82/EC)
legislation

Enzovax Intervet Ireland VPA10996/079/ 10^5 - 10^6.9 Lyophilisate for - QI04AE01 POM: - Chlamydophila Full application - Intramuscular
Limited 001 inclusion-body suspension for Prescription Only abortus live (Article 12(3) of use
forming units injection Medicine as attenuated strain Directive No - Subcutaneous
defined in ts 1b 2001/82/EC) use
relevant national
legislation

Epityl 60mg Chanelle VPA10987/100/ 60 mg/tablet Chewable tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use
Flavoured Pharmaceuticals 001 Prescription Only application
Tablets for Dogs Manufacturing Medicine as (Article 13(3) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Eprecis 20 Ceva Santé VPA10815/024/ 20 Solution for - QP54AA04 LM: Licensed - Eprinomectin Hybrid - Subcutaneous
mg/ml solution Animale 001 milligram(s)/millil injection Merchant as application use
for injection for itre defined in (Article 13(3) of
cattle relevant national Directive No
legislation 2001/82/EC)

Eprecis 5 mg/ml Ceva Santé VPA10815/025/ 5 Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Generic - Topical use
pour-on solution Animale 001 milligram(s)/millil Merchant as application
for cattle itre defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Eprinex 0.5% Boehringer VPA10454/033/ 0.5 percent Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Full application - Topical use
w/v Pour-on Ingelheim 001 weight/volume Merchant as (Article 12(3) of
Solution for Beef Vetmedica defined in Directive No
and Dairy Cattle GmbH relevant national 2001/82/EC)
legislation

Eprinex Multi 5 Boehringer VPA10454/034/ 5 Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Well-established - Topical use
mg/ml pour-on Ingelheim 001 milligram(s)/millil Merchant as use application
for beef and Vetmedica itre defined in (Article 13a of
dairy cattle, GmbH relevant national Directive No
sheep and goats legislation 2001/82/EC)

Eprivalan 5 Boehringer VPA10454/035/ 5 Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Generic - Topical use
mg/ml pour-on Ingelheim 001 milligram(s)/millil Merchant as application
solution for beef Vetmedica itre defined in (Article 13(1) of
and dairy cattle GmbH relevant national Directive No
legislation 2001/82/EC)

Eprizero 5 mg/ml Norbrook VPA22664/103/ 5 Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Hybrid - Topical use
Pour-On Solution Laboratories 001 milligram(s)/millil Merchant as application
for Beef and (Ireland) Limited itre defined in (Article 13(3) of
Dairy Cattle relevant national Directive No
legislation 2001/82/EC)

Epromec 5 Chanelle VPA10987/107/ 5 Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Generic - Topical use
mg/ml Pour-on Pharmaceuticals 001 milligram(s)/millil Merchant as application
Solution for beef Manufacturing itre defined in (Article 13(1) of
and dairy cattle Limited relevant national Directive No
legislation 2001/82/EC)

EQUEST ORAL Zoetis Belgium VPA10387/025/ 18.92 Oral gel - QP54AB02 LM: Licensed - Moxidectin Full application - Oral use
GEL, 18.92 S.A. 001 milligram(s)/gra Merchant as (Article 12(3) of
mg/g, oral gel for m defined in Directive No
horses and relevant national 2001/82/EC)
ponies legislation

Equest Pramox Zoetis Belgium VPA10387/026/ 19.5, 121.7 Oral gel - QP54AB52 LM: Licensed - Moxidectin Fixed - Oral use
19.5 mg/g + S.A. 001 milligram(s)/gra Merchant as - Praziquantel combination
121.7 mg/g oral m defined in application
gel relevant national (Article 13b of
legislation Directive No
2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 72 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Equibactin 250 Le Vet Beheer VPA10475/037/ 250, 50 Oral powder - QJ01EW10 POM: - Sulfadiazine Generic - Oral use
mg/g + 50 mg/g B.V. 001 milligram(s)/gra Prescription Only - Trimethoprim application
oral powder for m Medicine as (Article 13(1) of
horses defined in Directive No
relevant national 2001/82/EC)
legislation

Equibactin vet. Le Vet BV VPA10816/004/ 66.7, 333.3 Oral paste - QJ01EW10 POM: - Trimethoprim Generic - Oral use
(333 mg/g + 67 001 milligram(s)/gra Prescription Only - Sulfadiazine application
mg/g) Oral Paste m Medicine as (Article 13(1) of
for horses defined in Directive No
relevant national 2001/82/EC)
legislation

Equimax oral gel Virbac S.A. VPA10988/091/ 18.7, 140.3 Oral gel - QP54AA51 LM: Licensed - Ivermectin - Oral use
for horses 001 milligram(s)/gra Merchant as - Praziquantel
m defined in
relevant national
legislation

Equimax Tabs Virbac S.A. VPA10988/070/ 150, 20 Chewable tablet - QP54AA51 LM: Licensed - Praziquantel Full application - Oral use
150 mg / 20 mg 001 mg/tablet Merchant as - Ivermectin (Article 12(3) of
Chewable tablet defined in Directive No
for Horses relevant national 2001/82/EC)
legislation

Equimoxectin Zoetis Belgium VPA10387/093/ 18.92 Oral gel - QP54AB02 LM: Licensed - Moxidectin Informed - Oral use
18.92 mg/g, oral S.A. 001 milligram(s)/gra Merchant as consent
gel for horses m defined in application
and ponies relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Equinor 370 Norbrook VPA22664/114/ 370 Oral paste - QA02BC01 POM: - Omeprazole Generic - Oral use
mg/g Oral Paste Laboratories 001 milligram(s)/gra Prescription Only application
for Horses (Ireland) Limited m Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Equip Artervac Zoetis Belgium VPA10387/027/ . Emulsion for - QI05AA07 POM: - Equine arteritis Full application - Intramuscular
emulsion for S.A. 001 injection Prescription Only virus inactivated, (Article 12(3) of use
injection for Medicine as strain bucyrus Directive No
horses and defined in 2001/82/EC)
ponies relevant national
legislation

Equip EHV 1,4 Zoetis Belgium VPA10387/028/ . Suspension for - QI05AA05 POM: - Equine herpes Full application - Intramuscular
Suspension for S.A. 001 injection Prescription Only virus 1, strain (Article 12(3) of use
injection Medicine as 438/77 Directive No
defined in inactivated 2001/82/EC)
relevant national - Equine herpes
legislation virus 4, strain
405/76
inactivated
Equip F Zoetis Belgium VPA10387/029/ . Suspension for - QI05AA01 POM: - Inactivated Full application - Intramuscular
S.A. 001 injection Prescription Only equine influenza (Article 12(3) of use
Medicine as a newmarket 77 Directive No
defined in (H7 N7) 2001/82/EC)
relevant national - Inactivated
legislation equine influenza
a borlonge 91
(H3 N8)
- Inactivated
equine influenza
a Kentucky 98
(H3 N8)

Veterinary Medicines Authorised/Transfer Pending Products Page 73 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Equip FT Zoetis Belgium VPA10387/030/ . Suspension for - QI05AL01 POM: - Inactivated Full application - Intramuscular
S.A. 001 injection Prescription Only equine influenza (Article 12(3) of use
Medicine as a newmarket 77 Directive No
defined in (H7 N7) 2001/82/EC)
relevant national - Inactivated
legislation equine influenza
a borlonge 91
(H3 N8)
- Inactivated
equine influenza
a Kentucky 98
(H3 N8)
- Tetanus toxoid
(immunopurified)

Equip Rotavirus Zoetis Belgium VPA10387/031/ . Emulsion for - QI05AA09 POM: - Equine Full application - Intramuscular
emulsion for S.A. 001 injection Prescription Only rotavirus H2 (Article 12(3) of use
injection for Medicine as strain Directive No
horses defined in 2001/82/EC)
relevant national
legislation

Equip T Zoetis Belgium VPA10387/032/ . Suspension for - QI05AB03 POM: - Tetanus toxoid Full application - Intramuscular
S.A. 001 injection Prescription Only (immunopurified) (Article 12(3) of use
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Equipalazone 1 Dechra VPA22622/007/ 1.0 gram(s) Oral paste - QM01AA01 POM: - - Oral use
g Oral Paste Regulatory B.V. 001 Prescription Only Phenylbutazone
Medicine as
defined in
relevant national
legislation

Equipalazone 1 Dechra VPA22622/006/ 1.0 gram(s) Oral powder - QM01AA01 POM: - Well-established - Oral use
g Oral Powder Regulatory B.V. 001 Prescription Only Phenylbutazone use application
Medicine as (Article 13a of
defined in Directive No
relevant national 2001/82/EC)
legislation

Equipalazone Dechra VPA22622/008/ 200 Solution for - QM01AA01 POM: - - Intravenous


200 mg/ml Regulatory B.V. 001 milligram(s)/millil injection Prescription Only Phenylbutazone use
Solution for itre Medicine as
Injection defined in
relevant national
legislation

Equiparin 5,000 aniMedica VPA10826/006/ 5.000 Gel - QM02AC99 POM: - Heparin sodium Generic - Cutaneous use
IU/100 g gel for GmbH 001 international Prescription Only - Hydroxyethyl application
horses unit(s) Medicine as salicylate (Article 13(1) of
defined in - Levomenthol Directive No
relevant national 2001/82/EC)
legislation

Equiparin 50,000 aniMedica VPA10826/006/ 50,000 IU/100g Gel - QM02AC99 POM: - Heparin sodium Generic - Cutaneous use
IU/100 g gel for GmbH 002 Prescription Only - Hydroxyethyl application
horses Medicine as Salicylate (Article 13(1) of
defined in - Levomenthol Directive No
relevant national 2001/82/EC)
legislation

Equipramox 19.5 Zoetis Belgium VPA10387/094/ 19.5, 121.7 Oral gel - QP54AB52 LM: Licensed - Moxidectin Informed - Oral use
mg/g + 121.7 S.A. 001 milligram(s)/gra Merchant as - Praziquantel consent
mg/g oral gel m defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 74 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Equipred 50 mg CP-Pharma VPA10810/017/ 50 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Hybrid - Oral use
tablets for horse Handelsgesellsc 001 Prescription Only application
haft mbH Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

EquiShield EHV Dechra VPA22622/025/ . Emulsion for - QI05AA05 POM: - Inactivated Full application - Intramuscular
emulsion for Regulatory B.V. 001 injection Prescription Only equine herpes (Article 12(3) of use
injection for Medicine as virus ehv msv Directive No
horses defined in bio 82S 2001/82/EC)
relevant national
legislation

Equizol 400 mg CP-Pharma VPA10810/014/ 400 mg/sachet Gastro-resistant - QA02BC01 POM: - Omeprazole Hybrid - Oral use
gastro-resistant Handelsgesellsc 001 granules Prescription Only application
granules for haft mbH Medicine as (Article 13(3) of
horses defined in Directive No
relevant national 2001/82/EC)
legislation

EQVALAN DUO, Boehringer VPA10454/036/ 0.12, 0.6 Oral paste - QP54AA51 LM: Licensed - Ivermectin Fixed - Oral use
oral paste Ingelheim 001 g/syringe Merchant as - Praziquantel combination
Vetmedica defined in application
GmbH relevant national (Article 13b of
legislation Directive No
2001/82/EC)
EQVALAN Oral Boehringer VPA10454/037/ 18.7 Oral paste - QP54AA01 LM: Licensed - Ivermectin Full application - Oral use
Paste for Horses Ingelheim 001 milligram(s)/gra Merchant as (Article 12(3) of
18.7 mg/g Vetmedica m defined in Directive No
GmbH relevant national 2001/82/EC)
legislation

ERADIA 125 Virbac S.A. VPA10988/109/ 125 Oral suspension - QP51AA01 POM: - Metronidazole Hybrid - Oral use
mg/ml oral 001 milligram(s)/millil Prescription Only application
suspension for itre Medicine as (Article 13(3) of
dogs defined in Directive No
relevant national 2001/82/EC)
legislation

ERAQUELL 18.7 Virbac S.A. VPA10988/104/ 18.7 Oral paste - QP54AA01 LM: Licensed - Ivermectin Generic - Oral use
mg/g Oral Paste 001 milligram(s)/gra Merchant as application
m defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Eraquell Tabs, Virbac S.A. VPA10988/077/ 20 mg/tablet Chewable tablet - QP54AA01 LM: Licensed - Ivermectin Full application - Oral use
20 mg Chewable 001 Merchant as (Article 12(3) of
tablets for defined in Directive No
Horses relevant national 2001/82/EC)
legislation

Erythrocin 16.5 Ceva Santé VPA10815/061/ 16.5 percent Powder for oral - QJ01FA01 POM: - Erythromycin Full application - Oral use
% w/w Soluble Animale 001 weight/weight solution Prescription Only (Article 12(3) of
Powder for Oral Medicine as Directive No
Solution defined in 2001/82/EC)
relevant national
legislation

Espacox 50 Industrial VPA10509/005/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Hybrid - Oral use
mg/ml oral Veterinaria, S.A. 001 milligram(s)/millil Prescription Only application
suspension for itre Medicine as (Article 13(3) of
pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Estrumate Intervet Ireland VPA10996/227/ 0.25 Solution for - QG02AD90 POM: - Cloprostenol Full application - Intramuscular
Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 75 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Eurican DAP Boehringer VPA10454/038/ . Lyophilisate and - QI07AD02 POM: - Attenuated Full application - Subcutaneous
lyophilisate and Ingelheim 001 solvent for Prescription Only canine distemper (Article 12(3) of use
solvent for Vetmedica suspension for Medicine as virus, strain ba5 Directive No
suspension for GmbH injection defined in - Attenuated 2001/82/EC)
injection relevant national canine
legislation adenovirus type
2, strain dk13
- Attenuated
canine
parvovirus, strain
cgf

Eurican DAPPi Boehringer VPA10454/039/ . Lyophilisate and - QI07AD04 POM: - Attenuated Full application - Subcutaneous
lyophilisate and Ingelheim 001 solvent for Prescription Only canine distemper (Article 12(3) of use
solvent for Vetmedica suspension for Medicine as virus, strain ba5 Directive No
suspension for GmbH injection defined in - Attenuated 2001/82/EC)
injection relevant national canine
legislation adenovirus type
2, strain dk13
- Attenuated
canine
parvovirus, strain
cag2
- Attenuated
canine
parainfluenza
virus type 2,
strain cgf
2004/75

Eurican DHPPi Boehringer VPA10454/040/ . Lyophilisate for - QI07AD04 POM: - Attenuated Full application - Subcutaneous
lyophilisate for Ingelheim 001 suspension for Prescription Only canine distemper (Article 12(3) of use
suspension for Vetmedica injection Medicine as virus, strain ba5 Directive No
injection GmbH defined in - Attenuated 2001/82/EC)
relevant national canine
legislation adenovirus type
2, strain dk13
- Attenuated
canine
parvovirus, strain
cag2
- Attenuated
canine
parainfluenza
virus type 2,
strain cgf
2004/75

Eurican L Boehringer VPA10454/041/ . Suspension for - QI07AB01 POM: - Inactivated Full application - Subcutaneous
Ingelheim 001 injection Prescription Only leptospira (Article 12(3) of use
Vetmedica Medicine as canicola Directive No
GmbH defined in - Inactivated 2001/82/EC)
relevant national leptospira
legislation icterohaemorrha
giae
Eurican L multi Boehringer VPA10454/042/ . Suspension for - QI07AB01 POM: - Inactivated Full application - Subcutaneous
Suspension for Ingelheim 001 injection Prescription Only leptospira (Article 12(3) of use
injection Vetmedica Medicine as interrogans Directive No
GmbH defined in serogroup 2001/82/EC)
relevant national canicola strain
legislation 16070
- Inactivated
leptospira
interrogans
serogroup
icterohaemorrha
giae strain 16069
- Inactivated
leptospira
interrogans
serogroup
grippotyphosa
strain mal 1540

Veterinary Medicines Authorised/Transfer Pending Products Page 76 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Eurofen 100 mg Chanelle VPA10987/117/ 100 milligram(s) Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for Dogs Pharmaceuticals 003 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Eurofen 20 mg Chanelle VPA10987/117/ 20 milligram(s) Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for Dogs Pharmaceuticals 001 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Eurofen 50 mg Chanelle VPA10987/117/ 50 milligram(s) Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for Dogs Pharmaceuticals 002 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Euthanimal 200 Alfasan VPA10980/014/ 200 Solution for - QN51AA01 VPO: Veterinary - Sodium Full application - Intravenous
mg/ml, solution Nederland B.V 001 milligram(s)/millil injection Practitioner Only pentobarbital (Article 12(3) of use
for injection itre as defined in Directive No
relevant national 2001/82/EC)
legislation

Euthanimal 400 Alfasan VPA10980/014/ 400 Solution for - QN51AA01 VPO: Veterinary - Sodium Full application - Intravenous
mg/ml, solution Nederland B.V 002 milligram(s)/millil injection Practitioner Only pentobarbital (Article 12(3) of use
for injection itre as defined in Directive No
relevant national 2001/82/EC)
legislation

Euthasol vet. Le Vet BV VPA10816/011/ 400 Solution for - QN51AA01 VPO: Veterinary - Pentobarbital Hybrid - Intracardiac
400 mg/ml, 001 milligram(s)/millil injection Practitioner Only application use
solution for itre as defined in (Article 13(3) of - Intraperitoneal
injection relevant national Directive No use
legislation 2001/82/EC) - Intravenous
use

EUTHATAL Dopharma VPA10791/012/ 200 Solution for - QN51AA01 VPO: Veterinary - Pentobarbital Full application - Intravenous
solution for Research B.V. 001 milligram(s)/millil injection Practitioner Only sodium (Article 12(3) of use
injection 200 mg itre as defined in Directive No
in 1 ml relevant national 2001/82/EC)
legislation

Euthoxin 500 Chanelle VPA10987/115/ 500 Solution for - QN51AA01 VPO: Veterinary - Pentobarbital Hybrid - Intracardiac
mg/ml solution Pharmaceuticals 001 milligram(s)/millil injection Practitioner Only application use
for injection. Manufacturing itre as defined in (Article 13(3) of - Intraperitoneal
Limited relevant national Directive No use
legislation 2001/82/EC) - Intravenous
use
- ZZZ
Intrapulmonary
use
Excenel Flow, 50 Zoetis Belgium VPA10387/033/ 50 Suspension for - QJ01DD90 POM: - Ceftiofur - Intramuscular
mg/ml, S.A. 001 milligram(s)/millil injection Prescription Only use
suspension for itre Medicine as - Subcutaneous
injection for pigs defined in use
and cattle relevant national
legislation

Exidot 100 mg Chanelle VPA10987/138/ 100 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use
Spot-on solution Pharmaceuticals 003 Prescription Only application
for Medium Dog Manufacturing Medicine as (Article 13(3) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 77 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Exidot 250 mg Chanelle VPA10987/138/ 250 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use
Spot-on solution Pharmaceuticals 004 Prescription Only application
for Large Dogs Manufacturing Medicine as (Article 13(3) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Exidot 40 mg Chanelle VPA10987/138/ 40 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use
Spot-on solution Pharmaceuticals 001 Prescription Only application
for Small Cats, Manufacturing Medicine as (Article 13(3) of
Small Pet Limited defined in Directive No
Rabbits & Small relevant national 2001/82/EC)
Dogs legislation

Exidot 400 mg Chanelle VPA10987/138/ 400 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use
Spot-on solution Pharmaceuticals 005 Prescription Only application
for Extra Large Manufacturing Medicine as (Article 13(3) of
Dogs Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Exidot 80 mg Chanelle VPA10987/138/ 80 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use
Spot-on solution Pharmaceuticals 002 Prescription Only application
for Large Cats Manufacturing Medicine as (Article 13(3) of
and Large Pet Limited defined in Directive No
Rabbits relevant national 2001/82/EC)
legislation

Exitel 230/20 mg Chanelle VPA10987/103/ 230, 20 Film-coated - QP52AA51 CAM: - Pyrantel Hybrid - Oral use
Flavoured Film- Pharmaceuticals 001 mg/tablet tablet Companion embonate application
Coated Tablets Manufacturing Animal Medicine - Praziquantel (Article 13(3) of
for Cats Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Exitel Plus Chanelle VPA10987/078/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use
Tablets for Dogs Pharmaceuticals 001 mg/tablet Companion - Pyrantel application
Manufacturing Animal Medicine - Febantel (Article 10(3) of
Limited as defined in Directive No
relevant national 2001/83/EC)
legislation

Exitel Plus XL Chanelle VPA10987/078/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Exitel Plus XL Chanelle VPA10987/078/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Exitel Plus XL Chanelle VPA10987/078/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Exodus Oral Bimeda Animal VPA22033/018/ 400 Oral paste - QP52AF02 LM: Licensed - Pyrantel - Oral use
Paste Health Limited 001 milligram(s)/gra Merchant as embonate
m defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 78 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Ezeepour 2.5% Bimeda Animal VPA22033/019/ 2.5 percent Pour-on solution - QP53AC08 LM: Licensed - Cypermethrin - Topical use
w/v Pour on Health Limited 001 weight/volume Merchant as technical (93%)
Solution defined in (cis: trans 50:50)
relevant national
legislation

Fasifree 10% w/v Bimeda Animal VPA22033/020/ 10 percent Oral suspension - QP52AC01 LM: Licensed - Triclabendazole - Oral use
Oral Suspension Health Limited 001 weight/volume Merchant as
defined in
relevant national
legislation

Fasimec Duo 50 Elanco GmbH VPA22020/024/ 50, 1 Oral suspension - QP54AA51 LM: Licensed - Triclabendazole Fixed - Oral use
mg/ml + 1 mg/ml 001 milligram(s)/millil Merchant as - Ivermectin combination
oral suspension itre defined in application
for sheep relevant national (Article 13b of
legislation Directive No
2001/82/EC)
Fasinex 240 Elanco GmbH VPA22020/003/ 240 Oral suspension - QP52AC01 LM: Licensed - Triclabendazole Full application - Oral use
mg/ml oral 001 milligram(s)/millil Merchant as (Article 12(3) of
suspension for itre defined in Directive No
cattle relevant national 2001/82/EC)
legislation

Fasinex 5% w/v Elanco GmbH VPA22020/004/ 5 percent Oral suspension - QP52AC LM: Licensed - Triclabendazole Full application - Oral use
Oral Suspension 001 weight/volume Merchant as (Article 12(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Fasinex Super Elanco GmbH VPA22020/005/ 19.5 percent Oral suspension - QP52A LM: Licensed - Triclabendazole - Oral use
19.5% w/v Oral 001 weight/volume Merchant as - Levamisole
Suspension defined in hydrochloride
relevant national
legislation

Fatromectin 5 ECO Animal VPA22693/006/ 5 Pour-on solution - QP54AA01 LM: Licensed - Ivermectin - Topical use
mg/ml pour-on Health Europe 001 milligram(s)/millil Merchant as
solution for Limited itre defined in
cattle. relevant national
legislation

Felimazole 1.25 Dechra VPA22622/009/ 1.25 mg/tablet Coated tablet - QH03BB02 POM: - Thiamazole Full application - Oral use
mg Coated Regulatory B.V. 003 Prescription Only (Article 12(3) of
tablets for cats Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Felimazole 2.5 Dechra VPA22622/009/ 2.5 mg/tablet Coated tablet - QH03BB02 POM: - Thiamazole Full application - Oral use
mg Coated Regulatory B.V. 001 Prescription Only (Article 12(3) of
Tablets for Cats Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Felimazole 5 mg Dechra VPA22622/009/ 5 mg/tablet Coated tablet - QH03BB02 POM: - Thiamazole - Oral use
Coated Tablets Regulatory B.V. 002 Prescription Only
for Cats Medicine as
defined in
relevant national
legislation

FELIMINTIC, Laboratoire TVM VPA10386/002/ 80/20 mg/tablet Tablet - QP52AA51 CAM: - Pyrantel Hybrid - Oral use
80/20 mg tablets 001 Companion - Praziquantel application
for cats Animal Medicine (Article 13(3) of
as defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 79 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Fenafluke 5% Pharvet (Ireland) VPA10462/003/ 50/50 Oral suspension - QP52AC13 LM: Licensed - Fenbendazole Informed - Oral use
w/v Oral Ltd 001 milligram(s)/millil - QP52AX Merchant as - Rafoxanide consent
Suspension itre defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Fenafluke 5% Pharvet (Ireland) VPA10462/003/ 50/50 Oral suspension - QP52AC13 LM: Licensed - Fenbendazole Informed - Oral use
w/v Oral Ltd 001 milligram(s)/millil - QP52AX Merchant as - Rafoxanide consent
Suspension itre defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Fenben 10 Oral Ancare Ireland VPA10915/002/ 100 Oral suspension - QP52AC13 LM: Licensed - Fenbendazole - Oral use
Suspension Ltd. 001 milligram(s)/millil Merchant as
itre defined in
relevant national
legislation

Fenbenor 10 % Pharvet (Ireland) VPA10462/002/ 100 Drench - QP52AC13 LM: Licensed - Fenbendazole - Oral use
Oral Drench Ltd 001 milligram(s)/millil Merchant as
itre defined in
relevant national
legislation

Fenbenor 2.5% Pharvet (Ireland) VPA10462/002/ 25 Oral suspension - QP52AC13 LM: Licensed - Fenbendazole Informed - Oral use
w/v Oral Drench Ltd 002 milligram(s)/millil Merchant as consent
itre defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Fenflor 300 Krka, d.d., Novo VPA10774/010/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular
mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
cattle defined in Directive No use
relevant national 2001/82/EC)
legislation

Fenflor 300 Krka, d.d., Novo VPA10774/009/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular
mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of
pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Fenoflox 100 Chanelle VPA10987/072/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin - Intramuscular
mg/ml Solution Pharmaceuticals 002 milligram(s)/millil injection Prescription Only use
for Injection for Manufacturing itre Medicine as - Intravenous
Cattle and Pigs Limited defined in use
relevant national - Subcutaneous
legislation use

Fenoflox 50 Chanelle VPA10987/072/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin - Intramuscular


mg/ml Solution Pharmaceuticals 001 milligram(s)/millil injection Prescription Only use
for Injection for Manufacturing itre Medicine as - Intravenous
Cattle, Pigs, Limited defined in use
Dogs and Cats relevant national - Subcutaneous
legislation use

Fermectin 1 % Chanelle VPA10987/148/ 1 percent Solution for - QP54AA01 LM: Licensed - Ivermectin - Subcutaneous
Solution for Pharmaceuticals 001 weight/volume injection Merchant as use
Injection for Pigs Manufacturing defined in
Limited relevant national
legislation

Fertigest 0.004 Vetpharma VPA10516/016/ 0.004 Solution for - QH01CA90 POM: - Buserelin Generic - Intramuscular
mg/ml Solution Animal Health, 001 milligram(s)/millil injection Prescription Only application use
for Injection S.L. itre Medicine as (Article 13(1) of - Subcutaneous
defined in Directive No use
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 80 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Fertipig HCG 40 Ceva Santé VPA10815/012/ 40/ 80 Lyophilisate and - QG03GA99 POM: - Gonadotrophin, Well-established - Intramuscular
IU/ml / PMSG 80 Animale 001 international solvent for Prescription Only equine serum use application use
IU/ml lyophilisate unit(s)/millilitre solution for Medicine as (pmsg) (Article 13a of
and solvent for injection defined in - Gonadotrophin, Directive No
solution for relevant national chorionic (hcg) 2001/82/EC)
injection for pigs legislation - Gonadotrophin,
equine serum
(pmsg)
- Gonadotrophin,
chorionic (hcg)

Finadyne 50 Intervet Ireland VPA10996/228/ 50 Solution for - QM01AG90 POM: - Flunixin Full application - Intramuscular
mg/ml Solution Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
for Injection itre Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national
legislation

Finadyne Intervet Ireland VPA10996/272/ 50 Pour-on solution - QM01AG90 POM: - Flunixin Full application - Topical use
Transdermal 50 Limited 001 milligram(s)/millil Prescription Only (Article 12(3) of
mg/ml pour-on itre Medicine as Directive No
solution for cattle defined in 2001/82/EC)
relevant national
legislation

Finilac 50 Le Vet Beheer VPA10475/015/ 50 Oral solution - QG02CB03 POM: - Cabergoline Generic - Oral use
microgram/ml B.V. 001 microgram(s)/mil Prescription Only application
oral solution for lilitre Medicine as (Article 13(1) of
dogs and cats defined in Directive No
relevant national 2001/82/EC)
legislation

Fipnil 134 mg Chanelle VPA10987/095/ 134 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 002 Prescription Only application
for medium dogs Manufacturing Medicine as (Article 13(3) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Fipnil 268 mg Chanelle VPA10987/095/ 268 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 003 Prescription Only application
for large dogs Manufacturing Medicine as (Article 13(3) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Fipnil 402 mg Chanelle VPA10987/095/ 402 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 004 Prescription Only application
for extra large Manufacturing Medicine as (Article 13(3) of
dogs Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Fipnil 50 mg Chanelle VPA10987/096/ 50 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-on solution Pharmaceuticals 001 Prescription Only application
for Cats Manufacturing Medicine as (Article 13(3) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Fipnil 67 mg Chanelle VPA10987/095/ 67 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 001 Prescription Only application
for small dogs Manufacturing Medicine as (Article 13(3) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 81 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
FIPREX DUO 50 Vet-Agro Multi- VPA20742/005/ 50,60 mg/pipette Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
mg+ 60 mg spot- trade company 001 Prescription Only - (S)-methopene application
on solution for Sp z o.o. Medicine as (Article 13(3) of
cats and ferrets defined in Directive No
relevant national 2001/82/EC)
legislation

Fiprex Duo L 268 Vet-Agro Multi- VPA20742/004/ 268,241.2 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
mg + 241.2 mg trade company 003 mg/pipette Prescription Only - (S)-methoprene application
spot-on solution Sp z o.o. Medicine as (Article 13(3) of
for dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Fiprex Duo M Vet-Agro Multi- VPA20742/004/ 134,120.6 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
134 mg + 120.6 trade company 002 mg/pipette Prescription Only - (S)-methoprene application
mg spot-on Sp z o.o. Medicine as (Article 13(3) of
solution for dogs defined in Directive No
relevant national 2001/82/EC)
legislation

FIPREX DUO S Vet-Agro Multi- VPA20742/004/ 67,60.3 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
67 mg + 60.3 mg trade company 001 mg/pipette Prescription Only - (S)-methoprene application
spot-on solution Sp z o.o. Medicine as (Article 13(3) of
for dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Fiprex Duo XL Vet-Agro Multi- VPA20742/004/ 402,361.8 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
402 mg + 361.8 trade company 004 mg/pipette Prescription Only - (S)-methoprene application
mg spot-on Sp z o.o. Medicine as (Article 13(3) of
solution for dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Fiproclear 134 Norbrook VPA22664/107/ 134 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
mg Spot-On Laboratories 002 Prescription Only application
Solution for (Ireland) Limited Medicine as (Article 13(3) of
Medium Dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Fiproclear 268 Norbrook VPA22664/107/ 268 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
mg Spot-On Laboratories 003 Prescription Only application
Solution for (Ireland) Limited Medicine as (Article 13(3) of
Large Dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Fiproclear 402 Norbrook VPA22664/107/ 402 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
mg Spot-On Laboratories 004 Prescription Only application
Solution for Very (Ireland) Limited Medicine as (Article 13(3) of
Large Dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Fiproclear 50 mg Norbrook VPA22664/108/ 50 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-On Solution Laboratories 001 Prescription Only application
for Cats (Ireland) Limited Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Fiproclear 67 mg Norbrook VPA22664/107/ 67 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-On Solution Laboratories 001 Prescription Only application
for Small Dogs (Ireland) Limited Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Fiproclear Norbrook VPA22664/137/ 134/120.6 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
Combo 134 mg / Laboratories 002 mg/pipette Merchant as - (S)-methopene application
120.6 mg spot- (Ireland) Limited defined in (Article 13(1) of
on solution for relevant national Directive No
medium dogs legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 82 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Fiproclear Norbrook VPA22664/137/ 268/241.2 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
Combo 268 mg / Laboratories 003 mg/pipette Merchant as - (S)-methopene application
241.2 mg spot- (Ireland) Limited defined in (Article 13(1) of
on solution for relevant national Directive No
large dogs legislation 2001/82/EC)

Fiproclear Norbrook VPA22664/137/ 402/361.8 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
Combo 402 mg / Laboratories 004 mg/pipette Merchant as - (S)-methopene application
361.8 mg spot- (Ireland) Limited defined in (Article 13(1) of
on solution for relevant national Directive No
very large dogs legislation 2001/82/EC)

Fiproclear Norbrook VPA22664/134/ 50/60 mg/pipette Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
Combo 50 mg / Laboratories 001 Merchant as - (S)-methopene application
60 mg spot-on (Ireland) Limited defined in (Article 13(1) of
solution for cats relevant national Directive No
and ferrets legislation 2001/82/EC)

Fiproclear Norbrook VPA22664/137/ 67/60.3 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
Combo 67 mg / Laboratories 001 mg/pipette Merchant as - (S)-methopene application
60.3 mg spot-on (Ireland) Limited defined in (Article 13(1) of
solution for small relevant national Directive No
dogs legislation 2001/82/EC)

Firodyl 250 mg Ceva Santé VPA10815/057/ 250 mg/tablet Chewable tablet - QM01AH90 POM: - Firocoxib Hybrid - Oral use
chewable tablets Animale 002 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Firodyl 62.5 mg Ceva Santé VPA10815/057/ 62.5 mg/tablet Chewable tablet - QM01AH90 POM: - Firocoxib Hybrid - Oral use
chewable tablets Animale 001 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Fleanil 134 mg Norbrook VPA22664/105/ 134 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid
Spot-On Solution Laboratories 002 Merchant as application
for Medium Dog (Ireland) Limited defined in (Article 13(3) of
relevant national Directive No
legislation 2001/82/EC)

FLEANIL 2.5 Norbrook VPA22664/002/ 2.5 Cutaneous - QP53AX15 POM: - Fipronil Generic - Topical use
mg/ml Laboratories 001 milligram(s)/millil spray, solution Prescription Only application
Cutaneous (Ireland) Limited itre Medicine as (Article 13(1) of
Spray, Solution defined in Directive No
for Cats and relevant national 2001/82/EC)
Dogs legislation

Fleanil 268 mg Norbrook VPA22664/105/ 268 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid
Spot-On Solution Laboratories 003 Merchant as application
for Large Dogs (Ireland) Limited defined in (Article 13(3) of
relevant national Directive No
legislation 2001/82/EC)

Fleanil 402 mg Norbrook VPA22664/105/ 402 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid
Spot-On Solution Laboratories 004 Merchant as application
for Very Large (Ireland) Limited defined in (Article 13(3) of
Dogs relevant national Directive No
legislation 2001/82/EC)

Fleanil 50 mg Norbrook VPA22664/106/ 50.0 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Generic, hybrid
Spot-On Solution Laboratories 001 Merchant as or similar
for Cats (Ireland) Limited defined in biological
relevant national application
legislation (Article 13 of
Directive No
2001/82/EC)
Fleanil 67 mg Norbrook VPA22664/105/ 67 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid
Spot-On Solution Laboratories 001 Merchant as application
for Small Dogs (Ireland) Limited defined in (Article 13(3) of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 83 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Fleanil Combo Norbrook VPA22664/136/ 134, 120.6 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
134 mg / 120.6 Laboratories 002 mg/pipette Merchant as - S-methoprene application
mg spot-on (Ireland) Limited defined in (Article 13(1) of
solution for relevant national Directive No
medium dogs legislation 2001/82/EC)

Fleanil Combo Norbrook VPA22664/136/ 268, 241.2 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
268 mg / 241.2 Laboratories 003 mg/pipette Merchant as - (S)-methopene application
mg spot-on (Ireland) Limited defined in (Article 13(1) of
solution for large relevant national Directive No
dogs legislation 2001/82/EC)

Fleanil Combo Norbrook VPA22664/136/ 402, 361.8 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
402 mg / 361.8 Laboratories 004 mg/pipette Merchant as - S-methoprene application
mg spot-on (Ireland) Limited defined in (Article 13(1) of
solution for very relevant national Directive No
large dogs legislation 2001/82/EC)

Fleanil Combo Norbrook VPA22664/132/ 50, 60 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
50 mg / 60 mg Laboratories 001 mg/pipette Merchant as - (S)-methoprene application
spot-on solution (Ireland) Limited defined in (Article 13(1) of
for cats and relevant national Directive No
ferrets legislation 2001/82/EC)

Fleanil Combo Norbrook VPA22664/136/ 67, 60.3 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
67 mg / 60.3 mg Laboratories 001 mg/pipette Merchant as - (S)-methoprene application
spot-on solution (Ireland) Limited defined in (Article 13(1) of
for small dogs relevant national Directive No
legislation 2001/82/EC)

Fleatix 134 mg Chanelle VPA10987/106/ 134 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 002 Merchant as application
for medium dogs Manufacturing defined in (Article 13(3) of
Limited relevant national Directive No
legislation 2001/82/EC)

Fleatix 268 mg Chanelle VPA10987/106/ 268 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 003 Merchant as application
for large dogs Manufacturing defined in (Article 13(3) of
Limited relevant national Directive No
legislation 2001/82/EC)

Fleatix 402 mg Chanelle VPA10987/106/ 402 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 004 Merchant as application
for extra large Manufacturing defined in (Article 13(3) of
dogs Limited relevant national Directive No
legislation 2001/82/EC)

Fleatix 50 mg Chanelle VPA10987/105/ 50 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use
Spot on solution Pharmaceuticals 001 Merchant as application
for cats Manufacturing defined in (Article 13(3) of
Limited relevant national Directive No
legislation 2001/82/EC)

Fleatix 67 mg Chanelle VPA10987/106/ 67 mg/pipette Spot-on solution - QP53AX15 LM: Licensed - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 001 Merchant as application
for small dogs Manufacturing defined in (Article 13(3) of
Limited relevant national Directive No
legislation 2001/82/EC)

Fleatix Combo Chanelle VPA10987/106/ 134, 120.6 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Hybrid - Spot-on use
134 mg/120.6 Pharmaceuticals 008 mg/pipette Merchant as - (S)-methoprene application
mg Spot-on Manufacturing defined in (Article 13(3) of
Solution for Limited relevant national Directive No
Medium Dogs legislation 2001/82/EC)

Fleatix Combo Chanelle VPA10987/106/ 268, 241.2 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Hybrid - Spot-on use
268 mg/241.2 Pharmaceuticals 007 mg/pipette Merchant as - (S)-methoprene application
mg Spot-on Manufacturing defined in (Article 13(3) of
Solution for Limited relevant national Directive No
Large Dogs legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 84 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Fleatix Combo Chanelle VPA10987/106/ 402, 361.8 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Hybrid - Spot-on use
402 mg/361.8 Pharmaceuticals 006 mg/pipette Merchant as - (S)-methoprene application
mg Spot-on Manufacturing defined in (Article 13(3) of
Solution for Extra Limited relevant national Directive No
Large Dogs legislation 2001/82/EC)

Fleatix Combo Chanelle VPA10987/106/ 50, 60 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Hybrid - Spot-on use
50 mg/60 mg Pharmaceuticals 009 mg/pipette Merchant as - (S)-methoprene application
Spot-on Solution Manufacturing defined in (Article 13(3) of
for Cats and Limited relevant national Directive No
Ferrets legislation 2001/82/EC)

Fleatix Combo Chanelle VPA10987/106/ 67, 60.3 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Hybrid - Spot-on use
67 mg/60.3 mg Pharmaceuticals 005 mg/pipette Merchant as - (S)-methoprene application
Spot-on Solution Manufacturing defined in (Article 13(3) of
for Small Dogs Limited relevant national Directive No
legislation 2001/82/EC)

Flectron Fly Zoetis Belgium VPA10387/034/ 935 Ear tag - QP53AC08 LM: Licensed - Cypermethrin Full application - Topical use
Tags 935 mg S.A. 001 milligram(s)/tag Merchant as (Article 12(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Flexiben 10% Bimeda Animal VPA22033/021/ 10 percent Oral suspension - QP52AC11 LM: Licensed - Albendazole Informed - Oral use
SC Oral Health Limited 001 weight/volume Merchant as consent
Suspension defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
FLIMABEND 100 Krka, d.d., Novo VPA10774/015/ 100 Oral suspension - QP52AC12 POM: - Flubendazole Hybrid - Oral use
mg/g suspension mesto 001 milligram(s)/gra Prescription Only application
for use in m Medicine as (Article 13(3) of
drinking water for defined in Directive No
chickens and relevant national 2001/82/EC)
pigs legislation

Flordofen 300 Dopharma VPA10791/006/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular
mg/ml Solution Research B.V. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC)
legislation

FLORFENIKEL Kela n.v. VPA10981/013/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular
300 mg/ml 001 milligram(s)/millil injection Prescription Only application use
solution for itre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle and pigs relevant national 2001/82/EC)
legislation

Florgane 300 Emdoka bvba VPA10534/001/ 300 Suspension for - QJ01BA90 POM: - Florfenicol Hybrid - Intramuscular
mg/ml 001 milligram(s)/millil injection Prescription Only application use
Suspension for itre Medicine as (Article 13(3) of
Injection for defined in Directive No
Cattle and Pigs relevant national 2001/82/EC)
legislation

FLORINJECT LABORATORIO VPA10665/006/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular
300 mg/ml S CALIER S.A. 001 milligram(s)/millil injection Prescription Only application use
solution for itre Medicine as (Article 13(1) of - Subcutaneous
injection for defined in Directive No use
cattle and pigs relevant national 2001/82/EC)
legislation

Florkem 300 Ceva Santé VPA10815/008/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular
mg/ml solution Animale 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of
cattle and pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 85 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
FLOROLAB 100 Labiana Life VPA10402/003/ 100 Solution for use - QJ01BA90 POM: - Florfenicol Hybrid - Per Oral
mg/ml solution Sciences, S.A. 001 milligram(s)/millil in drinking water Prescription Only application
for use in itre Medicine as (Article 13(3) of
drinking water for defined in Directive No
pigs relevant national 2001/82/EC)
legislation

Floxabactin 15 Le Vet BV VPA10816/006/ 15 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg tablets for 001 Prescription Only application
cats and dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Floxabactin 150 Le Vet BV VPA10816/006/ 150 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg tablets for 003 Prescription Only application
dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Floxabactin 50 Le Vet BV VPA10816/006/ 50 mg/tablet Tablet - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg tablets for 002 Prescription Only application
dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Floxamax 100 SP Veterinaria, VPA10790/002/ 100 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml S.A. 001 milligram(s)/millil Prescription Only application
concentrate for itre Medicine as (Article 13(1) of
oral solution for defined in Directive No
chickens and relevant national 2001/82/EC)
turkeys legislation

Floxibac 100 Chanelle VPA10987/071/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin - Intramuscular
mg/ml Solution Pharmaceuticals 002 milligram(s)/millil injection Prescription Only use
for Injection for Manufacturing itre Medicine as - Intravenous
Cattle and Pigs Limited defined in use
relevant national - Subcutaneous
legislation use

Floxibac 50 Chanelle VPA10987/071/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin - Intramuscular


mg/ml Solution Pharmaceuticals 001 milligram(s)/millil injection Prescription Only use
for Injection for Manufacturing itre Medicine as - Intravenous
Cattle, Pigs, Limited defined in use
Dogs and Cats relevant national - Subcutaneous
legislation use

Flubendazole Elanco GmbH VPA22020/037/ 50 Oral powder - QP52AC12 POM: - Flubendazole Generic - Oral use
Elanco 50 mg/g 001 milligram(s)/gra Prescription Only application
oral powder for m Medicine as (Article 13(1) of
pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Flubenol 5 % Elanco GmbH VPA22020/006/ 5 percent Premix for - QP52AC12 POM: - Flubendazole - Oral use
w/w Premix for 001 weight/weight medicated Prescription Only
Medicated feeding stuff Medicine as
Feeding Stuff defined in
relevant national
legislation

Flubenol 5 %w/w Elanco GmbH VPA22020/028/ 5 percent Oral powder - QP52AC12 POM: - Flubendazole Full application - Oral use
Oral Powder for 001 weight/weight Prescription Only (Article 12(3) of
Pigs Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Flukiver 5% w/v Elanco GmbH VPA22020/001/ 5 percent Oral suspension - QP52AG09 LM: Licensed - Closantel (as - Oral use
Oral Suspension 001 weight/volume Merchant as closantel
defined in sodium)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 86 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Flukiver 50 Elanco GmbH VPA22020/002/ 50 Solution for - QP52AG09 LM: Licensed - Closantel - Subcutaneous
mg/ml Solution 001 milligram(s)/millil injection Merchant as use
for Injection itre defined in
relevant national
legislation

Flukiver Combi Elanco GmbH VPA22020/039/ 50, 75 Oral suspension - QP52A LM: Licensed - Closantel Generic - Oral use
50 mg/ml + 75 001 milligram(s)/millil Merchant as - Mebendazole application
mg/ml oral itre defined in (Article 13(1) of
suspension relevant national Directive No
legislation 2001/82/EC)

Flunazine 50 Bimeda Animal VPA22033/061/ 50 Solution for - QM01AG90 POM: - Flunixin - Intravenous
mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only use
for Injection for itre Medicine as
cattle, horses defined in
and pigs relevant national
legislation

Flunixin Injection Norbrook VPA22664/046/ 50 Solution for - QM01AG90 POM: - Flunixin Generic - Intramuscular
Laboratories 001 milligram(s)/millil injection Prescription Only application use
(Ireland) Limited itre Medicine as (Article 13(1) of - Intravenous
defined in Directive No use
relevant national 2001/82/EC)
legislation

Fly and Lice Zoetis Belgium VPA10387/048/ 1 percent Spot-on solution - QP53AC11 LM: Licensed - Deltamethrin Full application - Topical use
Spot On S.A. 001 weight/volume Merchant as (Article 12(3) of
Insecticide 1% defined in Directive No
w/v relevant national 2001/82/EC)
legislation

Folligon PMSG Intervet Ireland VPA10996/055/ 200 international Powder and - QG03GA03 POM: - Gonadotrophin Full application - Intramuscular
200 IU/ml Limited 001 unit(s)/millilitre solvent for Prescription Only (Article 12(3) of use
lyophilisate and suspension for Medicine as Directive No - Subcutaneous
solvent for injection defined in 2001/82/EC) use
solution for relevant national
injection legislation

Folliplan, 4 Intervet Ireland VPA10996/275/ 4 Oral solution - QG03DX90 POM: - Altrenogest Generic - Oral use
mg/ml oral Limited 001 milligram(s)/millil Prescription Only application
solution for pigs itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Folltropin 700 IU Vetoquinol VPA10983/050/ 700 international Powder and - QG03GA90 POM: - Porcine follicle Full application - Intramuscular
Powder and Ireland Limited 001 unit/vial solvent for Prescription Only stimulating (Article 12(3) of use
Solvent for solution for Medicine as hormone Directive No
solution for injection defined in 2001/82/EC)
injection relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 87 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Footvax Intervet Ireland VPA10996/232/ . Emulsion for - QI04AB03 POM: - Dichelobacter Generic - Subcutaneous
Emulsion for Limited 001 injection Prescription Only nodosus application use
Injection Medicine as serotype A (Article 13(1) of
defined in - Dichelobacter Directive No
relevant national nodosus 2001/82/EC)
legislation serotype B1
- Dichelobacter
nodosus
serotype B2
- Dichelobacter
nodosus
serotype C
- Dichelobacter
nodosus
serotype D
- Dichelobacter
nodosus
serotype E
- Dichelobacter
nodosusserotype
F
- Dichelobacter
nodosus
serotype G
- Dichelobacter
nodosus
serotype H
- Dichelobacter
nodosus
serotype I
Forcyl 160 mg/ml Vetoquinol VPA10983/051/ 160 Solution for - QJ01MA93 POM: - Marbofloxacin Full application - Intramuscular
solution for Ireland Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
injection for itre Medicine as Directive No - Intravenous
cattle defined in 2001/82/EC) use
relevant national
legislation

FORCYL swine Vetoquinol VPA10983/052/ 160 Solution for - QJ01MA93 POM: - Marbofloxacin Full application - Intramuscular
160 mg/ml Ireland Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
solution for itre Medicine as Directive No
injection for pigs defined in 2001/82/EC)
relevant national
legislation

Fortekor 2.5 mg Elanco GmbH VPA22020/017/ 2.5 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use
tablets for cats 001 Prescription Only hydrochloride application
and dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Fortekor Flavour Elanco GmbH VPA22020/018/ 20 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use
20 mg Tablets 002 Prescription Only hydrochloride application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Fortekor Flavour Elanco GmbH VPA22020/018/ 5 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use
5 mg Tablets for 001 Prescription Only hydrochloride application
cats and dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Fortemec 1 % Ancare Ireland VPA10915/011/ 1 percent Pour-on solution - QP54AA02 LM: Licensed - Abamectin Informed - Topical use
w/v Pour On Ltd. 001 weight/volume Merchant as consent
Solution defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 88 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Framomycin 150 Elanco GmbH VPA22020/025/ 150 Solution for - QJ01GB POM: - Framycetin Full application - Intramuscular
mg/ml Solution 001 milligram(s)/millil injection Prescription Only sulphate (Article 12(3) of use
for Injection itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Frontline Combo Boehringer VPA10454/046/ 50, 60 Spot-on solution - QP53AX65 POM: - Fipronil - Topical use
Spot-on Cat Ingelheim 001 mg/pipette Prescription Only - (S)-methoprene
Vetmedica Medicine as
GmbH defined in
relevant national
legislation

Frontline Combo Boehringer VPA10454/047/ 268.0, 241.2 Spot-on solution - QP53AX65 POM: - Fipronil - Topical use
Spot-on Dog L Ingelheim 003 mg/pipette Prescription Only - (S)-methoprene
Vetmedica Medicine as
GmbH defined in
relevant national
legislation

Frontline Combo Boehringer VPA10454/047/ 134.0, 120.6 Spot-on solution - QP53AX65 POM: - Fipronil - Topical use
Spot-on Dog M Ingelheim 002 mg/pipette Prescription Only - (S)-methoprene
Vetmedica Medicine as
GmbH defined in
relevant national
legislation

Frontline Combo Boehringer VPA10454/047/ 67.0, 60.3 Spot-on solution - QP53AX65 POM: - Fipronil - Topical use
Spot-on Dog S Ingelheim 001 mg/pipette Prescription Only - (S)-methoprene
Vetmedica Medicine as
GmbH defined in
relevant national
legislation

Frontline Combo Boehringer VPA10454/047/ 402.0, 361.8 Spot-on solution - QP53AX65 POM: - Fipronil - Topical use
Spot-on Dog XL Ingelheim 004 mg/pipette Prescription Only - (S)-methoprene
Vetmedica Medicine as
GmbH defined in
relevant national
legislation

Frontline Spot Boehringer VPA10454/048/ 10 percent Spot-on solution - QP53AX15 POM: - Fipronil Full application - Topical use
On Cat Ingelheim 001 weight/volume Prescription Only (Article 12(3) of
Vetmedica Medicine as Directive No
GmbH defined in 2001/82/EC)
relevant national
legislation

Frontline Spot Boehringer VPA10454/049/ 10 percent Spot-on solution - QP53AX15 POM: - Fipronil Full application - Topical use
On Dog Ingelheim 001 weight/volume Prescription Only (Article 12(3) of
Vetmedica Medicine as Directive No
GmbH defined in 2001/82/EC)
relevant national
legislation

Frontline Spray Boehringer VPA10454/050/ 0.25 percent Cutaneous - QP53AX15 POM: - Fipronil Full application - Cutaneous use
0.25 %w/v Ingelheim 001 weight/volume spray, solution Prescription Only (Article 12(3) of
Vetmedica Medicine as Directive No
GmbH defined in 2001/82/EC)
relevant national
legislation

Fungiconazol Le Vet Beheer VPA10475/012/ 200 mg/tablet Tablet - QJ02AB02 POM: - Ketoconazole Generic - Oral use
200 mg tablets B.V. 001 Prescription Only application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 89 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Fungiconazol Le Vet Beheer VPA10475/012/ 400 mg/tablet Tablet - QJ02AB02 POM: - Ketoconazole Generic - Oral use
400 mg tablets B.V. 002 Prescription Only application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Furosoral 10 mg Le Vet Beheer VPA10475/017/ 10 mg/tablet Tablet - QC03CA01 POM: - Furosemide Hybrid - Oral use
tablets for cats B.V. 001 Prescription Only application
and dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Furosoral 40 mg Le Vet Beheer VPA10475/017/ 40 mg/tablet Tablet - QC03CA01 POM: - Furosemide Generic - Oral use
tablets for cats B.V. 002 Prescription Only application
and dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Fuselieve 1 mg/g Norbrook VPA22664/147/ 1,5 Gel - QD07CC01 POM: - Betamethasone Hybrid - Topical use
+ 5 mg/g Gel for Laboratories 001 milligram(s)/gra Prescription Only - Fusidic acid application
Dogs (Ireland) Limited m Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Gabbrovet 140 Ceva Santé VPA10815/050/ 140 Solution for use - QA07AA06 POM: - Paromomycin Generic - Oral use
mg/ml solution Animale 001 milligram(s)/millil in drinking water, Prescription Only application
for use in itre Milk or milk Medicine as (Article 13(1) of
drinking water, replacer defined in Directive No
milk or milk relevant national 2001/82/EC)
replacer for pre- legislation
ruminant cattle
and pigs
Gallifen 200 Huvepharma NV VPA10782/030/ 200 Suspension for - QP52AC13 POM: - Fenbendazole Hybrid - In drinking
mg/ml 001 milligram(s)/millil use in drinking Prescription Only application water use
suspension for itre water Medicine as (Article 13(3) of
use in drinking defined in Directive No
water for relevant national 2001/82/EC)
chickens and legislation
pheasants
Gallifen 40 mg/g Huvepharma NV VPA10782/022/ 40 Premix for - QP52AC13 POM: - Fenbendazole Hybrid - Oral use
premix for 001 milligram(s)/gra medicated Prescription Only application
medicated m feeding stuff Medicine as (Article 13(3) of
feeding stuff for defined in Directive No
chickens and relevant national 2001/82/EC)
pheasants legislation

GALLIMUNE Boehringer VPA10454/051/ . Emulsion for - QI01AA13 POM: - Inactivated Full application - Intramuscular
302 ND+IB+EDS Ingelheim 001 injection Prescription Only newcastle (Article 12(3) of use
Vetmedica Medicine as disease virus, Directive No
GmbH defined in ulster 2c strain 2001/82/EC)
relevant national - Inactivated
legislation infectious
bronchitis virus,
mass41 strain
- Inactivated egg
drop syndrome
virus (eds76),
v127 strain

Veterinary Medicines Authorised/Transfer Pending Products Page 90 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
GALLIMUNE Boehringer VPA10454/052/ . Emulsion for - QI01AA21 POM: - Inactivated Full application - Intramuscular
303 ND+IB+ART Ingelheim 001 injection Prescription Only newcastle (Article 12(3) of use
Emulsion for Vetmedica Medicine as disease virus, Directive No
injection GmbH defined in ulster 2c strain 2001/82/EC)
relevant national - Inactivated
legislation infectious
bronchitis virus,
mass41 strain
- Inactivated
avian
rhinotracheitis
virus (swollen
head syndrome),
vco3 strain

GALLIMUNE Boehringer VPA10454/053/ . Emulsion for - QI01AA18 POM: - Inactivated Full application - Intramuscular
407 Ingelheim 001 injection Prescription Only newcastle (Article 12(3) of use
ND+IB+EDS+A Vetmedica Medicine as disease virus, Directive No
RT Emulsion for GmbH defined in ulser 2C strain, 2001/82/EC)
injection relevant national at least
legislation - Inactivated
infectious
bronchitis virus,
mass41 strain, at
least
- Inactivated egg
drop syndrome
virus (EDS76),
V127 strain, at
least
- Inactivated
avian
rhinotracheitis
virus (swollen
head syndrome),
vc03 strain, at
least

Gallimune Se + Boehringer VPA10454/054/ . Emulsion for - QI01AB01 POM: - Inactivated Full application - Intramuscular
St, water-in-oil Ingelheim 001 injection Prescription Only Salmonella (Article 12(3) of use
emulsion for Vetmedica Medicine as Enteritidis PT4 Directive No
injection GmbH defined in - Inactivated 2001/82/EC)
relevant national Salmonella
legislation Typhimurium DT
104
GALLIVAC IB88 Boehringer VPA10454/056/ . Effervescent - QI01AD07 POM: - Live attenuated Full application - Nebulisation
NEO Ingelheim 001 tablet Prescription Only coronavirus, (Article 12(3) of use
effervescent Vetmedica Medicine as CR88121 strain Directive No
tablet for GmbH defined in 2001/82/EC)
suspension for relevant national
nebulisation for legislation
chickens
GALLIVAC IBD Boehringer VPA10454/057/ . Lyophilisate for - QI01AD09 POM: - Infectious Full application - Inhalation use
Ingelheim 001 suspension Prescription Only bursal disease (Article 12(3) of - Oral use
Vetmedica Medicine as virus, attenuated Directive No
GmbH defined in strain S706 2001/82/EC)
relevant national
legislation

GalluDoxx 500 Huvepharma NV VPA10782/023/ 500 Powder for use - QJ01AA02 POM: - Doxycycline Generic - In drinking
mg/g powder for 001 milligram(s)/gra in drinking water Prescription Only hyclate application water use
use in drinking m Medicine as (Article 13(1) of
water/milk defined in Directive No
replacer for relevant national 2001/82/EC)
calves, chickens legislation
and turkeys

Gastazole 370 Chanelle VPA10987/124/ 370 Oral paste - QA02BC01 POM: - Omeprazole Generic - Oral use
mg/g oral paste Pharmaceuticals 001 milligram(s)/gra Prescription Only application
for horses Manufacturing m Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 91 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Gastrobim 370 Bimeda Animal VPA22033/072/ 370 Oral paste - QA02BC01 POM: - Omeprazole Generic - Oral use
mg/g oral paste Health Limited 001 milligram(s)/gra Prescription Only application
for horses m Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

GastroGard 370 Boehringer VPA10454/058/ 370 Oral paste - QA02BC01 POM: - Omeprazole Full application - Oral use
mg/g oral paste Ingelheim 001 milligram(s)/gra Prescription Only (Article 12(3) of
Vetmedica m Medicine as Directive No
GmbH defined in 2001/82/EC)
relevant national
legislation

Genesis 1% Ancare Ireland VPA10915/007/ 1 percent Pour-on solution - QP54AA LM: Licensed - Abamectin - Topical use
Pour-on Solution Ltd. 001 weight/volume Merchant as
defined in
relevant national
legislation

Genesis Sheep Ancare Ireland VPA10915/009/ 0.8 Oral solution - QP54AA02 LM: Licensed - Abamectin 12(3) full dossier - Per Oral
Drench 0.8 Ltd. 001 milligram(s)/millil Merchant as
mg/ml abamectin itre defined in
oral solution relevant national
legislation

Genestran 75 aniMedica VPA10826/010/ 75 Solution for - QG02AD90 POM: - (+)-cloprostenol Well-established - Intramuscular
micrograms/ml GmbH 001 microgram(s)/mil injection Prescription Only (as (+)- use application use
solution for lilitre Medicine as cloprostenol (Article 13a of
injection for defined in sodium) Directive No
cattle, horses relevant national 2001/82/EC)
and pigs legislation

Genta 50 mg/ml Kela n.v. VPA10981/011/ 50 Solution for - QJ01GB03 POM: - Gentamicin - Intramuscular
solution for 001 milligram(s)/millil injection Prescription Only use
injection itre Medicine as
defined in
relevant national
legislation

Gentaject 10% Franklin VPA10976/002/ 100 Solution for - QJ01GB03 POM: - Gentamicin Full application - Intravenous
Solution for Pharmaceuticals 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
Injection for Ltd. itre Medicine as Directive No
Horses defined in 2001/82/EC)
relevant national
legislation

Gleptoferron Labiana Life VPA10402/001/ 200 Solution for - QB03AC91 LM: Licensed - Iron (as Generic - Intramuscular
Labiana 200 Sciences, S.A. 001 milligram(s)/millil injection Merchant as gleptoferron application use
mg/ml Solution itre defined in complex) (Article 13(1) of
for Injection relevant national Directive No
legislation 2001/82/EC)

Gleptosil 200 Ceva Santé VPA10815/027/ 200 Solution for - QB03AC91 LM: Licensed - Iron (as - Intramuscular
mg/ml Solution Animale 001 milligram(s)/millil injection Merchant as gleptoferron use
for Injection itre defined in complex)
relevant national
legislation

GLEPTOVEX SP Veterinaria, VPA10790/010/ 200 Solution for - QB03AC91 LM: Licensed - Iron Generic - Intramuscular
200 mg/ml S.A. 001 milligram(s)/millil injection Merchant as application use
solution for itre defined in (Article 13(1) of
injection for pigs relevant national Directive No
legislation 2001/82/EC)

GLETVAX 6 Zoetis Belgium VPA10387/035/ . Suspension for - QI09AB08 LM: Licensed - E.coli k88ab Full application - Intramuscular
S.A. 001 injection Merchant as antigen (Article 12(3) of use
defined in - E.coli k88ac Directive No - Subcutaneous
relevant national antigen 2001/82/EC) use
legislation - E.coli k99
antigen
- E.coli 987p
antigen
- Purified toxoids
of Cl. perfringens

Veterinary Medicines Authorised/Transfer Pending Products Page 92 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Glucadex 2 Kepro BV VPA22633/001/ 2 Solution for - QH02AB02 POM: - Generic - Intraarticular
mg/ml solution 001 milligram(s)/millil injection Prescription Only Dexamethasone application use
for injection for itre Medicine as (Article 13(1) of- Intramuscular
horses, cattle, defined in Directive No use
goats, pigs, dogs relevant national 2001/82/EC) - Intravenous
and cats legislation use
- Periarticular
use
- Subcutaneous
use
Glucose 5g/100 B. Braun VPA10465/001/ 5 grams/100 Solution for - QB05B POM: - Glucose Well-established - Intravenous
ml B. Braun Vet Melsungen AG 001 millilitres infusion Prescription Only monohydrate use application use
Care solution for Medicine as (Article 13a of
infusion for defined in Directive No
cattle, horse, relevant national 2001/82/EC)
sheep, goat, pig, legislation
dog and cat
Gold Fleece Bimeda Animal VPA22033/023/ 60 percent Concentrate for - QP53AF03 LM: Licensed - Dimpylate - Topical use
Sheep Dip 60 % Health Limited 001 weight/weight dip solution Merchant as (Diazinon
w/w Concentrate defined in Stabilised
for Dip Solution relevant national Technical)
legislation

Golden Udder Collective VPA10914/001/ 10, 1.5 percent Gel - QD11AC08 LM: Licensed - Sulphur for - Topical use
Gel Chemical 001 weight/volume Merchant as external use
Company Ltd. defined in - Salicylic acid
relevant national
legislation

Gonavet Veyx 50 Veyx-Pharma VPA10539/004/ 50 Solution for - QH01CA01 POM: - Gonadorelin [6- Generic - Intramuscular
micrograms/ml GmbH 001 microgram(s)/mil injection Prescription Only D-Phe] application use
solution for lilitre Medicine as (Article 13(1) of - Subcutaneous
injection for defined in Directive No use
cattle, pigs and relevant national 2001/82/EC)
horses legislation

Grisol V Powder Vetoquinol UK VPA10966/029/ 7.5 percent Oral powder - QD01BA01 POM: - Griseofulvin Full application - Oral use
7.5% w/w oral Limited 001 weight/weight Prescription Only (Article 12(3) of
powder Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Gullivers Flea & Chanelle VPA10987/055/ 3.9 Collar - QP53AF03 CAM: - Dimpylate - Topical use
Tick Collar for Pharmaceuticals 001 gram(s)/collar Companion
dogs Manufacturing Animal Medicine
Limited as defined in
relevant national
legislation

Gulliver's Flea Chanelle VPA10987/014/ 2.1 Collar - QP53AF03 CAM: - Dimpylate - Topical use
Collar for Cats Pharmaceuticals 001 gram(s)/collar Companion
Manufacturing Animal Medicine
Limited as defined in
relevant national
legislation

Gullivers Flea Chanelle VPA10987/040/ 0.05, 0.5 percent Shampoo - QP53AC30 CAM: - Pyrethrins - Topical use
Shampoo Pharmaceuticals 001 weight/volume Companion - Piperonyl
Manufacturing Animal Medicine butoxide
Limited as defined in
relevant national
legislation

Gutal 1000 mg/g Huvepharma NV VPA10782/016/ 1000 Premix for - QA07XA91 POM: - Zinc oxide Generic - Oral use
premix for 001 milligram(s)/gra medicated Prescription Only application
medicated m feeding stuff Medicine as (Article 13(1) of
feeding stuff for defined in Directive No
piglets relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 93 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
HATCHPAK IB Boehringer VPA10454/061/ . Effervescent - QI01AD07 POM: - Live avian Full application - Nebulisation
H120 NEO Ingelheim 001 tablet Prescription Only infectious (Article 12(3) of use
effervescent Vetmedica Medicine as bronchitis virus Directive No
tablet for GmbH defined in (strain h120) 2001/82/EC)
nebuliser relevant national
suspension for legislation
chickens
Hedylon 25 mg LIVISTO Int'l, VPA10425/009/ 25 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Generic - Oral use
tablets for dogs S.L. 002 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Hedylon 5 mg LIVISTO Int'l, VPA10425/009/ 5 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Generic - Oral use
tablets for dogs S.L. 001 Prescription Only application
and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Helmex Cat 80 ZYLAVET VPA10407/002/ 80/20 mg/tablet Chewable/dispe - QP52AA51 CAM: - Pyrantel (as Generic - Oral use
mg/20 mg Pharmaceuticals 001 rsible tablet Companion pyrantel application
Chewable Ltd Animal Medicine embonate) (Article 13(1) of
Tablets for Cats as defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Helodip 3.1 % Bimeda Animal VPA22033/024/ 3.1 percent Teat dip - QD08AX LM: Licensed - Ammonium Full application - Topical use
w/v Teat Dip Health Limited 001 weight/volume Merchant as lauryl sulphate (Article 12(3) of
Concentrate defined in (as a Directive No
relevant national concentrate 27- 2001/82/EC)
legislation 28% w/w)

HEMOSILATE Ecuphar VPA10389/004/ 125 Solution for - QB02BX01 VPO: Veterinary - Etamsylate Generic - Intramuscular
125 mg/ml Veterinaria 001 milligram(s)/millil injection Practitioner Only application use
Solution for S.L.U. itre as defined in (Article 13(1) of - Intravenous
injection relevant national Directive No use
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 94 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Heptavac P Plus Intervet Ireland VPA10996/146/ . Suspension for - QI04AB05 LM: Licensed - Clostridium Full application - Subcutaneous
Limited 001 injection Merchant as perfringens beta (Article 12(3) of use
defined in toxoid (strains Directive No
relevant national 554 and 578) 2001/82/EC)
legislation - Clostridium
perfringens
epsilon toxoid
(strain 603)
- Clostridium
septicum toxoid
(strain 505)
- Clostridium
tetani toxoid
(strain s1123/91)
- Clostridium
novyi toxoid
(strain 754)
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
655
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
656
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
657
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
658
- Clostridium
chauvoei cells
and equivalent
toxoid of strain
1048
- Formalin
pasteurella
haemolytica
strain a1
(s1006/77)
- Formalin
pasteurella
haemolytica
strain a2
(s1126/92)
- Formalin
pasteurella
haemolytica
strain a6
(s1084/81)
- Formalin
pasteurella
haemolytica
strain a7
(s1078/81)
- Formalin
pasteurella
haemolytica
strain a9
(s994/77)
- Formalin
pasteurella
trehalosi strain t3
(s1109/84)
- Formalin
pasteurella
trehalosi strain t4
(s1085/81)
- Formalin
pasteurella
trehalosi strain
t10 (s1075/81)
Veterinary Medicines Authorised/Transfer Pending Products - Formalin Page 95 of 201
pasteurella
trehalosi strain
t15 (s1105/84)
Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Hexaguard GEA Farm VPA10844/001/ 0.74 percent Teat dip - QD08AC02 LM: Licensed - Chlorhexidine - Topical use
Technologies 001 weight/volume Merchant as gluconate
(UK) Ltd defined in
relevant national
legislation

Hexasol LA Norbrook VPA22664/049/ 300,20 Solution for - QJ01AA56 POM: - Oxytetracycline Fixed - Intramuscular
Solution for Laboratories 001 milligram(s)/millil injection Prescription Only - Flunixin (as combination use
Injection (Ireland) Limited itre Medicine as flunixin application
defined in meglumine) (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

HIDROCOL, SP Veterinaria, VPA10790/009/ 4000000 Solution for use - QA07AA10 POM: - Colistin Hybrid - Oral use
4000000 IU/ml S.A. 001 international in drinking water, Prescription Only application
solution for use unit(s)/millilitre Milk or milk Medicine as (Article 13(3) of
in drinking replacer defined in Directive No
water/milk relevant national 2001/82/EC)
legislation

Hipra LHV Bonapp HOVR10466/00 Oral solution LM: Licensed - Solidago - Oral use
7/001 Merchant as - Euphrasia
defined in officinalis
relevant national - Echinacea
legislation angustifolia
- Allium cepa
HIPRABOVIS Laboratorios VPA10846/005/ . Emulsion for - QI02AB POM: - Mannheimia Full application - Subcutaneous
SOMNI/LktEmul Hipra S.A. 001 injection Prescription Only haemolytica (Article 12(3) of use
sion for injection Medicine as biotype a, Directive No
for cattle defined in serotype a1 2001/82/EC)
relevant national leukotoxoid
legislation - Haemophilus
somnus bailie
strain,
inactivated
HIPRABOVIS-4 Laboratorios VPA10846/003/ - percent Powder and - QI02AH POM: - Inactivated - Intramuscular
Hipra S.A. 001 solvent for Prescription Only infectious bovine use
suspension for Medicine as rhinotracheitis
injection defined in virus strain LA
relevant national - Inactivated
legislation parainfluenza-3
virus, strain SF4
- Inactivated
bovine diarrhoea
virus strain
NADL
- Live bovine
respiratory strain
lym-56

HIPRACIN10 Laboratorios VPA10846/002/ 10 international Solution for - QH01BB02 POM: - Oxytocin - Intramuscular
IU/ml Synthetic Hipra S.A. 001 unit(s) injection Prescription Only use
Oxytocin, Medicine as - Intravenous
solution for defined in use
injection relevant national
legislation

Hipracox Broilers Laboratorios VPA10846/009/ . Oral suspension - QI01AN01 POM: - Eimeria Full application - Oral use
Oral suspension Hipra S.A. 001 Prescription Only acervulina, strain (Article 12(3) of
for chicken Medicine as 003 Directive No
defined in - Eimeria 2001/82/EC)
relevant national maxima, strain
legislation 013
- Eimeria mitis,
strain 006
- Eimeria
praecox, strain
007
- Eimeria tenella,
strain 004

Veterinary Medicines Authorised/Transfer Pending Products Page 96 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Hipragumboro Laboratorios VPA10846/017/ . Lyophilisate for - QI01AD09 POM: - Avian infectious Full application - In drinking
CW Lyophilisate Hipra S.A. 001 use in drinking Prescription Only bursal disease (Article 12(3) of water use
for use in water Medicine as virus, live Directive No
drinking water defined in 2001/82/EC)
relevant national
legislation

HIPRAGUMBO Laboratorios VPA10846/014/ . Lyophilisate for - QI01AD09 POM: - Live Infectious Full application - Oral use
RO-G97 Hipra S.A. 001 suspension Prescription Only Bursal Disease (Article 12(3) of
Medicine as Virus, strain Directive No
defined in GM97 2001/82/EC)
relevant national
legislation

Histodine 10 Le Vet Beheer VPA10475/029/ 10 Solution for - QR06AB04 POM: - Generic - Intramuscular
mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only Chlorphenamine application use
for injection for itre Medicine as maleate (Article 13(1) of - Intravenous
cattle defined in Directive No use
relevant national 2001/82/EC)
legislation

Hornex 42.7% Agri-Lloyd VPA22762/001/ 42.7 percent Cutaneous paste - QD11AX LM: Licensed - Sodium Generic - Cutaneous use
w/w Cutaneous Limited 001 weight/weight Merchant as hydroxide application
paste defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

HuveGuard Huvepharma NV VPA10782/027/ . Oral suspension - QI01AN POM: - Eimeria Full application - Ocular use
MMAT 001 Prescription Only acervulina (Article 12(3) of - Oral use
suspension for Medicine as - Eimeria Directive No
oral suspension defined in maxima 2001/82/EC)
for chickens relevant national - Eimeria mitis
legislation - Eimeria tenella

HuveGuard NB Huvepharma NV VPA10782/025/ . Oral suspension - QI01AN01 POM: - Eimeria brunetti Full application - Oral use
suspension for 001 Prescription Only strain roybru (Article 12(3) of
oral suspension Medicine as 3+28 Directive No
for chickens defined in - Eimeria 2001/82/EC)
relevant national necatrix strain
legislation mednec 3+8

HY-50 Vet. 17 Dechra VPA22622/010/ 17 Solution for - QM09AX01 POM: - Sodium Generic - Intraarticular
mg/ml solution Regulatory B.V. 001 milligram(s)/millil injection Prescription Only hyaluronate application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
horses defined in Directive No use
relevant national 2001/82/EC)
legislation

HydroDoxx 500 Huvepharma NV VPA10782/007/ 500 Powder for oral - QJ01AA02 POM: - Doxycycline Generic - Oral use
mg/g Powder for 001 milligram(s)/gra solution Prescription Only application
use in drinking m Medicine as (Article 13(1) of
water for defined in Directive No
chickens and relevant national 2001/82/EC)
pigs legislation

Hymatil 300 Industrial VPA10509/001/ 300 Solution for - QJ01FA91 VPO: Veterinary - Tilmicosin Generic - Subcutaneous
mg/ml solution Veterinaria, S.A. 001 milligram(s)/millil injection Practitioner Only application use
for injection for itre as defined in (Article 13(1) of
cattle and sheep relevant national Directive No
legislation 2001/82/EC)

Hyogen Ceva Santé VPA10815/026/ . Emulsion for - QI09AB13 POM: - Inactivated Full application - Intramuscular
emulsion for Animale 001 injection Prescription Only bacterin of (Article 12(3) of use
injection for pigs Medicine as mycoplasma Directive No
defined in hyopneumoniae 2001/82/EC)
relevant national strain 2940
legislation

Hyonate 10 Boehringer VPA10454/062/ 10 Solution for - QM09AX01 VPO: Veterinary - Sodium - Intraarticular
mg/ml solution Ingelheim 001 milligram(s)/millil injection Practitioner Only hyaluronate use
for injection Vetmedica itre as defined in - Intravenous
GmbH relevant national use
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 97 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
HyperCard 10 Dechra VPA22622/011/ 10 mg/tablet Coated tablet - QC08DB01 POM: - Diltiazem - Oral use
mg Coated Regulatory B.V. 001 Prescription Only
Tablets for Cats Medicine as
defined in
relevant national
legislation

Hypersol 500 HUVEPHARMA VPA10453/001/ 500 Oral powder - QJ01AA06 POM: - Oxytetracycline Generic - Oral use
mg/g Powder for SA 001 milligram(s)/gra Prescription Only application
use in Drinking m Medicine as (Article 13(1) of
water defined in Directive No
relevant national 2001/82/EC)
legislation

Hypophysin LA Veyx-Pharma VPA10539/003/ 35 Solution for - QH01BB03 POM: - Carbetocin Hybrid - Intramuscular
35 microgram/ml GmbH 001 microgram(s)/mil injection Prescription Only application use
solution for lilitre Medicine as (Article 13(3) of - Intravenous
injection for defined in Directive No use
cattle and pigs relevant national 2001/82/EC)
legislation

Hypophysin LA Veyx-Pharma VPA10539/003/ 70 Solution for - QH01BB03 POM: - Carbetocin Hybrid - Intramuscular
70 microgram/ml GmbH 002 microgram(s)/mil injection Prescription Only application use
solution for lilitre Medicine as (Article 13(3) of - Intravenous
injection for defined in Directive No use
cattle and pigs relevant national 2001/82/EC)
legislation

Imaverol 100 AUDEVARD VPA10481/001/ 100 Cutaneous - QD01AC90 LM: Licensed - Enilconazole Full application - Topical use
mg/ml 001 milligram(s)/millil emulsion Merchant as (Article 12(3) of
Concentrate for itre defined in Directive No
Cutaneous relevant national 2001/82/EC)
Emulsion legislation

Imec 10 mg/ml ECO Animal VPA22693/007/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin Informed - Subcutaneous
Solution for Health Europe 001 milligram(s)/millil injection Merchant as consent use
Injection Limited itre defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Imec 5 mg/ml ECO Animal VPA22693/005/ 5 Pour-on solution - QP54AA01 LM: Licensed - Ivermectin - Topical use
pour-on solution Health Europe 001 milligram(s)/millil Merchant as
for cattle Limited itre defined in
relevant national
legislation

Imidacloprid Chanelle VPA10987/139/ 100 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use
Chanelle 100 mg Pharmaceuticals 003 Prescription Only application
Spot-on solution Manufacturing Medicine as (Article 13(3) of
for Medium Dog Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Imidacloprid Chanelle VPA10987/139/ 250 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use
Chanelle 250 mg Pharmaceuticals 004 Prescription Only application
Spot-on solution Manufacturing Medicine as (Article 13(3) of
for Large Dogs Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Imidacloprid Chanelle VPA10987/139/ 40 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use
Chanelle 40 mg Pharmaceuticals 001 Prescription Only application
Spot-on solution Manufacturing Medicine as (Article 13(3) of
for Small Cats, Limited defined in Directive No
Small Pet relevant national 2001/82/EC)
Rabbits & Small legislation
Dogs

Imidacloprid Chanelle VPA10987/139/ 400 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use
Chanelle 400 mg Pharmaceuticals 005 Prescription Only application
Spot-on solution Manufacturing Medicine as (Article 13(3) of
for Extra Large Limited defined in Directive No
Dogs relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 98 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Imidacloprid Chanelle VPA10987/139/ 80 mg/pipette Spot-on solution - QP53AX17 POM: - Imidacloprid Hybrid - Spot-on use
Chanelle 80 mg Pharmaceuticals 002 Prescription Only application
Spot-on solution Manufacturing Medicine as (Article 13(3) of
for Large Cats Limited defined in Directive No
and Large Pet relevant national 2001/82/EC)
Rabbits legislation

Imizol 85 mg/ml Intervet Ireland VPA10996/234/ 85 Solution for - QP51AE01 POM: - Imidocarb - Subcutaneous
Solution for Limited 001 milligram(s)/millil injection Prescription Only use
Injection itre Medicine as
defined in
relevant national
legislation

IMOCOLIBOV Boehringer VPA10454/063/ . Suspension for - QI02AC LM: Licensed - Inactivated Full application - Subcutaneous
Ingelheim 001 injection - QI04AC Merchant as e.coli serotype (Article 12(3) of use
Vetmedica defined in 09 Directive No
GmbH relevant national - Inactivated 2001/82/EC)
legislation e.coli serotype
08
- Inactivated
e.coli serotype
015
- Inactivated
e.coli serotype
078
- Inactivated
e.coli serotype
0101
- Inactivated
e.coli serotype
00117
- Inactivated
e.coli (antigen
k99)
- Inactivated
e.coli (antigen y)
- Inactivated
e.coli (antigen
31a)

IMOCOLIBOV Boehringer VPA10454/063/ . Suspension for - QI02AC LM: Licensed - Inactivated Full application - Subcutaneous
Ingelheim 001 injection - QI04AC Merchant as e.coli serotype (Article 12(3) of use
Vetmedica defined in 09 Directive No
GmbH relevant national - Inactivated 2001/82/EC)
legislation e.coli serotype
08
- Inactivated
e.coli serotype
015
- Inactivated
e.coli serotype
078
- Inactivated
e.coli serotype
0101
- Inactivated
e.coli serotype
00117
- Inactivated
e.coli (antigen
k99)
- Inactivated
e.coli (antigen y)
- Inactivated
e.coli (antigen
31a)

Imoxicate 100 Krka, d.d., Novo VPA10774/067/ 100,25 Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use
mg/25 mg spot- mesto 002 mg/pipette Prescription Only - Moxidectin application
on solution for Medicine as (Article 13(3) of
medium dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 99 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Imoxicate 250 Krka, d.d., Novo VPA10774/067/ 250,62.5 Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use
mg/62.5 mg mesto 003 mg/pipette Prescription Only - Moxidectin application
spot-on solution Medicine as (Article 13(3) of
for large dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Imoxicate 40 Krka, d.d., Novo VPA10774/067/ 40,10 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use
mg/10 mg spot- mesto 001 Prescription Only - Moxidectin application
on solution for Medicine as (Article 13(3) of
small dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Imoxicate 40 Krka, d.d., Novo VPA10774/065/ 40,4 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use
mg/4 mg spot-on mesto 001 Prescription Only - Moxidectin application
solution for small Medicine as (Article 13(3) of
cats and ferrets defined in Directive No
relevant national 2001/82/EC)
legislation

Imoxicate 400 Krka, d.d., Novo VPA10774/067/ 400,100 Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use
mg/100 mg spot- mesto 004 mg/pipette Prescription Only - Moxidectin application
on solution for Medicine as (Article 13(3) of
extra-large dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Imoxicate 80 Krka, d.d., Novo VPA10774/066/ 80,8 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use
mg/8 mg spot-on mesto 001 Prescription Only - Moxidectin application
solution for large Medicine as (Article 13(3) of
cats defined in Directive No
relevant national 2001/82/EC)
legislation

INDUPART 75 Vetpharma VPA10516/010/ 75 Solution for - QG02AD90 POM: - D-cloprostenol Generic - Intramuscular
micrograms /mL Animal Health, 001 microgram(s)/mil injection Prescription Only application use
solution for S.L. lilitre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle, pigs and relevant national 2001/82/EC)
horses legislation

Ingelvac Boehringer VPA10454/007/ . Suspension for - QI09AB13 LM: Licensed - Inactivated Full application - Intramuscular
MycoFLEX Ingelheim 001 injection Merchant as mycoplasma (Article 12(3) of use
suspension for Vetmedica defined in hyopneumoniae, Directive No
injection for pigs GmbH relevant national j strain isolate b- 2001/82/EC)
legislation 3745

Ingelvac Boehringer VPA10454/008/ 10<sup>4.4 Lyophilisate and - QI09AD03 POM: - Attenuated prrs Full application - Intramuscular
PRRSFLEX EU Ingelheim 001 </sup>- solvent for Prescription Only 94881 virus (Article 12(3) of use
lyophilisate and Vetmedica 10<sup>6.6</su suspension for Medicine as Directive No
solvent for GmbH p> tissue culture injection defined in 2001/82/EC)
suspension for infective dose 50 relevant national
injection for pigs legislation

INMEVA, Laboratorios VPA10846/018/ . Suspension for - QI04AB POM: - Chlamydophila Full application - Subcutaneous
suspension for Hipra S.A. 001 injection Prescription Only abortus strain (Article 12(3) of use
injection Medicine as A22 inactivated Directive No
defined in - Salmonella 2001/82/EC)
relevant national enterica subsp.
legislation enterica serovar
Abortusovis
strain Sao

Insecinor 10 Norbrook VPA22664/119/ 10 Spot-on solution - QP53AC11 LM: Licensed - Deltamethrin Generic - Topical use
mg/ml Spot-on Laboratories 001 milligram(s)/millil Merchant as application
Solution for (Ireland) Limited itre defined in (Article 13(1) of
cattle and sheep relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 100 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Insistor 10 mg/ml Richter Pharma VPA10801/012/ 10 Solution for - QN02AC90 VPO: Veterinary - Methadone Generic - Intramuscular
solution for AG 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
injection for dogs itre as defined in (Article 13(1) of - Intravenous
and cats relevant national Directive No use
legislation 2001/82/EC) - Subcutaneous
use

Interclox DC Chem-Pharm VPA10823/011/ 500, 250 <br/> Intramammary - QJ51RC POM: - Ampicillin Informed - Intramammary
Intramammary 001 mg/syringe suspension Prescription Only - Cloxacillin consent use
Suspension Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Interject 15% Interchem VPA10555/006/ 15 percent Solution for - QJ01AA06 POM: - Oxytetracycline Informed - Intramuscular
Injection Ireland Ltd 001 weight/volume injection Prescription Only hydrochloride consent use
Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Intertrim Chem-Pharm VPA10823/005/ 40, 200 Solution for - QJ01EW10 POM: - Trimethoprim Informed - Intramuscular
001 milligram(s)/millil injection Prescription Only - Sulfadiazine consent use
itre Medicine as application - Intravenous
defined in (Article 13c of use
relevant national Directive No - Subcutaneous
legislation 2001/82/EC) use

INTRA Intracare B.V. VPA10409/001/ 499 Solution for use - QA07XA POM: - Zinc disodium Full application - In drinking
DYSOVINOL 001 milligram(s)/millil in drinking water Prescription Only EDTA (Article 12(3) of water use
499 mg/ml itre Medicine as Directive No
solution for use defined in 2001/82/EC)
in drinking water relevant national
for pigs legislation

Intra-Epicaine 20 Dechra VPA22622/013/ 20 Solution for - QN01BB03 VPO: Veterinary - Mepivacaine Well-established - Epidural use
mg/ml solution Regulatory B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride use application - Intraarticular
for injection for itre as defined in (Article 13a of use
horses relevant national Directive No - Intrabursal use
legislation 2001/82/EC) - Perineural use

Intubeaze 20 Dechra VPA22622/014/ 20 laryngopharyng - QR02AD02 VPO: Veterinary - Lidocaine Generic -


mg/ml Regulatory B.V. 001 milligram(s)/millil eal spray, Practitioner Only Hydrochloride application Laryngopharyng
laryngopharyng itre solution as defined in Monohydrate (Article 13(1) of eal use
eal spray, relevant national Directive No
solution for cats legislation 2001/82/EC)

Ioguard Ready to GEA Farm VPA10844/003/ 0.5 percent Teat dip/spray - QD08AG03 LM: Licensed - Iodine - Topical use
Use Teat Dip Technologies 001 weight/volume solution Merchant as
(UK) Ltd defined in
relevant national
legislation

Ioguard GEA Farm VPA10844/002/ 2.5 percent Teat dip/spray - QD08AG03 LM: Licensed - Iodine - Topical use
Superconcentrat Technologies 001 weight/volume solution Merchant as
e (UK) Ltd defined in
relevant national
legislation

Isaderm 5 mg/g Dechra VPA10803/006/ 5, 1 Gel - QD07CC01 POM: - Fusidic acid Generic - Cutaneous use
+ 1 mg/g gel for Veterinary 001 milligram(s)/gra Prescription Only - Betamethasone application
dogs Products A/S m Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Isathal 10 mg/g Dechra VPA10803/004/ 10 Eye drops, - QS01AA13 POM: - Fusidic acid ZZZ --Unknown- - Ocular use
eye drops, Veterinary 001 milligram(s)/gra suspension Prescription Only
suspension for Products A/S m Medicine as
dogs, cats and defined in
rabbits relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 101 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Iso - Vet 1000 Piramal Critical VPA22583/001/ 1000 Inhalation - QN01AB06 VPO: Veterinary - Isoflurane Generic - Inhalation use
mg/g Inhalation Care B.V. 001 milligram(s)/gra vapour, liquid Practitioner Only application
Vapour, liquid m as defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Isocare 1000 Ecuphar NV VPA10491/008/ 1000 Inhalation - QN01AB06 VPO: Veterinary - Isoflurane Generic - Inhalation use
mg/g Inhalation 001 milligram(s)/gra vapour, liquid Practitioner Only application
Vapour, Liquid m as defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

ISOFLURIN Vetpharma VPA10516/012/ 1000 Inhalation - QN01AB06 VPO: Veterinary - Isoflurane Generic - Inhalation use
1000 mg/g Animal Health, 001 milligram(s)/gra vapour, liquid Practitioner Only application
Inhalation S.L. m as defined in (Article 13(1) of
Vapour, Liquid relevant national Directive No
legislation 2001/82/EC)

Isothesia 1000 Piramal Critical VPA22583/002/ 1000 Inhalation - QN01AB06 VPO: Veterinary - Isoflurane Generic - Inhalation use
mg/g inhalation Care B.V. 001 milligram(s)/gra vapour, liquid Practitioner Only application
vapour, liquid m as defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Itrafungol 10 Elanco GmbH VPA22020/014/ 10 Oral solution - QJ02AC02 POM: - Itraconazole Full application - Oral use
mg/ml Oral 001 milligram(s)/millil Prescription Only (Article 12(3) of
Solution itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Iverpraz, 18.7 Norbrook VPA22664/148/ 18.7, 140.3 Oral paste - QP54AA51 LM: Licensed - Ivermectin Hybrid - Oral use
mg/g + 140.3 Laboratories 001 milligram(s)/gra Merchant as - Praziquantel application
mg/g Oral Paste (Ireland) Limited m defined in (Article 13(3) of
for Horses relevant national Directive No
legislation 2001/82/EC)

Ivomec Classic Boehringer VPA10454/064/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin Full application - Subcutaneous
Injection for Ingelheim 001 milligram(s)/millil injection Merchant as (Article 12(3) of use
Cattle and Vetmedica itre defined in Directive No
Sheep 10 mg/ml GmbH relevant national 2001/82/EC)
legislation

Ivomec Classic Boehringer VPA10454/065/ 5 Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Full application - Topical use
Pour-On for Ingelheim 001 milligram(s)/millil Merchant as (Article 12(3) of
Cattle 5 mg/ml Vetmedica itre defined in Directive No
GmbH relevant national 2001/82/EC)
legislation

IVOMEC Boehringer VPA10454/066/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin Full application - Subcutaneous
Injection for Pigs Ingelheim 001 milligram(s)/millil injection Merchant as (Article 12(3) of use
10 mg/ml Vetmedica itre defined in Directive No
GmbH relevant national 2001/82/EC)
legislation

Ivomec Premix Boehringer VPA10454/067/ 0.6 percent Premix for - QP54AA01 POM: - Ivermectin Full application - Oral use
for Pigs Ingelheim 001 weight/weight medicated Prescription Only (Article 12(3) of
Vetmedica feeding stuff Medicine as Directive No
GmbH defined in 2001/82/EC)
relevant national
legislation

Ivomec Super Boehringer VPA10454/068/ 10, 100 Solution for - QP54AA51 LM: Licensed - Ivermectin Fixed - Subcutaneous
Injection for Ingelheim 001 milligram(s)/millil injection Merchant as - Clorsulon combination use
Cattle Vetmedica itre defined in application
GmbH relevant national (Article 13b of
legislation Directive No
2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 102 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Kali Sulphuricum Galway HOVR10537/01 200 c Oral solution LM: Licensed - Kali - Oral use
200c Homoeopathics 1/001 Merchant as sulphuricum
(Manufacturing) defined in
Limited relevant national
legislation

Kanacef M.C. Interchem VPA10555/001/ . Intramammary - QJ51RD01 POM: - Cefalexin Informed - Intramammary
Intramammary Ireland Ltd 001 suspension Prescription Only - Kanamycin consent use
Suspension Medicine as monosulfate application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

KARIFLOX 100 Laboratorios VPA10786/002/ 100 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml Oral Karizoo S.A. 001 milligram(s)/millil Prescription Only application
Solution for itre Medicine as (Article 13(1) of
Chickens and defined in Directive No
Turkeys relevant national 2001/82/EC)
legislation

KARIFLOX 25 Laboratorios VPA10786/004/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml oral Karizoo S.A. 001 milligram(s)/millil Prescription Only application
solution for itre Medicine as (Article 13(1) of
calves defined in Directive No
relevant national 2001/82/EC)
legislation

KARIFLOX 5 Laboratorios VPA10786/003/ 5 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml oral Karizoo S.A. 001 milligram(s)/millil Prescription Only application
solution for itre Medicine as (Article 13(1) of
piglets defined in Directive No
relevant national 2001/82/EC)
legislation

Keelogane SC Bimeda Animal VPA22033/025/ 25 Oral suspension - QP52AC11 LM: Licensed - Albendazole Informed - Oral use
25 mg/ml Oral Health Limited 001 milligram(s)/millil Merchant as consent
suspension itre defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
KEFAMAST Dry Bimeda Animal VPA22033/041/ 500/500 Intramammary - QJ51RD01 POM: - Cefalexin - Intramammary
Cow Health Limited 001 mg/syringe suspension Prescription Only - use
Intramammary Medicine as Dihydrostreptom
Suspension defined in ycin
relevant national
legislation

Kefloril 300 Vetoquinol VPA10983/053/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular
mg/ml Solution Ireland Limited 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC)
legislation

Kelacyl 100 Kela n.v. VPA10981/014/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular
mg/ml, solution 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Kelaprofen 100 Kela n.v. VPA10981/012/ 100 Solution for - QM01AE03 POM: - Ketoprofen Generic - Intramuscular
mg/ml, solution 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle, horses defined in Directive No use
and pigs. relevant national 2001/82/EC)
legislation

Kenocidin CID LINES N.V. VPA10792/003/ 5 Liquid - QD08AC02 LM: Licensed - Chlorhexidine Full application - Topical use
Chlorhexidine 001 milligram(s)/millil Merchant as digluconate (Article 12(3) of
digluconate 5 itre defined in Directive No
mg/ml, Teat dip relevant national 2001/82/EC)
solution for cattle legislation
(dairy)

Veterinary Medicines Authorised/Transfer Pending Products Page 103 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Kenocidin CID LINES N.V. VPA10792/004/ 5 Teat dip/spray - QD08AC02 LM: Licensed - Chlorhexidine Full application - Topical use
SPRAY AND 001 milligram(s)/millil solution Merchant as digluconate (Article 12(3) of
DIPChlorhexidin itre defined in Directive No
e digluconate 5 relevant national 2001/82/EC)
mg/ml, Teat Dip / legislation
Teat Spray
solution for cattle
(dairy)
Kenostart 3 mg/g CID LINES N.V. VPA10792/001/ 3 Teat dip - QD08AG03 LM: Licensed - Available iodine Full application - Topical use
teat dip solution 001 milligram(s)/gra Merchant as (Article 12(3) of
for cattle (dairy). m defined in Directive No
relevant national 2001/82/EC)
legislation

KENOSTART CID LINES N.V. VPA10792/002/ 3 Teat dip - QD08AG03 LM: Licensed - Available iodine Full application - Topical use
SPRAY AND 001 milligram(s)/gra Merchant as (Article 12(3) of
DIP 3 mg/g Teat m defined in Directive No
Dip or Spray relevant national 2001/82/EC)
Solution for legislation
cattle (dairy)
Kesium 250 mg Ceva Santé VPA10815/034/ 250 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use
Chewable tablets Animale 003 Prescription Only - Clavulanic acid application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Kesium 50 mg Ceva Santé VPA10815/034/ 50 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use
Chewable tablets Animale 001 Prescription Only - Clavulanic acid application
for cats and dog Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Kesium 500 mg Ceva Santé VPA10815/034/ 500 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use
Chewable tablets Animale 004 Prescription Only - Clavulanic acid application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Kesium 62.5 mg Ceva Santé VPA10815/034/ 62.5 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use
Chewable tablets Animale 002 Prescription Only - Clavulanic acid application
for cats and dog Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Kesium 625 mg Ceva Santé VPA10815/034/ 625 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use
Chewable tablets Animale 005 Prescription Only - Clavulanic acid application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Ketabel 100 Bela-Pharm VPA10445/005/ 10 percent Solution for - QN01AX03 VPO: Veterinary - Ketamine Generic - Intramuscular
mg/ml solution GmbH & Co. KG 001 injection Practitioner Only hydrochloride application use
for injection as defined in (Article 13(1) of - Intraperitoneal
relevant national Directive No use
legislation 2001/82/EC) - Intravenous
use

Ketamidor 100 Richter Pharma VPA10801/006/ 100 Solution for - QN01AX03 VPO: Veterinary - Ketamine Hybrid - Intramuscular
mg/ml solution AG 001 milligram(s)/millil injection Practitioner Only application use
for injection itre as defined in (Article 13(3) of - Intravenous
relevant national Directive No use
legislation 2001/82/EC) - Subcutaneous
use

Ketavet 100 Zoetis Belgium VPA10387/036/ 100 Solution for - QN01AX03 VPO: Veterinary - Ketamine Generic - Intramuscular
mg/ml solution S.A. 001 milligram(s)/millil injection Practitioner Only application use
for injection for itre as defined in (Article 13(1) of - Intravenous
dogs, cats and relevant national Directive No use
horses legislation 2001/82/EC) - Subcutaneous
use

Veterinary Medicines Authorised/Transfer Pending Products Page 104 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Ketink 100 Industrial VPA10509/002/ 100 Solution for - QM01AE03 POM: - Ketoprofen Generic - Intramuscular
mg/ml solution Veterinaria, S.A. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle, horses defined in Directive No use
and pigs relevant national 2001/82/EC)
legislation

Ketodolor 100 Le Vet Beheer VPA10475/008/ 100 Solution for - QM01AE03 POM: - Ketoprofen Generic - Intramuscular
mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
horses, cattle, defined in Directive No use
pigs relevant national 2001/82/EC)
legislation

Ketofen 10 % Ceva Santé VPA10815/051/ 10 percent Solution for - QM01AE03 POM: - Ketoprofen - Intramuscular
Solution for Animale 001 weight/volume injection Prescription Only use
Injection Medicine as - Intravenous
defined in use
relevant national
legislation

KEYTIL 300 Vetpharma VPA10516/019/ 300, 90 Solution for - QJ01FA99 VPO-1: - Tilmicosin Fixed - Subcutaneous
mg/ml + 90 Animal Health, 001 milligram(s)/millil injection Veterinary - Ketoprofen combination use
mg/ml solution S.L. itre Practitioner Only application
for injection as defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Kilo-mec 0.5 % ECO Animal VPA22693/018/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Informed - Topical use
Pour-On Solution Health Europe 001 Merchant as consent
for Cattle Limited defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Kilo-mec 1% ECO Animal VPA22693/020/ 1 percent Solution for - QP54AA01 LM: Licensed - Ivermectin Informed - Subcutaneous
Solution for Health Europe 001 weight/volume injection Merchant as consent use
Injection Limited defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Lactatrim MC Norbrook VPA22664/042/ 40, 200 Intramammary - QJ51E POM: - Trimethoprim Fixed - Intramammary
Lactating Cow Laboratories 001 mg/syringe suspension Prescription Only - Sulphadiazine combination use
Intramammary (Ireland) Limited Medicine as application
Suspension. defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Lactovac Zoetis Belgium VPA10387/037/ strain Suspension for - QI02AL01 LM: Licensed - Inactivated Full application - Subcutaneous
Suspension for S.A. 001 1005/78&#160; injection Merchant as bovine rotavirus, (Article 12(3) of use
injection at least 107.4 defined in strain 1005/78 Directive No
relevant national - Inactivated 2001/82/EC)
legislation bovine rotavirus,
strain holland
- Inactivated
bovine
coronavirus,
strain 800
- Inactivated
e.coli k99/f41,
strain s1091/83

LANFLOX 100 Vetpharma VPA10516/004/ 100 Solution for use - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml Solution Animal Health, 001 milligram(s)/millil in drinking water Prescription Only application
for use in S.L. itre Medicine as (Article 13(1) of
drinking water for defined in Directive No
Chickens and relevant national 2001/82/EC)
Turkeys legislation

Lanodip Kilco VPA10948/001/ 26.7 Teat dip/spray - QD08AG03 LM: Licensed - Iodine Well-established - Topical use
Concentrate (International) 002 milligram(s)/millil solution Merchant as use application
Teat Dip 3:1 Ltd. itre defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 105 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Lanodip Kilco VPA10948/001/ 33.37 Teat dip/spray - QD08AG LM: Licensed - Iodine Well-established - Topical use
Concentrate (International) 003 milligram(s)/millil solution Merchant as use application
Teat Dip 4:1 Ltd. itre defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

Lanodip Kilco VPA10948/001/ 20 Teat dip solution - QD08AG LM: Licensed - Iodine - Topical use
Concentrate (International) 001 milligram(s)/millil Merchant as
Teat Dip Solution Ltd. itre defined in
2:1 relevant national
legislation

Lanodip Ready Kilco VPA10948/001/ 6.7 Teat dip/spray - QD08AG03 LM: Licensed - Iodine Well-established - Topical use
To Use Teat Dip (International) 004 milligram(s)/millil solution Merchant as use application
Ltd. itre defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

Lapseli LHV Bonapp HOVR10466/00 . Oral solution LM: Licensed - Silica (colloidal, Simplified - Oral use
9/001 Merchant as anhydrous) Registration of a
defined in - Carbo Veterinary
relevant national vegetabilis Homeopathic
legislation - Solidago Medicinal
virgaurea Product (Article
- Phytolacca 16, Directive
decandra 2001/82/EC)
- Thuja
occidentalis
- Calendula
officinalis
- Atropa
belladonna

Larocop 20 Chanelle VPA10987/025/ 20 Suspension for - QA12CX LM: Licensed - Copper - Intramuscular
mg/ml Pharmaceuticals 001 milligram(s)/millil injection Merchant as use
Suspension for Manufacturing itre defined in
injection Limited relevant national
legislation

Laurabolin 25 Intervet Ireland VPA10996/002/ 25 Solution for - QA14AB01 POM: - Nandrolone Full application - Intramuscular
mg/ml solution Limited 001 milligram(s)/millil injection Prescription Only laurate (Article 12(3) of use
for injection itre Medicine as Directive No - Subcutaneous
defined in 2001/82/EC) use
relevant national
legislation

Laxatract Le Vet Beheer VPA10475/041/ 667 Syrup - QA06AD11 POM: - Lactulose, Generic - Oral use
667mg/ml syrup B.V. 001 milligram(s)/millil Prescription Only liquid application
for dogs and cat itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

LECTADE Plus Elanco GmbH VPA22020/030/ . Powder for oral - QA07CQ02 LM: Licensed - Sodium - Oral use
Powder for Oral 001 solution Merchant as chloride
Solution defined in - Glycine
relevant national - Potassium
legislation dihydrogen
phosphate
- Sodium acid
citrate
- Potassium
citrate
- Sodium citrate
- Glucose
monohydrate
Leptavoid-H Intervet Ireland VPA10996/235/ . Suspension for - QI02AB03 LM: Licensed - Leptospira Full application - Subcutaneous
Suspension for Limited 001 injection Merchant as interrogans (Article 12(3) of use
injection for defined in serovar hardjo Directive No
cattle relevant national 204 (inactivated) 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 106 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Leucogen Virbac S.A. VPA10988/040/ <div class="mp- Suspension for - QI06AA01 POM: - Feline leukemia Informed - Subcutaneous
001 gridCell">. injection Prescription Only virus envelope consent use
Medicine as antigen p45 application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Levacide 1.5 Norbrook VPA22664/027/ 1.5 percent Oral solution - QP52AE51 LM: Licensed - Levamisole - Oral use
%w/v SC Worm Laboratories 001 weight/volume Merchant as
Drench (Ireland) Limited defined in
relevant national
legislation

Levacide Norbrook VPA22664/025/ 75 Solution for - QP52AE01 LM: Licensed - Levamisole Full application - Subcutaneous
Injection 75 Laboratories 001 milligram(s)/millil injection Merchant as hydrochloride (Article 12(3) of use
mg/ml (Ireland) Limited itre defined in Directive No
relevant national 2001/82/EC)
legislation

Levacide Low Norbrook VPA22664/026/ 75 Oral solution - QP52AE01 LM: Licensed - Levamisole - Oral use
Volume Worm Laboratories 001 milligram(s)/millil Merchant as
Drench 75 mg/m (Ireland) Limited itre defined in
relevant national
legislation

Levacide Pour- Norbrook VPA22664/047/ 200 Pour-on solution - QP52AE01 LM: Licensed - Levamisole - Topical use
on 200 mg/ml Laboratories 001 milligram(s)/millil Merchant as
(Ireland) Limited itre defined in
relevant national
legislation

Levafas Norbrook VPA22664/024/ 3, 6 percent Oral suspension - QP52AE51 LM: Licensed - Levamisole - Oral use
Diamond Fluke Laboratories 001 weight/volume Merchant as hydrochloride
and Worm (Ireland) Limited defined in - Oxyclozanide
Drench relevant national
legislation

Levafluke Oral Biochem Ltd VPA10926/008/ Oral suspension - QP52AE51 LM: Licensed - Levamisole Informed - Oral use
Drench 001 Merchant as hydrochloride consent
defined in - Rafoxanide application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Levapharm Chem-Pharm VPA10823/010/ 75 Solution for - QP52AE01 LM: Licensed - Levamisole Informed - Subcutaneous
Injection 75 001 milligram(s)/millil injection Merchant as consent use
mg/ml itre defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Leventa 1 mg/ml Intervet Ireland VPA10996/199/ 1 Oral solution - QH03AA01 POM: - Levothyroxine Well-established - Oral use
oral solution for Limited 001 milligram(s)/millil Prescription Only sodium (as use application
dogs itre Medicine as multihydrate) (Article 13a of
defined in equivalent to Directive No
relevant national 0.97 milligram 2001/82/EC)
legislation levothyroxine

Levicare Hi- Ancare Ireland VPA10915/004/ 3.75 percent Oral solution - QP52AE01 LM: Licensed - Levamisole - Oral use
Mineral Oral Ltd. 001 weight/volume Merchant as hydrochloride
Solution defined in
relevant national
legislation

Libeo 10 mg Ceva Santé VPA10815/037/ 10 mg/tablet Chewable tablet - QC03CA01 POM: - Furosemide Generic - Oral use
chewable tablets Animale 001 Prescription Only application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Libeo 40 mg Ceva Santé VPA10815/037/ 40 mg/tablet Chewable tablet - QC03CA01 POM: - Furosemide Generic - Oral use
chewable tablets Animale 002 Prescription Only application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 107 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Libromide 325 Dechra VPA22622/015/ 325 mg/tablet Tablet - QN05CM11 POM: - Potassium Full application - Oral use
mg tablets for Regulatory B.V. 001 Prescription Only bromide (Article 12(3) of
dogs Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Liceban 2.5% Bimeda Animal VPA22033/026/ 2.5 percent Pour-on solution - QP53AC08 LM: Licensed - Cypermethrin Informed - Topical use
w/v Pour on Health Limited 001 weight/volume Merchant as technical (93%) consent
Solution defined in (cis: trans 50:50)application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
LidoBel 20 Bela-Pharm VPA10445/004/ 20 Solution for - QN01BB02 VPO: Veterinary - Lidocaine Generic - Intramuscular
mg/ml solution GmbH & Co. KG 001 milligram(s)/millil injection Practitioner Only hydrochloride ph. application use
for injection for itre as defined in eur. (Article 13(1) of - Perineural use
horses, dogs, relevant national Directive No - Subcutaneous
and cats. legislation 2001/82/EC) use
- Submucosal
use
Lignocaine Chem-Pharm VPA10823/019/ 20, 0.027 Solution for - QN01BB52 VPO: Veterinary - Lidocaine Informed - Intramuscular
Adrenaline 001 milligram(s)/millil injection Practitioner Only hydrochloride consent use
Solution for itre as defined in - Epinephrine application - Perineural use
Injection relevant national acid tartrate (Article 13c of - Subcutaneous
legislation Directive No use
2001/82/EC)

Lincocin Soluble Zoetis Belgium VPA10387/038/ 400 Powder for use - QJ01FF02 POM: - Lincomycin (as Full application - Oral use
Powder, 400 S.A. 001 milligram(s)/gra in drinking water Prescription Only Lincomycin (Article 12(3) of
mg/g powder for m Medicine as hydrochloride) Directive No
use in drinking defined in 2001/82/EC)
water relevant national
legislation

Lincocin Sterile Zoetis Belgium VPA10387/039/ 100 Solution for - QJ01FF02 POM: - Lincomycin (as Full application - Intramuscular
Solution S.A. 001 milligram(s)/millil injection Prescription Only Lincomycin (Article 12(3) of use
itre Medicine as hydrochloride) Directive No - Intravenous
defined in 2001/82/EC) use
relevant national
legislation

LINCOPHAR Ecuphar VPA10389/003/ 400 Oral solution - QJ01FF02 POM: - Lincomycin (as Hybrid - In drinking
400 mg/ml Veterinaria 001 milligram(s)/millil Prescription Only Lincomycin application water use
solution for use S.L.U. itre Medicine as hydrochloride) (Article 13(3) of
in drinking water defined in Directive No
for chickens relevant national 2001/82/EC)
legislation

Linco-Spectin Zoetis Belgium VPA10387/040/ 222, 444.7 Powder for use - QJ01FF52 POM: - Lincomycin Full application - Oral use
100, 222/444.7 S.A. 001 milligram(s)/gra in drinking water Prescription Only - Spectinomycin (Article 12(3) of
mg/g Powder for m Medicine as Directive No
use in drinking defined in 2001/82/EC)
water for pigs relevant national
and chickens legislation

Linco-Spectin Kernfarm BV PVPA22031/001 222, 444.7 Powder for oral - QJ01FF52 POM: - Lincomycin - Oral use
100, 222/444.7 /001 milligram(s)/gra solution Prescription Only - Spectinomycin
mg/g Powder for m Medicine as
use in drinking defined in
water for pigs relevant national
and chickens legislation

Linco-Spectin Zoetis Belgium VPA10387/041/ 50/100 Solution for - QJ01FF52 POM: - Lincomycin - Intramuscular
Sterile Solution S.A. 001 milligram(s)/millil injection Prescription Only - Spectinomycin use
itre Medicine as
defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 108 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Linspec 50/100 Chanelle VPA10987/079/ 50, 100 Solution for - QJ01FF52 POM: - Lincomycin (as Generic - Intramuscular
mg/ml Solution Pharmaceuticals 001 milligram(s)/millil injection Prescription Only Lincomycin application use
for injection for Manufacturing itre Medicine as hydrochloride) (Article 13(1) of
dogs, cats, pigs Limited defined in - Spectinomycin Directive No
and pre-ruminant relevant national (as 2001/82/EC)
calves legislation spectinomycin
sulphate ph.eur.)

Liquid Life Aid Norbrook VPA22664/023/ . Oral solution - QA07CQ02 LM: Licensed - Glucose - Oral use
Concentrate for Laboratories 001 milligram(s)/millil Merchant as monohydrate
Oral Solution for (Ireland) Limited itre defined in - Sodium
Cattle, Pigs and relevant national chloride
Sheep legislation - Sodium
propionate
- Potassium
dihydrogen
orthophosphate
- Glycine
Lismay 444.7 Laboratorios VPA10436/004/ 444.7,222.0 Powder for use - QJ01FF52 POM: - Spectinomycin Generic - In drinking
mg/g + 222.0 Maymó, S.A. 001 milligram(s)/gra in drinking water Prescription Only - Lincomycin application water use
mg/g powder for m Medicine as (Article 13(1) of
use in drinking defined in Directive No
water for pigs relevant national 2001/82/EC)
legislation

Longocilline 150 Ceva Santé VPA10815/023/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin Generic - Intramuscular
mg/ml Animale 001 milligram(s)/millil injection Prescription Only application use
suspension for itre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle and pigs relevant national 2001/82/EC)
legislation

Lutalyse Zoetis Belgium VPA10387/042/ 5 Solution for - QG02AD01 POM: - Dinoprost - Intramuscular
S.A. 001 milligram(s)/millil injection Prescription Only use
itre Medicine as
defined in
relevant national
legislation

Lutalyse High Zoetis Belgium VPA10387/042/ 12.5 Solution for - QG02AD01 POM: - Dinoprost Full application - Intramuscular
Concentration S.A. 002 milligram(s)/millil injection Prescription Only (Article 12(3) of use
12.5 mg/ml itre Medicine as Directive No
solution for defined in 2001/82/EC)
injection for relevant national
cattle legislation

M+PAC Intervet Ireland VPA10996/236/ 1.47-4.24 Emulsion for - QI09AB13 POM: - Inactivated Full application - Intramuscular
Limited 001 Relative potency injection Prescription Only mycoplasma (Article 12(3) of use
Medicine as hyopneumoniae Directive No
defined in 2001/82/EC)
relevant national
legislation

Macromectin Norbrook VPA22664/076/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Generic - Topical use
0.5% w/v Pour- Laboratories 001 weight/volume Merchant as application
On Solution (Ireland) Limited defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Macromectin 0.8 Norbrook VPA22664/075/ 0.8 Oral solution - QP54AA01 LM: Licensed - Ivermectin - Oral use
mg/ml oral Laboratories 001 milligram(s)/millil Merchant as
solution for (Ireland) Limited itre defined in
sheep relevant national
legislation

Macrosyn 100 Bimeda Animal VPA22033/073/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular
mg/ml solution Health Limited 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
cattle, pigs and defined in Directive No use
sheep relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 109 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Magnesium Chem-Pharm VPA10823/016/ 25 percent Solution for - QA12CC02 LM: Licensed - Magnesium Informed - Subcutaneous
Sulphate 25 % 001 weight/volume injection Merchant as sulphate consent use
Solution for defined in application
Injection relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Magnesium Chanelle VPA10987/037/ 25 percent Solution for - QA12CC02 LM: Licensed - Magnesium - Intravenous
Sulphate 25% Pharmaceuticals 001 weight/volume injection Merchant as sulphate use
Solution for Manufacturing defined in heptahydrate - Subcutaneous
Injection Limited relevant national use
legislation

Magniject 25% Norbrook VPA22664/030/ 25 percent Solution for - QA12CC02 LM: Licensed - Magnesium - Subcutaneous
Solution for Laboratories 001 weight/volume injection Merchant as sulphate use
Injection (Ireland) Limited defined in heptahydrate
relevant national
legislation

Malaseb Dechra VPA10803/005/ 20 Shampoo - QD08AC52 POM: - Chlorhexidine Generic - Topical use
shampoo for Veterinary 001 milligram(s)/millil Prescription Only digluconate application
dogs and cats Products A/S itre Medicine as - Miconazole (Article 13(1) of
defined in nitrate Directive No
relevant national 2001/82/EC)
legislation

Mamyzin 269.5 Boehringer VPA10454/009/ 269.5 Powder and - QJ01CE90 POM: - Penethamate Known active - Intramuscular
mg/ml Powder Ingelheim 001 milligram(s)/millil solvent for Prescription Only hydriodide substance use
and Solvent for Vetmedica itre suspension for Medicine as (Article 12(3) of
Suspension for GmbH injection defined in Directive No
Injection for relevant national 2001/82/EC)
cattle legislation

Maprelin 75 Veyx-Pharma VPA10539/001/ 75 Solution for - QH01CA POM: - Peforelin Full application - Intramuscular
microgram/ml GmbH 001 microgram(s)/mil injection Prescription Only (Article 12(3) of use
solution for lilitre Medicine as Directive No
injection for pigs defined in 2001/82/EC)
relevant national
legislation

MAQS Formic NOD Apiary VPA22670/001/ 68.2 Bee-hive strip - QP53AG01 LM: Licensed - Formic acid Full application - Cutaneous use
Acid 68.2g Ireland Ltd 001 gram(s)/strip Merchant as (Article 12(3) of
Beehive Strips defined in Directive No
for Honey Bees relevant national 2001/82/EC)
legislation

Maracycline 500 Univet Limited VPA10990/029/ 500 Premix for - QJ01AA06 POM: - Oxytetracycline - Oral use
mg/g Premix for 001 milligram(s)/gra medicated Prescription Only
Medicated m feeding stuff Medicine as
Feeding defined in
relevant national
legislation

Maracycline Univet Limited VPA10990/031/ 100 percent Premix for - QJ01AA06 POM: - Oxytetracycline - Oral use
Powder 100 % 001 weight/weight medicated Prescription Only hydrochloride
w/w Premix for feeding stuff Medicine as
Medicated Feed defined in
relevant national
legislation

Marbim 100 Bimeda Animal VPA22033/062/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular
mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only application use
for Injection for itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Marbocare Emdoka bvba VPA10534/004/ 20 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use
flavour 20 mg 002 Prescription Only application
tablets for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 110 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Marbocare Emdoka bvba VPA10534/004/ 5 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use
flavour 5 mg 001 Prescription Only application
tablets for dogs Medicine as (Article 13(1) of
and cats defined in Directive No
relevant national 2001/82/EC)
legislation

Marbocare Emdoka bvba VPA10534/004/ 80 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use
flavour 80 mg 003 Prescription Only application
tablets for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

MARBOCYL 1% Vetoquinol VPA10983/037/ 1 percent Powder and - QJ01MA93 POM: - Marbofloxacin - Intravenous
SA, powder and Ireland Limited 001 weight/volume solvent for Prescription Only use
solvent for solution for Medicine as - Subcutaneous
solution for injection defined in use
injection, for cats relevant national
and dogs legislation

Marbocyl 10 % Vetoquinol VPA10983/034/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin - Intramuscular
Solution for Ireland Limited 001 milligram(s)/millil injection Prescription Only use
Injection itre Medicine as - Intravenous
defined in use
relevant national - Subcutaneous
legislation use

Marbocyl 2 %w/v Vetoquinol VPA10983/032/ 20 Solution for - QJ01MA93 POM: - Marbofloxacin - Intramuscular
Solution for Ireland Limited 001 milligram(s)/millil injection Prescription Only use
Injection itre Medicine as - Intravenous
defined in use
relevant national - Subcutaneous
legislation use

Marbocyl Bolus Vetoquinol VPA10983/035/ 50 mg/tablet Bolus - QJ01MA93 POM: - Marbofloxacin - Oral use
50 mg Tablet Ireland Limited 001 Prescription Only
Medicine as
defined in
relevant national
legislation

Marbocyl P 20 Vetoquinol VPA10983/054/ 20 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Full application - Oral use
mg Tablets Ireland Limited 002 Prescription Only (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Marbocyl P 5 mg Vetoquinol VPA10983/054/ 5 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Full application - Oral use
Tablets Ireland Limited 001 Prescription Only (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Marbocyl P 80 Vetoquinol VPA10983/054/ 80 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Full application - Oral use
mg Tablets Ireland Limited 003 Prescription Only (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Marbodex Aural Norbrook VPA22664/124/ 3, 10, 0.9 Ear drops, - QS02CA06 POM: - Clotrimazole Generic - Auricular use
Ear Drops, Laboratories 001 milligram(s)/millil suspension Prescription Only - application
Suspension for (Ireland) Limited itre Medicine as Dexamethasone (Article 13(1) of
Dogs defined in - Marbofloxacin Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 111 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Marbodug 100 Emdoka bvba VPA10534/006/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular
mg/ml Solution 002 milligram(s)/millil injection Prescription Only application use
for Injection for itre Medicine as (Article 13(1) of - Intravenous
Cattle and Pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Marbodug 20 Emdoka bvba VPA10534/006/ 20 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular
mg/ml solution 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Marbonor 100 Norbrook VPA22664/100/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular
mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only application use
for Injection for (Ireland) Limited itre Medicine as (Article 13(1) of - Intravenous
cattle and pig defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Marbosyva 100 Laboratorios VPA10495/003/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular
mg/ml solution SYVA, S.A.U 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Marbox 100 Ceva Santé VPA10815/014/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular
mg/ml solution Animale 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC)
legislation

Marfloxin 100 Krka, d.d., Novo VPA10774/014/ 100 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular
mg/ml solution mesto 002 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Marfloxin 20 mg Krka, d.d., Novo VPA10774/016/ 20 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use
tablets for dogs mesto 002 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Marfloxin 20 Krka, d.d., Novo VPA10774/014/ 20 Solution for - QJ01MA93 POM: - Marbofloxacin Generic - Intramuscular
mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
calves, pigs, defined in Directive No use
dogs and cats relevant national 2001/82/EC) - Subcutaneous
legislation use

Marfloxin 5 mg Krka, d.d., Novo VPA10774/016/ 5 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use
tablets for cats mesto 001 Prescription Only application
and dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Marfloxin 80 mg Krka, d.d., Novo VPA10774/016/ 80 mg/tablet Tablet - QJ01MA93 POM: - Marbofloxacin Generic - Oral use
tablets for dogs mesto 003 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Masocare Evans Vanodine VPA10918/003/ 0.54 percent Teat dip/spray - QD08AG03 LM: Licensed - Iodine - Topical use
Platinum 0.54% International Plc 001 weight/volume solution Merchant as
w/v Teat defined in
Dip/Spray relevant national
Solution legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 112 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Masodine 1:3 Evans Vanodine VPA10918/002/ 2.15 percent Teat dip/spray - QD08AG03 LM: Licensed - Iodine - Topical use
Concentrate International Plc 001 weight/volume solution Merchant as
2.15% w/v for defined in
Teat Dip/Spray relevant national
Solution legislation

Masodip Evans Vanodine VPA10918/004/ 0.436 percent Teat dip/spray - QD08AC02 LM: Licensed - Chlorhexidine ZZZ --Unknown- - Topical use
Platinum 0.436 International Plc 001 weight/volume solution Merchant as gluconate
% w/v Teat defined in
Dip/Spray relevant national
Solution legislation

MASTERFLOX FATRO S.p.A. VPA10836/003/ 40 Solution for - QJ01MA93 POM: - Marbofloxacin Hybrid - Intramuscular
40 mg/ml 001 milligram(s)/millil injection Prescription Only application use
solution for itre Medicine as (Article 13(3) of
injection for pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Mastermectin ECO Animal VPA22693/022/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Informed - Topical use
0.5% Pour-On Health Europe 001 weight/volume Merchant as consent
Solution for Limited defined in application
Cattle relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Mastermectin 10 ECO Animal VPA22693/021/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin - Subcutaneous
mg/ml Solution Health Europe 001 milligram(s)/millil injection Merchant as use
for injection for Limited itre defined in
cattle, sheep and relevant national
pigs legislation

Mastiplan LC, Intervet Ireland VPA10996/205/ 300, 20 Intramammary - QJ51RV01 POM: - Cefapirin Fixed - Intramammary
300mg/20mg Limited 001 mg/syringe suspension Prescription Only - Prednisolone combination use
(Cefapirin/Predn Medicine as application
isolone), defined in (Article 13b of
intramammary relevant national Directive No
suspension for legislation 2001/82/EC)
lactating cows
MASTRACIN LHV Bonapp HOVR10466/00 Oral solution LM: Licensed - Silicea - Oral use
4/001 Merchant as - Carbo
defined in vegetabilis
relevant national
legislation

Maximec Horse Bimeda Animal VPA22033/028/ 18.7 Oral paste - QP54AA01 LM: Licensed - Ivermectin - Oral use
Oral Paste 18.7 Health Limited 001 milligram(s)/gra Merchant as
mg/g m defined in
relevant national
legislation

Maximec Bimeda Animal VPA22033/063/ 1 percent Solution for - QP54AA01 LM: Licensed - Ivermectin - Subcutaneous
Injection for Pigs Health Limited 001 weight/volume injection Merchant as use
1% w/v Solution defined in
for Injection relevant national
legislation

Maxoject 10 Chem-Pharm VPA10823/006/ 10 percent Solution for - QJ01AA06 POM: - Oxytetracycline Informed - Intramuscular
%w/v Solution 001 weight/volume injection Prescription Only hydrochloride consent use
for Injection Medicine as application - Intravenous
defined in (Article 13c of use
relevant national Directive No
legislation 2001/82/EC)

Maxoject LA 200 Chem-Pharm VPA10823/007/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Informed - Intramuscular
mg/ml Solution 001 milligram(s)/millil injection Prescription Only consent use
for Injection itre Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 113 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
MAXYL 500 Vetpharma VPA10516/011/ 500 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - Oral use
mg/g POWDER Animal Health, 001 milligram(s)/gra in drinking water Prescription Only trihydrate application
FOR USE IN S.L. m Medicine as (Article 13(1) of
DRINKING defined in Directive No
WATER FOR relevant national 2001/82/EC)
CHICKENS, legislation
TURKEYS,
DUCKS AND
PIGS
Mectaject 1% Bimeda Animal VPA22033/064/ 1 percent Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
w/v Solution for Health Limited 001 weight/volume injection Merchant as application use
Injection defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Mectaject Plus Bimeda Animal VPA22033/029/ 10, 100 Solution for - QP54AA51 LM: Licensed - Ivermectin Informed - Subcutaneous
Solution for Health Limited 001 milligram(s)/millil injection Merchant as - Clorsulon consent use
Injection itre defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Medesedan 10 CP-Pharma VPA10810/003/ 10 Solution for - QN05CM90 VPO: Veterinary - Detomindine Generic - Intramuscular
mg/ml, Solution Handelsgesellsc 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for Injection for haft mbH itre as defined in (Article 13(1) of - Intravenous
Horses and relevant national Directive No use
Cattle legislation 2001/82/EC)

Medetor 1 mg/ml CP-Pharma VPA10810/002/ 1.0 Solution for - QN05CM91 VPO: Veterinary - Medetomidine Generic - Intramuscular
Solution for Handelsgesellsc 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
Injection for Dog haft mbH itre as defined in (Article 13(1) of - Intravenous
and Cat relevant national Directive No use
legislation 2001/82/EC)

Medimec 0.5 Chanelle VPA10987/153/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin - Topical use
%w/v Pour-on Pharmaceuticals 001 weight/volume Merchant as
Solution Manufacturing defined in
Limited relevant national
legislation

Medimec Chanelle VPA10987/156/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin - Subcutaneous
Injection 10 Pharmaceuticals 001 milligram(s)/millil injection Merchant as use
mg/ml solution Manufacturing itre defined in
for injection Limited relevant national
legislation

Megacal-M Ballinskelligs VPA10956/001/ 4.6, 2.0, 0.8 Solution for - QA12A LM: Licensed - Calcium - Intravenous
Injection Vet. Products Lt 001 percent injection Merchant as - Phosphorous use
weight/volume defined in - Magnesium - Subcutaneous
relevant national use
legislation

Megapen - Strep Franklin VPA10976/008/ 200, 200 Suspension for - QJ01RA POM: - Procaine Full application - Intramuscular
Injection Pharmaceuticals 001 milligram(s)/millil injection Prescription Only benzylpenicillin (Article 12(3) of use
Ltd. itre Medicine as - Directive No
defined in Dihydrostreptom 2001/82/EC)
relevant national ycin sulphate
legislation

Mektix 12.5 Krka, d.d., Novo VPA10774/061/ 12.5, 125.0 Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/125 mg mesto 002 mg/tablet Prescription Only oxime application
chewable tablets Medicine as - Praziquantel (Article 13(1) of
for dogs defined in Directive No
weighing at least relevant national 2001/82/EC)
5 kg legislation

Mektix 16 mg/40 Krka, d.d., Novo VPA10774/062/ 16, 40 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg chewable mesto 002 Prescription Only oxime application
tablets for cats Medicine as - Praziquantel (Article 13(1) of
weighing at least defined in Directive No
2 kg relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 114 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Mektix 2.5 mg/25 Krka, d.d., Novo VPA10774/061/ 2.5, 25.0 Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg chewable mesto 001 mg/tablet Prescription Only oxime application
tablets for small Medicine as - Praziquantel (Article 13(1) of
dogs and defined in Directive No
puppies relevant national 2001/82/EC)
weighing at least legislation
0.5 kg

Mektix 4 mg/10 Krka, d.d., Novo VPA10774/062/ 4, 10 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg chewable mesto 001 Prescription Only oxime application
tablets for small Medicine as - Praziquantel (Article 13(1) of
cats and kittens defined in Directive No
weighing at least relevant national 2001/82/EC)
0.5 kg legislation

Menbutil 100 aniMedica VPA10826/023/ 100 Solution for - QA05AX90 POM: - Menbutone Generic - Intramuscular
mg/ml solution GmbH 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle, pigs, defined in Directive No use
horses, sheep relevant national 2001/82/EC)
and goats legislation

Mepiblock 20 Dechra VPA22622/012/ 20 Solution for - QN01BB03 POM: - Mepivacaine Hybrid - Epidural use
mg/ml solution Regulatory B.V. 001 milligram(s)/millil injection Prescription Only hydrochloride application - Intraarticular
for injection for itre Medicine as (Article 13(3) of use
horses defined in Directive No
relevant national 2001/82/EC)
legislation

Mepidor 20 Richter Pharma VPA10801/010/ 20 Solution for - QN01BB03 VPO: Veterinary - Mepivacaine Hybrid - Epidural use
mg/ml solution AG 001 milligram(s)/millil injection Practitioner Only hydrochloride application - Intraarticular
for injection for itre as defined in (Article 13(3) of use
horses relevant national Directive No
legislation 2001/82/EC)

Merilym 3, Boehringer VPA10454/069/ . Suspension for - QI07AB04 POM: - Borrelia garinii Full application - Subcutaneous
suspension for Ingelheim 001 injection Prescription Only - Borrelia afzelii (Article 12(3) of use
injection for dogs Vetmedica Medicine as - Borrelia Directive No
GmbH defined in burgdorferi 2001/82/EC)
relevant national sensu stricto
legislation

Metaxol 20/100 Eurovet Animal VPA10989/066/ 20, 100 Oral solution - QJ01EW11 POM: - Generic - Oral use
mg/ml solution Health B.V. 001 milligram(s)/millil Prescription Only Sulfamethoxazo application
for use in itre Medicine as le (Article 13(1) of
drinking water for defined in - Trimethoprim Directive No
pigs and relevant national 2001/82/EC)
chickens legislation

Metomotyl 2.5 Le Vet Beheer VPA10475/009/ 2.5 Solution for - QA03FA01 POM: - Hybrid - Intramuscular
mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only Metoclopramide application use
for injection for itre Medicine as (as hydrochloride (Article 13(3) of - Subcutaneous
cats and dogs defined in monohydrate) Directive No use
relevant national 2001/82/EC)
legislation

Metomotyl 5 Le Vet Beheer VPA10475/009/ 5 Solution for - QA03FA01 POM: - Generic - Intramuscular
mg/ml solution B.V. 002 milligram(s)/millil injection Prescription Only Metoclopramide application use
for injection for itre Medicine as (as hydrochloride (Article 13(1) of - Subcutaneous
cats and dogs defined in monohydrate) Directive No use
relevant national 2001/82/EC)
legislation

Metricure 500 Intervet Ireland VPA10996/053/ 500 mg/syringe Intrauterine - QG51AA POM: - Cephapirin - Intrauterine use
mg Intrauterine Limited 001 suspension Prescription Only
Suspension Medicine as
defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 115 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Metrobactin 250 Le Vet Beheer VPA10475/022/ 250 mg/tablet Tablet - QJ01XD01 POM: - Metronidazole Generic - Oral use
mg tablets for B.V. 001 - QP51AA01 Prescription Only application
dogs and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Metrobactin 250 Le Vet Beheer VPA10475/022/ 250 mg/tablet Tablet - QJ01XD01 POM: - Metronidazole Generic - Oral use
mg tablets for B.V. 001 - QP51AA01 Prescription Only application
dogs and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Metrobactin 500 Le Vet Beheer VPA10475/022/ 500 mg/tablet Tablet - QJ01XD01 POM: - Metronidazole Generic - Oral use
mg tablets for B.V. 002 - QP51AA01 Prescription Only application
dogs and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Metrobactin 500 Le Vet Beheer VPA10475/022/ 500 mg/tablet Tablet - QJ01XD01 POM: - Metronidazole Generic - Oral use
mg tablets for B.V. 002 - QP51AA01 Prescription Only application
dogs and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Metrocare Ecuphar NV VPA10491/012/ 250 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Generic - Oral use
Flavour 250 mg 001 Prescription Only application
tablets for dogs Medicine as (Article 13(1) of
and cats defined in Directive No
relevant national 2001/82/EC)
legislation

Metrocare Ecuphar NV VPA10491/012/ 500 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Hybrid - Oral use
Flavour 500 mg 002 Prescription Only application
tablets for dogs Medicine as (Article 13(3) of
and cats defined in Directive No
relevant national 2001/82/EC)
legislation

Metrovis 100 mg LIVISTO Int'l, VPA10425/011/ 100 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Generic - Per Oral
tablets for dogs S.L. 001 Prescription Only application
and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Metrovis 250 mg LIVISTO Int'l, VPA10425/011/ 250 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Generic - Per Oral
tablets for dogs S.L. 002 Prescription Only application
and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Metrovis 750 mg LIVISTO Int'l, VPA10425/011/ 750 mg/tablet Tablet - QP51AA01 POM: - Metronidazole Generic - Per Oral
tablets for dogs S.L. 003 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Micotil 300 Elanco GmbH VPA22020/019/ 300 Solution for - QJ01FA91 VPO: Veterinary - Tilmicosin - Subcutaneous
mg/ml Solution 001 milligram(s)/millil injection Practitioner Only use
for Injection itre as defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 116 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Milaxyn Plus Chanelle VPA10987/083/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use
Tablets for dogs Pharmaceuticals 001 mg/tablet Companion - Pyrantel application
Manufacturing Animal Medicine - Febantel (Article 13(3) of
Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Milaxyn Plus XL Chanelle VPA10987/083/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Milaxyn Plus XL Chanelle VPA10987/083/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Milaxyn Plus XL Chanelle VPA10987/083/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Milbactor 12.5 Krka, d.d., Novo VPA10774/030/ 12.5, 125.0 Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/125 mg mesto 002 mg/tablet Prescription Only oxime application
tablets for dogs Medicine as - Praziquantel (Article 13(1) of
weighing at least defined in Directive No
5 kg relevant national 2001/82/EC)
legislation

Milbactor 16 Krka, d.d., Novo VPA10774/032/ 16, 40 mg/tablet Film-coated - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/40 mg film- mesto 002 tablet Prescription Only oxime application
coated tablets for Medicine as - Praziquantel (Article 13(1) of
cats weighing at defined in Directive No
least 2 kg relevant national 2001/82/EC)
legislation

Milbactor 2.5 Krka, d.d., Novo VPA10774/030/ 2.5, 25.0 Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/25 mg tablets mesto 001 mg/tablet Prescription Only oxime application
for small dogs Medicine as - Praziquantel (Article 13(1) of
and puppies defined in Directive No
weighing at least relevant national 2001/82/EC)
0.5 kg legislation

Milbactor 4 Krka, d.d., Novo VPA10774/032/ 4, 10 mg/tablet Film-coated - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/10 mg film- mesto 001 tablet Prescription Only oxime application
coated tablets for Medicine as - Praziquantel (Article 13(1) of
small cats and defined in Directive No
kittens weighing relevant national 2001/82/EC)
at least 0.5 kg legislation

MILBEMAX Elanco GmbH VPA22020/008/ 12.5, 125.0 Chewable tablet - QP54AB51 POM: - Milbemycin Full application - Oral use
chewable tablets 004 mg/tablet Prescription Only oxime (Article 12(3) of
for dogs Medicine as - Praziquantel Directive No
defined in 2001/82/EC)
relevant national
legislation

MILBEMAX Elanco GmbH VPA22020/008/ 2.5, 25 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Full application - Oral use
chewable tablets 003 Prescription Only oxime (Article 12(3) of
for small dogs Medicine as - Praziquantel Directive No
and puppies defined in 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 117 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
MILBEMAX film- Elanco GmbH VPA22020/009/ 16.00, 40.00 Film-coated - QP54AB51 POM: - Milbemycin Fixed - Oral use
coated tablets for 002 mg/tablet tablet Prescription Only oxime combination
cats Medicine as - Praziquantel application
defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

MILBEMAX film- Elanco GmbH VPA22020/009/ 4.0, 10.0 Film-coated - QP54AB51 POM: - Milbemycin Fixed - Oral use
coated tablets for 001 mg/tablet tablet Prescription Only oxime combination
small cats and Medicine as - Praziquantel application
kittens defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

MILBEMAX Elanco GmbH VPA22020/008/ 2.5, 25.0 Tablet - QP54AB51 POM: - Milbemycin Fixed - Oral use
tablets for small 001 mg/tablet Prescription Only oxime combination
dogs and Medicine as - Praziquantel application
puppies defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

MILBEMAX® Elanco GmbH VPA22020/008/ 12.5, 125.0 Tablet - QP54AB51 POM: - Milbemycin Fixed - Oral use
tablets for dogs 002 mg/tablet Prescription Only oxime combination
Medicine as - Praziquantel application
defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Milbetab 12.5 Chanelle VPA10987/135/ 12.5, 125 Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/125 mg Pharmaceuticals 001 mg/tablet Prescription Only oxime application
Tablets for Dogs Manufacturing Medicine as - Praziquantel (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Milbetrin 12.5 Chanelle VPA10987/137/ 12.5, 125 Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/125 mg Pharmaceuticals 001 mg/tablet Prescription Only oxime application
Tablets for Dogs Manufacturing Medicine as - Praziquantel (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Milbotyl 300 Chanelle VPA10987/075/ 300 Solution for - QJ01FA91 VPO: Veterinary - Tilmicosin Generic - Subcutaneous
mg/ml solution Pharmaceuticals 001 milligram(s)/millil injection Practitioner Only application use
for injection Manufacturing itre as defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Milgusto 16 Krka, d.d., Novo VPA10774/064/ 16, 40 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/40 mg mesto 002 Prescription Only oxime application
chewable tablets Medicine as - Praziquantel (Article 13(1) of
for cats weighing defined in Directive No
at least 2 kg relevant national 2001/82/EC)
legislation

Milgusto 4 mg/10 Krka, d.d., Novo VPA10774/064/ 4, 10 mg/tablet Chewable tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg chewable mesto 001 Prescription Only oxime application
tablets for small Medicine as - Praziquantel (Article 13(1) of
cats and kittens defined in Directive No
weighing at least relevant national 2001/82/EC)
0.5 kg legislation

Milipraz 12.5 Chanelle VPA10987/136/ 12.5 mg, 125 mg Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/125 mg Pharmaceuticals 001 mg/tablet Prescription Only oxime application
Tablets for Dogs Manufacturing Medicine as - Praziquantel (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 118 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Milprazon 12.5 Krka, d.d., Novo VPA10774/029/ 12.5, 125.0 Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/125 mg mesto 002 mg/tablet Prescription Only oxime application
tablets for dogs Medicine as - Praziquantel (Article 13(1) of
weighing at least defined in Directive No
5 kg relevant national 2001/82/EC)
legislation

Milprazon 16 Krka, d.d., Novo VPA10774/031/ 16, 40 mg/tablet Film-coated - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/40 mg film- mesto 002 tablet Prescription Only oxime application
coated tablets for Medicine as - Praziquantel (Article 13(1) of
cats weighing at defined in Directive No
least 2 kg relevant national 2001/82/EC)
legislation

Milprazon 2.5 Krka, d.d., Novo VPA10774/029/ 2.5, 25.0 Tablet - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/25 mg tablets mesto 001 mg/tablet Prescription Only oxime application
for small dogs Medicine as - Praziquantel (Article 13(1) of
and puppies defined in Directive No
weighing at least relevant national 2001/82/EC)
0.5 kg legislation

Milprazon 4 Krka, d.d., Novo VPA10774/031/ 4, 10 mg/tablet Film-coated - QP54AB51 POM: - Milbemycin Generic - Oral use
mg/10 mg film- mesto 001 tablet Prescription Only oxime application
coated tablets for Medicine as - Praziquantel (Article 13(1) of
small cats and defined in Directive No
kittens weighing relevant national 2001/82/EC)
at least 0.5 kg legislation

Milpro 12.5 Virbac S.A. VPA10988/095/ 12.5, 125 Tablet - QP54AB51 POM: - Milbemycin Hybrid - Oral use
mg/125 mg film- 002 mg/tablet Prescription Only oxime application
coated tablets for Medicine as - Praziquantel (Article 13(3) of
dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Milpro 16 mg/40 Virbac S.A. VPA10988/096/ 16, 40 mg/tablet Tablet - QP54AB51 POM: - Milbemycin Hybrid - Oral use
mg film-coated 002 Prescription Only oxime application
tablets for cats Medicine as - Praziquantel (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Milpro 2.5 mg/25 Virbac S.A. VPA10988/095/ 2.5, 25.0 Tablet - QP54AB51 POM: - Milbemycin Hybrid - Oral use
mg film-coated 001 mg/tablet Prescription Only oxime application
tablets for small Medicine as - Praziquantel (Article 13(3) of
dogs and defined in Directive No
puppies relevant national 2001/82/EC)
legislation

Milpro 4 mg/10 Virbac S.A. VPA10988/096/ 4, 10 mg/tablet Tablet - QP54AB51 POM: - Milbemycin Hybrid - Oral use
mg film-coated 001 Prescription Only oxime application
tablets for small Medicine as - Praziquantel (Article 13(3) of
cats and kittens defined in Directive No
relevant national 2001/82/EC)
legislation

Modulis 100 Ceva Santé VPA10815/043/ 100 Oral solution - QL04AA01 POM: - Ciclosporin Generic - Oral use
mg/ml oral Animale 001 milligram(s)/millil Prescription Only application
solution for dogs itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Morlam Laboratories VPA10396/001/ 60 mg/sponge Medicated - QG03DA02 POM: - Full application - Vaginal use
Intravaginal Ovejero S.A. 001 sponge Prescription Only Medroxyprogest (Article 12(3) of
Sponge Medicine as erone acetate Directive No
defined in 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 119 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Morphasol 10 aniMedica VPA10826/009/ 10 Solution for - QN02AF01 POM: - Butorphanol (as Hybrid - Intravenous
mg/ml solution GmbH 001 milligram(s)/millil injection Prescription Only tartrate) application use
for injection for itre Medicine as (Article 13(3) of
horses defined in Directive No
relevant national 2001/82/EC)
legislation

Morphasol 4 aniMedica VPA10826/007/ 4 Solution for - QN02AF01 POM: - Butorphanol (as Well-established - Intravenous
mg/ml solution GmbH 001 milligram(s)/millil injection Prescription Only tartrate) use application use
for injection for itre Medicine as (Article 13a of
dogs and cats defined in Directive No
relevant national 2001/82/EC)
legislation

MOXAPULVIS V.M.D. n.v/s.a. VPA10817/003/ 500 Powder for use - QJ01CA04 POM: - Amoxicillin Hybrid - Oral use
500 mg/g 001 milligram(s)/gra in drinking water Prescription Only trihydrate application
powder for use in m Medicine as (Article 13(3) of
drinking water defined in Directive No
relevant national 2001/82/EC)
legislation

Moxiclear 100 Norbrook VPA22664/140/ 100, 25 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Spot-on use
mg + 25 mg Laboratories 002 mg/pipette Prescription Only - Moxidectin application
spot-on solution (Ireland) Limited Medicine as (Article 13(1) of
for medium dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Moxiclear 250 Norbrook VPA22664/140/ 250, 62.5 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Spot-on use
mg + 62.5 mg Laboratories 003 mg/pipette Prescription Only - Moxidectin application
spot-on solution (Ireland) Limited Medicine as (Article 13(1) of
for large dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Moxiclear 40 mg Norbrook VPA22664/140/ 40, 10 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Spot-on use
+ 10 mg spot-on Laboratories 001 mg/pipette Prescription Only - Moxidectin application
solution for small (Ireland) Limited Medicine as (Article 13(1) of
dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Moxiclear 40 mg Norbrook VPA22664/139/ 40, 4 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Spot-on use
+ 4 mg spot-on Laboratories 001 Prescription Only - Moxidectin application
solution for small (Ireland) Limited Medicine as (Article 13(1) of
cats and ferrets defined in Directive No
relevant national 2001/82/EC)
legislation

Moxiclear 400 Norbrook VPA22664/140/ 400, 100 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Spot-on use
mg + 100 mg Laboratories 004 mg/pipette Prescription Only - Moxidectin application
spot-on solution (Ireland) Limited Medicine as (Article 13(1) of
for very-large defined in Directive No
dogs relevant national 2001/82/EC)
legislation

Moxiclear 80 mg Norbrook VPA22664/139/ 80, 8 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Spot-on use
+ 8 mg spot-on Laboratories 002 Prescription Only - Moxidectin application
solution for large (Ireland) Limited Medicine as (Article 13(1) of
cats defined in Directive No
relevant national 2001/82/EC)
legislation

Moxodex 1 Chanelle VPA10987/111/ 1 Oral solution - QP54AB02 LM: Licensed - Moxidectin Generic - Oral use
mg/ml oral Pharmaceuticals 001 milligram(s)/millil Merchant as application
solution for Manufacturing itre defined in (Article 13(1) of
sheep Limited relevant national Directive No
legislation 2001/82/EC)

Moxodex 5 Chanelle VPA10987/129/ 5 Pour-on solution - QP54AB02 LM: Licensed - Moxidectin Generic - Topical
mg/ml Pour-on Pharmaceuticals 001 milligram(s)/millil Merchant as application
solution for cattle Manufacturing itre defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 120 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Multiject IMM Norbrook VPA22664/008/ 100,000 Intramammary - QJ51RV01 POM: - Procaine Well-established - Intramammary
Intramammary Laboratories 001 international suspension Prescription Only benzylpenicillin use application use
Suspension (Ireland) Limited unit(s) Medicine as - Streptomycin (Article 13a of
defined in sulphate Directive No
relevant national - Neomycin 2001/82/EC)
legislation sulphate
- Prednisolone
Multimast Dry Bimeda Animal VPA22033/030/ 100, 100, 400 Intramammary - QJ51RC POM: - Neomycin Informed - Intramammary
Cow Health Limited 001 mg/syringe suspension Prescription Only sulphate consent use
Intramammary Medicine as - Penethamate application
Suspension defined in hydriodide (Article 13c of
relevant national - Procaine Directive No
legislation benzylpenicillin 2001/82/EC)

Multimin Solution Warburton VPA10431/001/ 60, 10, 15, 5 Solution for - QA12CX99 POM: - Zinc Full application - Subcutaneous
for Injection for Technology 001 milligram(s)/millil injection Prescription Only - Manganese (Article 12(3) of use
Cattle Limited itre Medicine as - Copper Directive No
defined in - Selenium 2001/82/EC)
relevant national
legislation

Multishield DC Bimeda Animal VPA22033/065/ 70000 IU, 77.2 Intramammary - QJ51RC POM: - Neomycin Generic - Intramammary
Intramammary Health Limited 001 mg, 227.2 mg suspension Prescription Only - Penethamate application use
Suspension for per syringe Medicine as - Benzylpenicillin (Article 13(1) of
Cows defined in Directive No
relevant national 2001/82/EC)
legislation

Multivitamin Chem-Pharm VPA10823/017/ . Solution for - QA11JA LM: Licensed - Vitamin A Informed - Intramuscular
Injection 001 injection Merchant as palmitate consent use
defined in - Vitamin D3 application - Subcutaneous
relevant national - Vitamin E (Article 13c of use
legislation acetate Directive No
- Thiamine 2001/82/EC)
hydrochloride
- Riboflavin
sodium
phosphate
- Pyridoxine
hydrochloride
- Nicotinamide
- Dexpanthenol
- Vitamin B12
MUSTELIGEN D Virbac S.A. VPA10988/113/ 10^2.9 - 10^5.1 Lyophilisate and - QI20DD01 POM: - Canine Full application - Subcutaneous
lyophilisate and 001 cell culture solvent for Prescription Only Distemper Virus, (Article 12(3) of use
solvent for infective dose suspension for Medicine as Strain Lederle, Directive No
suspension for 50/dose injection defined in Live 2001/82/EC)
injection for relevant national
ferrets legislation

MYCOFLOR 200 SP Veterinaria, VPA10790/007/ 200 Concentrate for - QJ01BA90 POM: - Florfenicol Hybrid - In drinking
mg/ml, solution S.A. 001 milligram(s)/millil use in drinking Prescription Only application water use
for use in itre water Medicine as (Article 13(3) of
drinking water for defined in Directive No
pigs relevant national 2001/82/EC)
legislation

MYCOFLOR, SP Veterinaria, VPA10790/004/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular
300 mg/ml S.A. 001 milligram(s)/millil injection Prescription Only application use
solution for itre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle and pigs relevant national 2001/82/EC)
legislation

Mycomas 100 Univet Limited VPA10990/047/ 100 Solution for use - QJ01MA90 POM: - Enrofloxacin Informed - In drinking
mg/ml Solution 001 milligram(s)/millil in drinking water Prescription Only consent water use
for use in itre Medicine as application
drinking water defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 121 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Myodine 25 Le Vet Beheer VPA10475/027/ 25 Solution for - QA14AB01 POM: - Nandrolone Generic - Intramuscular
mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only Laurate application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
dogs and cats defined in Directive No use
relevant national 2001/82/EC)
legislation

MYPRAVAC Laboratorios VPA10846/004/ 50 percent Suspension for - QI09AB13 LM: Licensed - Inactivated Fixed - Intramuscular
SUISSuspension Hipra S.A. 001 injection Merchant as Mycoplasma combination use
for injection defined in hyopneumoniae application
relevant national strain J (Article 13b of
legislation Directive No
2001/82/EC)
Nafpenzal DC Intervet Ireland VPA10996/074/ 300, 100, 100 Intramammary - QJ51RC23 POM: - Procaine Full application - Intramammary
Intramammary Limited 001 mg/syringe suspension Prescription Only benzylpenicillin (Article 12(3) of use
Suspension Medicine as - Directive No
defined in Dihydrostreptom 2001/82/EC)
relevant national ycin (as the
legislation sulfate)
- Nafcillin (as the
sodium salt) usp

Nandrosol 25 CP-Pharma VPA10810/015/ 25 Solution for - QA14AB01 POM: - Nandrolone Generic - Intramuscular
mg/ml solution Handelsgesellsc 001 milligram(s)/millil injection Prescription Only laurate application use
for injection for haft mbH itre Medicine as (Article 13(1) of - Subcutaneous
dogs and cats defined in Directive No use
relevant national 2001/82/EC)
legislation

Narketan-10 100 Vetoquinol VPA10983/055/ 100 Solution for - QN01AX03 VPO: Veterinary - Ketamine - Intramuscular
mg/ml Solution Ireland Limited 001 milligram(s)/millil injection Practitioner Only use
for Injection itre as defined in - Intravenous
relevant national use
legislation - Subcutaneous
use

NEFOTEK 100 Vetpharma VPA10516/005/ 100 Solution for - QM01AE03 POM: - Ketoprofen Generic - Intramuscular
mg/ml solution Animal Health, 001 milligram(s)/millil injection Prescription Only application use
for injection for S.L. itre Medicine as (Article 13(1) of - Intravenous
cattle, horses defined in Directive No use
and pigs relevant national 2001/82/EC)
legislation

Nelio 2.5 mg Ceva Santé VPA10815/031/ 2.5 mg/tablet Tablet - QC09AA07 POM: - Benazepril Full application - Oral use
Tablet for Cats Animale 002 Prescription Only hydrochloride (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Nelio 20 mg Ceva Santé VPA10815/032/ 20 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use
Tablet for dogs Animale 002 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Nelio 5 mg tablet Ceva Santé VPA10815/031/ 5 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use
for cats Animale 001 Prescription Only hydrochloride application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Nelio 5 mg Ceva Santé VPA10815/032/ 5 mg/tablet Tablet - QC09AA07 POM: - Benazepril Generic - Oral use
Tablet for Dogs Animale 001 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 122 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Nematel-P 439 Le Vet Beheer VPA10475/005/ 439 Oral paste - QP52AF02 LM: Licensed - Pyrantel Well-established - Oral use
mg/g oral paste B.V. 001 milligram(s)/gra Merchant as embonate use application
for horses m defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

NEMOVAC Boehringer VPA10454/070/ . Lyophilisate for - QI01AD01 POM: - Live Full application - Oral use
Ingelheim 001 suspension Prescription Only pneumovirus, (Article 12(3) of
Vetmedica Medicine as PL21 strain Directive No
GmbH defined in 2001/82/EC)
relevant national
legislation

NEOMAY 500 Laboratorios VPA10436/003/ 500,000 Powder for use - QA07AA01 POM: - Neomycin Hybrid - In drinking
000 IU/g powder Maymó, S.A. 001 international in drinking Prescription Only application water use
for use in unit(s)/gram water/milk Medicine as (Article 13(3) of
drinking defined in Directive No
water/milk relevant national 2001/82/EC)
replacer legislation

Neopen Intervet Ireland VPA10996/006/ 100/200 Suspension for - QJ01RA01 POM: - Neomycin - Intramuscular
Suspension for Limited 002 milligram(s)/millil injection Prescription Only - Procaine use
Injection itre Medicine as benzylpenicillin
defined in
relevant national
legislation

NEOPRINIL Virbac S.A. VPA10988/090/ 5 Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Generic - Topical use
POUR-ON 5 001 milligram(s)/millil Merchant as application
mg/ml pour-on itre defined in (Article 13(1) of
solution for cattle relevant national Directive No
legislation 2001/82/EC)

Nerfasin 100 Le Vet BV VPA10816/013/ 100 Solution for - QN05CM92 VPO: Veterinary - Xylazine (as Generic - Intramuscular
mg/ml, solution 002 milligram(s)/millil injection Practitioner Only hydrochloride) application use
for injection for itre as defined in (Article 13(1) of - Intravenous
cattle and horse relevant national Directive No use
legislation 2001/82/EC) - Subcutaneous
use

Nerfasin 20 Le Vet BV VPA10816/013/ 20 Solution for - QN05CM92 VPO: Veterinary - Xylazine (as Generic - Intramuscular
mg/ml, solution 001 milligram(s)/millil injection Practitioner Only hydrochloride) application use
for injection for itre as defined in (Article 13(1) of - Intravenous
cattle, horses, relevant national Directive No use
dogs and cats legislation 2001/82/EC) - Subcutaneous
use

Nexmectin 18.7 ECO Animal VPA22693/015/ 18.7 Oral paste - QP54AA01 LM: Licensed - Ivermectin Informed - Oral use
mg/g Oral Paste Health Europe 001 milligram(s)/gra Merchant as consent
for Horses Limited m defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Nextmune CEVA-Phylaxia VPA10463/009/ . Concentrate and - QI01AD09 POM: - Live attenuated Full application - In ovo
concentrate and Veterinary 001 solvent for Prescription Only IBD virus, (Article 12(3) of - Subcutaneous
solvent for Biologicals Co. suspension for Medicine as serotype 1, strain Directive No use
suspension for Ltd injection defined in G-61 2001/82/EC)
injection for relevant national
chickens legislation

NIFENCOL 100 Vetpharma VPA10516/009/ 100 Solution for use - QJ01BA90 POM: - Florfenicol Hybrid - Oral use
mg/ml Solution Animal Health, 001 milligram(s)/millil in drinking water Prescription Only application
for use in S.L. itre Medicine as (Article 13(3) of
Drinking Water defined in Directive No
for Pigs relevant national 2001/82/EC)
legislation

Nifencol 300 Vetpharma VPA10516/007/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular
mg/ml solution Animal Health, 001 milligram(s)/millil injection Prescription Only application use
for injection for S.L. itre Medicine as (Article 13(1) of - Subcutaneous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 123 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
NIMATEK 100 Eurovet Animal VPA10989/062/ 100 Solution for - QN01AX03 VPO: Veterinary - Ketamine Hybrid - Intramuscular
mg/ml, Solution Health B.V. 001 milligram(s)/millil injection Practitioner Only application use
for injection for itre as defined in (Article 13(3) of - Intravenous
dogs, cats and relevant national Directive No use
horses legislation 2001/82/EC) - Subcutaneous
use

Nobilis CAV P4 Intervet Ireland VPA10996/131/ . Lyophilisate and - QI01AD04 POM: - Chick anaemia Full application - Intramuscular
Limited 001 solvent for Prescription Only agent virus strain (Article 12(3) of use
suspension for Medicine as 26p4 Directive No - Subcutaneous
injection defined in 2001/82/EC) use
relevant national
legislation

Nobilis Diluent Intervet Ireland VPA10996/203/ . LM: Licensed 12(3) full dossier - Nasal
Oculo Nasal Limited 001 Merchant as - Ocular
defined in
relevant national
legislation

Nobilis E.coli Intervet Ireland VPA10996/083/ . Emulsion for - QI01AB05 POM: - F11-antigen (E. Full application - Intramuscular
inac emulsion for Limited 001 injection Prescription Only coli fimbrial (Article 12(3) of use
injection for Medicine as antigen) Directive No - Subcutaneous
chickens defined in - FT-antigen (E. 2001/82/EC) use
relevant national coli flagellar toxin
legislation antigen)

Nobilis Gumboro Intervet Ireland VPA10996/134/ . Powder for oral - QI01AD09 POM: - Gumboro Full application - Oral use
228E Limited 001 solution Prescription Only disease virus (Article 12(3) of
Medicine as strain 228e Directive No
defined in 2001/82/EC)
relevant national
legislation

Nobilis Gumboro Intervet Ireland VPA10996/133/ . Lyophilisate for - QI01AD09 POM: - Gumboro Full application - Oral use
D78 live Limited 001 suspension Prescription Only disease virus (Article 12(3) of
Medicine as strain D78 Directive No
defined in 2001/82/EC)
relevant national
legislation

Nobilis IB Ma5 Intervet Ireland VPA10996/136/ . Lyophilisate for - QI01AD07 POM: - Live attenuated Full application - Oculonasal use
Limited 001 solution Prescription Only IB virus strain (Article 12(3) of - Oral use
Medicine as Ma5 Directive No
defined in 2001/82/EC)
relevant national
legislation

Nobilis Intervet Ireland VPA10996/094/ . Emulsion for - QI01AA13 POM: - Infectious Full application - Intramuscular
IB+ND+EDS Limited 001 injection Prescription Only bronchitis virus (Article 12(3) of use
emulsion for Medicine as strain M41 (pre- Directive No - Subcutaneous
injection defined in inactivation) 2001/82/EC) use
relevant national - Newcastle
legislation disease virus
strain clone 30
(pre-inactivation)
- Egg drop
syndrome’76
strain BC14
- Infectious
bronchitis virus
strain M41
inducing
- Inactivated ND
virus strain clone
30 inducing
- Inactivated egg
drop syndrome’
76 inducing

Veterinary Medicines Authorised/Transfer Pending Products Page 124 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Nobilis Intervet Ireland VPA10996/192/ . Emulsion for - QI01AA13 POM: - Infectious - Intramuscular
IBmulti+ND+ED Limited 001 injection Prescription Only bronchitis virus use
S Medicine as strain M41 - Subcutaneous
defined in - Infectious use
relevant national bronchitis virus
legislation strain 249g
- Egg drop
syndrome’76
strain BC14
- Newcastle
disease virus
strain clone 30
Nobilis MS Live, Intervet Ireland VPA10996/269/ . Lyophilisate for - QI01AE03 POM: - Live attenuated Full application - ZZZ Spray
lyophilisate for Limited 001 suspension Prescription Only mycoplasma (Article 12(3) of
oculonasal Medicine as synoviae strain Directive No
suspension for defined in ms1 2001/82/EC)
chickens relevant national
legislation

Nobilis ND C2 Intervet Ireland VPA10996/187/ . Lyophilisate for - QI01AD06 POM: - Live attenuated Full application - Nebulisation
lyophilisate for Limited 001 oculonasal Prescription Only newcastle (Article 12(3) of use
oculonasal suspension Medicine as disease virus Directive No - Oculonasal use
suspension for defined in (ndv) strain c2 2001/82/EC)
chickens relevant national
legislation

Nobilis ND Clone Intervet Ireland VPA10996/091/ . Lyophilisate for - QI01AD06 POM: - Live newcastle Full application - Oral use
30 live Limited 001 suspension Prescription Only disease virus (Article 12(3) of
Medicine as clone 30 Directive No
defined in 2001/82/EC)
relevant national
legislation

Nobilis Rhino CV Intervet Ireland VPA10996/190/ . Lyophilisate for - QI01AD01 POM: - Live attenuated Full application - Nasal use
Limited 001 suspension for Prescription Only avian (Article 12(3) of - Ocular use
oculonasal or Medicine as rhinotracheitis Directive No - Oral use
spray app defined in virus strain trt 2001/82/EC)
relevant national 11/94
legislation

Nobilis Rismavac Intervet Ireland VPA10996/086/ 3.0 log10 - 4.1 Concentrate for - QI01AD03 POM: - Live chicken Full application - Intramuscular
+ CA126 Limited 001 log10 plaque solution for Prescription Only herpes virus (Article 12(3) of use
forming unit injection Medicine as strain CVI-988 Directive No - Subcutaneous
defined in - Live turkey 2001/82/EC) use
relevant national herpes virus
legislation strain FC126

Nobilis Intervet Ireland VPA10996/087/ . Emulsion for - QI01AA18 POM: - Infectious Full application - Intramuscular
RT+IBmulti+G+ Limited 001 injection Prescription Only bronchitis virus (Article 12(3) of use
ND Medicine as strain M41 Directive No
defined in - Infectious 2001/82/EC)
relevant national bronchitis virus
legislation strain 249g
- Avian
rhinotracheitis
virus strain But1
#8544 (subgroup
A)
- Infectious
bursal disease
virus strain D78
- Newcastle
disease virus
strain clone 30

Veterinary Medicines Authorised/Transfer Pending Products Page 125 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Nobilis Intervet Ireland VPA10996/181/ . Emulsion for - QI01AA18 POM: - Infectious Full application - Intramuscular
RT+IBmulti+ND Limited 001 injection Prescription Only bronchitis virus (Article 12(3) of use
+EDS Medicine as strain M41 (pre- Directive No
defined in inactivation) 2001/82/EC)
relevant national - Infectious
legislation bronchitis virus
strain 249g
- Avian
rhinotracheitis
strain But1
#8544
- Egg drop
syndrome 76
strain bc14
- Newcastle
disease virus
strain clone 30
Nobilis TRT inac Intervet Ireland VPA10996/180/ . Emulsion for - QI01AA17 POM: - Inactivated - Intramuscular
Limited 001 injection Prescription Only avian use
Medicine as rhinotracheitis
defined in virus
relevant national (BUT1#8544)
legislation subtype A

Nobilis TRT Live Intervet Ireland VPA10996/088/ . Lyophilisate for - QI01AD01 POM: - Turkey Full application - Intraocular use
Limited 001 suspension Prescription Only rhinotracheitis (Article 12(3) of - ZZZ Intranasal
Medicine as virus strain but1 Directive No use
defined in #8544 2001/82/EC) - ZZZ Spray
relevant national
legislation

Nobivac DHP Intervet Ireland VPA10996/174/ . Lyophilisate for - QI07AD02 POM: - Canine Full application - Subcutaneous
Limited 001 suspension for Prescription Only distemper virus, (Article 12(3) of use
injection Medicine as strain Directive No
defined in onderstepoort 2001/82/EC)
relevant national - Canine
legislation adenovirus type
2 strain
manhattan lpv3
(live)
- Canine
parvovirus strain
154 (live)
Nobivac DHPPi Intervet Ireland VPA10996/166/ . Lyophilisate for - QI07AD04 POM: - Canine Full application - Subcutaneous
Limited 001 solution for Prescription Only distemper virus (Article 12(3) of use
injection Medicine as strain Directive No
defined in ondertespoort 2001/82/EC)
relevant national (live)
legislation - Canine
adenovirus type
2 strain
manhattan lpv3
(live)
- Canine
parvovirus strain
154 (live)
- Canine
parainfluenza
virus strain
Cornell (Live)
Nobivac Ducat Intervet Ireland VPA10996/182/ . Lyophilisate and - QI06AD03 POM: - Live feline Full application - Subcutaneous
Limited 001 solvent for Prescription Only calicivirus, strain (Article 12(3) of use
suspension for Medicine as F9 Directive No
injection defined in - Live feline 2001/82/EC)
relevant national rhinotracheitis
legislation virus strain
G2620A
Nobivac KC Intervet Ireland VPA10996/129/ . Lyophilisate and - QI07AF POM: - Bordetella Full application - Intra-nasal
Limited 001 solvent for nasal Prescription Only bronchiseptica (Article 12(3) of
drops, Medicine as - Canine Directive No
suspension defined in parainfluenza 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 126 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Nobivac Lepto 2 Intervet Ireland VPA10996/169/ . Suspension for - QI07AB01 POM: - Leptospira Full application - Subcutaneous
Suspension for Limited 001 injection Prescription Only interrogans (Article 12(3) of use
Injection for Medicine as serogroup Directive No
Dogs defined in Canicola; 2001/82/EC)
relevant national serovar portland-
legislation vere, strain Ca-
12-000
- Leptospira
interrogans
serogroup
icterohaemorrha
giae strain 820k

Nobivac Parvo-C Intervet Ireland VPA10996/167/ . Lyophilisate for - QI07AD01 POM: - Canine Full application - Subcutaneous
Limited 001 suspension for Prescription Only parvovirus (Article 12(3) of use
injection Medicine as attenuated strain Directive No
defined in 154 2001/82/EC)
relevant national
legislation

Nobivac Rabies Intervet Ireland VPA10996/170/ 2-6 International Suspension for - QI07AA02 POM: - Inactivated Full application - Intramuscular
Limited 001 Units/dose injection Prescription Only rabies virus (Article 12(3) of use
Medicine as antigen Directive No - Subcutaneous
defined in suspension 2001/82/EC) use
relevant national
legislation

Nobivac Respira Intervet Ireland VPA10996/277/ . Suspension for - QI07AB03 POM: - Bordetella Full application - Subcutaneous
Bb suspension Limited 002 injection Prescription Only Bronchiseptica (Article 12(3) of use
for injection for Medicine as Fimbriae Directive No
dogs defined in 2001/82/EC)
relevant national
legislation

Nobivac Respira Intervet Ireland VPA10996/277/ . Suspension for - QI07AB03 POM: - Bordetella Full application - Subcutaneous
Bb suspension Limited 001 injection in pre- Prescription Only Bronchiseptica (Article 12(3) of use
for injection in filled syringe Medicine as Fimbriae Directive No
pre-filled syringe defined in 2001/82/EC)
for dogs relevant national
legislation

Nobivac Solvent Intervet Ireland VPA10996/177/ . Solvent for - QV07AB POM: Full application
Limited 001 parenteral use Prescription Only (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Nobivac Tricat Intervet Ireland VPA10996/204/ . Lyophilisate and - QI06AD04 POM: - Feline Full application - Subcutaneous
Trio, lyophilisate Limited 001 solvent for Prescription Only calicivrus, strain (Article 12(3) of use
and solvent for suspension for Medicine as f9 live attenuated Directive No
suspension for injection defined in - Feline herpes 2001/82/EC)
injection, for cats relevant national virus type 1,
legislation strain g2620a
live attenuated
- Feline
panleucopenia
virus, strain mw-
1 live attenuated

Norbrook Fipronil Norbrook VPA22664/097/ 134 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
134 mg Spot-On Laboratories 002 Prescription Only application
Solution for (Ireland) Limited Medicine as (Article 13(3) of
Medium Dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Norbrook Fipronil Norbrook VPA22664/097/ 268 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
268 mg Spot-On Laboratories 003 Prescription Only application
Solution for (Ireland) Limited Medicine as (Article 13(3) of
Large Dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 127 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Norbrook Fipronil Norbrook VPA22664/097/ 402 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
402 mg Spot-On Laboratories 004 Prescription Only application
Solution for Very (Ireland) Limited Medicine as (Article 13(3) of
Large Dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Norbrook Fipronil Norbrook VPA22664/096/ 50 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
50 mg Spot-On Laboratories 001 Prescription Only application
Solution for cats (Ireland) Limited Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Norbrook Fipronil Norbrook VPA22664/097/ 67 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
67 mg Spot-On Laboratories 001 Prescription Only application
Solution for (Ireland) Limited Medicine as (Article 13(3) of
Small Dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Norbrook Fipronil Norbrook VPA22664/138/ 134, 120.6 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
and (S)- Laboratories 002 mg/pipette Merchant as - (S)-methoprene application
Methoprene 134 (Ireland) Limited defined in (Article 13(1) of
mg / 120.6 mg relevant national Directive No
spot-on solution legislation 2001/82/EC)
for medium dogs

Norbrook Fipronil Norbrook VPA22664/138/ 268, 241.2 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
and (S)- Laboratories 003 mg/pipette Merchant as - (S)-methoprene application
Methoprene 268 (Ireland) Limited defined in (Article 13(1) of
mg / 241.2 mg relevant national Directive No
spot-on solution legislation 2001/82/EC)
for large dogs

Norbrook Fipronil Norbrook VPA22664/138/ 402, 361.8 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
and (S)- Laboratories 004 mg/pipette Merchant as - (S)-methoprene application
Methoprene 402 (Ireland) Limited defined in (Article 13(1) of
mg / 361.8 mg relevant national Directive No
spot-on solution legislation 2001/82/EC)
for very large
dogs
Norbrook Fipronil Norbrook VPA22664/133/ 50, 60 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
and (S)- Laboratories 001 mg/pipette Merchant as - (S)-methoprene application
Methoprene 50 (Ireland) Limited defined in (Article 13(1) of
mg / 60 mg spot- relevant national Directive No
on solution for legislation 2001/82/EC)
cats and ferrets

Norbrook Fipronil Norbrook VPA22664/138/ 67, 60.3 Spot-on solution - QP53AX65 LM: Licensed - Fipronil Generic - Topical use
and (S)- Laboratories 001 mg/pipette Merchant as - (S)-methoprene application
Methoprene 67 (Ireland) Limited defined in (Article 13(1) of
mg / 60.3 mg relevant national Directive No
spot-on solution legislation 2001/82/EC)
for small dogs

Norfenicol 300 Norbrook VPA22664/093/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular
mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only application use
for Injection for (Ireland) Limited itre Medicine as (Article 13(1) of - Subcutaneous
Cattle and Pigs defined in Directive No use
relevant national 2001/82/EC)
legislation

Normazole 5 Norbrook VPA22664/145/ 5 Oral solution - QH03BB02 POM: - Thiamazole Hybrid - Oral use
mg/ml Oral Laboratories 001 milligram(s)/millil Prescription Only application
Solution for Cats (Ireland) Limited itre Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 128 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Norocarp 20 mg Norbrook VPA22664/067/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use
Tablets for Dogs Laboratories 001 Prescription Only
(Ireland) Limited Medicine as
defined in
relevant national
legislation

Norocarp 50 mg Norbrook VPA22664/067/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen - Oral use
Tablets for Dogs Laboratories 002 Prescription Only
(Ireland) Limited Medicine as
defined in
relevant national
legislation

Norocarp 50 Norbrook VPA22664/073/ 50 Solution for - QM01AE91 POM: - Carprofen Well-established - Intravenous
mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only use application use
for Injection for (Ireland) Limited itre Medicine as (Article 13a of - Subcutaneous
Cattle defined in Directive No use
relevant national 2001/82/EC)
legislation

Norocarp Large Norbrook VPA22664/074/ 50 Solution for - QM01AE91 POM: - Carprofen Generic - Intravenous
Animal 5 %w/v Laboratories 001 milligram(s)/millil injection Prescription Only application use
Solution for (Ireland) Limited itre Medicine as (Article 13(1) of - Subcutaneous
Injection for defined in Directive No use
young cattle, relevant national 2001/82/EC)
horses and legislation
ponies
Norocillin 300 Norbrook VPA22664/012/ 300 Suspension for - QJ01CE01 POM: - Procaine Full application - Intramuscular
mg/ml Laboratories 001 milligram(s)/millil injection Prescription Only benzylpenicillin (Article 12(3) of use
Suspension for (Ireland) Limited itre Medicine as Directive No
Injection defined in 2001/82/EC)
relevant national
legislation

Noroclav 250 mg Norbrook VPA22664/094/ 250 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Oral use
chewable Laboratories 002 Prescription Only - Clavulanic acid application
flavoured tablets (Ireland) Limited Medicine as (Article 13(3) of
for cats and dog defined in Directive No
relevant national 2001/82/EC)
legislation

Noroclav 250 mg Norbrook VPA22664/072/ 250 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin - Oral use
Tablets for dogs Laboratories 002 Prescription Only - Clavulanic acid
(Ireland) Limited Medicine as
defined in
relevant national
legislation

Noroclav 50 mg Norbrook VPA22664/094/ 50 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Oral use
chewable Laboratories 001 Prescription Only - Clavulanic acid application
flavoured tablets (Ireland) Limited Medicine as (Article 13(3) of
for cats and dog defined in Directive No
relevant national 2001/82/EC)
legislation

Noroclav 50 mg Norbrook VPA22664/072/ 50 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin - Oral use
Tablets for Dogs Laboratories 001 Prescription Only - Clavulanic acid
and Cats (Ireland) Limited Medicine as
defined in
relevant national
legislation

Noroclav 500 mg Norbrook VPA22664/094/ 500 mg/tablet Chewable tablet - QJ01CR02 POM: - Amoxicillin Hybrid - Oral use
chewable Laboratories 003 Prescription Only - Clavulanic acid application
flavoured tablets (Ireland) Limited Medicine as (Article 13(3) of
for dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 129 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Noroclav 500 mg Norbrook VPA22664/082/ 500 milligram(s) Tablet - QJ01CR02 POM: - Amoxicillin Generic - Oral use
Palatable Laboratories 001 Prescription Only - Clavulanic acid application
Tablets for Dogs (Ireland) Limited Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Noroclav Norbrook VPA22664/058/ 140, 35 Suspension for - QJ01CR02 POM: - Amoxicillin - Intramuscular
Injection for Laboratories 001 milligram(s)/millil injection Prescription Only - Clavulanic acid use
Cattle and Dogs (Ireland) Limited itre Medicine as - Subcutaneous
defined in use
relevant national
legislation

Noroclav Norbrook VPA22664/090/ 200, 50, 10 Intramammary - QJ51RV01 POM: - Amoxicillin Hybrid - Intramammary
Intramammary Laboratories 001 mg/syringe suspension Prescription Only - Clavulanic acid application use
Suspension for (Ireland) Limited Medicine as - Prednisolone (Article 13(3) of
Lactating Cows defined in Directive No
relevant national 2001/82/EC)
legislation

Noroclox DC Norbrook VPA22664/011/ 500 mg/syringe Intramammary - QJ51CF02 POM: - Cloxacillin - Intramammary
Intramammary Laboratories 001 suspension Prescription Only Benzathine use
Suspension (Ireland) Limited Medicine as
defined in
relevant national
legislation

Noroclox DC Norbrook VPA22664/043/ 600 mg/syringe Intramammary - QJ51CF02 POM: - Cloxacillin - Intramammary
Xtra Laboratories 001 suspension Prescription Only Benzathine use
Intramammary (Ireland) Limited Medicine as
Suspension defined in
relevant national
legislation

Norodine 24 % Norbrook VPA22664/021/ 24 percent Solution for - QJ01EW10 POM: - Trimethoprim Full application - Intramuscular
Solution for Laboratories 001 weight/volume injection Prescription Only - Sulfadiazine (Article 12(3) of use
Injection (Ireland) Limited Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national - Subcutaneous
legislation use

Norodine Equine Norbrook VPA22664/019/ 5.8, 28.83 Oral paste - QJ01E POM: - Trimethoprim Full application - Oral use
Oral Paste Laboratories 001 percent Prescription Only - Sulfadiazine (Article 12(3) of
(Ireland) Limited weight/weight Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Noromectin 0.5% Norbrook VPA22664/052/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Generic - Topical use
w/v Pour-On Laboratories 001 weight/volume Merchant as application
Solution for (Ireland) Limited defined in (Article 13(1) of
Cattle relevant national Directive No
legislation 2001/82/EC)

Noromectin 1% Norbrook VPA22664/051/ 1.0 percent Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
w/v Solution for Laboratories 001 weight/volume injection Merchant as application use
Injection for (Ireland) Limited defined in (Article 13(1) of
Cattle and Pigs relevant national Directive No
legislation 2001/82/EC)

Noromectin 1.0 Norbrook VPA22664/059/ 1.0 percent Solution for - QP54AA01 LM: Licensed - Ivermectin - Subcutaneous
% w/v Solution Laboratories 001 weight/volume injection Merchant as use
for Injection for (Ireland) Limited defined in
Sheep relevant national
legislation

Noromectin Norbrook VPA22664/062/ 1.87 percent Oral paste - QP54AA01 LM: Licensed - Ivermectin Well-established - Oral use
1.87% Oral Laboratories 001 weight/weight Merchant as use application
Paste for Horses (Ireland) Limited defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 130 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Noromectin Norbrook VPA22664/053/ 0.8 Oral solution - QP54AA01 LM: Licensed - Ivermectin Well-established - Oral use
Drench 0.8 Laboratories 001 milligram(s)/millil Merchant as use application
mg/ml Oral (Ireland) Limited itre defined in (Article 13a of
Solution for relevant national Directive No
Sheep legislation 2001/82/EC)

Noromectin Multi Norbrook VPA22664/068/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin - Subcutaneous
Injection Laboratories 001 milligram(s)/millil injection Merchant as use
(Ireland) Limited itre defined in
relevant national
legislation

Noropraz, 18.7 Norbrook VPA22664/117/ 18.7, 140.3 Oral paste - QP54AA51 LM: Licensed - Ivermectin Hybrid - Oral use
mg/g + 140.3 Laboratories 001 milligram(s)/gra Merchant as - Praziquantel application
mg/g Oral Paste (Ireland) Limited m defined in (Article 13(3) of
for Horses relevant national Directive No
legislation 2001/82/EC)

Noroseal 2.6 g Norbrook VPA22664/115/ 2.6 g/syringe Intramammary - QG52X LM: Licensed - Bismuth Hybrid - Intramammary
Intramammary Laboratories 001 suspension Merchant as subnitrate, heavy application use
Suspension for (Ireland) Limited defined in (Article 13(3) of
Cattle relevant national Directive No
legislation 2001/82/EC)

Norvax compact Intervet Ireland VPA10996/213/ . Emulsion for - QI10AA01 POM: - Salmon Full application - Intraperitoneal
PD emulsion for Limited 001 injection Prescription Only pancreas (Article 12(3) of use
injection for Medicine as disease virus Directive No
Atlantic salmon defined in (spdv) strain f93- 2001/82/EC)
relevant national 125
legislation

Novamune CEVA-Phylaxia VPA10463/006/ . Concentrate and - QI01AD09 POM: - Avian infectious Full application - Subcutaneous
concentrate and Veterinary 001 solvent for Prescription Only bursal disease (Article 12(3) of use
solvent for Biologicals Co. suspension for Medicine as virus, live Directive No
suspension for Ltd injection defined in 2001/82/EC)
injection for relevant national
chickens legislation

Novomate 277.8 Lohmann VPA22931/001/ 277.8 Powder and - QJ01CE90 POM: - Penethamate Hybrid - Intramuscular
mg/ml powder Pharma 001 milligram(s)/millil solvent for Prescription Only hydriodide application use
and solvent for Herstellung itre suspension for Medicine as (Article 13(3) of
suspension for GmbH injection defined in Directive No
injection for relevant national 2001/82/EC)
cattle legislation

NUFLOR 300 Intervet Ireland VPA10996/268/ 300 Solution for - QJ01BA90 POM: - Florfenicol Full application - Intramuscular
mg/ml solution Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
for injection for itre Medicine as Directive No - Subcutaneous
cattle and sheep defined in 2001/82/EC) use
relevant national
legislation

Nuflor 40 mg/g Intervet Ireland VPA10996/238/ 40 Premix for - QJ01BA90 POM: - Florfenicol Full application - Oral use
Premix for Limited 001 milligram(s)/gra medicated Prescription Only (Article 12(3) of
Medicated m feeding stuff Medicine as Directive No
Feeding Stuff for defined in 2001/82/EC)
Swine relevant national
legislation

Nuflor Minidose Intervet Ireland VPA10996/207/ 450 Solution for - QJ01BA90 POM: - Florfenicol Hybrid - Intramuscular
450 mg/ml Limited 001 milligram(s)/millil injection Prescription Only application use
solution for itre Medicine as (Article 13(3) of - Subcutaneous
injection for defined in Directive No use
cattle relevant national 2001/82/EC)
legislation

NUFLOR Swine Intervet Ireland VPA10996/241/ 300 Solution for - QJ01BA90 POM: - Florfenicol Full application - Intramuscular
300 mg/ml Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
Solution for itre Medicine as Directive No
injection defined in 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 131 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Nullamec 5 Bimeda Animal VPA22033/066/ 5 Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Generic - Pour-on use
mg/ml pour-on Health Limited 001 milligram(s)/millil Merchant as application
solution for cattle itre defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

OCNIL 400 mg/g Vetpharma VPA10516/015/ 400 Powder for use - QJ01FF02 POM: - Lincomycin Generic - In drinking
powder for use in Animal Health, 001 milligram(s)/gra in drinking water Prescription Only application water use
drinking water S.L. m Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Octacillin 697 Eurovet Animal VPA10989/051/ 697 Powder for oral - QJ01CA04 POM: - Amoxicillin - Oral use
mg/g powder for Health B.V. 001 milligram(s)/gra solution Prescription Only
use in drinking m Medicine as
water for defined in
chickens relevant national
legislation

Octacillin 800 Eurovet Animal VPA10989/073/ 800 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - In drinking
mg/g powder for Health B.V. 001 milligram(s)/gra in drinking water Prescription Only trihydrate application water use
use in drinking m Medicine as (Article 13(1) of
water for pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Oestracton 52.4 Vetoquinol SA VPA10521/003/ 52.4 Solution for - QH01CA01 POM: - Gonadorelin[6- Generic - Intramuscular
microgram/ml 001 microgram(s)/mil injection Prescription Only D-phe]acetate application use
solution for lilitre Medicine as (Article 13(1) of - Subcutaneous
injection for defined in Directive No use
cattle, horses, relevant national 2001/82/EC)
pigs legislation

Olab Sultrim Old Castle VPA10892/001/ 21 percent Premix for - QJ01EW10 POM: - Trimethoprim Informed - Oral use
21% premix for Laboratories Ltd 001 medicated Prescription Only - Sulfadiazine consent
medicated feed feeding stuff Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Omeproshield Boehringer VPA10454/071/ 370 Oral paste - QA02BC01 POM: - Omeprazole Informed - Oral use
370 mg/g oral Ingelheim 001 milligram(s)/gra Prescription Only consent
paste for horses Vetmedica m Medicine as application
GmbH defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Ophtocycline 10 Le Vet Beheer VPA10475/028/ 10 Eye ointment - QS01AA02 POM: - Generic - Ocular use
mg/g eye B.V. 001 milligram(s)/gra Prescription Only Chlortetracycline application
ointment for m Medicine as hydrochloride (Article 13(1) of
dogs, cats and defined in Directive No
horses relevant national 2001/82/EC)
legislation

Opticlox Eye Norbrook VPA22664/007/ 16.7 percent Eye ointment - QS01AA90 POM: - Cloxacillin Full application - ZZZ
Ointment 16.7% Laboratories 001 weight/weight Prescription Only (Article 12(3) of Conjunctival use
w/w (Ireland) Limited Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Optimmune 2 Intervet Ireland VPA10996/242/ 2 Eye ointment - QS01XA90 POM: - Ciclosporin Full application - Ocular use
mg/g Eye Limited 001 milligram(s)/gra Prescription Only (Article 12(3) of
Ointment m Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Optomease Vet Virbac S.A. VPA10988/114/ 200 Concentrate for - QN01AX92 POM: - Benzocaine Generic - Water-borne
200 mg/ml 001 milligram(s)/millil solution for fish Prescription Only application use
concentrate for itre treatment Medicine as (Article 13(1) of
solution for fish defined in Directive No
treatment relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 132 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Orafluke 10 % Interchem VPA10555/003/ 10 percent Oral suspension - QP52AC13 LM: Licensed - Fenbendazole Informed - Oral use
w/v Oral Ireland Ltd 002 weight/volume Merchant as - Rafoxanide consent
Suspension defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Orafluke 5 % w/v Interchem VPA10555/003/ 5 percent Oral suspension - QP52AC13 LM: Licensed - Fenbendazole Informed - Oral use
Oral Suspension Ireland Ltd 001 weight/volume - QP52AG05 Merchant as - Rafoxanide consent
defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Orafluke 5 % w/v Interchem VPA10555/003/ 5 percent Oral suspension - QP52AC13 LM: Licensed - Fenbendazole Informed - Oral use
Oral Suspension Ireland Ltd 001 weight/volume - QP52AG05 Merchant as - Rafoxanide consent
defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
ORAMEC Boehringer VPA10454/072/ 0.8 Oral solution - QP54AA01 LM: Licensed - Ivermectin Full application - Oral use
Drench for Ingelheim 001 milligram(s)/millil Merchant as (Article 12(3) of
Sheep 0.8 mg/ml Vetmedica itre defined in Directive No
GmbH relevant national 2001/82/EC)
legislation

Orazole 10% w/v Foran VPA10484/012/ 10 percent Drench - QP52AC13 LM: Licensed - Fenbendazole - Oral use
Oral Drench Healthcare 001 weight/volume Merchant as
Limited defined in
relevant national
legislation

Orbenin Dry Cow Zoetis Belgium VPA10387/045/ 500 mg/syringe Intramammary - QJ51CF02 POM: - Cloxacillin Full application - Intramammary
500 mg S.A. 001 suspension Prescription Only (Article 12(3) of use
Intramammary Medicine as Directive No
Suspension defined in 2001/82/EC)
relevant national
legislation

Orbenin Extra Zoetis Belgium VPA10387/046/ 600 mg/syringe Intramammary - QJ51CF02 POM: - Cloxacillin Full application - Intramammary
Dry Cow 600 mg S.A. 001 suspension Prescription Only (Article 12(3) of use
Intramammary Medicine as Directive No
Suspension defined in 2001/82/EC)
relevant national
legislation

Oridermyl ear ge Vetoquinol VPA10983/040/ . Gel - QS02CA04 POM: - Neomycin Full application - Auricular use
Ireland Limited 001 Prescription Only - Nystatin (Article 12(3) of
Medicine as - Triamcinolone Directive No
defined in acetonide 2001/82/EC)
relevant national - Permethrin
legislation (25:75) technical

Orniflox 25 Avimedical B.V. VPA10442/001/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml 001 milligram(s)/millil Prescription Only application
concentrate for itre Medicine as (Article 13(1) of
oral solution for defined in Directive No
pet rabbits, relevant national 2001/82/EC)
rodents, legislation
ornamental birds
and reptiles

Orospray Vetoquinol VPA10983/008/ 2.85, 50 Cutaneous - QD06AA52 POM: - Full application - Topical use
Ireland Limited 001 gram/100gram spray, powder Prescription Only Chlortetracycline (Article 12(3) of
Medicine as - Sulphanilamide Directive No
defined in 2001/82/EC)
relevant national
legislation

Osmonds Dry Bimeda Animal VPA22033/010/ 100, 100, 400 Intramammary - QJ51RC POM: - Neomycin Well-established - Intramammary
Cow Health Limited 001 mg/syringe suspension Prescription Only sulphate use application use
Intramammary Medicine as - Penethamate (Article 13a of
Suspension defined in hydriodide Directive No
relevant national - Procaine 2001/82/EC)
legislation benzylpenicillin

Veterinary Medicines Authorised/Transfer Pending Products Page 133 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Osmonds ECO Animal VPA22693/017/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Informed - Topical use
Lineout 0.5 % Health Europe 001 Merchant as consent
Pour-on Limited defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Osphos 51 Dechra VPA22622/016/ 51 Solution for - QM05BA02 POM: - Clodronic acid Full application - Intramuscular
mg/ml solution Regulatory B.V. 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
for injection for itre Medicine as Directive No
horses defined in 2001/82/EC)
relevant national
legislation

Osteopen 100 Chanelle VPA10987/131/ 100 Solution for - QM01AX90 VPO: Veterinary - Pentosan Generic - Subcutaneous
mg/ml Solution Pharmaceuticals 001 milligram(s)/millil injection Practitioner Only polysulphate application use
for injection for Manufacturing itre as defined in sodium (Article 13(1) of
dogs Limited relevant national Directive No
legislation 2001/82/EC)

Otimectin vet. 1 Le Vet BV VPA10816/016/ 1 Gel - QS02QA03 POM: - Ivermectin Full application - Auricular use
mg/g ear gel for 001 milligram(s)/gra Prescription Only (Article 12(3) of
cats m Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Otomax Ear Intervet Ireland VPA10996/244/ . international Ear drops, - QS02CA90 POM: - Gentamicin Fixed - Topical use
Drops Limited 001 unit(s) suspension Prescription Only - Betamethasone combination
Suspension Medicine as - Clotrimazole application
defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Otoxolan ear Krka, d.d., Novo VPA10774/047/ 3, 10, 1 Ear drops, - QS02CA06 POM: - Marbofloxacin Generic - Auricular use
drops, mesto 001 milligram(s)/millil suspension Prescription Only - Clotrimazole application
suspension for itre Medicine as - (Article 13(1) of
dogs defined in Dexamethasone Directive No
relevant national acetate 2001/82/EC)
legislation

Ovarelin 50 Ceva Santé VPA10815/004/ 50 Solution for - QH01CA01 POM: - Gonadorelin Full application - Intramuscular
ug/ml, solution Animale 001 microgram(s)/mil injection Prescription Only (Article 12(3) of use
for injection for lilitre Medicine as Directive No
cattle defined in 2001/82/EC)
relevant national
legislation

Ovarid Tablets Virbac S.A. VPA10988/081/ 20 mg/tablet Tablet - QG03AC05 POM: - Megestrol - Oral use
20 mg 002 Prescription Only acetate
Medicine as
defined in
relevant national
legislation

Ovarid Tablets 5 Virbac S.A. VPA10988/081/ 5 mg/tablet Tablet - QG03AC05 POM: - Megestrol - Oral use
mg 001 Prescription Only acetate
Medicine as
defined in
relevant national
legislation

Ovimec 0.8 Ancare Ireland VPA10915/012/ 0.8 Oral solution - QP54AA02 LM: Licensed - Abamectin Informed - Oral use
mg/ml Oral Ltd. 001 milligram(s)/millil Merchant as consent
Solution for itre defined in application
Sheep relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Ovimectin 10 Bimeda Animal VPA22033/067/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
mg/ml Solution Health Limited 001 milligram(s)/millil injection Merchant as application use
for Injection for itre defined in (Article 13(1) of
Sheep relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 134 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Ovipast Plus Intervet Ireland VPA10996/147/ . Suspension for - QI04AB02 LM: Licensed - Mannheimia Full application - Subcutaneous
Limited 001 injection Merchant as haemolyticastrai (Article 12(3) of use
defined in ns Directive No
relevant national - Mannheimia 2001/82/EC)
legislation haemolyticastrai
ns
- Mannheimia
haemolyticastrai
ns
- Mannheimia
haemolyticastrai
ns
- Mannheimia
haemolyticastrai
ns
- Pasteurella
trehalosistrains
- Pasteurella
trehalosistrains
- Pasteurella
trehalosistrains
- Pasteurella
trehalosistrains
Ovisect 12.5 Osmond Ireland VPA10451/001/ 12.5 Pour-on solution - QP53AC08 LM: Licensed - Cypermethrin Generic - Topical use
mg/ml Pour-On On Farm 001 milligram(s)/millil Merchant as technical high-cis application
Solution for Business Limited itre defined in (80:20) (Article 13(1) of
Sheep relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 135 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
OVIVAC P PLU Intervet Ireland VPA10996/149/ . Suspension for - QI04AB05 LM: Licensed - Clostridium Immunological - Subcutaneous
Limited 001 injection Merchant as perfringens type veterinary use
defined in d, strain 603 medicinal
relevant national epsilon toxoid product
legislation - Clostridium application
septicum (Article 13d of
s1110/85 toxoid Directive No
- Clostridium 2001/82/EC)
tetani, strain
51123/91 toxoid
- Clostridium
chauvoei strain
no. 655
- Clostridium
chauvoei strain
no. 656
- Clostridium
chauvoei strain
no. 657
- Clostridium
chauvoei strain
no. 658
- Clostridium
chauvoei strain
no. 1048
- Formalin killed
cells of
mannheimia
haemolytica
serotypes a1
- Formalin killed
cells of
mannheimia
haemolytica
serotypes a2
- Formalin killed
cells of
mannheimia
haemolytica
serotypes a6
- Formalin killed
cells of
mannheimia
haemolytica
serotypes a7
- Formalin killed
cells of
mannheimia
haemolytica
serotypes a9
- Formalin killed
cells of
pasteurella
trehalosi
serotypes t3
- Formalin killed
cells of
pasteurella
trehalosi
serotypes t4
- Formalin killed
cells of
pasteurella
trehalosi
serotypes t10
- Formalin
pasteurella
trehalosi strain
t15 (s1105/84)

Ovuplant 2.1 mg Dechra VPA22622/017/ 2.1 milligram(s) Implant - QH01CA93 POM: - Deslorelin Full application - Subcutaneous
Implantation Regulatory B.V. 001 Prescription Only acetate (Article 12(3) of use
Tablets for Medicine as Directive No
Horses (Mares) defined in 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 136 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Oxfencare Oral Ancare Ireland VPA10915/001/ 22.65 Oral suspension - QP52AC02 LM: Licensed - Oxfendazole - Oral use
Suspension Ltd. 001 milligram(s)/millil Merchant as
itre defined in
relevant national
legislation

OXTRA DD 100 FATRO S.p.A. VPA10836/010/ 100 Solution for - QJ01AA06 POM: - Oxytetracycline Generic - Intramuscular
mg/ml solution 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle, sheep, defined in Directive No use
pigs, horses, relevant national 2001/82/EC) - Subcutaneous
dogs and cats legislation use

Oxycomplex NS Bimeda Animal VPA22033/042/ 100, 20 Solution for - QJ01AA56 POM: - Oxytetracycline - Intramuscular
Solution for Health Limited 001 milligram(s)/millil injection Prescription Only - Flunixin use
Injection itre Medicine as - Intravenous
defined in use
relevant national
legislation

Oxyfluke 34 Norbrook VPA22664/141/ 34 Oral suspension - QP52AG06 LM: Licensed - Oxyclozanide Generic - Oral use
mg/ml Oral Laboratories 001 milligram(s)/millil Merchant as application
Suspension for (Ireland) Limited itre defined in (Article 13(1) of
Cattle and relevant national Directive No
Sheep legislation 2001/82/EC)

Oxytetracycline Kela n.v. VPA10981/005/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline - Intramuscular
20% w/v L.A. 001 milligram(s)/millil injection Prescription Only use
Solution for itre Medicine as
Injection defined in
relevant national
legislation

Oxytetracycline Alfasan VPA10980/001/ 10 percent Solution for - QJ01AA06 POM: - Oxytetracycline - Intramuscular
Injection 10% Nederland B.V 001 weight/volume injection Prescription Only hydrochloride use
Medicine as
defined in
relevant national
legislation

Oxytobel 10 Bela-Pharm VPA10445/001/ 10 international Solution for - QH01BB02 POM: - Oxytocin Generic - Intramuscular
IU/ml solution for GmbH & Co. KG 001 unit(s)/millilitre injection Prescription Only application use
injection for Medicine as (Article 13(1) of - Intravenous
Horses, Cattle, defined in Directive No use
Pigs, Sheep, relevant national 2001/82/EC) - Subcutaneous
Goats, Dogs and legislation use
Cats
Oxytocin aniMedica VPA10826/004/ 10 international Solution for - QH01BB02 POM: - Oxytocin Well-established - Intramuscular
aniMedica GmbH 001 unit(s)/millilitre injection Prescription Only use application use
Medicine as (Article 13a of - Subcutaneous
defined in Directive No use
relevant national 2001/82/EC)
legislation

Oxytocin Eurovet Animal VPA10989/044/ 10 international Solution for - QH01BB02 POM: - Oxytocin - Intramuscular
Solution for Health B.V. 001 unit(s)/millilitre injection Prescription Only use
Injection Medicine as - Intravenous
defined in use
relevant national
legislation

Panacur 10 % Intervet Ireland VPA10996/111/ 10 percent Oral suspension - QP52AC13 LM: Licensed - Fenbendazole Full application - Oral use
w/v Oral Limited 001 weight/volume Merchant as (Article 12(3) of
Suspension defined in Directive No
relevant national 2001/82/EC)
legislation

Panacur Equine Intervet Ireland VPA10996/113/ 22.2 percent Granules - QP52AC13 LM: Licensed - Fenbendazole Full application - Oral use
Granules 22.2 % Limited 001 weight/weight Merchant as (Article 12(3) of
w/w defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 137 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Panacur Equine Intervet Ireland VPA10996/118/ 18.75 percent Oral paste - QP52AC13 LM: Licensed - Fenbendazole Full application - Oral use
Oral Paste 18.75 Limited 001 weight/weight Merchant as (Article 12(3) of
%w/w defined in Directive No
relevant national 2001/82/EC)
legislation

Panacur Intervet Ireland VPA10996/188/ 187.5 Oral paste - QP52AC13 POM: - Fenbendazole Full application - Oral use
PetPaste 187.5 Limited 001 milligram(s)/gra Prescription Only (Article 12(3) of
mg/g oral paste m Medicine as Directive No
for dogs and cat defined in 2001/82/EC)
relevant national
legislation

Panomec 10 Boehringer VPA10454/073/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin - Subcutaneous
mg/ml Solution Ingelheim 001 milligram(s)/millil injection Merchant as use
for Injection for Vetmedica itre defined in
Cattle, Sheep GmbH relevant national
and Pigs legislation

Paracox Intervet Ireland VPA10996/245/ . Oral suspension - QI01AN01 POM: - Eimeria Full application - Oral use
suspension for Limited 001 Prescription Only acervulina hp (Article 12(3) of
oral suspension Medicine as - Eimeria brunetti Directive No
for chickens defined in hp 2001/82/EC)
relevant national - Eimeria
legislation maxima cp
- Eimeria
maxima mfp
- Eimeria mitis
hp
- Eimeria
necatrix hp
- Eimeria
praecox hp
- Eimeria tenella
hp
Paracox-5, Intervet Ireland VPA10996/215/ . Oral suspension - QI01AN01 POM: - Eimeria Full application - Oral use
suspension for Limited 001 Prescription Only acervulina hp (Article 12(3) of
oral suspension Medicine as - Eimeria Directive No
for chickens defined in maxima cp 2001/82/EC)
relevant national - Eimeria
legislation maxima mfp
- Eimeria mitis
hp
- Eimeria tenella
hp
Parafend 2.265 Norbrook VPA22664/040/ 2.265 percent Oral suspension - QP52AC02 LM: Licensed - Oxfendazole - Oral use
% Oral Laboratories 001 weight/volume Merchant as
Suspension (Ireland) Limited defined in
relevant national
legislation

Parafend Plus Norbrook VPA22664/070/ 25/50 Oral suspension - QP52AC52 LM: Licensed - Oxfendazole Fixed - Oral use
Oral Suspension Laboratories 001 milligram(s)/millil Merchant as - Closantel combination
(Ireland) Limited itre defined in application
relevant national (Article 13b of
legislation Directive No
2001/82/EC)
Paramectin Norbrook VPA22664/061/ 0.08 percent Drench - QP54AA01 LM: Licensed - Ivermectin Well-established - Oral use
0.08% w/v Laboratories 001 weight/volume Merchant as use application
Drench for (Ireland) Limited defined in (Article 13a of
Sheep relevant national Directive No
legislation 2001/82/EC)

Paramectin 0.5 Norbrook VPA22664/066/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin - Topical use
% Pour-On Laboratories 001 weight/volume Merchant as
Solution for (Ireland) Limited defined in
Cattle relevant national
legislation

Paramectin 1% Norbrook VPA22664/065/ 1.0 percent Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
Solution for Laboratories 001 weight/volume injection Merchant as application use
Injection (Ireland) Limited defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 138 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Paramove, Solvay VPA10480/001/ 49.5 percent Concentrate for - QD08AX01 POM: - Hydrogen Generic - Cutaneous use
49.5% w/w Chemicals 001 weight/weight solution for fish Prescription Only peroxide application
Hydrogen International S.A treatment Medicine as (Article 13(1) of
Peroxide defined in Directive No
concentrate for relevant national 2001/82/EC)
solution for fish legislation
treatment
Parazole 10% Foran VPA10484/021/ 10 percent Oral suspension - QP52AC13 CAM: - Fenbendazole - Oral use
w/v Oral Healthcare 001 weight/volume Companion
Suspension Limited Animal Medicine
as defined in
relevant national
legislation

Parazole Foran VPA10484/022/ 100 Suspension for - QP52AC13 CAM: - Fenbendazole Generic - Oral use
Dog/Cat 100 Healthcare 001 milligram(s)/millil injection Companion application
mg/ml Oral Limited itre Animal Medicine (Article 13(1) of
Suspension as defined in Directive No
relevant national 2001/82/EC)
legislation

Parex 134 mg CF Pharma VPA10515/002/ 134 milligram(s) Spot-on solution - QP53AX15 LM: Licensed - Fipronil - Topical use
spot-on solution Limited 002 Merchant as
for medium dogs defined in
relevant national
legislation

Parex 268 mg CF Pharma VPA10515/002/ 268 milligram(s) Spot-on solution - QP53AX15 LM: Licensed - Fipronil - Topical use
spot-on solution Limited 003 Merchant as
for large dogs defined in
relevant national
legislation

Parex CF Pharma VPA10515/002/ 402 milligram(s) Spot-on solution - QP53AX15 LM: Licensed - Fipronil - Topical use
402mg/dose Limited 004 Merchant as
Spot-on-solution defined in
relevant national
legislation

Parex 50 mg CF Pharma VPA10515/001/ 50 milligram(s) Spot-on solution - QP53AX15 LM: Licensed - Fipronil - Topical use
spot-on solution Limited 001 Merchant as
for cats defined in
relevant national
legislation

Parex 67 mg CF Pharma VPA10515/002/ 67 milligram(s) Spot-on solution - QP53AX15 LM: Licensed - Fipronil - Topical use
spot-on solution Limited 001 Merchant as
for small dogs defined in
relevant national
legislation

Parofor 140 Huvepharma NV VPA10782/026/ 140 Oral solution - QA07AA06 POM: - Paromomycin Generic - Oral use
mg/ml solution 001 milligram(s)/millil Prescription Only application
for use in itre Medicine as (Article 13(1) of
drinking water, defined in Directive No
milk or milk relevant national 2001/82/EC)
replacer for pre- legislation
ruminant cattle
and pigs
Parofor 175 Huvepharma NV VPA10782/031/ 175 Solution for - QJ01GB92 POM: - Paromomycin Generic - Intramuscular
mg/ml solution 001 milligram(s)/millil injection Prescription Only sulfate application use
for injection for itre Medicine as (Article 13(1) of
pigs. defined in Directive No
relevant national 2001/82/EC)
legislation

Parofor 70000 Huvepharma NV VPA10782/014/ 70000 Powder for use - QA07AA06 POM: - Paromomycin Generic - Oral use
IU/g powder for 001 international in drinking water Prescription Only application
use in drinking unit(s)/gram Medicine as (Article 13(1) of
water, milk or defined in Directive No
milk replacer for relevant national 2001/82/EC)
pre-ruminant legislation
cattle and pigs

Veterinary Medicines Authorised/Transfer Pending Products Page 139 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Parofor crypto Huvepharma NV VPA10782/035/ 140000 Oral solution - QA07AA06 POM: - Paromomycin Full application - Oral use
140 000 IU/ml 001 international Prescription Only (Article 12(3) of
oral solution for unit(s)/millilitre Medicine as Directive No
pre-ruminant defined in 2001/82/EC)
cattle relevant national
legislation

Parofor crypto Huvepharma NV VPA10782/033/ 140000 Oral solution - QA07AA06 POM: - Paromomycin Full application - Oral use
140 000 IU/ml 001 international Prescription Only sulfate (Article 12(3) of
oral solution for unit(s)/millilitre Medicine as Directive No
sheep and goats defined in 2001/82/EC)
relevant national
legislation

PARVORUVAX Ceva Santé VPA10815/052/ . Suspension for - QI09AL01 LM: Licensed - Porcine Full application - Intramuscular
Animale 001 injection Merchant as parvovirus (Article 12(3) of use
defined in inactivated k-22 Directive No
relevant national strain 2001/82/EC)
legislation - Erysipelothrix
rhusiopathiae
(lysed bacterial
cells), serotype 2

PARVOVAX Ceva Santé VPA10815/053/ . Emulsion for - QI09AA02 POM: - Porcine Full application - Intramuscular
Animale 001 injection Prescription Only parvovirus (Article 12(3) of use
Medicine as inactivated k-22 Directive No
defined in strain 2001/82/EC)
relevant national
legislation

Pathocef 25 Zoetis Belgium VPA10387/047/ 25 Intramammary - QJ51DA32 POM: - Cefoperazone Full application - Intramammary
mg/ml S.A. 001 milligram(s)/millil suspension Prescription Only (Article 12(3) of use
intramammary itre Medicine as Directive No
suspension defined in 2001/82/EC)
relevant national
legislation

Pen & Strep Norbrook VPA22664/009/ 200, 200 Suspension for - QJ01RA01 POM: - Procaine - Intramuscular
Suspension for Laboratories 001 milligram(s)/millil injection Prescription Only benzylpenicillin use
Injection (Ireland) Limited itre Medicine as -
defined in Dihydrostreptom
relevant national ycin
legislation

PEN/STREP Chem-Pharm VPA10823/002/ 200/200 Suspension for - QJ01RA01 POM: - Procaine Informed - Intramuscular
Injection 001 milligram(s)/millil injection Prescription Only benzylpenicillin consent use
itre Medicine as - application
defined in Dihydrostreptom (Article 13c of
relevant national ycin Directive No
legislation 2001/82/EC)

Penethaone Divasa-Farmavic VPA10505/004/ 236.3 Powder and - QJ01CE90 POM: - Penethamate Generic - Intramuscular
236.3 mg/ml S.A. 001 milligram(s)/millil solvent for Prescription Only hydriodide application use
powder and itre suspension for Medicine as - Penethamate (Article 13(1) of
solvent for injection defined in hydriodide Directive No
suspension for relevant national - Penethamate 2001/82/EC)
injection for legislation hydriodide
cattle
Pen-Strep 20/20 Alfasan VPA10980/009/ 200, 200, 20 Suspension for - QJ01RA01 POM: - Procaine - Intramuscular
Suspension for Nederland B.V 001 milligram(s)/millil injection Prescription Only benzylpenicillin use
Injection itre Medicine as - Streptomycin
defined in sulphate
relevant national - Procaine
legislation hydrochloride

Pentomycin Univet Limited VPA10990/005/ 200, 200 Suspension for - QJ01CE09 POM: - Benzylpenicillin Informed - Intramuscular
Suspension for 001 milligram(s)/millil injection Prescription Only procaine consent use
Injection itre Medicine as - application
defined in Dihydrostreptom (Article 13c of
relevant national ycin (as the Directive No
legislation sulfate) 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 140 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Peptaleve 370 Norbrook VPA22664/149/ 370 Oral paste - QA02BC01 POM: - Omeprazole Generic - Oral use
mg/g Oral Paste Laboratories 001 milligram(s)/gra Prescription Only application
for Horses (Ireland) Limited m Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Peptizole 370 Norbrook VPA22664/113/ 370 Oral paste - QA02BC01 POM: - Omeprazole Generic - Oral use
mg/g Oral Paste Laboratories 001 milligram(s)/gra Prescription Only application
for Horses (Ireland) Limited m Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Permacyl 236.3 Divasa-Farmavic VPA10505/005/ 236.3 Powder and - QJ01CE90 POM: - Penethamate Generic - Intramuscular
mg/ml powder S.A. 001 milligram(s)/millil solvent for Prescription Only hydriodide application use
and solvent for itre suspension for Medicine as - Penethamate (Article 13(1) of
suspension for injection defined in hydriodide Directive No
injection for relevant national - Penethamate 2001/82/EC)
cattle legislation hydriodide

Pestigon 134 mg Norbrook VPA22664/095/ 134 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-On Solution Laboratories 002 Prescription Only application
for Medium Dog (Ireland) Limited Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Pestigon 2.5 Norbrook VPA22664/001/ 2.5 Cutaneous - QP53AX15 POM: - Fipronil Generic - Topical use
mg/ml Laboratories 001 milligram(s)/millil spray, solution Prescription Only application
Cutaneous (Ireland) Limited itre Medicine as (Article 13(1) of
Spray, Solution defined in Directive No
for Cats and relevant national 2001/82/EC)
Dogs legislation

Pestigon 268 mg Norbrook VPA22664/095/ 268 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-On Solution Laboratories 003 Prescription Only application
for large dogs (Ireland) Limited Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Pestigon 402 mg Norbrook VPA22664/095/ 402 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-On Solution Laboratories 004 Prescription Only application
for very large (Ireland) Limited Medicine as (Article 13(3) of
dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Pestigon 50 mg Norbrook VPA22664/098/ 50 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-On Solution Laboratories 001 Prescription Only application
for Cats (Ireland) Limited Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Pestigon 67 mg Norbrook VPA22664/095/ 67 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-On Solution Laboratories 001 Prescription Only application
for Small Dogs (Ireland) Limited Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

PestiGon Combo Norbrook VPA22664/135/ 134, 120.6 Spot-on solution - QP53AX65 POM: - Fipronil Generic - Topical use
134 mg / 120.6 Laboratories 002 mg/pipette Prescription Only - (S)-methoprene application
mg spot-on (Ireland) Limited Medicine as (Article 13(1) of
solution for defined in Directive No
medium dogs relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 141 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
PestiGon Combo Norbrook VPA22664/135/ 268, 241.2 Spot-on solution - QP53AX65 POM: - Fipronil Generic - Topical use
268 mg / 241.2 Laboratories 003 mg/pipette Prescription Only - (S)-methoprene application
mg spot-on (Ireland) Limited Medicine as (Article 13(1) of
solution for large defined in Directive No
dogs relevant national 2001/82/EC)
legislation

PestiGon Combo Norbrook VPA22664/135/ 402, 361.8 Spot-on solution - QP53AX65 POM: - Fipronil Generic - Topical use
402 mg / 361.8 Laboratories 004 mg/pipette Prescription Only - (S)-methoprene application
mg spot-on (Ireland) Limited Medicine as (Article 13(1) of
solution for very defined in Directive No
large dogs relevant national 2001/82/EC)
legislation

PestiGon Combo Norbrook VPA22664/131/ 50, 60 Spot-on solution - QP53AX65 POM: - Fipronil Generic - Topical use
50 mg / 60 mg Laboratories 001 mg/pipette Prescription Only - (S)-methoprene application
spot-on solution (Ireland) Limited Medicine as (Article 13(1) of
for cats and defined in Directive No
ferrets relevant national 2001/82/EC)
legislation

PestiGon Combo Norbrook VPA22664/135/ 67, 60.3 Spot-on solution - QP53AX65 POM: - Fipronil Generic - Topical use
67 mg / 60.3 mg Laboratories 001 mg/pipette Prescription Only - (S)-methoprene application
spot-on solution (Ireland) Limited Medicine as (Article 13(1) of
for small dogs defined in Directive No
relevant national 2001/82/EC)
legislation

PG 600 Powder Intervet Ireland VPA10996/025/ 600 international Powder and - QG03GA99 POM: - Gonadotrophin Full application - Intramuscular
and solvent for Limited 001 unit(s) solvent for Prescription Only equine serum (Article 12(3) of use
solution for solution for Medicine as - Gonadotrophin Directive No
injection injection defined in chorionic 2001/82/EC)
relevant national
legislation

PGF Veyx Veyx-Pharma VPA10539/002/ 0.0875 Solution for - QG02AD90 POM: - Cloprostenol Generic - Intramuscular
0.0875 mg/ml GmbH 001 milligram(s)/millil injection Prescription Only application use
solution for itre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle and pigs relevant national 2001/82/EC)
legislation

PGF Veyx forte Veyx-Pharma VPA10539/002/ 0.250 Solution for - QG02AD90 POM: - Cloprostenol Generic - Intramuscular
0.250 mg/ml GmbH 002 milligram(s)/millil injection Prescription Only application use
solution for itre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle and pigs relevant national 2001/82/EC)
legislation

Pharmacillin 300 Chem-Pharm VPA10823/001/ 300 Suspension for - QJ01CE09 POM: - Procaine 13c informed - Intra-Muscular
mg/ml 001 milligram(s)/millil injection Prescription Only benzylpenicillin consent
suspension for itre Medicine as
injection defined in
relevant national
legislation

Pharmasin 100 Huvepharma NV VPA10782/012/ 100 percent Granules for use - QJ01FA90 POM: - Tylosin Tartrate Generic - Oral use
% w/w Granules 001 weight/weight in drinking water Prescription Only application
for Use in Medicine as (Article 13(1) of
Drinking Water defined in Directive No
for Pigs, relevant national 2001/82/EC)
Chickens, legislation
Turkeys and
Calves
Pharmasin 100 Huvepharma NV VPA10782/006/ 100,000 Premix for - QJ01FA90 POM: - Tylosin Generic - Oral use
000 IU/g Premix 002 international medicated Prescription Only application
for medicated unit(s)/gram feeding stuff Medicine as (Article 13(1) of
feeding stuff for defined in Directive No
pigs, broilers and relevant national 2001/82/EC)
pullets legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 142 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Pharmasin 20 Huvepharma NV VPA10782/001/ 20,000 Granules - QJ01FA90 POM: - Tylosin Generic - Oral use
000 IU/g Oral 002 international Prescription Only application
Granules for pig unit(s)/gram Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Pharmasin 200 Huvepharma NV VPA10782/015/ 200,000 Solution for - QJ01FA90 POM: - Tylosin Generic - Intramuscular
mg/ml solution 001 international injection Prescription Only application use
for injection for unit(s)/millilitre Medicine as (Article 13(1) of - Intravenous
cattle, sheep, defined in Directive No use
goats and pigs relevant national 2001/82/EC)
legislation

Pharmasin 250 Huvepharma NV VPA10782/006/ 250,000 Premix for - QJ01FA90 POM: - Tylosin (base) Generic - Oral use
000 IU/g Premix 003 international medicated Prescription Only application
for medicated unit(s)/gram feeding stuff Medicine as (Article 13(1) of
feeding stuff for defined in Directive No
pigs, broilers and relevant national 2001/82/EC)
pullets legislation

Pharmazan C Chem-Pharm VPA10823/020/ 1.5, 3.0 percent Oral suspension - QP52AE51 LM: Licensed - Levamisole Informed - Oral use
Oral Suspension 001 weight/volume Merchant as hydrochloride consent
for Sheep and defined in - Oxyclozanide application
Cattle relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Phenocillin 800 Eurovet Animal VPA10989/065/ 800 Powder for use - QJ01CE02 POM: - Hybrid - Oral use
mg/g powder for Health B.V. 001 milligram(s)/gra in drinking water Prescription Only Phenoxymethyl application
use in drinking m Medicine as penicillin (Article 13(3) of
water for defined in Directive No
chickens relevant national 2001/82/EC)
legislation

Phenoleptil 100 Le Vet BV VPA10816/012/ 100 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use
mg Tablets for 004 Prescription Only application
dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Phenoleptil 12.5 Le Vet BV VPA10816/012/ 12.5 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use
mg tablets for 001 Prescription Only application
dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Phenoleptil 25 Le Vet BV VPA10816/012/ 25 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use
mg Tablets for 003 Prescription Only application
dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Phenoleptil 50 Le Vet BV VPA10816/012/ 50 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use
mg tablets for 002 Prescription Only application
dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Phenotab CP-Pharma VPA10810/019/ 100 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Generic - Oral use
Flavoured 100 Handelsgesellsc 003 Prescription Only application
mg Tablets for haft mbH Medicine as (Article 13(1) of
dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Phenotab CP-Pharma VPA10810/019/ 25 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use
Flavoured 25 mg Handelsgesellsc 001 Prescription Only application
Tablets for dogs haft mbH Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 143 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Phenotab CP-Pharma VPA10810/019/ 60 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Hybrid - Oral use
Flavoured 60 mg Handelsgesellsc 002 Prescription Only application
Tablets for dogs haft mbH Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Phenovet 60 mg Laboratoire TVM VPA10386/003/ 60 mg/tablet Tablet - QN03AA02 POM: - Phenobarbital Generic - Oral use
tablets for dogs 001 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Phenoxypen Dopharma VPA10791/001/ 325 Powder for oral - QJ01CE02 POM: - Full application - Oral use
Water Soluble Research B.V. 001 milligram(s)/gra solution Prescription Only Phenoxymethyl (Article 12(3) of
Powder, 325 m Medicine as penicillin Directive No
mg/g powder for defined in 2001/82/EC)
oral solution for relevant national
chickens legislation

Phenylarthrite Vetoquinol VPA10983/013/ 20 percent Solution for - QM01AA01 POM: - Full application - Intramuscular
solution for Ireland Limited 001 weight/volume injection Prescription Only Phenylbutazone (Article 12(3) of use
injection Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national
legislation

Phosphonortonic Vetoquinol VPA10983/022/ 20 percent Solution for - QA12CX90 LM: Licensed - Toldimfos 12(3) full dossier - Intra-Muscular
20% Injectable Ireland Limited 001 weight/volume injection Merchant as sodium trihydrate - Intra-venous
Solution defined in
relevant national
legislation

Pigfen 200 Huvepharma NV VPA10782/029/ 200 Suspension for - QP52AC13 POM: - Fenbendazole Hybrid - In drinking
mg/ml 001 milligram(s)/millil use in drinking Prescription Only application water use
suspension for itre water Medicine as (Article 13(3) of
use in drinking defined in Directive No
water for pigs relevant national 2001/82/EC)
legislation

Pigfen 40 mg/g Huvepharma NV VPA10782/019/ 40 Granules - QP52AC13 POM: - Fenbendazole Well-established - Oral use
granules for pigs 001 milligram(s)/gra Prescription Only use application
m Medicine as (Article 13a of
defined in Directive No
relevant national 2001/82/EC)
legislation

Pigfen 40 mg/g Huvepharma NV VPA10782/021/ 40 Premix for - QP52AC13 POM: - Fenbendazole Hybrid - Oral use
premix for 001 milligram(s)/gra medicated Prescription Only application
medicated m feeding stuff Medicine as (Article 13(3) of
feeding stuff for defined in Directive No
pigs relevant national 2001/82/EC)
legislation

Pigzin Premix, DSM Nutritional VPA10443/001/ 100 percent Premix for - QA07XA91 POM: - Zinc oxide Full application - Oral use
100% w/w Products (UK) 001 weight/weight medicated Prescription Only (Article 12(3) of
Premix for Ltd feeding stuff Medicine as Directive No
medicated defined in 2001/82/EC)
feeding stuff relevant national
legislation

Pimocard 1.25 Eurovet Animal VPA10989/067/ 1.25 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Generic - Oral use
mg flavoured Health B.V. 001 Prescription Only application
tablets for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Pimocard 10 mg Eurovet Animal VPA10989/067/ 10 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use
flavoured tablets Health B.V. 004 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 144 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Pimocard 2.5 mg Eurovet Animal VPA10989/067/ 2.5 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use
flavoured tablets Health B.V. 002 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Pimocard 5 mg Eurovet Animal VPA10989/067/ 5 mg/tablet Tablet - QC01CE90 POM: - Pimobendan Generic - Oral use
flavoured tablets Health B.V. 003 Prescription Only application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Pimotab 1.25 mg CP-Pharma VPA10810/018/ 1.25 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Per Oral
chewable tablets Handelsgesellsc 001 Prescription Only application
for dogs haft mbH Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Pimotab 10 mg CP-Pharma VPA10810/018/ 10 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Per Oral
chewable tablets Handelsgesellsc 004 Prescription Only application
for dogs haft mbH Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Pimotab 15 mg CP-Pharma VPA10810/018/ 15 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Per Oral
chewable tablets Handelsgesellsc 005 Prescription Only application
for dogs haft mbH Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Pimotab 2.5 mg CP-Pharma VPA10810/018/ 2.5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Per Oral
chewable tablets Handelsgesellsc 002 Prescription Only application
for dogs haft mbH Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Pimotab 5 mg CP-Pharma VPA10810/018/ 5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Per Oral
chewable tablets Handelsgesellsc 003 Prescription Only application
for dogs haft mbH Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

PIRESOL 300 SP Veterinaria, VPA10790/014/ 300 Solution for use - QN02BE01 POM: - Hybrid - In drinking
mg/ml solution S.A. 001 milligram(s)/millil in drinking water Prescription Only PARACETAMOL application water use
for use in itre Medicine as (Article 13(3) of
drinking water for defined in Directive No
pigs relevant national 2001/82/EC)
legislation

PIRETAMOL GLOBAL VET VPA10477/003/ 300 Oral solution - QN02BE01 POM: - Paracetamol Full application - In drinking
300 mg/ml HEALTH SL 001 milligram(s)/millil Prescription Only (Article 12(3) of water use
solution for use itre Medicine as Directive No
in drinking water defined in 2001/82/EC)
for pigs relevant national
legislation

Planate 0.0875 Intervet Ireland VPA10996/246/ 0.0875 Solution for - QG02AD90 POM: - Cloprostenol Full application - Intramuscular
mg/ml Solution Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
for injection itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 145 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Planipart Boehringer VPA10454/017/ 30 Solution for - QG02CA91 VPO: Veterinary - Clenbuterol Full application - Intravenous
Solution for Ingelheim 001 microgram(s)/mil injection Practitioner Only hydrochloride (Article 12(3) of use
Injection 30 Vetmedica lilitre as defined in Directive No
microgram/ml GmbH relevant national 2001/82/EC)
legislation

Plenix LC 75 mg, Ceva Santé VPA10815/044/ 75 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Generic - Intramammary
intramammary Animale 001 ointment Prescription Only application use
ointment for Medicine as (Article 13(1) of
lactating cows defined in Directive No
relevant national 2001/82/EC)
legislation

Ploff LHV Bonapp HOVR10466/00 . Oral solution LM: Licensed - Actaea Simplified - Oral use
5/001 Merchant as racemose Registration of a
defined in - Euphrasia Veterinary
relevant national officinalis Homeopathic
legislation - Echinacea Medicinal
angustifolia Product (Article
16, Directive
2001/82/EC)
Pluset powder LABORATORIO VPA10665/001/ 50/50 Powder and - QG03GA POM: - Follicle Full application - Intramuscular
and solvent for S CALIER S.A. 001 international solvent for Prescription Only stimulating (Article 12(3) of use
solution for unit(s)/millilitre solution for Medicine as hormone (fshp) Directive No
injection injection defined in - Luteinizing 2001/82/EC)
relevant national hormone (lhp)
legislation - Follicle
stimulating
hormone (fshp)
- Luteinizing
hormone (lhp)
PolyVar Yellow Elanco GmbH VPA22020/058/ 275 Bee-hive strip - QP53AC05 LM: Licensed - Flumethrin Full application - Topical use
275 mg bee-hive 001 milligram/strip Merchant as (Article 12(3) of
strip defined in Directive No
relevant national 2001/82/EC)
legislation

Porcilis APP Intervet Ireland VPA10996/100/ . Suspension for - QI09AB07 POM (E): - Concentrate of Full application - Intramuscular
suspension for Limited 001 injection Prescription Only actinobacillus (Article 12(3) of use
injection for pigs Exempt as pleuropneumoni Directive No
defined in ae antigens 2001/82/EC)
relevant national containing
legislation - Omp (outer
membrane
protein)
- Apxi (105
kilodalton type i
toxoid)
- Apxii (105
kilodalton type ii
toxoid)
- Apxiii (120
kilodalton
macrophage
toxoid)
Porcilis Ery + Intervet Ireland VPA10996/097/ . Suspension for - QI09AL01 LM: Licensed - Inactivated Immunological - Intramuscular
Parvo Limited 001 injection Merchant as porcine veterinary use
suspension for defined in parvovirus strain medicinal
injection for pigs relevant national 014 product
legislation - Inactivated application
erysipelothrix (Article 13d of
rhusiopathiae Directive No
strain M2 2001/82/EC)
(Serotype 2)
Porcilis ERY Intervet Ireland VPA10996/096/ . Suspension for - QI09AB LM: Licensed - Erysipelothrix Full application - Intramuscular
suspension for Limited 001 injection Merchant as rhusiopathiae (Article 12(3) of use
injection for pigs defined in strain m2 Directive No
relevant national (serotype 2) 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 146 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Porcilis Intervet Ireland VPA10996/279/ . Suspension for - QI09AL07 LM: Licensed - E.rhusiopathiae Full application - Intramuscular
Ery+Parvo+Lept Limited 001 injection Merchant as strain m2 (Article 12(3) of use
o suspension for defined in - Porcine parvo Directive No
injection for pigs relevant national virus 2001/82/EC)
legislation - Leptospira
canicola
- Leptospira
icterohaemorrha
giae
- Leptospira
australis
- Leptospira
grippotyphosa
- Leptospira
pomona
- Leptospira
tarassovi

Porcilis Glässer Intervet Ireland VPA10996/179/ . enzyme-linked Suspension for - QI09AB07 POM: - Inactivated Full application - Intramuscular
Suspension for Limited 001 immunosorbent injection Prescription Only whole cells of (Article 12(3) of use
injection for pigs assay unit/dose Medicine as Haemophilis Directive No
defined in parasuis 2001/82/EC)
relevant national serotype 5, strain
legislation 4800

Porcilis Intervet Ireland VPA10996/278/ . Lyophilisate and - QI09AB POM: - Inactivated Full application - Intramuscular
Lawsonia Limited 001 solvent for Prescription Only Lawsonia (Article 12(3) of use
lyophilisate and emulsion for Medicine as intracellularis Directive No
solvent for injection defined in strain SPAH-08 2001/82/EC)
emulsion for relevant national
injection for pigs legislation

Porcilis M Hyo ID Intervet Ireland VPA10996/264/ . Emulsion for - QI09AB13 POM: - Inactivated Full application - Intradermal use
ONCE emulsion Limited 001 injection Prescription Only whole cell (Article 12(3) of
for injection for Medicine as concentrate of Directive No
pigs defined in m. 2001/82/EC)
relevant national hyopneumoniae
legislation strain 11

Porcilis M Hyo, Intervet Ireland VPA10996/196/ . Suspension for - QI09AB13 POM: - Mycoplasma Full application - Intramuscular
suspension for Limited 001 injection Prescription Only hyopneumoniae (Article 12(3) of use
injection Medicine as strain 11 Directive No
defined in inactivated whole 2001/82/EC)
relevant national cell concentrate
legislation

Porcilis Parvo Intervet Ireland VPA10996/098/ . Suspension for - QI09AA02 LM: Licensed - Inactivated Full application - Intramuscular
Limited 001 injection Merchant as porcine (Article 12(3) of use
defined in parvovirus strain Directive No
relevant national 014 2001/82/EC)
legislation

Porcilis PRRS Intervet Ireland VPA10996/128/ . Lyophilisate and - QI09AD03 POM: - Porcine Full application - Intradermal use
lyophilisate and Limited 001 solvent for Prescription Only reproductive (Article 12(3) of - Intramuscular
solvent for suspension for Medicine as respiratory Directive No use
suspension for injection defined in syndrome (prrs) 2001/82/EC)
injection for pigs relevant national virus strain dv
legislation live

Porcimec 10 Bimeda Animal VPA22033/052/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
mg/ml solution Health Limited 001 milligram(s)/millil injection Merchant as application use
for injection for itre defined in (Article 13(1) of
pigs relevant national Directive No
legislation 2001/82/EC)

Porcimectin 1%, Bimeda Animal VPA22033/053/ 1.0 percent Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
Solution for Health Limited 001 weight/volume injection Merchant as application use
Injection for pigs defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 147 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Poulvac Bursa Zoetis Belgium VPA10387/049/ . Lyophilisate for - QI01AD09 POM: - Live infectious Full application - Oral use
Plus Lyophilisate S.A. 001 suspension Prescription Only bursal disease (Article 12(3) of
for suspension in Medicine as virus, strain Directive No
drinking water defined in V877 2001/82/EC)
relevant national
legislation

Poulvac Bursine Zoetis Belgium VPA10387/091/ tissue culture Lyophilisate for - QI01AD09 POM: - Infectious Full application - In drinking
2 lyophilisate for S.A. 001 infective dose suspension Prescription Only bursal disease (Article 12(3) of water use
suspension for 50/dose Medicine as virus strain lukert Directive No - ZZZ Spray
spray defined in 2001/82/EC)
vaccination or for relevant national
use in drinking legislation
water for
chickens

Poulvac IB QX Zoetis Belgium VPA10387/051/ . 50% Embryo Lyophilisate for - QI01AD07 POM: - Live attenuated Full application - ZZZ Spray
lyophilisate for S.A. 001 Infective suspension for Prescription Only avian infectious (Article 12(3) of
suspension for Dose/dose spray Medicine as bronchitis virus Directive No
spray for administration defined in strain L1148 2001/82/EC)
chickens relevant national
legislation

POULVAC IBMM Zoetis Belgium VPA10387/053/ . Lyophilisate for - QI01AD07 POM: - Avian infectious Full application - Oral use
+ ARK S.A. 001 suspension for Prescription Only bronchitis virus (Article 12(3) of
Lyophilisate for spray Medicine as strain Directive No
suspension for administration defined in massachusetts 2001/82/EC)
spray relevant national 1263
administration for legislation - Avian infectious
chickens bronchitis virus
strain arkansas
3168

Powdox Vetpharma VPA10516/006/ 500 Powder for use - QJ01AA02 POM: - Doxycycline Generic - In drinking
Doxycycline 500 Animal Health, 001 milligram(s)/gra in drinking water Prescription Only application water use
mg/g powder for S.L. m Medicine as (Article 13(1) of
use in drinking defined in Directive No
water for pigs, relevant national 2001/82/EC)
chickens and legislation
turkeys

Prascend 1 mg Boehringer VPA10454/011/ 1 mg/tablet Tablet - QN04BC02 POM: - Pergolide Full application - Oral use
tablets for horse Ingelheim 001 Prescription Only (Article 12(3) of
Vetmedica Medicine as Directive No
GmbH defined in 2001/82/EC)
relevant national
legislation

Prazical Plus Chanelle VPA10987/089/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use
Tablets for dogs Pharmaceuticals 001 mg/tablet Companion - Pyrantel application
Manufacturing Animal Medicine - Febantel (Article 13(3) of
Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Prazical Plus XL Chanelle VPA10987/089/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Prazical Plus XL Chanelle VPA10987/089/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 148 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Prazical Plus XL Chanelle VPA10987/089/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Prazitel 230/20 Chanelle VPA10987/101/ 230, 20 Film-coated - QP52AA51 CAM: - Pyrantel Hybrid - Oral use
mg Flavoured Pharmaceuticals 001 mg/tablet tablet Companion embonate application
Film-Coated Manufacturing Animal Medicine - Praziquantel (Article 13(3) of
Tablets for Cats Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Prazitel Plus Chanelle VPA10987/076/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use
Tablets for Dogs Pharmaceuticals 001 mg/tablet Companion - Pyrantel application
Manufacturing Animal Medicine - Febantel (Article 10(3) of
Limited as defined in Directive No
relevant national 2001/83/EC)
legislation

Prazitel Plus XL Chanelle VPA10987/076/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Prazitel Plus XL Chanelle VPA10987/076/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Prazitel Plus XL Chanelle VPA10987/076/ 175,504,525 Tablet - QP52AA01 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet - QP52AC05 Companion - Pyrantel application
Manufacturing - QP52AF02 Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Prazpronto 20mg Chanelle VPA10987/165/ 20 mg/pipette Spot-on solution - QP52AA01 CAM: - Praziquantel Generic - Spot-on use
Spot-on Solution Pharmaceuticals 001 Companion application
for Cats and Manufacturing Animal Medicine (Article 13(1) of
Kittens Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Prazpronto 40 Chanelle VPA10987/165/ 40 milligram(s) Spot-on solution - QP52AA01 CAM: - Praziquantel Generic - Spot-on use
mg Spot-on Pharmaceuticals 002 Companion application
solution for Manufacturing Animal Medicine (Article 13(1) of
medium cats Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Prazpronto 60 Chanelle VPA10987/165/ 60 milligram(s) Spot-on solution - QP52AA01 CAM: - Praziquantel Generic - Spot-on use
mg Spot-on Pharmaceuticals 003 Companion application
solution for large Manufacturing Animal Medicine (Article 13(1) of
cats Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 149 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Prednicortone 20 Le Vet Beheer VPA10475/018/ 20 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Generic - Oral use
mg tablets for B.V. 002 Prescription Only application
dogs and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Prednicortone 5 Le Vet Beheer VPA10475/018/ 5 mg/tablet Tablet - QH02AB06 POM: - Prednisolone Generic - Oral use
mg tablets for B.V. 001 Prescription Only application
dogs and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

PREVENDOG Vetpharma VPA10516/021/ 0.636 Medicated collar - QP53AC11 CAM: - Deltamethrin Hybrid - Cutaneous use
0.636 g Animal Health, 001 gram(s)/collar Companion application
medicated collar S.L. Animal Medicine (Article 13(3) of
for very small as defined in Directive No
dogs relevant national 2001/82/EC)
legislation

PREVENDOG Vetpharma VPA10516/021/ 1.056 Medicated collar - QP53AC11 CAM: - Deltamethrin Hybrid - Cutaneous use
1.056 g Animal Health, 002 gram(s)/collar Companion application
medicated collar S.L. Animal Medicine (Article 13(3) of
for small to as defined in Directive No
medium dogs relevant national 2001/82/EC)
legislation

PREVENDOG Vetpharma VPA10516/021/ 1.304 Medicated collar - QP53AC11 CAM: - Deltamethrin Hybrid - Cutaneous use
1.304 g Animal Health, 003 gram(s)/collar Companion application
medicated collar S.L. Animal Medicine (Article 13(3) of
for large to very as defined in Directive No
large dogs relevant national 2001/82/EC)
legislation

Previron 200 Laboratorios VPA10846/015/ 200 Solution for - QB03AC LM: Licensed - Iron (as Well-established - Intramuscular
mg/ml solution Hipra S.A. 001 milligram(s)/millil injection Merchant as gleptoferron) use application use
for injection for itre defined in (Article 13a of
pigs relevant national Directive No
legislation 2001/82/EC)

Prid delta 1.55 g Ceva Santé VPA10815/013/ 1.55 gram(s) Vaginal delivery - QG03DA04 VPO: Veterinary - Progesterone Generic - Vaginal use
vaginal delivery Animale 001 system Practitioner Only application
system for cattle as defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

PRID E 1.55 g LAPROVET VPA10483/001/ 1.55 gram(s) Vaginal delivery - QG03DA04 POM: - Progesterone Generic - Vaginal use
vaginal delivery 001 system Prescription Only application
system for cattle Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Prilactone Next Ceva Santé VPA10815/035/ 10 mg/tablet Chewable tablet - QC03DA01 POM: - Spironolactone Full application - Oral use
10 mg chewable Animale 001 Prescription Only (Article 12(3) of
tablets for dogs Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Prilactone Next Ceva Santé VPA10815/035/ 100 mg/tablet Chewable tablet - QC03DA01 POM: - Spironolactone Full application - Oral use
100 mg Animale 003 Prescription Only (Article 12(3) of
chewable tablets Medicine as Directive No
for dogs defined in 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 150 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Prilactone Next Ceva Santé VPA10815/035/ 50 mg/tablet Chewable tablet - QC03DA01 POM: - Spironolactone Full application - Oral use
50 mg chewable Animale 002 Prescription Only (Article 12(3) of
tablets for dogs Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Primectin 0.5% Norbrook VPA22664/078/ 0.5 percent Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Informed - Topical use
w/v Pour-On Laboratories 001 weight/volume Merchant as consent
Solution (Ireland) Limited defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Primidoxine Norbrook VPA22664/022/ 40, 200 Solution for - QJ01EW13 POM: - Trimethoprim - Intramuscular
Solution for Laboratories 001 milligram(s)/millil injection Prescription Only - Sulfadoxine use
Injection (Ireland) Limited itre Medicine as - Intravenous
defined in use
relevant national - Subcutaneous
legislation use

PRIMOPEN 300 FATRO S.p.A. VPA10836/007/ 300 Suspension for - QJ01CE09 POM: - Benzylpenicillin Hybrid - Intramuscular
mg/ml 001 milligram(s)/millil injection Prescription Only (procaine) application use
suspension for itre Medicine as monohydrate (Article 13(3) of
injection for defined in Directive No
cattle, pigs and relevant national 2001/82/EC)
horses legislation

Prinocate 100 Krka, d.d., Novo VPA10774/070/ 100,25 Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use
mg/25 mg spot- mesto 002 mg/pipette Prescription Only - Moxidectin application
on solution for Medicine as (Article 13(3) of
medium dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Prinocate 250 Krka, d.d., Novo VPA10774/070/ 250,62.5 Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use
mg/62.5 mg mesto 003 mg/pipette Prescription Only - Moxidectin application
spot-on solution Medicine as (Article 13(3) of
for large dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Prinocate 40 Krka, d.d., Novo VPA10774/070/ 40,10 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use
mg/10 mg spot- mesto 001 Prescription Only - Moxidectin application
on solution for Medicine as (Article 13(3) of
small dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Prinocate 40 Krka, d.d., Novo VPA10774/068/ 40,4 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use
mg/4 mg spot-on mesto 001 Prescription Only - Moxidectin application
solution for small Medicine as (Article 13(3) of
cats and ferrets defined in Directive No
relevant national 2001/82/EC)
legislation

Prinocate 400 Krka, d.d., Novo VPA10774/070/ 400,100 Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use
mg/100 mg spot- mesto 004 mg/pipette Prescription Only - Moxidectin application
on solution for Medicine as (Article 13(3) of
extra-large dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Prinocate 80 Krka, d.d., Novo VPA10774/069/ 80,8 mg/pipette Spot-on solution - QP54AB52 POM: - Imidacloprid Hybrid - Spot-on use
mg/8 mg spot-on mesto 001 Prescription Only - Moxidectin application
solution for large Medicine as (Article 13(3) of
cats defined in Directive No
relevant national 2001/82/EC)
legislation

Prinovox 100 mg Elanco GmbH VPA22020/057/ 100 + 25 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Topical use
+ 25 mg spot-on 002 mg/pipette Prescription Only - Moxidectin application
solution for Medicine as (Article 13(1) of
medium dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 151 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Prinovox 250 mg Elanco GmbH VPA22020/057/ 250 + 62.5 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Topical use
+ 62.5 mg spot- 003 mg/pipette Prescription Only - Moxidectin application
on solution for Medicine as (Article 13(1) of
large dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Prinovox 40 mg Elanco GmbH VPA22020/057/ 40 + 10 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Topical use
+ 10 mg spot-on 001 mg/pipette Prescription Only - Moxidectin application
solution for small Medicine as (Article 13(1) of
dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Prinovox 40 mg Elanco GmbH VPA22020/056/ 40 + 4 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Topical use
+ 4 mg spot-on 001 mg/pipette Prescription Only - Moxidectin application
solution for small Medicine as (Article 13(1) of
cats and ferrets defined in Directive No
relevant national 2001/82/EC)
legislation

Prinovox 400 mg Elanco GmbH VPA22020/057/ 400 + 100 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Topical use
+ 100 mg spot- 004 mg/pipette Prescription Only - Moxidectin application
on solution for Medicine as (Article 13(1) of
extra-large dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Prinovox 80 mg Elanco GmbH VPA22020/056/ 80 + 8 Spot-on solution - QP54AB52 POM: - Imidacloprid Generic - Topical use
+ 8 mg spot-on 002 mg/pipette Prescription Only - Moxidectin application
solution for large Medicine as (Article 13(1) of
cats defined in Directive No
relevant national 2001/82/EC)
legislation

Pro Penstrep Interchem VPA10555/007/ 200, 200 Suspension for - QJ01RA01 POM: - Benzylpenicillin Informed - Intramuscular
Suspension for Ireland Ltd 001 milligram(s)/millil injection Prescription Only procaine (lecithin consent use
Injection for itre Medicine as coated 1%) application
Cattle, Sheep defined in - (Article 13c of
and Pigs relevant national Dihydrostreptom Directive No
legislation ycin (as the 2001/82/EC)
sulfate)

Proactive 0.15 DeLaval NV VPA10827/001/ 0.15 percent Teat dip/spray - QD08AG03 LM: Licensed - Available Full application - Dipping
%w/w Teat 001 weight/weight solution Merchant as iodine, ph. eur. (Article 12(3) of - ZZZ Spray
Dip/Spray defined in (as Directive No
Solution relevant national iodine/sodium 2001/82/EC)
legislation iodide/poloxamer
complex 0.86)

PROBENCIL MEVET S.A.U. VPA22009/001/ 300 Suspension for - QJ01CE09 POM: - Benzylpenicillin Generic - Intramuscular
300 mg/ml 001 milligram(s)/millil injection Prescription Only procaine application use
suspension for itre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle and pigs relevant national 2001/82/EC)
legislation

Procactive 300 Laboratorios VPA10495/006/ 300 Suspension for - QJ01CE09 POM: - Benzylpenicillin Generic - Intramuscular
mg/ml SYVA, S.A.U 001 milligram(s)/millil injection Prescription Only procaine application use
Suspension for itre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle and pigs. relevant national 2001/82/EC)
legislation

Procamidor Duo Richter Pharma VPA10801/014/ 40, 0.036 Solution for - QN01BA52 VPO: Veterinary - Procaine Generic - Perineural use
40 mg/ml + AG 001 milligram(s)/millil injection Practitioner Only hydrochloride application - Subcutaneous
0.036 mg/ml itre as defined in - Adrenaline (Article 13(1) of use
solution for relevant national tartrate Directive No
injection legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 152 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Procapen aniMedica VPA10826/019/ 3 g/syringe Intramammary - QJ51CE09 POM: - Procaine Generic - Intramammary
Injector 3 g GmbH 001 suspension Prescription Only benzylpenicillin application use
intramammary Medicine as (Article 13(1) of
suspension for defined in Directive No
cattle relevant national 2001/82/EC)
legislation

Procillin 300 Bimeda Animal VPA22033/043/ 300 Suspension for - QJ01CE09 POM: - Procaine - Intramuscular
mg/ml Health Limited 001 milligram(s)/millil injection Prescription Only benzylpenicillin use
Suspension for itre Medicine as
Injection for defined in
Cattle, Sheep relevant national
and Pigs legislation

Procycline LA Interchem VPA10555/008/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Informed - Intramuscular
200 mg/ml Ireland Ltd 001 milligram(s)/millil injection Prescription Only consent use
solution for itre Medicine as application
injection defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Pro-Dynam Oral Dechra VPA10803/001/ 1.0 g/sachet Oral powder - QM01AA01 POM: - Full application - Oral use
Powder 1 g Veterinary 001 Prescription Only Phenylbutazone (Article 12(3) of
phenylbutazone Products A/S Medicine as Directive No
per sachet defined in 2001/82/EC)
relevant national
legislation

Progressis Ceva Santé VPA10815/054/ . Emulsion for - QI09AA05 POM: - Inactivated Full application - Intramuscular
Emulsion for Animale 001 injection Prescription Only porcine (Article 12(3) of use
injection for pigs Medicine as reproductive and Directive No
(sows and gilts) defined in respiratory 2001/82/EC)
relevant national syndrome (prrs)
legislation virus, p120 strain

Proin 15 mg Pegasus VPA22713/001/ 15 mg/tablet Tablet - QG04BX91 POM: - Hybrid - Oral use
chewable tablets Laboratories 001 Prescription Only Phenylpropanol application
for dogs Ireland Limited Medicine as amine (Article 13(3) of
defined in hydrochloride Directive No
relevant national 2001/82/EC)
legislation

Proin 50 mg Pegasus VPA22713/001/ 50 mg/tablet Tablet - QG04BX91 POM: - Hybrid - Oral use
chewable tablets Laboratories 002 Prescription Only Phenylpropanol application
for dogs Ireland Limited Medicine as amine (Article 13(3) of
defined in hydrochloride Directive No
relevant national 2001/82/EC)
legislation

Prolusyn 50 Cyton AH VPA22776/002/ 50.0 Solution for - QH01CA01 POM: - Gonadorelin Generic - Intramuscular
micrograms/ml Biosciences 001 microgram(s)/mil injection Prescription Only Acetate application use
solution for GmbH lilitre Medicine as (Article 13(1) of
injection for defined in Directive No
cattle relevant national 2001/82/EC)
legislation

Promec 18.7 ECO Animal VPA22693/016/ 18.7 Oral paste - QP54AA01 LM: Licensed - Ivermectin Informed - Oral use
mg/g Oral Paste Health Europe 001 milligram(s)/gra Merchant as consent
for Horses Limited m defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Promox LA 150 Interchem VPA10555/010/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin (as Informed - Intramuscular
mg/ml Ireland Ltd 001 milligram(s)/millil injection Prescription Only amoxicillin consent use
Suspension for itre Medicine as trihydrate) application
Injection defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Pronestesic 40 FATRO S.p.A. VPA10836/004/ 40, 0.036 Solution for - QN01BA52 VPO: Veterinary - Procaine Generic - Subcutaneous
mg/ml / 0.036 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
mg/ml solution itre as defined in - Epinephrine (Article 13(1) of
for injection for relevant national tartrate Directive No
horses, cattle, legislation 2001/82/EC)
pigs and sheep

Veterinary Medicines Authorised/Transfer Pending Products Page 153 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Propalin Syrup Vetoquinol VPA10983/056/ 50 Syrup - QG04BX91 POM: - Full application - Oral use
Ireland Limited 001 milligram(s)/millil Prescription Only Phenylpropanol (Article 12(3) of
itre Medicine as amine Directive No
defined in hydrochloride 2001/82/EC)
relevant national
legislation

Propen 300 Interchem VPA10555/009/ 300 Suspension for - QJ01CE09 POM: - Benzylpenicillin Informed - Intramuscular
mg/ml Ireland Ltd 001 milligram(s)/millil injection Prescription Only procaine consent use
Suspension for itre Medicine as application
Injection for defined in (Article 13c of
Cattle, Sheep relevant national Directive No
and Pigs legislation 2001/82/EC)

Propodine 10 Dechra VPA22622/034/ 10.0 Emulsion for - QN01AX10 VPO: Veterinary - Propofol Well-established - Intravenous
mg/ml emulsion Regulatory B.V. 001 milligram(s)/millil injection/infusion Practitioner Only use application use
for itre as defined in (Article 13a of
injection/infusion relevant national Directive No
for dogs and cat legislation 2001/82/EC)

PropoFlo Plus 10 Zoetis Belgium VPA10387/056/ 10 Emulsion for - QN01AX10 VPO: Veterinary - Propofol Full application - Intravenous
mg/ml, Emulsion S.A. 001 milligram(s)/millil injection Practitioner Only (Article 12(3) of use
for injection for itre as defined in Directive No
dogs and cats relevant national 2001/82/EC)
legislation

Propomitor 10 Orion VPA10664/008/ 10 Emulsion for - QN01AX10 VPO: Veterinary - Propofol Well-established - Intravenous
mg/ml emulsion Corporation 001 milligram(s)/millil injection/infusion Practitioner Only use application use
for itre as defined in (Article 13a of
injection/infusion relevant national Directive No
for dogs and cat legislation 2001/82/EC)

Proposure 10 Axience VPA22873/001/ 10 Emulsion for - QN01AX10 VPO: Veterinary - Propofol Well-established - Intravenous
mg/ml emulsion 001 milligram(s)/millil injection Practitioner Only use application use
for injection for itre as defined in (Article 13a of
dogs and cats relevant national Directive No
legislation 2001/82/EC)

Prosolvin 7.5 Virbac S.A. VPA10988/078/ 7.5 Solution for - QG02AD91 POM: - Luprostiol Full application - Intramuscular
mg/ml Solution 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
for Injection itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Protect Oral Provita Eurotech VPA10865/001/ 0.373, 0.373, Oral suspension - QA07 LM: Licensed - Lactobacillus 12(3) full dossier - Per Oral
Suspension for Limited 001 0.373 percent Merchant as acidophilus LA
New Born weight/weight defined in 101
Calves relevant national - Lactobacillus
legislation acidophilus LA
107
- Enterococcus
faecium SF 101
PROWORMER Ceva Santé VPA10815/019/ 525,175,175 Tablet - QP52AA51 CAM: - Febantel Hybrid - Oral use
Flavoured tablets Animale 002 mg/tablet Companion - Pyrantel application
for large dogs Animal Medicine - Praziquantel (Article 13(3) of
as defined in Directive No
relevant national 2001/82/EC)
legislation

PROWORMER Ceva Santé VPA10815/019/ 150,50,50 Tablet - QP52AA51 CAM: - Febantel Hybrid - Oral use
Flavoured tablets Animale 001 mg/tablet Companion - Pyrantel application
for medium and Animal Medicine - Praziquantel (Article 13(3) of
small dogs as defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 154 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
PULMODOX 5 Virbac S.A. VPA10988/062/ 5 percent Premix for - QJ01AA02 POM: - Doxycyline - Oral use
% PREMIX 001 weight/weight medicated Prescription Only
feeding stuff Medicine as
defined in
relevant national
legislation

Pulmotil G100 Elanco GmbH VPA22020/012/ 100 Premix for - QJ01FA91 POM: - Tilmicosin (as - Oral use
Premix for 001 gram(s)/kilogra medicated Prescription Only phosphate)
medicated m(s) feeding stuff Medicine as
feedingstuff defined in
relevant national
legislation

Pulmotil G200 Elanco GmbH VPA22020/012/ 200 Premix for - QJ01FA91 POM: - Tilmicosin (as - Oral use
Premix for 002 gram(s)/kilogra medicated Prescription Only phosphate)
medicated m(s) feeding stuff Medicine as
feedingstuff defined in
relevant national
legislation

Pulmovet 250 Dopharma VPA10791/010/ 250 Solution for use - QJ01FA91 POM: - Tilmicosin Generic - In drinking
mg/ml solution Research B.V. 001 milligram(s)/millil in drinking water, Prescription Only application water/milk use
for use in itre Milk or milk Medicine as (Article 13(1) of - Oral use
drinking water or replacer defined in Directive No
milk replacer for relevant national 2001/82/EC)
cattle, pigs, legislation
chickens and
turkeys
Qivitan 25 mg/ml LIVISTO Int'l, VPA10425/003/ 25 Suspension for - QJ01DE90 POM: - Cefquinome Generic - Intramuscular
suspension for S.L. 001 milligram(s)/millil injection Prescription Only application use
injection for itre Medicine as (Article 13(1) of
cattle and pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Qivitan LC 75 LIVISTO Int'l, VPA10425/006/ 75 mg/syringe Intramammary - QJ51DE90 POM: - Cefquinome Hybrid - Intramammary
mg S.L. 001 ointment Prescription Only application use
intramammary Medicine as (Article 13(3) of
ointment for defined in Directive No
lactating cows relevant national 2001/82/EC)
legislation

Qualimec 10 ECO Animal VPA22693/002/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin Well-established - Subcutaneous
mg/ml Solution Health Europe 001 milligram(s)/millil injection Merchant as use application use
for Injection. Limited itre defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

Qualimec Cattle ECO Animal VPA22693/004/ 5 Pour-on solution - QP54AA01 LM: Licensed - Ivermectin - Topical use
Pour-on Health Europe 001 milligram(s)/millil Merchant as
Limited itre defined in
relevant national
legislation

Quanifen (50 mg Chanelle VPA10987/063/ 50, 500 Tablet - QP52AA51 CAM: - Praziquantel - Oral use
Praziquantel / Pharmaceuticals 001 mg/tablet Companion - Fenbendazole
500 mg Manufacturing Animal Medicine
Fenbendazole) Limited as defined in
Tablets for Cats relevant national
and Dogs legislation

Quenazole (50 Chanelle VPA10987/062/ 50/500 mg/tablet Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use
mg praziquantel / Pharmaceuticals 001 Companion - Fenbendazole application
500 mg Manufacturing Animal Medicine (Article 13(3) of
Fenbendazole) Limited as defined in Directive No
Tablets for Cats relevant national 2001/82/EC)
and Dogs legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 155 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Quinoflox 100 GLOBAL VET VPA10477/001/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml solution HEALTH SL 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Rabisin Boehringer VPA10454/074/ . Suspension for - QI07AA02 POM: - Rabies virus Full application - Intramuscular
Ingelheim 001 injection Prescription Only glycoprotein (Article 12(3) of use
Vetmedica Medicine as Directive No - Subcutaneous
GmbH defined in 2001/82/EC) use
relevant national
legislation

Rafazole Oral Chanelle VPA10987/012/ 30, 30 Oral suspension - QP52AE51 LM: Licensed - Rafoxanide - Oral use
Suspension Pharmaceuticals 001 milligram(s)/millil Merchant as - Levamisole
Manufacturing itre defined in hydrochloride
Limited relevant national
legislation

Ranide 30 mg/ml Univet Limited VPA10990/027/ 30 Oral suspension - QP52AG05 LM: Licensed - Rafoxanide - Oral use
Oral Drench 001 milligram(s)/millil Merchant as
itre defined in
relevant national
legislation

Rapidexon 2 Eurovet Animal VPA10989/056/ 2 Solution for - QH02AB02 POM: - Generic - Intraarticular
mg/ml solution Health B.V. 001 milligram(s)/millil injection Prescription Only Dexamethasone application use
for injection itre Medicine as (Article 13(1) of - Intrabursal use
defined in Directive No - Intramuscular
relevant national 2001/82/EC) use
legislation - Intravenous
use

Receptal 0.004 Intervet Ireland VPA10996/123/ 0.004 Solution for - QH01CA90 POM: - Buserelin Full application - Intramuscular
mg/ml Solution Limited 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
for injection itre Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national - Subcutaneous
legislation use

Recicort 1.77 Le Vet Beheer VPA10475/025/ 1.77, 17.7 Ear drops, - QD07XB02 POM: - Triamcinolone Generic - Auricular use
mg/ml + 17.7 B.V. 001 milligram(s)/millil solution Prescription Only acetonide application
mg/ml ear drops, itre Medicine as - Salicylic acid (Article 13(1) of
solution for dogs defined in Directive No
and cats relevant national 2001/82/EC)
legislation

Regumate Intervet Ireland VPA10996/124/ 2.2 Oral solution - QG03DX90 POM: - Altrenogest Full application - Oral use
Equine 2.2 Limited 001 milligram(s)/millil Prescription Only (Article 12(3) of
mg/ml oral itre Medicine as Directive No
solution for defined in 2001/82/EC)
horses relevant national
legislation

Release 300 WDT - VPA10660/001/ 300 Solution for - QN51AA01 VPO: Veterinary - Pentobarbital Hybrid - Intracardiac
mg/ml, solution Wirtschaftsgeno 001 milligram(s)/millil injection Practitioner Only sodium application use
for injection ssenschaft itre as defined in (Article 13(3) of - Intraperitoneal
deutscher relevant national Directive No use
Tierarzte eG legislation 2001/82/EC) - Intravenous
use
- ZZZ
Intrapulmonary
use
Repidose Ready Intervet Ireland VPA10996/254/ 1250 mg/tablet Bolus - QP52AC02 LM: Licensed - Oxfendazole Full application - Oral use
Pulse Limited 001 Merchant as (Article 12(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 156 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Repose 500 Le Vet Beheer VPA10475/030/ 500 Solution for - QN51AA01 VPO: Veterinary - Pentobarbital Hybrid - Intracardiac
mg/ml solution B.V. 001 milligram(s)/millil injection Practitioner Only sodium application use
for injection itre as defined in (Article 13(3) of - Intraperitoneal
relevant national Directive No use
legislation 2001/82/EC) - Intravenous
use

Reprocine 0.07 Vetoquinol SA VPA10521/002/ 0.07 Solution for - QH01BB03 POM: - Carbetocin Well-established - Intramuscular
mg/ml solution 001 milligram(s)/millil injection Prescription Only use application use
for injection for itre Medicine as (Article 13a of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC)
legislation

ReproCyc PRRS Boehringer VPA10454/012/ . Lyophilisate and - QI09AD03 POM: - Live attenuated Full application - Intramuscular
EU lyophilisate Ingelheim 001 solvent for Prescription Only prrs 94881 virus (Article 12(3) of use
and solvent for Vetmedica suspension for Medicine as Directive No
suspension for GmbH injection defined in 2001/82/EC)
injection for pigs relevant national
legislation

Resflam 300/20 Norbrook VPA22664/085/ 300, 20 Solution for - QJ01AA56 POM: - Oxytetracycline Informed - Intramuscular
mg/ml Solution Laboratories 001 milligram(s)/millil injection Prescription Only - Flunixin consent use
for Injection for (Ireland) Limited itre Medicine as application
Cattle defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

RESFLOR Intervet Ireland VPA10996/255/ 300/16.5 Solution for - QJ01BA99 POM: - Florfenicol Fixed - Subcutaneous
300/16.5 mg/mL Limited 001 milligram(s)/millil injection Prescription Only - Flunixin combination use
Solution for itre Medicine as application
Injection for defined in (Article 13b of
Cattle relevant national Directive No
legislation 2001/82/EC)

RESPICHLOR Interchem VPA10555/004/ 150 Oral powder - QJ01AA03 POM: - - Oral use
15% w/w Oral Ireland Ltd 001 milligram(s)/gra Prescription Only Chlortetracycline
Powder m Medicine as hydrochloride
defined in
relevant national
legislation

Revertor 5 mg/ml CP-Pharma VPA10810/004/ 5 Solution for - QV03AB90 POM: - Atipamezole Generic - Intramuscular
Solution for Handelsgesellsc 001 milligram(s)/millil injection Prescription Only hydrochloride application use
Injection for haft mbH itre Medicine as (Article 13(1) of
Dogs and Cats defined in Directive No
relevant national 2001/82/EC)
legislation

Revozyn RTU Eurovet Animal VPA10989/071/ 400 Suspension for - QJ01CE90 POM: - Penethamate Hybrid - Intramuscular
400 mg/ml Health B.V. 001 milligram(s)/millil injection Prescription Only hydriodide application use
suspension for itre Medicine as (Article 13(3) of
injection for defined in Directive No
cattle. relevant national 2001/82/EC)
legislation

Rhemox 500 Industrial VPA10509/006/ 500 Powder for use - QJ01CA04 POM: - Amoxicillin Generic - In drinking
mg/g powder for Veterinaria, S.A. 001 milligram(s)/gra in drinking water Prescription Only trihydrate application water use
use in drinking m Medicine as (Article 13(1) of
water for pigs, defined in Directive No
chicken broilers, relevant national 2001/82/EC)
duck broilers and legislation
turkeys for meat
production

Ridacox 50 J. & M. VPA10954/012/ 50 Oral suspension - QP51AJ01 LM: Licensed - Toltrazuril Generic - Oral use
mg/ml oral Veterinary 001 milligram(s)/millil Merchant as application
suspension for Services Ltd itre defined in (Article 10(1) of
cattle and sheep relevant national Directive No
legislation 2001/83/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 157 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Ridafluke 30 Chanelle VPA10987/013/ 30 Oral suspension - QP52AG05 LM: Licensed - Rafoxanide - Oral use
mg/ml Oral Pharmaceuticals 001 milligram(s)/millil Merchant as
Suspension Manufacturing itre defined in
Limited relevant national
legislation

Ridamec 1 Chanelle VPA10987/112/ 1 Oral solution - QP54AB02 LM: Licensed - Moxidectin Generic - Oral use
mg/ml oral Pharmaceuticals 001 milligram(s)/millil Merchant as application
solution for Manufacturing itre defined in (Article 13(1) of
sheep Limited relevant national Directive No
legislation 2001/82/EC)

Ridaworm 20 mg Chanelle VPA10987/164/ 20 mg/pipette Spot-on solution - QP52AA01 CAM: - Praziquantel Hybrid - Spot-on use
Spot-on Solution Pharmaceuticals 001 Companion application
for small cats Manufacturing Animal Medicine (Article 13(3) of
Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Ridaworm 40 mg Chanelle VPA10987/164/ 40 mg/pipette Spot-on solution - QP52AA01 CAM: - Praziquantel Hybrid - Spot-on use
Spot-on Solution Pharmaceuticals 002 Companion application
for medium cats Manufacturing Animal Medicine (Article 13(3) of
Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Ridaworm 60 mg Chanelle VPA10987/164/ 60 mg/pipette Spot-on solution - QP52AA01 CAM: - Praziquantel Hybrid - Spot-on use
Spot-on Solution Pharmaceuticals 003 Companion application
for large cats Manufacturing Animal Medicine (Article 13(3) of
Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Rifen 100 mg/ml Richter Pharma VPA10801/003/ 100 Solution for - QM01AE03 POM: - Ketoprofen Generic - Intramuscular
solution for AG 001 milligram(s)/millil injection Prescription Only application use
injection for itre Medicine as (Article 13(1) of - Intravenous
horses, cattle defined in Directive No use
and swine relevant national 2001/82/EC)
legislation

Rilexine 300 mg Virbac S.A. VPA10988/018/ 300 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin - Oral use
Tablets for dogs 002 Prescription Only
Medicine as
defined in
relevant national
legislation

Rilexine 600 mg Virbac S.A. VPA10988/018/ 600 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin - Oral use
Tablets for dogs 003 Prescription Only
Medicine as
defined in
relevant national
legislation

Rilexine 75 mg Virbac S.A. VPA10988/018/ 75 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin - Oral use
Tablets for dogs 001 Prescription Only
and cats Medicine as
defined in
relevant national
legislation

RIMADYL Cattle Zoetis Belgium VPA10387/058/ 50 Solution for - QM01AE91 POM: - Carprofen Full application - Intravenous
50 mg/ml S.A. 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
Solution for itre Medicine as Directive No - Subcutaneous
Injection defined in 2001/82/EC) use
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 158 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Rimadyl Zoetis Belgium VPA10387/059/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Palatable S.A. 003 Prescription Only application
Tablets 100 mg Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Rimadyl Zoetis Belgium VPA10387/059/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Palatable S.A. 001 Prescription Only application
Tablets 20 mg Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Rimadyl Zoetis Belgium VPA10387/059/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Palatable S.A. 002 Prescription Only application
Tablets 50 mg Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Rimifin 100 mg Chanelle VPA10987/066/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for dogs Pharmaceuticals 003 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Rimifin 20 mg Chanelle VPA10987/066/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for dogs Pharmaceuticals 001 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Rimifin 50 mg Chanelle VPA10987/066/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for dogs Pharmaceuticals 002 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Rino LHV Bonapp HOVR10466/00 Oral solution LM: Licensed - Thuya - Oral use
1/001 Merchant as - Calendula
defined in officinalis
relevant national - Calcarea
legislation carbonica
- Bellis perennis
- Silicea
- Solidago
virgaurea
Rispoval 3 BRSV Zoetis Belgium VPA10387/060/ 10^5.0 - 10^8.6 Lyophilisate and - QI02AH POM (E): - Parainfluenza 3 Full application - Intramuscular
Pi3 BVD S.A. 001 cell culture suspension for Prescription Only virus, modified (Article 12(3) of use
Lyophilisate and infective dose suspension for Exempt as live, strain rlb103 Directive No
suspension for 50/dose injection defined in - Bovine 2001/82/EC)
suspension for relevant national respiratory
injection for legislation syncytial virus,
cattle modified live,
strain 375
- Inactivated
bovine viral
diarrhoea virus
1, strain 5960
(cytopathic)
- Inactivated
bovine viral
diarrhoea virus
type 1 strain
6309 (non
cytopathic)

Veterinary Medicines Authorised/Transfer Pending Products Page 159 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Rispoval IBR- Zoetis Belgium VPA10387/061/ . Suspension for - QI02AA03 POM (E): - Bovine herpes Full application - Subcutaneous
Marker S.A. 001 injection Prescription Only virus type 1 (Article 12(3) of use
Inactivated Exempt as (BHV-1), strain Directive No
defined in difivac 2001/82/EC)
relevant national
legislation

Rispoval IBR- Zoetis Belgium VPA10387/062/ . Lyophilisate and - QI02AD01 POM (E): - Bovine herpes Full application - Intramuscular
Marker Live S.A. 001 solvent for Prescription Only virus type 1 (Article 12(3) of use
suspension for Exempt as (BHV-1), strain Directive No - ZZZ Intranasal
injection defined in difivac (gE- 2001/82/EC) use
relevant national negative),
legislation modified live
(attenuated)
virus
RISPOVAL RS Zoetis Belgium VPA10387/063/ . Powder for - QI02AD04 POM (E): - Live attenuated Full application - Intramuscular
S.A. 001 suspension for Prescription Only bovine (Article 12(3) of use
injection Exempt as respiratory Directive No
defined in syncytial virus; 2001/82/EC)
relevant national strain rb94
legislation

Rispoval RS+PI3 Zoetis Belgium VPA10387/064/ 10^5.0-10^8.6 / pdr and diluent - QI02AD07 POM (E): - Bovine Full application - ZZZ Intranasal
IntraNasal S.A. 001 10^5.0-10^7.2 for intra-nasal Prescription Only parainfluenza 3 (Article 12(3) of use
cell culture soln Exempt as virus (pi3v), rlb Directive No
infective dose 50 defined in 103, attenuated 2001/82/EC)
relevant national - Bovine
legislation respiratory
syncytial virus
(brsv), strain 375
attenuated
Robonex 5 Norbrook VPA22664/104/ 5 Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Hybrid - Topical use
mg/ml Pour-On Laboratories 001 milligram(s)/millil Merchant as application
Solution for Beef (Ireland) Limited itre defined in (Article 13(3) of
and Dairy Cattle relevant national Directive No
legislation 2001/82/EC)

Rofeniflex 100 Chanelle VPA10987/067/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
mg Tablets for Pharmaceuticals 003 Prescription Only application
dogs Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Rofeniflex 20 mg Chanelle VPA10987/067/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for dogs Pharmaceuticals 001 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Rofeniflex 50 mg Chanelle VPA10987/067/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
Tablets for dogs Pharmaceuticals 002 Prescription Only application
Manufacturing Medicine as (Article 13(1) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Rominervin 10 Le Vet Beheer VPA10475/040/ 10 Solution for - QN05CM93 VPO: Veterinary - Romifidine Generic - Intravenous
mg/ml solution B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection for itre as defined in (Article 13(1) of
horses relevant national Directive No
legislation 2001/82/EC)

Ronaxan 100 mg Boehringer VPA10454/075/ 100 mg/tablet Tablet - QJ01AA02 POM: - Doxycycline - Oral use
tablet Ingelheim 002 Prescription Only
Vetmedica Medicine as
GmbH defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 160 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Ronaxan 20 mg Boehringer VPA10454/075/ 20 mg/tablet Tablet - QJ01AA02 POM: - Doxycycline - Oral use
tablet Ingelheim 001 Prescription Only
Vetmedica Medicine as
GmbH defined in
relevant national
legislation

ROXACIN 100 LABORATORIO VPA10665/002/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml solution S CALIER S.A. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Rumbul Rumen Agrimin Ltd VPA10940/001/ 15 gram/dose Bolus - QA12CC LM: Licensed - Magnesium Full application - Oral use
Bullet 15 g 001 Merchant as (Article 12(3) of
continuous defined in Directive No
release relevant national 2001/82/EC)
intraruminal legislation
device
Sheep/Calves
Rumbul Rumen Agrimin Ltd VPA10940/002/ 40 gram/dose Bolus - QA12CC LM: Licensed - Magnesium Full application - Oral use
Bullet 40 g 001 Merchant as (Article 12(3) of
continuous defined in Directive No
release relevant national 2001/82/EC)
intraruminal legislation
device Cattle
Rumenil 34 Chanelle VPA10987/113/ 34 Oral suspension - QP52AG05 LM: Licensed - Oxyclozanide Generic - Oral use
mg/ml oral Pharmaceuticals 001 milligram(s)/millil Merchant as application
suspension for Manufacturing itre defined in (Article 13(1) of
cattle Limited relevant national Directive No
legislation 2001/82/EC)

Rycarfa 100 mg Krka, d.d., Novo VPA10774/027/ 100 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
tablets for dogs mesto 003 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Rycarfa 20 mg Krka, d.d., Novo VPA10774/027/ 20 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
tablets for dogs mesto 001 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Rycarfa 50 mg Krka, d.d., Novo VPA10774/027/ 50 mg/tablet Tablet - QM01AE91 POM: - Carprofen Generic - Oral use
tablets for dogs mesto 002 Prescription Only application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Rycarfa 50 Krka, d.d., Novo VPA10774/028/ 50 Solution for - QM01AE91 POM: - Carprofen Generic - Intravenous
mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
dogs and cats defined in Directive No use
relevant national 2001/82/EC)
legislation

Salmoporc IDT Biologika VPA10524/008/ . Lyophilisate and - QI09AE02 POM: - Salmonella Similar biological - Oral use
lyophilisate and GmbH 001 solvent for Prescription Only typhimurium application - Subcutaneous
solvent for suspension for Medicine as mutant, strain (Article 13(4) of use
suspension for injection defined in 421/125 Directive No
injection for pigs relevant national 2001/82/EC)
legislation

Salmoporc Ceva Santé VPA10815/064/ . Lyophilisate and - QI09AE02 POM: - Salmonella Similar biological - Oral use
lyophilisate and Animale 001 solvent for Prescription Only typhimurium application - Subcutaneous
solvent for suspension for Medicine as mutant, strain (Article 13(4) of use
suspension for injection defined in 421/125 Directive No
injection for pigs relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 161 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Salmoporc Ceva Santé VPA10815/064/ . Lyophilisate for - QI09AE02 POM: - Salmonella Similar biological - Oral use
lyophilisate for Animale 002 oral suspension Prescription Only typhimurium application
oral suspension Medicine as mutant, strain (Article 13(4) of
for pigs defined in 421/125 Directive No
relevant national 2001/82/EC)
legislation

Salmoporc IDT Biologika VPA10524/008/ . Lyophilisate for - QI09AE02 POM: - Salmonella Similar biological - Oral use
lyophilisate for GmbH 002 oral suspension Prescription Only typhimurium application
oral suspension Medicine as mutant, strain (Article 13(4) of
for pigs defined in 421/125 Directive No
relevant national 2001/82/EC)
legislation

SALMOVAC 440 IDT Biologika VPA10524/007/ 1x10^8 - 8x10^8 Oral lyophilisate - QI01AE01 POM: - Salmonella Full application - Oral use
Lyophilisate for GmbH 001 Colony forming Prescription Only enteritidis, strain (Article 12(3) of
use in drinking units Medicine as no. 441/014 Directive No
water defined in 2001/82/EC)
relevant national
legislation

SALMOVAC 440 Ceva Santé VPA10815/063/ 1x10^8 - 8x10^8 Oral lyophilisate - QI01AE01 POM: - Salmonella Full application - Oral use
Lyophilisate for Animale 001 Colony forming Prescription Only enteritidis, strain (Article 12(3) of
use in drinking units Medicine as no. 441/014 Directive No
water defined in 2001/82/EC)
relevant national
legislation

Santiola 50 Krka, d.d., Novo VPA10774/048/ 50 Solution for - QP52AG09 LM: Licensed - Closantel Generic - Subcutaneous
mg/ml solution mesto 001 milligram(s)/millil injection Merchant as application use
for injection for itre defined in (Article 13(1) of
cattle and sheep relevant national Directive No
legislation 2001/82/EC)

Scabivax Intervet Ireland VPA10996/256/ . Suspension for - QI04AD01 POM: - Contagious Full application - Skin
Contagious Limited 001 skin scarification Prescription Only pustular (Article 12(3) of scarification
pustular Medicine as dermatitis Directive No
dermatitis (Orf) defined in 2001/82/EC)
vaccine relevant national
Suspension for legislation
skin scarification

Scalibor Intervet Ireland VPA10996/173/ 0.76 gram(s) Collar - QP53AC11 POM: - Deltamethrin - Topical use
Protectorband Limited 001 Prescription Only
0.76 g medicated Medicine as
collar for small defined in
and medium relevant national
sized dogs legislation

Scalibor Intervet Ireland VPA10996/173/ 1.0 gram(s) Collar - QP53AC11 POM: - Deltamethrin - Topical use
Protectorband Limited 002 Prescription Only
1.0 g medicated Medicine as
collar for large defined in
sized dogs relevant national
legislation

Seclaris DC 250 Ceva Santé VPA10815/047/ 250 mg/syringe Intramammary - QJ51DB90 POM: - Cefalonium (as Hybrid - Intramammary
mg Animale 001 suspension Prescription Only cefalonium application use
Intramammary Medicine as dihydrate?) (Article 13(3) of
Suspension for defined in Directive No
dry cows relevant national 2001/82/EC)
legislation

Sedalin Oral Gel Vetoquinol VPA10983/057/ 3.5 percent Oral gel - QN05AA04 POM: - Acepromazine Full application - Oral use
3.5 %w/v Ireland Limited 001 weight/volume Prescription Only (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 162 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Sedanol 40 Richter Pharma VPA10801/015/ 40 Solution for - QN05AD90 POM: - Azaperone Generic - Intramuscular
mg/ml solution AG 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of
pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Sedastart 1 Le Vet BV VPA10816/008/ 1 Solution for - QN05CM91 VPO: Veterinary - Medetomidine Generic - Intramuscular
mg/ml solution 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection for itre as defined in (Article 13(1) of - Intravenous
cats and dogs relevant national Directive No use
legislation 2001/82/EC)

Sedastop 5 Le Vet BV VPA10816/009/ 5 Solution for - QV03AB90 POM: - Atipamezole Generic - Intramuscular
mg/ml solution 001 milligram(s)/millil injection Prescription Only hydrochloride application use
for injection for itre Medicine as (Article 13(1) of
cats and dogs defined in Directive No
relevant national 2001/82/EC)
legislation

SEDATOR, 1.0 Eurovet Animal VPA10989/057/ 1.0 Solution for - QN05CM91 VPO: Veterinary - Medetomidine Generic - Intramuscular
mg/ml, solution Health B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection for itre as defined in (Article 13(1) of - Intravenous
cats and dogs relevant national Directive No use
legislation 2001/82/EC) - Subcutaneous
use

Sedaxylan, 20 Eurovet Animal VPA10989/050/ 20 Solution for - QN05CM92 VPO: Veterinary - Xylazine base Generic - Intramuscular
mg/ml solution Health B.V. 001 milligram(s)/millil injection Practitioner Only application use
for injection for itre as defined in (Article 13(1) of - Intravenous
dogs, cats, relevant national Directive No use
horses and cattl legislation 2001/82/EC) - Subcutaneous
use

Sedecalm 1 Industrial VPA10509/007/ 1 Solution for - QN05CM91 VPO: Veterinary - Medetomidine Generic - Intramuscular
mg/ml solution Veterinaria, S.A. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection for itre as defined in (Article 13(1) of - Intravenous
dogs and cats relevant national Directive No use
legislation 2001/82/EC) - Subcutaneous
use

Sedivet 10 Boehringer VPA10454/013/ 10 Solution for - QN05CM93 VPO: Veterinary - Romifidine Full application - Intravenous
mg/ml Solution Ingelheim 001 milligram(s)/millil injection Practitioner Only (Article 12(3) of use
for Injection for Vetmedica itre as defined in Directive No
horses GmbH relevant national 2001/82/EC)
legislation

Selames 120 mg Krka, d.d., Novo VPA10774/056/ 120 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use
spot-on solution mesto 003 Prescription Only application
for dogs 10.1– Medicine as (Article 13(1) of
20.0 kg defined in Directive No
relevant national 2001/82/EC)
legislation

Selames 15 mg Krka, d.d., Novo VPA10774/055/ 15 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use
spot-on solution mesto 001 Prescription Only application
for cats and dogs Medicine as (Article 13(1) of
= 2.5 kg defined in Directive No
relevant national 2001/82/EC)
legislation

Selames 240 mg Krka, d.d., Novo VPA10774/056/ 240 mg/pipette Spot-on solution - QP54AA05 Not applicable - Selamectin Generic - Spot-on use
spot-on solution mesto 004 application
for dogs 20.1– (Article 13(1) of
40.0 kg Directive No
2001/82/EC)
Selames 30 mg Krka, d.d., Novo VPA10774/056/ 30 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use
spot-on solution mesto 001 Prescription Only application
for dogs 2.6–5.0 Medicine as (Article 13(1) of
kg defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 163 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Selames 360 mg Krka, d.d., Novo VPA10774/056/ 360 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use
spot-on solution mesto 005 Prescription Only application
for dogs 40.1– Medicine as (Article 13(1) of
60.0 kg defined in Directive No
relevant national 2001/82/EC)
legislation

Selames 45 mg Krka, d.d., Novo VPA10774/055/ 45 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use
spot-on solution mesto 002 Prescription Only application
for cats 2.6–7.5 Medicine as (Article 13(1) of
kg defined in Directive No
relevant national 2001/82/EC)
legislation

Selames 60 mg Krka, d.d., Novo VPA10774/055/ 60 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use
spot-on solution mesto 003 Prescription Only application
for cats 7.6–10.0 Medicine as (Article 13(1) of
kg defined in Directive No
relevant national 2001/82/EC)
legislation

Selames 60 mg Krka, d.d., Novo VPA10774/056/ 60 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Generic - Spot-on use
spot-on solution mesto 002 Prescription Only application
for dogs 5.1– Medicine as (Article 13(1) of
10.0 kg defined in Directive No
relevant national 2001/82/EC)
legislation

SELAPRO 120 Norbrook VPA22664/144/ 120 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
mg spot-on Laboratories 006 Prescription Only application
solution for (Ireland) Limited Medicine as (Article 13(3) of
medium dogs defined in Directive No
(10.1–20.0 kg) relevant national 2001/82/EC)
legislation

SELAPRO 15 Norbrook VPA22664/144/ 15 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
mg spot-on Laboratories 001 Prescription Only application
solution for dogs (Ireland) Limited Medicine as (Article 13(3) of
and cats (< 2.5 defined in Directive No
kg) relevant national 2001/82/EC)
legislation

SELAPRO 240 Norbrook VPA22664/144/ 240 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
mg spot-on Laboratories 007 Prescription Only application
solution for large (Ireland) Limited Medicine as (Article 13(3) of
dogs (20.1–40.0 defined in Directive No
kg) relevant national 2001/82/EC)
legislation

SELAPRO 30 Norbrook VPA22664/144/ 30 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
mg spot-on Laboratories 004 Prescription Only application
solution for very (Ireland) Limited Medicine as (Article 13(3) of
small dogs (2.6– defined in Directive No
5.0 kg) relevant national 2001/82/EC)
legislation

SELAPRO 360 Norbrook VPA22664/144/ 360 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
mg spot-on Laboratories 008 Prescription Only application
solution for very (Ireland) Limited Medicine as (Article 13(3) of
large dogs defined in Directive No
(40.1–60.0 kg) relevant national 2001/82/EC)
legislation

SELAPRO 45 Norbrook VPA22664/144/ 45 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
mg spot-on Laboratories 002 Prescription Only application
solution for cats (Ireland) Limited Medicine as (Article 13(3) of
(2.6–7.5 kg) defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 164 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
SELAPRO 60 Norbrook VPA22664/144/ 60 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
mg spot-on Laboratories 003 Prescription Only application
solution for large (Ireland) Limited Medicine as (Article 13(3) of
cats (7.6–10.0 defined in Directive No
kg) relevant national 2001/82/EC)
legislation

SELAPRO 60 Norbrook VPA22664/144/ 60 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
mg spot-on Laboratories 005 Prescription Only application
solution for small (Ireland) Limited Medicine as (Article 13(3) of
dogs (5.1–10.0 defined in Directive No
kg) relevant national 2001/82/EC)
legislation

SELECTAN 300 Laboratorios VPA10846/008/ 300 Solution for - QJ01BA90 POM: - Florfenicol Generic - Intramuscular
mg/ml solution Hipra S.A. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of
cattle and swine defined in Directive No
relevant national 2001/82/EC)
legislation

SELECTAN Laboratorios VPA10846/012/ 23 Concentrate for - QJ01BA90 POM: - Florfenicol Generic - Oral use
ORAL 23 mg/ml Hipra S.A. 001 milligram(s)/millil use in drinking Prescription Only application
solution for use itre water Medicine as (Article 13(1) of
in drinking water defined in Directive No
for pigs relevant national 2001/82/EC)
legislation

Selehold 120 mg Krka, d.d., Novo VPA10774/054/ 120 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
spot-on solution mesto 003 Prescription Only application
for dogs 10.1– Medicine as (Article 13(3) of
20.0 kg defined in Directive No
relevant national 2001/82/EC)
legislation

Selehold 15 mg Krka, d.d., Novo VPA10774/053/ 15 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
spot-on solution mesto 001 Prescription Only application
for cats and dogs Medicine as (Article 13(3) of
= 2.5 kg defined in Directive No
relevant national 2001/82/EC)
legislation

Selehold 240 mg Krka, d.d., Novo VPA10774/054/ 240 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
spot-on solution mesto 004 Prescription Only application
for dogs 20.1– Medicine as (Article 13(3) of
40.0 kg defined in Directive No
relevant national 2001/82/EC)
legislation

Selehold 30 mg Krka, d.d., Novo VPA10774/054/ 30 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
spot-on solution mesto 001 Prescription Only application
for dogs 2.6–5.0 Medicine as (Article 13(3) of
kg defined in Directive No
relevant national 2001/82/EC)
legislation

Selehold 360 mg Krka, d.d., Novo VPA10774/054/ 360 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
spot-on solution mesto 005 Prescription Only application
for dogs 40.1– Medicine as (Article 13(3) of
60.0 kg defined in Directive No
relevant national 2001/82/EC)
legislation

Selehold 45 mg Krka, d.d., Novo VPA10774/053/ 45 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
spot-on solution mesto 002 Prescription Only application
for cats 2.6–7.5 Medicine as (Article 13(3) of
kg defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 165 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Selehold 60 mg Krka, d.d., Novo VPA10774/053/ 60 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
spot-on solution mesto 003 Prescription Only application
for cats 7.6–10.0 Medicine as (Article 13(3) of
kg defined in Directive No
relevant national 2001/82/EC)
legislation

Selehold 60 mg Krka, d.d., Novo VPA10774/054/ 60 mg/pipette Spot-on solution - QP54AA05 POM: - Selamectin Hybrid - Spot-on use
spot-on solution mesto 002 Prescription Only application
for dogs 5.1– Medicine as (Article 13(3) of
10.0 kg defined in Directive No
relevant national 2001/82/EC)
legislation

Selgian 20 kg, Ceva Santé VPA10815/062/ 8.37 mg/tablet Film-coated - QN06A POM: - Selegiline - Oral use
Film coated Animale 002 tablet Prescription Only hydrochloride
tablets Medicine as
defined in
relevant national
legislation

Selgian 40 kg, Ceva Santé VPA10815/062/ 16.74 mg/tablet Film-coated - QN06A POM: - Selegiline - Oral use
Film coated Animale 003 tablet Prescription Only hydrochloride
tablets Medicine as
defined in
relevant national
legislation

Selgian 8 kg, Ceva Santé VPA10815/062/ 3.35 mg/tablet Film-coated - QN06A POM: - Selegiline - Oral use
Film coated Animale 001 tablet Prescription Only hydrochloride
tablets Medicine as
defined in
relevant national
legislation

SEMELCEF FATRO S.p.A. VPA10836/006/ 1000 mg/tablet Tablet - QJ01DB05 POM: - Cefadroxil Generic - Oral use
1000 mg tablets 002 Prescription Only application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

SEMELCEF 200 FATRO S.p.A. VPA10836/006/ 200 mg/tablet Tablet - QJ01DB05 POM: - Cefadroxil Generic - Oral use
mg tablets for 001 Prescription Only application
dogs and cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Sensiblex 40 Veyx-Pharma VPA10539/005/ 40.0 Solution for - QG02CX90 POM: - Denaverine Generic - Intramuscular
mg/ml solution GmbH 001 milligram(s)/millil injection Prescription Only hydrochloride application use
for injection for itre Medicine as (Article 13(1) of
cattle defined in Directive No
relevant national 2001/82/EC)
legislation

Septotryl II Vetoquinol VPA10983/026/ 40, 200 Solution for - QJ01EW10 POM: - Trimethoprim Informed - Intramuscular
Solution for Ireland Limited 001 milligram(s)/millil injection Prescription Only - Sulfadiazine consent use
Injection itre Medicine as application - Intravenous
defined in (Article 13c of use
relevant national Directive No - Subcutaneous
legislation 2001/82/EC) use

Seresto 1.25 g + Elanco GmbH VPA22020/051/ 1.25 + 0.56 Collar - QP53AC55 POM: - Imidacloprid Fixed - Cutaneous use
0.56 g, collar for 001 gram(s)/collar Prescription Only - Flumethrin combination
cats Medicine as application
defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 166 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Seresto 1.25 g + Elanco GmbH VPA22020/051/ 1.25 + 0.56 Collar - QP53AC55 POM: - Imidacloprid Fixed - Cutaneous use
0.56 g, collar for 002 gram(s)/collar Prescription Only - Flumethrin combination
dogs <= 8 kg Medicine as application
defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Seresto 4.50 g + Elanco GmbH VPA22020/051/ 4.50 + 2.03 Collar - QP53AC55 POM: - Imidacloprid Fixed - Cutaneous use
2.03 g, collar for 003 gram(s)/collar Prescription Only - Flumethrin combination
dogs > 8 kg Medicine as application
defined in (Article 13b of
relevant national Directive No
legislation 2001/82/EC)

Sergeants Pet The Bob Martin VPA10881/016/ 0.1, 0.2, 0.5 Cutaneous - QP53AC CAM: - Tetramethrin Well-established - Topical use
Patrol Aerosol Company 001 percent spray, solution Companion (90%) use application
weight/weight Animal Medicine - Phenothrin (Article 13a of
as defined in - Piperonyl Directive No
relevant national Butoxide (90%) 2001/82/EC)
legislation

Sincrovet 75 Industria Italiana VPA10380/001/ 75 Solution for - QG02AD90 POM: - (+)-cloprostenol Informed - Intramuscular
micrograms/ml Integratori Trei 001 microgram(s)/mil injection Prescription Only (as (+)- consent use
solution for Spa lilitre Medicine as cloprostenol application
injection for defined in sodium) (Article 13c of
cattle, horses relevant national Directive No
and pigs legislation 2001/82/EC)

SLICE 2 mg/g Intervet Ireland VPA10996/257/ 2 Premix for - QP54AA06 POM: - Emamectin Full application - Oral use
premix for Limited 001 milligram(s)/gra medicated Prescription Only benzoate (Article 12(3) of
medicated m feeding stuff Medicine as Directive No
feeding stuff defined in 2001/82/EC)
relevant national
legislation

Sodium Chloride B. Braun VPA10465/004/ 0.9 grams/100 Solution for - QB05BB01 POM: - Sodium Well-established - Intravenous
0.9 g/100 ml B. Melsungen AG 001 millilitres infusion Prescription Only chloride use application use
Braun Vet Care Medicine as (Article 13a of
solution for defined in Directive No
infusion for relevant national 2001/82/EC)
cattle, horse, legislation
sheep, goat, pig,
dog and cat

Sodium Salicyl Dopharma VPA10791/003/ 800 Powder for oral - QN02BA04 POM: - Sodium Generic - Oral use
800 mg/g, Research B.V. 001 milligram(s)/gra solution Prescription Only salicylate application
powder for oral m Medicine as (Article 13(1) of
solution for cattle defined in Directive No
(calves) and pigs relevant national 2001/82/EC)
legislation

Solacyl 1000 Eurovet Animal VPA10989/054/ 1000 Powder for oral - QN02BA04 POM: - Sodium Generic - Oral use
mg/g, powder for Health B.V. 001 milligram(s)/gra solution Prescription Only salicylate application
oral solution for m Medicine as (Article 13(1) of
cattle and pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Solamocta 697 Eurovet Animal VPA10989/064/ 697 Powder for oral - QJ01CA04 POM: - Amoxicillin Hybrid - Oral use
mg/g powder for Health B.V. 001 milligram(s)/gra solution Prescription Only application
use in drinking m Medicine as (Article 13(3) of
water for defined in Directive No
chickens, ducks relevant national 2001/82/EC)
and turkeys legislation

Solantel 50 Norbrook VPA22664/128/ 50 Oral suspension - QP52AG09 LM: Licensed - Closantel Generic - Oral use
mg/ml Oral Laboratories 001 milligram(s)/millil Merchant as application
Suspension for (Ireland) Limited itre defined in (Article 13(1) of
Sheep relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 167 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Soloxine 0.1 mg Virbac S.A. VPA10988/069/ 0.1 mg/tablet Tablet - QH03AA01 POM: - Levothyroxine - Oral use
Tablet 001 Prescription Only sodium
Medicine as
defined in
relevant national
legislation

Soloxine 0.2 mg Virbac S.A. VPA10988/069/ 0.2 mg/tablet Tablet - QH03AA01 POM: - Levothyroxine - Oral use
Tablet 002 Prescription Only sodium
Medicine as
defined in
relevant national
legislation

Soloxine 0.3 mg Virbac S.A. VPA10988/069/ 0.3 mg/tablet Tablet - QH03AA01 POM: - Levothyroxine - Oral use
Tablet 003 Prescription Only sodium
Medicine as
defined in
relevant national
legislation

Soloxine 0.5 mg Virbac S.A. VPA10988/069/ 0.5 mg/tablet Tablet - QH03AA01 POM: - Levothyroxine - Oral use
Tablet 004 Prescription Only sodium
Medicine as
defined in
relevant national
legislation

Soloxine 0.8 mg Virbac S.A. VPA10988/069/ 0.8 mg/tablet Tablet - QH03AA01 POM: - Levothyroxine - Oral use
Tablet 005 Prescription Only sodium
Medicine as
defined in
relevant national
legislation

Soluchlor 150 Interchem VPA10555/011/ 150 Oral powder - QJ01AA03 POM: - Informed - Oral use
mg/g Oral Ireland Ltd 001 milligram(s)/gra Prescription Only Chlortetracycline consent
Powder for m Medicine as hydrochloride application
Calves defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Soludox 500 Eurovet Animal VPA10989/072/ 500 Powder for use - QJ01AA02 POM: - Doxycycline Hybrid - In drinking
mg/g powder for Health B.V. 001 milligram(s)/gra in drinking water Prescription Only hyclate application water use
use in drinking m Medicine as (Article 13(3) of
water for pigs defined in Directive No
and chickens relevant national 2001/82/EC)
legislation

Solupam 5 Le Vet Beheer VPA10475/142/ 5 Solution for - QN05BA01 VPO: Veterinary - Diazepam Generic - Intravenous
mg/ml solution B.V. 001 milligram(s)/millil injection Practitioner Only application use
for injection for itre as defined in (Article 13(1) of
dogs and cats relevant national Directive No
legislation 2001/82/EC)

Solvasol Norbrook VPA22664/060/ 180 Suspension for - QJ01DB01 POM: - Cefalexin - Intramuscular
Injection Laboratories 001 milligram(s)/millil injection Prescription Only use
(Ireland) Limited itre Medicine as - Subcutaneous
defined in use
relevant national
legislation

SOMNIPRON 10 Vetpharma VPA10516/014/ 10 Solution for - QN05CM90 VPO: Veterinary - Detomidine Generic - Intramuscular
mg/ml Solution Animal Health, 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection for S.L. itre as defined in (Article 13(1) of - Intravenous
horses and cattl relevant national Directive No use
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 168 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Somulose Dechra VPA22622/018/ 400/25 Solution for - QN05CB02 VPO: Veterinary - Secobarbital Well-established - Intravenous
Solution for Regulatory B.V. 001 milligram(s)/millil injection Practitioner Only sodium use application use
Injection itre as defined in - Cinchocaine (Article 13a of
relevant national Hydrochloride Directive No
legislation 2001/82/EC)

Spasmalgan Veyx-Pharma VPA10539/007/ 500.0,4.0 Solution for - QA03DB04 POM: - Metamizole Generic - Intramuscular
compositum 500 GmbH 001 milligram(s)/millil injection Prescription Only sodium application use
mg/ml + 4 mg/ml itre Medicine as monohydrate (Article 13(1) of - Intravenous
Solution for defined in - Hyoscine Directive No use
injection for relevant national butylbromide 2001/82/EC)
horses, cattle, legislation
pigs and dogs
Spasmipur 20 Richter Pharma VPA10801/013/ 20 Solution for - QA03BB01 POM: - Hyoscine Generic - Intramuscular
mg/ml solution AG 001 milligram(s)/millil injection Prescription Only butylbromide application use
for injection itre Medicine as (Article 13(1) of - Intravenous
defined in Directive No use
relevant national 2001/82/EC)
legislation

Spasmium Richter Pharma VPA10801/008/ 500.0/4.0 Solution for - QA03DB04 POM: - Metamizole Generic - Intramuscular
comp. 500 mg/ml AG 001 milligram(s)/millil injection Prescription Only sodium application use
+ 4 mg/ml itre Medicine as monohydrate (Article 13(1) of - Intravenous
solution for defined in - Hyoscine Directive No use
injection relevant national butylbromide 2001/82/EC)
legislation

Spectam Ceva Santé VPA10815/060/ 10 percent Solution for - QJ01XX04 POM: - Spectinomycin Full application - Intramuscular
Injectable 10 % Animale 001 weight/volume injection Prescription Only dihydrochloride (Article 12(3) of use
w/v Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Spectam Scour Ceva Santé VPA10815/059/ 50 Oral solution - QJ01XX04 POM: - Spectinomycin Full application - Oral use
Halt Oral Animale 001 milligram(s)/millil Prescription Only (Article 12(3) of
Solution 50 itre Medicine as Directive No
mg/ml defined in 2001/82/EC)
relevant national
legislation

SPECTRON 100 Laboratorios VPA10846/011/ 100 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml solution Hipra S.A. 001 milligram(s)/millil Prescription Only application
for use in itre Medicine as (Article 13(1) of
drinking water for defined in Directive No
chickens and relevant national 2001/82/EC)
turkeys legislation

Spirovac Zoetis Belgium VPA10387/065/ . Suspension for - QI02AB03 LM: Licensed - Inactivated Full application - Subcutaneous
S.A. 001 injection Merchant as leptospira (Article 12(3) of use
defined in borgpetersenii Directive No
relevant national serovar hardjo 2001/82/EC)
legislation type hardjobovis

Spizobactin Le Vet Beheer VPA10475/032/ 1,500,000, 250 Chewable tablet - QJ51RF01 POM: - Spiramycin Generic - Oral use
1,500,000 IU / B.V. 002 international Prescription Only - Metronidazole application
250 mg unit(s)/milligram Medicine as (Article 13(1) of
chewable tablets defined in Directive No
for dogs relevant national 2001/82/EC)
legislation

Spizobactin Le Vet Beheer VPA10475/032/ 3,000,000, 500 Chewable tablet - QJ51RF01 POM: - Spiramycin Generic - Oral use
3,000,000 IU / B.V. 003 international Prescription Only - Metronidazole application
500 mg unit(s)/milligram Medicine as (Article 13(1) of
chewable tablets defined in Directive No
for dogs relevant national 2001/82/EC)
legislation

Spizobactin Le Vet Beheer VPA10475/032/ 750,000, 125 Chewable tablet - QJ51RF01 POM: - Spiramycin Generic - Oral use
750,000 IU / 125 B.V. 001 international Prescription Only - Metronidazole application
mg chewable unit(s)/milligram Medicine as (Article 13(1) of
tablets for dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 169 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Sporimune 50 Le Vet Beheer VPA10475/004/ 50 Oral solution - QL04AA01 POM: - Ciclosporin Generic - Oral use
mg/ml oral B.V. 001 milligram(s)/millil Prescription Only application
solution for cats itre Medicine as (Article 13(1) of
and dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Spotinor 10 Norbrook VPA22664/118/ 10 Spot-on solution - QP53AC11 LM: Licensed - Deltamethrin Generic - Topical use
mg/ml Spot-on Laboratories 001 milligram(s)/millil Merchant as application
Solution for (Ireland) Limited itre defined in (Article 13(1) of
cattle and sheep relevant national Directive No
legislation 2001/82/EC)

Sputolosin Oral Boehringer VPA10454/014/ 5 Oral powder - QR05CB90 POM: - Dembrexine Full application - Oral use
Powder 5 mg/g Ingelheim 001 milligram(s)/gra Prescription Only hydrochloride (Article 12(3) of
Vetmedica m Medicine as monohydrate Directive No
GmbH defined in 2001/82/EC)
relevant national
legislation

STABOX 50 % Virbac S.A. VPA10988/052/ 50 percent Powder for oral - QJ01CA04 POM: - Amoxicillin Full application - Oral use
w/w Powder for 002 weight/weight solution Prescription Only (Article 12(3) of
Oral Solution for Medicine as Directive No
Pigs defined in 2001/82/EC)
relevant national
legislation

Stabox 5g Virbac S.A. VPA10988/052/ 5 gram/100gram Premix for - QJ01CA04 POM: - Amoxicillin - Oral use
Premix for 001 medicated Prescription Only
medicated feeding stuff Medicine as
feeding stuff defined in
relevant national
legislation

Startect Dual Zoetis Belgium VPA10387/066/ 10,1 Oral solution - QP54AA52 POM: - Derquantel Full application - Oral use
Active Startect S.A. 001 milligram(s)/millil Prescription Only - Abamectin (Article 12(3) of
for Sheep itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

STELLAMUNE Elanco GmbH VPA22020/040/ . Emulsion for - QI09AB13 POM: - Inactivated Full application - Intramuscular
MYCOPLASMA 001 injection Prescription Only mycoplasma (Article 12(3) of use
Medicine as hyopneumoniae Directive No
defined in (strain p-5722-3) 2001/82/EC)
relevant national
legislation

STENOROL Huvepharma NV VPA10782/036/ 0.5 Oral solution - QP51AX08 POM: - Halofuginone Generic - Per Oral
CRYPTO 0.5 001 milligram(s)/millil Prescription Only Base (As lactate application
mg/ml oral itre Medicine as salt) (Article 13(1) of
solution for defined in Directive No
calves relevant national 2001/82/EC)
legislation

Stimovar Laboratories VPA10396/002/ 7500 Powder and - QG03GA03 POM: - Equine serum 12(3) full dossier - Intra-Muscular
Injection Ovejero S.A. 001 international solvent for Prescription Only gonadotrophin - Subcutaneous
unit(s) solution for Medicine as for veterinary
infusion defined in use
relevant national
legislation

Strantel 230/20 Chanelle VPA10987/108/ 230, 20 Film-coated - QP52AA51 CAM: - Pyrantel Hybrid - Oral use
mg Flavoured Pharmaceuticals 001 mg/tablet tablet Companion embonate application
Film-Coated Manufacturing Animal Medicine - Praziquantel (Article 13(3) of
Tablets for Cats Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 170 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Strantel Plus Chanelle VPA10987/082/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use
Tablets for dogs Pharmaceuticals 001 mg/tablet Companion - Pyrantel application
Manufacturing Animal Medicine - Febantel (Article 13(3) of
Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Strantel Plus XL Chanelle VPA10987/082/ 175,504,525 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet Companion - Pyrantel application
Manufacturing Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Stresnil 40 Elanco GmbH VPA22020/007/ 40 Solution for - QN05AD90 POM: - Azaperone Full application - Intramuscular
mg/ml Solution 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
for Injection for itre Medicine as Directive No
Pigs defined in 2001/82/EC)
relevant national
legislation

Suifertil 4 mg/ml aniMedica VPA10826/021/ 4.0 Oral solution - QG03DX90 POM: - Altrenogest Generic - Oral use
oral solution for GmbH 001 milligram(s)/millil Prescription Only application
pigs itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Suiseng Coli /C Laboratorios VPA10846/019/ . Suspension for - QI09AB08 LM: Licensed - F4ab fimbrial Full application - Intramuscular
Suspension for Hipra S.A. 001 injection Merchant as adhesin of e.coli (Article 12(3) of use
injection for pigs defined in - F4ac fimbrial Directive No
relevant national adhesin of e.coli 2001/82/EC)
legislation - F5 fimbrial
adhesin of e.coli
- F6 fimbrial
adhesin of e. coli
- Lt enterotoxoid
of e. coli
- Clostridium
perfringens, type
C toxoid
- Clostridium
novyi, type B
toxoid

Suiseng Laboratorios VPA10846/010/ . Suspension for - QI09AB08 LM: Licensed - F4ab fimbrial Full application - Intramuscular
Suspension for Hipra S.A. 001 injection Merchant as adhesin of e.coli (Article 12(3) of use
injection for pigs defined in - F4ac fimbrial Directive No
relevant national adhesin of e.coli 2001/82/EC)
legislation - F5 fimbrial
adhesin of e.coli
- F6 fimbrial
adhesin of e. coli
- Lt enterotoxoid
of e. coli
- Clostridium
perfringens, type
C toxoid
- Clostridium
novyi, type B
toxoid

Veterinary Medicines Authorised/Transfer Pending Products Page 171 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Suivac APP ChemVet dk A/S VPA10395/001/ 1.0 - 10.0 unit(s) Emulsion for - QI09AB07 POM (E): - Actinobacillus Full application - Intramuscular
emulsion for 001 injection Prescription Only pleuropneumoni (Article 12(3) of use
injection for pigs Exempt as ae serotype 2, Directive No
defined in strain app 2001/82/EC)
relevant national 2TR98,
legislation inactivated
- APX I toxoid
- APX II toxoid
- APX III toxoid
- Actinobacillus
pleuropneumoni
ae serotype 9,
strain app
9KL97,
inactivated
Sulfaprex Premix LABORATORIO VPA10665/005/ 250/50 Premix for - QJ01EW10 POM: - Sulfadiazine Hybrid - Oral use
for medicated S CALIER S.A. 001 milligram(s)/gra medicated Prescription Only - Trimethoprim application
feeding stuff for m feeding stuff Medicine as (Article 13(3) of
pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Sulfoprim 15% Univet Limited VPA10990/033/ 125/25 Premix for - QJ01EW10 POM: - Trimethoprim Generic - Oral use
Premix for 001 gram(s)/kilogra medicated Prescription Only - Sulfadiazine application
Medicated Feed m(s) feeding stuff Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Sulfoprim 21% Univet Limited VPA10990/025/ 178.4/35.6 Premix for - QJ01EW10 POM: - Trimethoprim Generic - Oral use
Premix for 001 gram(s)/kilogra medicated Prescription Only - Sulfadiazine application
Medicated Feed m(s) feeding stuff Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Sulpha No.2 Chanelle VPA10987/018/ 99.01 percent Powder for oral - QJ01EQ POM: - Sulfadimidine - Oral use
Powder for Oral Pharmaceuticals 001 weight/weight solution Prescription Only
Solution Manufacturing Medicine as
Limited defined in
relevant national
legislation

Sulphadimidine Eurovet Animal VPA10989/012/ 1000 Powder for oral - QJ01EQ03 POM: - Sulphadimidine - Oral use
Sodium Powder Health B.V. 001 milligram(s)/gra solution - QP51AG01 Prescription Only sodium bp
for Oral Solution m Medicine as
defined in
relevant national
legislation

Sulphadimidine Eurovet Animal VPA10989/012/ 1000 Powder for oral - QJ01EQ03 POM: - Sulphadimidine - Oral use
Sodium Powder Health B.V. 001 milligram(s)/gra solution - QP51AG01 Prescription Only sodium bp
for Oral Solution m Medicine as
defined in
relevant national
legislation

Sulphamet Interchem VPA10555/005/ 40, 200 Solution for - QJ01E POM: - Trimethoprim Informed - Intramuscular
40/200 Solution Ireland Ltd 001 milligram(s)/millil injection Prescription Only - Sulfadiazine consent use
for Injection itre Medicine as application
defined in (Article 13c of
relevant national Directive No
legislation 2001/82/EC)

Sumex 1 %w/v Chanelle VPA10987/150/ 1.0 percent Solution for - QP54AA01 LM: Licensed - Ivermectin - Subcutaneous
solution for Pharmaceuticals 001 weight/volume injection Merchant as use
injection for Manufacturing defined in
cattle Limited relevant national
legislation

Sumex 1% w/v Chanelle VPA10987/151/ 1 percent Solution for - QP54AA01 LM: Licensed - Ivermectin - Subcutaneous
solution for Pharmaceuticals 001 weight/volume injection Merchant as use
injection for pigs Manufacturing defined in
Limited relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 172 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Sumex 5 mg/ml Chanelle VPA10987/160/ 5 Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Generic - Topical use
Pour on Solution Pharmaceuticals 001 milligram(s)/millil Merchant as application
for Cattle Manufacturing itre defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Summer Dip Hygeia VPA10203/002/ 10 percent Concentrate for - QP53AF03 LM: Licensed - Diazinon Well-established - Dipping
Concentrate for Chemicals Ltd 001 weight/volume dip emulsion Merchant as use application
dip emulsion defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

Supaverm Oral Elanco GmbH VPA22020/031/ 50, 75 Oral suspension - QP52AC09 LM: Licensed - Closantel Fixed - Oral use
Suspension 001 milligram(s)/millil - QP52AG09 Merchant as - Mebendazole combination
itre defined in application
relevant national (Article 13b of
legislation Directive No
2001/82/EC)
Supaverm Oral Elanco GmbH VPA22020/031/ 50, 75 Oral suspension - QP52AC09 LM: Licensed - Closantel Fixed - Oral use
Suspension 001 milligram(s)/millil - QP52AG09 Merchant as - Mebendazole combination
itre defined in application
relevant national (Article 13b of
legislation Directive No
2001/82/EC)
Sureseal 2.6 g Norbrook VPA22664/116/ 2.6 g/syringe Intramammary - QG52X LM: Licensed - Bismuth Hybrid - Intramammary
Intramammary Laboratories 001 suspension Merchant as subnitrate, heavy application use
Suspension for (Ireland) Limited defined in (Article 13(3) of
Cattle relevant national Directive No
legislation 2001/82/EC)

Surolan Ear Elanco GmbH VPA22020/032/ 23, 5, 0.529 Cutaneous - QD01AC52 POM: - Miconazole - Auricular use
Drops and 001 milligram(s)/millil suspension Prescription Only nitrate - Topical use
Cutaneous itre Medicine as - Prednisolone
Suspension defined in acetate
relevant national - Polymyxin B
legislation sulfate

Suvaxyn M Hyo Zoetis Belgium VPA10387/067/ . Suspension for - QI09AB13 LM: Licensed - Inactivated Full application - Intramuscular
Suspension for S.A. 001 injection Merchant as mycoplasma (Article 12(3) of use
injection for pigs defined in hyopneumoniae Directive No
relevant national 2001/82/EC)
legislation

Suvaxyn M.hyo - Zoetis Belgium VPA10387/068/ . Suspension for - QI09AB17 LM: Licensed - Inactivated Full application - Intramuscular
Parasuis, S.A. 001 injection Merchant as mycoplasma (Article 12(3) of use
suspension for defined in hyopneumoniae Directive No
injection for pigs relevant national (strain p-5722-3) 2001/82/EC)
legislation - Inactivated
haemophilus
parasuis serovar
4, strain 2170b
- Inactivated
haemophilus
parasuis serovar
5, strain ia84-
29755

Suvaxyn MH- Zoetis Belgium VPA10387/069/ . Relative Emulsion for - QI09AB13 LM: Licensed - Mycoplasma Full application - Intramuscular
One Emulsion S.A. 001 potency injection Merchant as hyopneumoniae, (Article 12(3) of use
for injection for defined in inactivated, Directive No
pigs relevant national strain p-5722-3 2001/82/EC)
legislation

Sympagesic 500 Dechra VPA22622/033/ 500, 4 Solution for - QA03DB04 POM: - Metamizole Generic - Intramuscular
mg/ml + 4 mg/ml Regulatory B.V. 001 milligram(s)/millil injection Prescription Only sodium application use
solution for itre Medicine as monohydrate (Article 13(1) of - Intravenous
injection for defined in - Hyoscine Directive No use
horses, cattle, relevant national butylbromide 2001/82/EC)
pigs and dogs legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 173 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Syncrostim 500 Ceva Santé VPA10815/015/ 500 international Lyophilisate and - QG03GA01 POM: - Gonadotrophin Generic - Intramuscular
IU lyophilisate Animale 001 unit(s) solvent for Prescription Only equine serum application use
and solvent for solution for Medicine as (ecg) (Article 13(1) of
solution for injection defined in Directive No
injection for relevant national 2001/82/EC)
cattle and sheep legislation

Synthadon 10 Le Vet Beheer VPA10475/011/ 10 Solution for - QN02AC52 VPO: Veterinary - Methadone Generic - Intramuscular
mg/ml solution B.V. 002 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection for itre as defined in (Article 13(1) of - Intravenous
cats and dogs relevant national Directive No use
legislation 2001/82/EC) - Subcutaneous
use

Synulox Bolus Zoetis Belgium VPA10387/072/ 400 milligram(s) Coated tablet - QJ01CR02 POM: - Amoxicillin Full application - Oral use
500 mg S.A. 001 Prescription Only - Clavulanic acid (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Synulox Zoetis Belgium VPA10387/073/ 200, 50, 10 Intramammary - QJ51RV01 POM: - Prednisolone Full application - Intramammary
Lactating Cow S.A. 001 mg/syringe suspension Prescription Only - Clavulanic acid (Article 12(3) of use
Intramammary Medicine as - Amoxicillin Directive No
suspension. defined in 2001/82/EC)
relevant national
legislation

Synulox Zoetis Belgium VPA10387/074/ 200/50 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin Known active - Oral use
Palatable S.A. 002 Prescription Only - Clavulanic acid substance
Tablets 250 mg Medicine as (Article 12(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Synulox Zoetis Belgium VPA10387/074/ 40/10 mg/tablet Tablet - QJ01CR02 POM: - Amoxicillin Known active - Oral use
Palatable S.A. 001 Prescription Only - Clavulanic acid substance
Tablets 50 mg Medicine as (Article 12(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Synulox Ready Zoetis Belgium VPA10387/075/ 140, 35 Suspension for - QJ01CR02 POM: - Amoxicillin Known active - Intramuscular
to Use Injection S.A. 001 milligram(s)/millil injection Prescription Only - Clavulanic acid substance use
itre Medicine as (Article 12(3) of - Subcutaneous
defined in Directive No use
relevant national 2001/82/EC)
legislation

Synulox Ready Zoetis Belgium VPA10387/075/ 140, 35 Suspension for - QJ01CR02 POM: - Amoxicillin Known active - Intramuscular
To Use Injection S.A. 002 milligram(s)/millil injection Prescription Only - Clavulanic acid substance use
itre Medicine as (Article 12(3) of - Subcutaneous
defined in Directive No use
relevant national 2001/82/EC)
legislation

SynVet-50; 50 Equimed VPA22694/001/ 50 mg/syringe Solution for - QM09AX01 VPO: Veterinary - Sodium Well-established - Intraarticular
mg solution for Pharma Ltd 001 injection Practitioner Only hyaluronate use application use
injection for as defined in (Article 13a of
horses relevant national Directive No
legislation 2001/82/EC)

TAF SPRAY Eurovet Animal VPA10989/063/ 28.5 Cutaneous - QD06AX POM: - Thiamphenicol Generic - Topical use
28.5 mg/g Health B.V. 001 milligram(s)/gra spray, solution Prescription Only application
Cutaneous m Medicine as (Article 13(1) of
Spray, Solution defined in Directive No
relevant national 2001/82/EC)
legislation

Taktic 12.5 %w/v Intervet Ireland VPA10996/125/ 12.5 percent Concentrate for - QP53AD01 LM: Licensed - Amitraz Full application - Topical use
Concentrate for Limited 001 weight/volume dip emulsion Merchant as (Article 12(3) of
dip emulsion defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 174 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Taneven LC 3 g WDT - VPA10660/004/ 3 gram(s) Intramammary - QJ51CE09 POM: - Benzylpenicillin Generic - Intramammary
intramammary Wirtschaftsgeno 001 suspension Prescription Only Procaine application use
suspension for ssenschaft Medicine as Monohydrate (Article 13(1) of
cattle deutscher defined in Directive No
Tierarzte eG relevant national 2001/82/EC)
legislation

Taurador 5 Norbrook VPA22664/111/ 5 Pour-on solution - QP54AA03 LM: Licensed - Doramectin Generic - Topical use
mg/ml Pour-on Laboratories 001 milligram(s)/millil Merchant as application
Solution for (Ireland) Limited itre defined in (Article 13(1) of
Cattle relevant national Directive No
legislation 2001/82/EC)

Tauramox 5 Norbrook VPA22664/130/ 5 Pour-on solution - QP54AB02 LM: Licensed - Moxidectin Generic - Topical use
mg/ml Pour-On Laboratories 001 milligram(s)/millil Merchant as application
Solution for (Ireland) Limited itre defined in (Article 13(1) of
Cattle relevant national Directive No
legislation 2001/82/EC)

Temprace 0.5 Le Vet Beheer VPA10475/033/ 0.5 Solution for - QN05AA04 VPO: Veterinary - Acepromazine Hybrid - Intravenous
mg/ml solution B.V. 001 milligram(s)/millil injection Practitioner Only application use
for injection for itre as defined in (Article 13(3) of
dogs and cats relevant national Directive No
legislation 2001/82/EC)

Terramycin Zoetis Belgium VPA10387/076/ 4 gram(s)/150 Cutaneous - QD06AA03 POM: - Oxytetracycline Full application - Topical use
Aerosol Spray S.A. 001 millilitre spray, Prescription Only hydrochloride (Article 12(3) of
suspension Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Terramycin LA Zoetis Belgium VPA10387/077/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Full application - Intramuscular
200 mg/ml S.A. 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
Solution for itre Medicine as Directive No - Intravenous
Injection defined in 2001/82/EC) use
relevant national - Subcutaneous
legislation use

Terrexine DC Univet Limited VPA10990/052/ 250 mg/syringe Intramammary - QJ51DB90 POM: - Cefalonium Hybrid - Intramammary
250 mg 001 suspension Prescription Only application use
Intramammary Medicine as (Article 13(3) of
Suspension for defined in Directive No
Dry Cows relevant national 2001/82/EC)
legislation

Terrexine LC Univet Limited VPA10990/023/ . Intramammary - QJ51 POM: - Cefalexin Full application - Intramammary
Intramammary 001 suspension Prescription Only - Kanamycin (Article 12(3) of use
Suspension for Medicine as monosulphate Directive No
lactating cows defined in 2001/82/EC)
relevant national
legislation

Tetanus Intervet Ireland VPA10996/150/ . Solution for - QI04AM02 POM: - Equine serum Full application - Intramuscular
Antitoxin Behring Limited 001 injection - QI05AM01 Prescription Only protein (Article 12(3) of use
- QI07AM Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national - Subcutaneous
legislation use
- ZZZ Intra-spinal

Tetanus Intervet Ireland VPA10996/150/ . Solution for - QI04AM02 POM: - Equine serum Full application - Intramuscular
Antitoxin Behring Limited 001 injection - QI05AM01 Prescription Only protein (Article 12(3) of use
- QI07AM Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national - Subcutaneous
legislation use
- ZZZ Intra-spinal

Veterinary Medicines Authorised/Transfer Pending Products Page 175 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Tetanus Intervet Ireland VPA10996/150/ . Solution for - QI04AM02 POM: - Equine serum Full application - Intramuscular
Antitoxin Behring Limited 001 injection - QI05AM01 Prescription Only protein (Article 12(3) of use
- QI07AM Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national - Subcutaneous
legislation use
- ZZZ Intra-spinal

Tetracure 200 Bimeda Animal VPA22033/068/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Generic - Intramuscular
mg/ml solution Health Limited 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of
cattle, sheep and defined in Directive No
pigs relevant national 2001/82/EC)
legislation

Tetra-Delta Zoetis Belgium VPA10387/078/ 105, 100, 100, Intramammary - QJ51RV01 POM: - Neomycin Full application - Intramammary
Milking Cow S.A. 001 100, 10 suspension Prescription Only sulphate (Article 12(3) of use
milligram/ 10 Medicine as - Procaine Directive No
millilitre defined in benzylpenicillin 2001/82/EC)
relevant national - Novobiocin
legislation sodium
-
Dihydrostreptom
ycin sulphate
- Prednisolone
Tetroxy 10 % Bimeda Animal VPA22033/032/ 10 percent Solution for - QJ01AA06 POM: - Oxytetracycline Informed - Intramuscular
Solution for Health Limited 001 weight/volume injection Prescription Only Hydrochloride consent use
Injection for Medicine as application
cattle, sheep and defined in (Article 13c of
pigs relevant national Directive No
legislation 2001/82/EC)

Tetroxy LA 200 Bimeda Animal VPA22033/044/ 200 Solution for - QJ01AA06 POM: - Oxytetracycline Well-established - Intramuscular
mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only use application use
for Injection itre Medicine as (Article 13a of
defined in Directive No
relevant national 2001/82/EC)
legislation

Therios 300 mg Ceva Santé VPA10815/033/ 300 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use
palatable tablets Animale 002 Prescription Only application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Therios 75 mg Ceva Santé VPA10815/033/ 75 mg/tablet Chewable tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use
Chewable Animale 001 Prescription Only application
Tablets for Cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Therios 750 mg Ceva Santé VPA10815/033/ 750 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Hybrid - Oral use
palatable tablets Animale 003 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Thiafeline 2.5 mg Le Vet Beheer VPA10475/006/ 2.5 mg/tablet Film-coated - QH03BB02 POM: - Thiamazole Generic - Oral use
Film-coated B.V. 001 tablet Prescription Only application
Tablets for Cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Thiafeline 5 mg Le Vet Beheer VPA10475/006/ 5 mg/tablet Film-coated - QH03BB02 POM: - Thiamazole Generic - Oral use
Film-coated B.V. 002 tablet Prescription Only application
Tablets for Cats Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 176 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Thyforon Eurovet Animal VPA10989/060/ 200 µg/tablet Tablet - QH03AA01 POM: - Levothyroxine Generic - Oral use
flavoured 200 Health B.V. 001 Prescription Only sodium application
microgram Medicine as (Article 13(1) of
tablets for dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Thyforon Eurovet Animal VPA10989/060/ 400 µg/tablet Tablet - QH03AA01 POM: - Levothyroxine Generic - Oral use
flavoured 400 Health B.V. 002 Prescription Only sodium application
microgram Medicine as (Article 13(1) of
tablets for dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Thyforon Eurovet Animal VPA10989/060/ 600 µg/tablet Tablet - QH03AA01 POM: - Levothyroxine Hybrid - Oral use
flavoured 600 Health B.V. 003 Prescription Only sodium application
microgram Medicine as (Article 13(3) of
tablets for dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Thyforon Eurovet Animal VPA10989/060/ 800 µg/tablet Tablet - QH03AA01 POM: - Levothyroxine Hybrid - Oral use
flavoured 800 Health B.V. 004 Prescription Only sodium application
microgram Medicine as (Article 13(3) of
tablets for dogs defined in Directive No
relevant national 2001/82/EC)
legislation

Thyronorm 5 Norbrook VPA22664/127/ 5 Oral solution - QH03BB02 POM: - Thiamazole Hybrid - Oral use
mg/ml Oral Laboratories 001 milligram(s)/millil Prescription Only application
Solution for Cats (Ireland) Limited itre Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Thyroxanil 200 Le Vet Beheer VPA10475/023/ 200 Tablet - QH03AA01 POM: - Levothyroxine Generic - Oral use
microgram B.V. 001 microgram(s) Prescription Only sodium application
tablets for dogs Medicine as (Article 13(1) of
and cats defined in Directive No
relevant national 2001/82/EC)
legislation

Thyroxanil 600 Le Vet Beheer VPA10475/023/ 600 Tablet - QH03AA01 POM: - Levothyroxine Generic - Oral use
microgram B.V. 002 microgram(s) Prescription Only sodium application
tablets for dogs Medicine as (Article 13(1) of
and cats defined in Directive No
relevant national 2001/82/EC)
legislation

Tialin 125 mg/ml Dechra VPA22622/019/ 125 Solution for use - QJ01XQ01 POM: - Tiamulin Generic - In drinking
solution for use Regulatory B.V. 001 milligram(s)/millil in drinking water Prescription Only hydrogen application water use
in drinking water itre Medicine as fumarate (Article 13(1) of
for pigs, defined in Directive No
chickens and relevant national 2001/82/EC)
turkeys legislation

Tialin 250 mg/ml Dechra VPA22622/019/ 250 Solution for use - QJ01XQ01 POM: - Tiamulin Generic - In drinking
solution for use Regulatory B.V. 002 milligram(s)/millil in drinking water Prescription Only hydrogen application water use
in drinking water itre Medicine as fumarate (Article 13(1) of
for pigs, defined in Directive No
chickens and relevant national 2001/82/EC)
turkeys legislation

Tilmodil 300 Emdoka bvba VPA10534/002/ 300 Solution for - QJ01FA91 VPO: Veterinary - Tilmicosin Generic - Subcutaneous
mg/ml Solution 001 milligram(s)/millil injection Practitioner Only application use
for Injection for itre as defined in (Article 13(1) of
cattle and sheep relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 177 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Tilmovet 100 Huvepharma NV VPA10782/004/ 100 Premix for - QJ01FA91 POM: - Tilmicosin Generic - Oral use
g/kg Premix for 002 gram(s)/kilogra medicated Prescription Only application
medicated m(s) feeding stuff Medicine as (Article 13(1) of
feeding stuff for defined in Directive No
pigs and rabbits relevant national 2001/82/EC)
legislation

Tilmovet 100 Huvepharma NV VPA10782/011/ 100 Granules - QJ01FA91 POM: - Tilmicosin - Oral use
mg/g oral 001 milligram(s)/gra Prescription Only
granules for pigs m Medicine as
defined in
relevant national
legislation

Tilmovet 200 Huvepharma NV VPA10782/004/ 200 Premix for - QJ01FA91 POM: - Tilmicosin Generic - Oral use
g/kg Premix for 001 gram(s)/kilogra medicated Prescription Only application
medicated m(s) feeding stuff Medicine as (Article 13(1) of
feeding stuff for defined in Directive No
pigs and rabbits relevant national 2001/82/EC)
legislation

Tilmovet 250 Huvepharma NV VPA10782/003/ 250 Oral solution - QJ01FA91 POM: - Tilmicosin Generic - Oral use
mg/ml 001 milligram(s)/millil Prescription Only application
Concentrate for itre Medicine as (Article 13(1) of
Oral Solution for defined in Directive No
pigs, chickens, relevant national 2001/82/EC)
turkeys and legislation
cattle (calves)

Tilmovet 300 Huvepharma NV VPA10782/032/ 300 Solution for - QJ01FA91 VPO: Veterinary - Tilmicosin Generic - Subcutaneous
mg/ml Solution 001 milligram(s)/millil injection Practitioner Only application use
for Injection for itre as defined in (Article 13(1) of
cattle and sheep relevant national Directive No
legislation 2001/82/EC)

Tilmovet 40 g/kg Huvepharma NV VPA10782/004/ 40 Premix for - QJ01FA91 POM: - Tilmicosin - Oral use
Premix for 003 gram(s)/kilogra medicated Prescription Only
medicated m(s) feeding stuff Medicine as
feeding stuff for defined in
pigs and rabbits relevant national
legislation

Tizoval 6 mg/g ECO Animal VPA22693/012/ 6 Premix for - QP54AA01 POM: - Ivermectin Informed - Oral use
Premix for Health Europe 001 milligram(s)/gra medicated Prescription Only consent
medicated Limited m feeding stuff Medicine as application
feeding stuff for defined in (Article 13c of
pigs relevant national Directive No
legislation 2001/82/EC)

Tolfedine 4% w/v Vetoquinol VPA10983/019/ 4 percent Solution for - QM01AG02 POM: - Tolfenamic acid - Intramuscular
Solution for Ireland Limited 001 weight/volume injection Prescription Only use
Injection for dogs Medicine as - Subcutaneous
and cats defined in use
relevant national
legislation

Tolfedine 6 mg Vetoquinol VPA10983/018/ 6 mg/tablet Tablet - QM01AG02 POM: - Tolfenamic acid - Oral use
tablets Ireland Limited 001 Prescription Only
Medicine as
defined in
relevant national
legislation

Tolfedine 60 mg Vetoquinol VPA10983/018/ 60 mg/tablet Tablet - QM01AG02 POM: - Tolfenamic acid - Oral use
tablets Ireland Limited 002 Prescription Only
Medicine as
defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 178 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
TOLFEDOL, 40 SP Veterinaria, VPA10790/006/ 40 Solution for - QM01AG02 POM: - Tolfenamic acid Generic - Intramuscular
mg/ml, solution S.A. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle, pigs, cats defined in Directive No use
and dogs relevant national 2001/82/EC) - Subcutaneous
legislation use

Tolfine Vetoquinol VPA10983/031/ 4 percent Solution for - QM01AG02 POM: - Tolfenamic acid Full application - Intramuscular
Ireland Limited 001 weight/volume injection Prescription Only (Article 12(3) of use
Medicine as Directive No - Intravenous
defined in 2001/82/EC) use
relevant national
legislation

Tolracol 50 Krka, d.d., Novo VPA10774/026/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use
mg/ml oral mesto 001 milligram(s)/millil Prescription Only application
suspension for itre Medicine as (Article 13(1) of
pigs, cattle and defined in Directive No
sheep relevant national 2001/82/EC)
legislation

Toltarox 50 Krka, d.d., Novo VPA10774/007/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use
mg/ml oral mesto 002 milligram(s)/millil Prescription Only application
suspension for itre Medicine as (Article 13(1) of
cattle defined in Directive No
relevant national 2001/82/EC)
legislation

Toltarox 50 Krka, d.d., Novo VPA10774/007/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use
mg/ml oral mesto 001 milligram(s)/millil Prescription Only application
suspension for itre Medicine as (Article 13(1) of
pigs defined in Directive No
relevant national 2001/82/EC)
legislation

TOPIMEC 0.8 Chanelle VPA10987/080/ 0.8 Oral solution - QP54AA01 LM: Licensed - Ivermectin Hybrid - Oral use
mg/ml Oral Pharmaceuticals 001 milligram(s)/millil Merchant as application
Solution for Manufacturing itre defined in (Article 13(3) of
Sheep Limited relevant national Directive No
legislation 2001/82/EC)

Topimec 5 mg/ml Chanelle VPA10987/159/ 5 Pour-on solution - QP54AA01 LM: Licensed - Ivermectin Generic - Topical use
Pour-on Solution Pharmaceuticals 001 milligram(s)/millil Merchant as application
Manufacturing itre defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Topimec Chanelle VPA10987/157/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin - Subcutaneous
Injection 10 Pharmaceuticals 001 milligram(s)/millil injection Merchant as use
mg/ml solution Manufacturing itre defined in
for injection Limited relevant national
legislation

Topimec Super Chanelle VPA10987/099/ 10, 100 Solution for - QP54AA51 LM: Licensed - Ivermectin Generic - Subcutaneous
Solution for Pharmaceuticals 001 milligram(s)/millil injection Merchant as - Clorsulon application use
Injection Manufacturing itre defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Torbugesic 10 Zoetis Belgium VPA10387/079/ 10 Solution for - QN02AF01 POM: - Butorphanol - Intramuscular
mg/ml Solution S.A. 001 milligram(s)/millil injection Prescription Only use
for Injection itre Medicine as - Intravenous
defined in use
relevant national - Subcutaneous
legislation use

Torbuphanol Vet Zoetis Belgium VPA10387/080/ 10 Solution for - QN02AF01 POM: - Butorphanol - Intramuscular
10 mg/ml S.A. 001 milligram(s)/millil injection Prescription Only use
solution for itre Medicine as - Intravenous
injection for defined in use
injection for relevant national - Subcutaneous
horses, dogs and legislation use
cats

Veterinary Medicines Authorised/Transfer Pending Products Page 179 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Torphadine 10 Le Vet Beheer VPA10475/038/ 10 Solution for - QN02AF01 POM: - Butorphanol Generic - Intramuscular
mg/ml solution B.V. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
dogs, cats and defined in Directive No use
horses relevant national 2001/82/EC) - Subcutaneous
legislation use

Toxovax Intervet Ireland VPA10996/080/ . Concentrate for - QI04AN01 POM: - Toxoplasma Full application - Intramuscular
Limited 001 solution for Prescription Only gondii (Article 12(3) of use
injection Medicine as tachyzoites s48 Directive No
defined in 2001/82/EC)
relevant national
legislation

Tralieve 20 mg Le Vet Beheer VPA10475/036/ 20 mg/tablet Chewable tablet - QN02AX02 POM: - Tramadol Hybrid - Oral use
chewable tablets B.V. 001 Prescription Only hydrochloride application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Tralieve 50 Le Vet Beheer VPA10475/034/ 50 Solution for - QN02AX02 VPO: Veterinary - Tramadol Generic - Intramuscular
mg/ml solution B.V. 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection for itre as defined in (Article 13(1) of - Intravenous
dogs relevant national Directive No use
legislation 2001/82/EC)

Tralieve 80 mg Le Vet Beheer VPA10475/036/ 80 mg/tablet Chewable tablet - QN02AX02 POM: - Tramadol Hybrid - Oral use
chewable tablets B.V. 002 Prescription Only hydrochloride application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Tramadog 50 Laboratoire TVM VPA10386/001/ 50 Solution for - QN02AX02 VPO: Veterinary - Tramadol Generic - Intramuscular
mg/ml solution 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection for itre as defined in (Article 13(1) of - Intravenous
dogs relevant national Directive No use
legislation 2001/82/EC)

Tramazole 10% Univet Limited VPA10990/038/ 10 percent Oral suspension - QP52AC11 LM: Licensed - Albendazole Generic - Oral use
Oral Drench 002 weight/volume Merchant as application
defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Tramazole 2.5% Univet Limited VPA10990/038/ 2.5 percent Oral suspension - QP52AC11 LM: Licensed - Albendazole Generic - Oral use
Oral Drench 001 weight/volume Merchant as application
defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Tramvetol 50 mg Virbac S.A. VPA10988/111/ 50 mg/tablet Tablet - QN02AX02 POM: - Tramadol Generic - Oral use
tablets for dogs 001 Prescription Only hydrochloride application
Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Tramvetol 50 Virbac S.A. VPA10988/112/ 50 Solution for - QN02AX02 VPO: Veterinary - Tramadol Generic - Intramuscular
mg/ml solution 001 milligram(s)/millil injection Practitioner Only hydrochloride application use
for injection for itre as defined in (Article 13(1) of - Intravenous
dogs relevant national Directive No use
legislation 2001/82/EC)

Tranquiline 35 Floris Veterinaire VPA10492/001/ 35 Oral gel - QN05AA04 POM: - Acepromazine Generic - Oral use
mg/ml Oral Gel Produkten BV 001 milligram(s)/millil Prescription Only application
for Dogs itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 180 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Tratol 50 mg/ml Krka, d.d., Novo VPA10774/011/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use
oral suspension mesto 001 milligram(s)/millil Prescription Only application
for pigs, cattle itre Medicine as (Article 13(1) of
and sheep defined in Directive No
relevant national 2001/82/EC)
legislation

Triazole Fluke Pharvet (Ireland) VPA10462/001/ 22.5/15.0 Oral suspension - QP52AE51 LM: Licensed - Levamisole Informed - Oral use
and Worm Ltd 001 milligram(s)/millil Merchant as hydrochloride consent
Drench itre defined in - Rafoxanide application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Tribex 10 % Oral Chanelle VPA10987/146/ 10 percent Oral suspension - QP52AC01 LM: Licensed - Triclabendazole Generic - Oral use
Suspension for Pharmaceuticals 002 weight/volume Merchant as application
Cattle Manufacturing defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Tribex 5 % Oral Chanelle VPA10987/146/ 5 percent Oral suspension - QP52AC01 LM: Licensed - Triclabendazole Well-established - Oral use
Suspension for Pharmaceuticals 001 weight/volume Merchant as use application
Sheep Manufacturing defined in (Article 13a of
Limited relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 181 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Tribovax 10 Intervet Ireland VPA10996/259/ . Suspension for - QI02AB01 LM: Licensed - C. perfringens - Subcutaneous
suspension for Limited 001 injection - QI04AB01 Merchant as type a toxoid use
injection for defined in (strain cn 1491)
cattle and sheep relevant national - C. perfringens
legislation type b toxoid
(strain cn 1240)
- C. perfringens
type c toxoid
(strain cn 883)
- C. chauvoei
whole culture
(strain cn 3796)
- C. novyi type b
toxoid (strain cn
6120)
- C. septicum
toxoid (strain cn
368)
- C. tetani toxoid
(strain cn 3911)
- C. sordellii
toxoid (strain
831)
- C.
haemolyticum
toxoid (strain cn
3629)
- C. perfringens
type d toxoid
(strain cn 3688)
- C. perfringens
type B&C (ß)
toxoid
- C. perfringens
type D (e) toxoid
- C. chauvoei
whole culture
- C. novyi toxoid
- C. septicum
toxoid
- C. tetani toxoid
- C. sordellii
toxoid
- C.
haemolyticum
- C. perfringens
type a (alpha)
toxoid

Veterinary Medicines Authorised/Transfer Pending Products Page 182 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Tribovax 10 Intervet Ireland VPA10996/259/ . Suspension for - QI02AB01 LM: Licensed - C. perfringens - Subcutaneous
suspension for Limited 001 injection - QI04AB01 Merchant as type a toxoid use
injection for defined in (strain cn 1491)
cattle and sheep relevant national - C. perfringens
legislation type b toxoid
(strain cn 1240)
- C. perfringens
type c toxoid
(strain cn 883)
- C. chauvoei
whole culture
(strain cn 3796)
- C. novyi type b
toxoid (strain cn
6120)
- C. septicum
toxoid (strain cn
368)
- C. tetani toxoid
(strain cn 3911)
- C. sordellii
toxoid (strain
831)
- C.
haemolyticum
toxoid (strain cn
3629)
- C. perfringens
type d toxoid
(strain cn 3688)
- C. perfringens
type B&C (ß)
toxoid
- C. perfringens
type D (e) toxoid
- C. chauvoei
whole culture
- C. novyi toxoid
- C. septicum
toxoid
- C. tetani toxoid
- C. sordellii
toxoid
- C.
haemolyticum
- C. perfringens
type a (alpha)
toxoid

Tribovax T Intervet Ireland VPA10996/260/ . Suspension for - QI02AB01 LM: Licensed - C. chauvoei Full application - Subcutaneous
Limited 001 injection Merchant as - C. (Article 12(3) of use
defined in haemolyticum Directive No
relevant national - C. 2001/82/EC)
legislation haemolyticum
cells
- C.noyvi B
- C. noyvi B cells
- C.septicum
CN3204 (3U/ml)
- C.septicum
CN368(7U/ml)
- C.tetani

Tricaine PHARMAQ AS VPA10804/006/ 1000 Powder for - QN01AX93 POM: - Tricaine Generic - Water-borne
Pharmaq 1000 001 milligram(s)/gra solution for fish Prescription Only methane application use
mg/g Powder for m treatment Medicine as sulfonate (Article 13(1) of
Solution for Fish defined in Directive No
Treatment relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 183 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Triclaben 10% Chanelle VPA10987/059/ 10 percent Oral suspension - QP52AC LM: Licensed - Triclabendazole Generic - Oral use
Oral Suspension Pharmaceuticals 001 Merchant as application
for Cattle Manufacturing defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Triclaben 5% Chanelle VPA10987/058/ 5 percent Oral suspension - QP52AC LM: Licensed - Triclabendazole Generic - Oral use
Oral Suspension Pharmaceuticals 001 weight/volume Merchant as application
for Sheep Manufacturing defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Trigoderm Gel Dechra VPA10803/002/ 0.5, 0.1 percent Gel - QD07CC01 POM: - Fusidic acid - Topical use
0.5 % w/w Veterinary 001 weight/weight Prescription Only - Betamethasone
Fusidic acid, 0.1 Products A/S Medicine as valerate
% w/w defined in
Betamethasone relevant national
legislation

Trimectin 1.0% Bimeda Animal VPA22033/069/ 1.0 percent Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
w/v Solution for Health Limited 001 weight/volume injection Merchant as application use
Injection defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Trimediazine Vetoquinol VPA10983/058/ 12.5/2.5 percent Premix for - QJ01EW10 POM: - Sulfadiazine - Oral use
15% Premix for Ireland Limited 001 weight/weight medicated Prescription Only - Trimethoprim
medicated feeding stuff Medicine as
feeding stuff defined in
relevant national
legislation

Trimediazine Vetoquinol VPA10983/059/ 5.0 / 25.0 Oral powder - QJ01EW10 POM: - Trimethoprim Full application - Oral use
Plain Oral Ireland Limited 001 percent Prescription Only - Sulfadiazine (Article 12(3) of
Powder weight/weight Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Trioxyl 500 mg/g Univet Limited VPA10990/048/ 500 Powder for use - QJ01CA04 POM: - Amoxicillin Informed - In drinking
powder for use in 001 milligram(s)/gra in drinking water Prescription Only consent water use
drinking water for m Medicine as application
chickens, defined in (Article 13c of
turkeys, ducks relevant national Directive No
and pigs legislation 2001/82/EC)

Trioxyl LA Univet Limited VPA10990/010/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin - Intramuscular
150mg/ml 001 milligram(s)/millil injection Prescription Only use
Suspension for itre Medicine as
Injection defined in
relevant national
legislation

Trippel-Oxy 150 Univet Limited VPA10990/037/ 150 Solution for - QJ01AA06 POM: - Oxytetracycline - Intramuscular
mg/ml Solution 001 milligram(s)/millil injection Prescription Only hydrochloride use
for Injection. itre Medicine as
defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 184 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
TRIVACTON 6 Boehringer VPA10454/076/ . Suspension for - QI02AL01 LM: Licensed - Inactivated Full application - Subcutaneous
Ingelheim 001 injection Merchant as bovine (Article 12(3) of use
Vetmedica defined in coronavirus Directive No
GmbH relevant national strain f15 2001/82/EC)
legislation - Inactivated
bovine rotavirus
strain ro1
- Inactivated
e.coli k99 strain
serotype o101
- Inactivated
e.coli y strain
serotype o117
- Inactivated
e.coli f41 strain
serotype o101
- Inactivated e.
coli 31a strain
serotype O78
Trodax 340 Boehringer VPA10454/077/ 340 Solution for - QP52AG08 LM: Licensed - Nitroxynil Full application - Subcutaneous
mg/ml Solution Ingelheim 001 milligram(s)/millil injection Merchant as (Article 12(3) of use
for Injection Vetmedica itre defined in Directive No
GmbH relevant national 2001/82/EC)
legislation

Troscan 100 mg Chanelle VPA10987/141/ 100 mg/tablet Film-coated - QP52AX01 CAM: - Nitroscanate Well-established - Oral use
film coated tablet Pharmaceuticals 001 tablet Companion use application
for Dogs Manufacturing Animal Medicine (Article 13a of
Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Troscan 500 mg Chanelle VPA10987/141/ 500 mg/tablet Film-coated - QP52AX01 CAM: - Nitroscanate Well-established - Oral use
film coated tablet Pharmaceuticals 002 tablet Companion use application
for Dogs Manufacturing Animal Medicine (Article 13a of
Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Trymox LA 150 Univet Limited VPA10990/051/ 150 Suspension for - QJ01CA04 POM: - Amoxicillin Generic - Intramuscular
mg/ml 001 milligram(s)/millil injection Prescription Only application use
Suspension for itre Medicine as (Article 13(1) of - Subcutaneous
Injection for defined in Directive No use
Cattle, Sheep, relevant national 2001/82/EC)
Pigs, Dogs and legislation
Cats
Tsefalen 1000 I.C.F. Srl VPA10479/001/ 1000 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use
mg film-coated Industria 002 Prescription Only application
tablets for dogs Chimica Fine Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Tsefalen 500 mg I.C.F. Srl VPA10479/001/ 500 mg/tablet Tablet - QJ01DB01 POM: - Cefalexin Generic - Oral use
film-coated Industria 001 Prescription Only application
tablets for dogs Chimica Fine Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Tuberculin PPD Prionics Lelystad VPA10526/001/ . Solution for - QI02AR01 VPO-1: - Bovine Full application - Intradermal use
Kit - B.V. 001 injection - QI02AR02 Veterinary tuberculin PPD (Article 12(3) of
Practitioner Only - Avian Directive No
as defined in tuberculin PPD 2001/82/EC)
relevant national
legislation

Tuberculin PPD Prionics Lelystad VPA10526/001/ . Solution for - QI02AR01 VPO-1: - Bovine Full application - Intradermal use
Kit - B.V. 001 injection - QI02AR02 Veterinary tuberculin PPD (Article 12(3) of
Practitioner Only - Avian Directive No
as defined in tuberculin PPD 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 185 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
TUDOMAX, 10 SP Veterinaria, VPA10790/011/ 10 Oral powder - QR05CB02 POM: - Bromhexine Hybrid - Oral use
mg/g, powder for S.A. 001 milligram(s)/gra Prescription Only application
use in drinking m Medicine as (Article 13(3) of
water/milk defined in Directive No
relevant national 2001/82/EC)
legislation

Tulaxa 100 Krka, d.d., Novo VPA10774/058/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular
mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
cattle, pigs and defined in Directive No use
sheep relevant national 2001/82/EC)
legislation

Tulaxa 25 mg/ml Krka, d.d., Novo VPA10774/058/ 25 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular
solution for mesto 002 milligram(s)/millil injection Prescription Only application use
injection for pigs itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Tulieve 100 Norbrook VPA22664/146/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular
mg/ml solution Laboratories 001 milligram(s)/millil injection Prescription Only application use
for injection for (Ireland) Limited itre Medicine as (Article 13(1) of - Subcutaneous
cattle, pigs and defined in Directive No use
sheep relevant national 2001/82/EC)
legislation

Tullavis 100 LIVISTO Int'l, VPA10425/014/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular
mg/ml solution S.L. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
cattle, pigs and defined in Directive No use
sheep relevant national 2001/82/EC)
legislation

Tullavis 25 LIVISTO Int'l, VPA10425/013/ 25 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular
mg/ml solution S.L. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of
pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Tuloxxin 100 Krka, d.d., Novo VPA10774/057/ 100 Solution for - QJ01FA94 POM: - Tulathromycin Generic - Intramuscular
mg/ml solution mesto 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Subcutaneous
cattle, pigs and defined in Directive No use
sheep relevant national 2001/82/EC)
legislation

TUR-3 emulsion Boehringer VPA10454/078/ . Emulsion for - QI01CA02 POM: - Inactivated Full application - Intramuscular
for injection for Ingelheim 001 injection Prescription Only newcastle (Article 12(3) of use
turkeys Vetmedica Medicine as disease virus Directive No
GmbH defined in - Paramyxovirus 2001/82/EC)
relevant national 3, inactivated
legislation - Inactivated
turkey
rhinotracheitis
virus

Turbomec Bimeda Animal VPA22033/070/ 1 percent Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
Injection for Health Limited 001 weight/volume injection Merchant as application use
Cattle and defined in (Article 13(1) of
Sheep, 1% w/v relevant national Directive No
Solution for legislation 2001/82/EC)
Injection
Tylan 200, 200 Elanco GmbH VPA22020/033/ 200 Solution for - QJ01FA90 POM: - Tylosin Full application - Intramuscular
mg/ml Solution 001 milligram(s)/millil injection Prescription Only (Article 12(3) of use
for Injection itre Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 186 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Tylan G20 Elanco GmbH VPA22020/034/ 20 Premix for - QJ01FA90 POM: - Tylosin - Oral use
Premix for 001 gram(s)/kilogra medicated Prescription Only
medicated m(s) feeding stuff Medicine as
feedingstuff defined in
relevant national
legislation

Tylan G250 Elanco GmbH VPA22020/034/ 250 Premix for - QJ01FA90 POM: - Tylosin - Oral use
Premix for 002 gram(s)/kilogra medicated Prescription Only
medicated m(s) feeding stuff Medicine as
feeding stuff defined in
relevant national
legislation

Tylan G50 Elanco GmbH VPA22020/034/ 50 Premix for - QJ01FA90 POM: - Tylosin - Oral use
Premix for 003 gram(s)/kilogra medicated Prescription Only
medicated m(s) feeding stuff Medicine as
feedingstuff defined in
relevant national
legislation

Tylan Soluble Elanco GmbH VPA22020/020/ 100 gram(s) Powder for oral - QJ01FA90 POM: - Tylosin (as - Oral use
Powder for Oral 001 solution Prescription Only tylosin tartrate)
Solution Medicine as
defined in
relevant national
legislation

Tyljet 200 mg/ml Ceva Santé VPA10815/055/ 200 Solution for - QJ01FA90 POM: - Tylosin Generic - Intramuscular
solution for Animale 001 milligram(s)/millil injection Prescription Only application use
injection for itre Medicine as (Article 13(1) of - Intravenous
cattle, sheep, defined in Directive No use
goats and pigs relevant national 2001/82/EC)
legislation

Tylo 200 mg/ml Kela n.v. VPA10981/004/ 200 Solution for - QJ01FA90 POM: - Tylosin - Intramuscular
solution for 001 milligram(s)/millil injection Prescription Only use
injection itre Medicine as
defined in
relevant national
legislation

Tylosin 20 % Alfasan VPA10980/005/ 20 percent Solution for - QJ01FA90 POM: - Tylosin - Intramuscular
Solution for Nederland B.V 001 weight/volume injection Prescription Only use
Injection Medicine as
defined in
relevant national
legislation

TYLOSIN BIOVET Joint VPA10464/001/ 200,000 Solution for - QJ01FA90 POM: - Tylosin Generic - Intramuscular
BIOVET JSC Stock Company 001 international injection Prescription Only application use
200 mg/ml unit(s)/millilitre Medicine as (Article 13(1) of - Intravenous
solution for defined in Directive No use
injection for relevant national 2001/82/EC)
cattle, sheep, legislation
goats and pigs
Tylucyl 200 Vetoquinol VPA10983/060/ 200 Solution for - QJ01FA90 POM: - Tylosin Generic - Intramuscular
mg/ml solution Ireland Limited 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC)
legislation

Ubro Red Dry Boehringer VPA10454/010/ 100, 300, 100 Intramammary - QJ51RC POM: - Penethamate Full application - Intramammary
Cow Ingelheim 001 mg/5ml suspension Prescription Only hydriodide (Article 12(3) of use
Intramammary Vetmedica Medicine as - Procaine Directive No
Suspension GmbH defined in benzylpenicillin 2001/82/EC)
relevant national - Framycetin
legislation sulphate

Veterinary Medicines Authorised/Transfer Pending Products Page 187 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Ubrolexin Boehringer VPA10454/016/ 200 mg/100,000 Intramammary - QJ51RD01 POM: - Cefalexin Well-established - Intramammary
intramammary Ingelheim 001 IU per syringe suspension Prescription Only - Kanamycin use application use
suspension for Vetmedica Medicine as (Article 13a of
lactating dairy GmbH defined in Directive No
cows relevant national 2001/82/EC)
legislation

Ubropen 600 mg Vetcare Oy VPA10832/002/ 600 mg/syringe Intramammary - QJ51CE09 POM: - Benzylpenicillin Generic - Intramammary
intramammary 001 suspension Prescription Only procaine application use
suspension for Medicine as (Article 13(1) of
lactating cows defined in Directive No
relevant national 2001/82/EC)
legislation

Ubroseal blue Univet Limited VPA10990/049/ 2.6 g/syringe Intramammary - QG52X POM: - Bismuth Hybrid - Intramammary
Dry Cow 2.6 g 001 suspension Prescription Only subnitrate, heavy application use
intramammary Medicine as (Article 13(3) of
suspension for defined in Directive No
cattle relevant national 2001/82/EC)
legislation

Ubrostar Red Boehringer VPA10454/001/ 100, 280, 100 Intramammary - QJ51RC25 POM: - Penethamate Generic - Intramammary
100 mg / 280 mg Ingelheim 001 mg/syringe suspension Prescription Only hydriodide application use
/ 100 mg Vetmedica Medicine as - Benethamine (Article 13(1) of
Intramammary GmbH defined in penicillin Directive No
Suspension for relevant national - Framycetin 2001/82/EC)
cattle legislation sulphate

UDDERgold Ecolab VPA10795/001/ 6.4 Teat dip solution - QG52A LM: Licensed - Sodium chlorite - Topical use
Platinum Deutschland 001 milligram(s)/millil Merchant as - Lactic acid
Germicidal GmbH itre defined in
Barrier Teat Dip relevant national
Solution legislation
Concentrates
(Base and
Activator) for
Teat Dip Solution
For Cattle (Dairy

UISCE-JECT, SP Veterinaria, VPA10790/013/ 100 percent Solvent for - QV07AB POM: - Water for Generic - Intramuscular
100 % v/v, S.A. 001 volume/volume parenteral use Prescription Only injections application use
solvent for Medicine as (Article 13(1) of - Intravenous
parenteral use defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Ultrapen LA 300 Norbrook VPA22664/045/ 300 Suspension for - QJ01CE09 POM: - Procaine Full application - Intramuscular
mg/ml Laboratories 001 milligram(s)/millil injection Prescription Only benzylpenicillin (Article 12(3) of use
Suspension for (Ireland) Limited itre Medicine as Directive No - Subcutaneous
Injection defined in 2001/82/EC) use
relevant national
legislation

Unicillin 300 Univet Limited VPA10990/003/ 300 Suspension for - QJ01CE09 POM: - Benzylpenicillin - Intramuscular
mg/ml 001 milligram(s)/millil injection Prescription Only procaine use
Suspension for itre Medicine as
Injection defined in
relevant national
legislation

Uniferon 20 % Pharmacosmos VPA10794/001/ 20 percent Solution for - QB03AC LM: Licensed - Elemental Iron - Intramuscular
w/v Solution for A/S 001 weight/volume injection Merchant as use
Injection defined in
relevant national
legislation

Unisol 100 Vetpharma VPA10516/003/ 100 Solution for use - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
mg/ml Oral Animal Health, 001 milligram(s)/millil in drinking water Prescription Only application
Solution for use S.L. itre Medicine as (Article 13(1) of
in drinking water defined in Directive No
for chickens and relevant national 2001/82/EC)
turkeys legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 188 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Unisol 100 Vetpharma VPA10516/001/ 100 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml solution Animal Health, 001 milligram(s)/millil injection Prescription Only application use
for injection for S.L. itre Medicine as (Article 13(1) of - Intravenous
cattle and pigs defined in Directive No use
relevant national 2001/82/EC) - Subcutaneous
legislation use

Unisol 25 mg/ml Vetpharma VPA10516/018/ 25 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
oral solution for Animal Health, 001 milligram(s)/millil Prescription Only application
calves S.L. itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Unisol 5 mg/ml Vetpharma VPA10516/017/ 5 Oral solution - QJ01MA90 POM: - Enrofloxacin Generic - Oral use
oral solution for Animal Health, 001 milligram(s)/millil Prescription Only application
piglets S.L. itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

UNISTRAIN Laboratorios VPA10846/013/ 10(3.5) - 10(5.5) Lyophilisate and - QI09AD03 POM: - Live attenuated Full application - Intradermal use
PRRS Hipra S.A. 001 cell culture solvent for Prescription Only prrsv, strain vp- (Article 12(3) of - Intramuscular
lyophilisate and infective dose suspension for Medicine as 046 bis Directive No use
solvent for 50/dose injection defined in 2001/82/EC)
suspension for relevant national
injection for pigs legislation

Univet Multidose Univet Limited VPA10990/026/ 22.5 / 15.0 Oral suspension - QP52AE51 LM: Licensed - Levamisole - Oral use
Fluke and Worm 001 milligram(s)/millil Merchant as hydrochloride
Drench itre defined in - Rafoxanide
relevant national
legislation

Unomec 5 mg/ml Chanelle VPA10987/110/ 5 Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Generic - Topical use
Pour-on Solution Pharmaceuticals 001 milligram(s)/millil Merchant as application
for beef and Manufacturing itre defined in (Article 13(1) of
dairy cattle Limited relevant national Directive No
legislation 2001/82/EC)

Unomox 1 mg/ml Chanelle VPA10987/119/ 1 Oral solution - QP54AB52 LM: Licensed - Moxidectin Generic - Oral use
oral solution for Pharmaceuticals 001 milligram(s)/millil Merchant as application
sheep Manufacturing itre defined in (Article 13(1) of
Limited relevant national Directive No
legislation 2001/82/EC)

Uraw LHV Bonapp HOVR10466/00 Oral solution LM: Licensed - Calcarea - Oral use
6/001 Merchant as carbonica
defined in - Euphrasia
relevant national officinalis
legislation - Thuya
- Solidago
virgaurea
Urilin 40 mg/ml Dechra VPA22622/020/ 40 Syrup - QG04BX91 POM: - Generic - Oral use
syrup for dogs Regulatory B.V. 001 milligram(s)/millil Prescription Only Phenylpropanol application
itre Medicine as amine (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Utertab 2000 mg aniMedica VPA10826/024/ 2000 mg/tablet Intrauterine - QG51AA02 POM: - Tetracycline Hybrid - Intrauterine use
intrauterine GmbH 001 tablet Prescription Only hydrochloride application
tablet for cattle Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Valbazen 100 Zoetis Belgium VPA10387/081/ 100 Oral suspension - QP52AC11 LM: Licensed - Albendazole Full application - Oral use
mg/ml Total S.A. 001 milligram(s)/millil Merchant as (Article 12(3) of
Spectrum itre defined in Directive No
Wormer relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 189 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
VALEMAS 50 FATRO S.p.A. VPA10836/005/ 50 Solution for - QJ01MA90 POM: - Enrofloxacin Generic - Intramuscular
mg/ml solution 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of - Intravenous
cattle, sheep, defined in Directive No use
goats, pigs, dogs relevant national 2001/82/EC) - Subcutaneous
and cats. legislation use

VANGUARD 7. Zoetis Belgium VPA10387/082/ . Lyophilisate and - QI07AI02 POM: - Canine Full application - Subcutaneous
S.A. 001 solvent for Prescription Only distemper virus (Article 12(3) of use
solution for Medicine as strain N-CDV Directive No
injection defined in (live, attenuated) 2001/82/EC)
relevant national - Canine
legislation adenovirus type
2 virus, strain
manhattan (live,
attenuated)
- Canine
parainfluenza
type 5 virus,
strain NL-CPI-5
(live, attenuated)
- Canine
parvovirus strain
NL-35-D (live,
attenuated)
- Leptospira
icterohaemorrha
giae inactivated
- Leptospira
canicola
inactivated

Vanguard CPV. Zoetis Belgium VPA10387/083/ . Solution for - QI07AD01 POM: - Live canine Full application - Subcutaneous
S.A. 001 injection Prescription Only parvovirus strain (Article 12(3) of use
Medicine as NL-35-D Directive No
defined in 2001/82/EC)
relevant national
legislation

VANGUARD Zoetis Belgium VPA10387/084/ . Solution for - QI07AI05 POM: - Live canine Full application - Subcutaneous
CPV-L. S.A. 001 injection Prescription Only parvovirus strain (Article 12(3) of use
Medicine as NL-35-D Directive No
defined in - Inactivated 2001/82/EC)
relevant national leptospira
legislation canicola
- Inactivated
leptospira
icterohaemorrha
giae
Vanguard Lepto- Zoetis Belgium VPA10387/085/ . Solution for - QI07AB01 POM: - Leptospira Full application - Subcutaneous
ci S.A. 001 injection Prescription Only icterohaemorrha (Article 12(3) of use
Medicine as giae inactivated Directive No
defined in - Leptospira 2001/82/EC)
relevant national canicola
legislation inactivated

Vasotop 0.625 Intervet Ireland VPA10996/138/ 0.625 mg/tablet Tablet - QC09AA05 POM: - Ramipril - Oral use
mg tablets Limited 004 Prescription Only
Medicine as
defined in
relevant national
legislation

Vasotop 1.25 mg Intervet Ireland VPA10996/138/ 1.25 mg/tablet Tablet - QC09AA05 POM: - Ramipril - Oral use
tablets Limited 001 Prescription Only
Medicine as
defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 190 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Vasotop 10.0 mg Intervet Ireland VPA10996/138/ 10 mg/tablet Tablet - QC09AA05 POM: - Ramipril - Oral use
tablets Limited 005 Prescription Only
Medicine as
defined in
relevant national
legislation

Vasotop 2.5 mg Intervet Ireland VPA10996/138/ 2.5 mg/tablet Tablet - QC09AA05 POM: - Ramipril - Oral use
tablets Limited 002 Prescription Only
Medicine as
defined in
relevant national
legislation

Vasotop 5 mg Intervet Ireland VPA10996/138/ 5 mg/tablet Tablet - QC09AA05 POM: - Ramipril - Oral use
tablets Limited 003 Prescription Only
Medicine as
defined in
relevant national
legislation

Vecoxan 2.5 Intervet Ireland VPA10996/285/ 2.5 Oral suspension - QP51AJ03 LM: Licensed - Diclazuril Full application - Oral use
mg/ml Oral Limited 001 milligram(s)/millil Merchant as (Article 12(3) of
Suspension for itre defined in Directive No
lambs and relevant national 2001/82/EC)
calves legislation

Veloxa LAVET VPA10482/002/ 50, 150, 50 Chewable tablet - QP52AA51 CAM: - Praziquantel - Oral use
Chewable Pharmaceuticals 001 mg/tablet Companion - Pyrantel
Tablets for Dogs Ltd Animal Medicine - Febantel
as defined in
relevant national
legislation

Veloxa XL LAVET VPA10482/003/ 175, 175, 525 Chewable tablet - QP52AA51 CAM: - Praziquantel Generic - Oral use
Chewable Pharmaceuticals 001 mg/tablet Companion - Pyrantel application
Tablets for Dogs Ltd Animal Medicine - Febantel (Article 13(1) of
as defined in Directive No
relevant national 2001/82/EC)
legislation

Ventipulmin Boehringer VPA10454/018/ 16 microgram Granules - QR03CC13 POM: - Clenbuterol Full application - Oral use
Granules 16 Ingelheim 001 per gram Prescription Only hydrochloride (Article 12(3) of
micrograms/gra Vetmedica Medicine as Directive No
m GmbH defined in 2001/82/EC)
relevant national
legislation

Ventipulmin Boehringer VPA10454/019/ 30 Solution for - QR03CC13 POM: - Clenbuterol Full application - Intravenous
Solution for Ingelheim 001 microgram(s)/mil injection Prescription Only hydrochloride (Article 12(3) of use
Injection 30 Vetmedica lilitre Medicine as Directive No
micrograms/ml GmbH defined in 2001/82/EC)
relevant national
legislation

Ventipulmin Boehringer VPA10454/020/ 25 Syrup - QR03CC13 POM: - Clenbuterol Full application - Oral use
Syrup 25 Ingelheim 001 microgram(s)/mil Prescription Only hydrochloride (Article 12(3) of
micrograms/ml Vetmedica lilitre Medicine as Directive No
GmbH defined in 2001/82/EC)
relevant national
legislation

Vermisole 75 Bimeda Animal VPA22033/045/ 75 Solution for - QP52AE01 LM: Licensed - Levamisole Well-established - Subcutaneous
mg/ml Solution Health Limited 001 milligram(s)/millil injection Merchant as hydrochloride use application use
for Injection itre defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

Vermisole Worm Bimeda Animal VPA22033/046/ 1.5 percent Oral solution - QP52AE01 LM: Licensed - Levamisole Well-established - Oral use
Drench for Cattle Health Limited 001 weight/volume Merchant as hydrochloride use application
and Sheep defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 191 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Versican Plus Bb Zoetis Belgium VPA10387/097/ . Lyophilisate + - QI07AE01 POM: - Bordetella Full application - Oral use
Oral lyophilisate S.A. 001 solvent for Prescription Only bronchiseptica, (Article 12(3) of
and solvent for suspension Medicine as live Directive No
oral suspension defined in 2001/82/EC)
for dogs relevant national
legislation

Versican Plus Zoetis Belgium VPA10387/098/ . Lyophilisate and - QI07AF01 POM: - Bordetella Full application - Nasal use
BbPi IN nasal S.A. 001 solvent for Prescription Only bronchiseptica, (Article 12(3) of
drops, suspension for Medicine as live Directive No
lyophilisate and nasal defined in - Canine 2001/82/EC)
solvent for administration relevant national parainfluenza
suspension for legislation virus, live
dogs
Versican Plus P Zoetis Belgium VPA10387/087/ . Lyophilisate and - QI07AD01 POM: - Canine Full application - Subcutaneous
lyophilisate and S.A. 001 solvent for Prescription Only parvovirus, live (Article 12(3) of use
solvent for suspension for Medicine as Directive No
suspension for injection defined in 2001/82/EC)
injection for dogs relevant national
legislation

Versifel Zoetis Belgium VPA10387/088/ . Suspension for - QI06AA01 POM: - Inactivated Full application - Subcutaneous
FeLV,suspensio S.A. 001 injection Prescription Only feline leukaemia (Article 12(3) of use
n for injection for Medicine as virus(FeLV) Directive No
cats defined in subtypes A, B 2001/82/EC)
relevant national and C
legislation

Versiguard Zoetis Belgium VPA10387/086/ Minimum 2.0 Suspension for - QI07AA02 POM: - Inactivated Full application - Intramuscular
Rabies, S.A. 001 international injection Prescription Only rabies virus, (Article 12(3) of use
suspension for unit(s) Medicine as strain vnukovo- Directive No - Subcutaneous
injection defined in 32 2001/82/EC) use
relevant national
legislation

Veteglan 0.075 LABORATORIO VPA10665/008/ 0.075 Solution for - QG02AD90 POM: - d-Cloprostenol Generic - Intramuscular
mg/ml Solution S CALIER S.A. 001 milligram(s)/millil injection Prescription Only application use
for injection for itre Medicine as (Article 13(1) of
cows, sows and defined in Directive No
mares relevant national 2001/82/EC)
legislation

Vetemex 10 CP-Pharma VPA10810/016/ 10 Solution for - QA04AD90 POM: - Maropitant Generic - Intravenous
mg/ml solution Handelsgesellsc 001 milligram(s)/millil injection Prescription Only application use
for injection for haft mbH itre Medicine as (Article 13(1) of - Subcutaneous
dogs and cats defined in Directive No use
relevant national 2001/82/EC)
legislation

VETERELIN LABORATORIO VPA10665/003/ 0.004 Solution for - QH01CA90 POM: - Buserelin Generic - Intramuscular
0.004 mg/ml S CALIER S.A. 001 milligram(s)/millil injection Prescription Only application use
solution for itre Medicine as (Article 13(1) of - Intravenous
injection for defined in Directive No use
cattle, horses, relevant national 2001/82/EC) - Subcutaneous
pigs and rabbits legislation use

Vetergesic Ceva Santé VPA10815/028/ 0.3 Solution for - QN02AE01 VPO: Veterinary - Buprenorphine Well-established - Intramuscular
Multidose, 0.3 Animale 001 milligram(s)/millil injection Practitioner Only use application use
mg/ml, solution itre as defined in (Article 13a of - Intravenous
for injection for relevant national Directive No use
dogs and cats legislation 2001/82/EC)

Vetflurane 1000 Virbac S.A. VPA10988/085/ 1000 Inhalation - QN01AB06 VPO: Veterinary - Isoflurane Generic - Inhalation use
mg/g Inhalation 001 milligram(s)/gra vapour, liquid Practitioner Only application
vapour, liquid m as defined in (Article 13(1) of
relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 192 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Vetimec 6 mg/g ECO Animal VPA22693/014/ 6 Premix for - QP54AA01 POM: - Ivermectin Generic - Oral use
Premix for Health Europe 001 milligram(s)/gra medicated Prescription Only application
medicated Limited m feeding stuff Medicine as (Article 13(1) of
feeding stuff for defined in Directive No
pigs relevant national 2001/82/EC)
legislation

Vetivex 1 (9 Dechra VPA22622/021/ 9 Solution for - QB05BB01 POM: - Sodium Generic - Intravenous
mg/ml) solution Regulatory B.V. 001 milligram(s)/millil infusion Prescription Only chloride application use
for infusion for itre Medicine as (Article 13(1) of
cattle, horses, defined in Directive No
dogs and cats relevant national 2001/82/EC)
legislation

Vetivex 11 Dechra VPA22622/022/ 3.2, 6, 0.4, 0.2 Solution for - QB05BB01 POM: - Sodium lactate Generic - Intravenous
(Hartmann's) Regulatory B.V. 001 milligram(s)/millil infusion Prescription Only - Sodium application use
solution for itre Medicine as chloride (Article 13(1) of
infusion for defined in - Potassium Directive No
cattle, horses, relevant national chloride 2001/82/EC)
dogs and cats legislation - Calcium
chloride

Vetmedin 0.75 Boehringer VPA10454/022/ 0.75 Solution for - QC01CE90 POM: - Pimobendan Generic - Intravenous
mg/ml solution Ingelheim 001 milligram(s)/millil injection Prescription Only application use
for injection for Vetmedica itre Medicine as (Article 13(1) of
dogs GmbH defined in Directive No
relevant national 2001/82/EC)
legislation

Vetmedin 1.25 Boehringer VPA10454/023/ 1.25 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use
mg chewable Ingelheim 001 Prescription Only application
tablets for dogs Vetmedica Medicine as (Article 13(1) of
GmbH defined in Directive No
relevant national 2001/82/EC)
legislation

Vetmedin 10 mg Boehringer VPA10454/023/ 10 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use
chewable tablets Ingelheim 004 Prescription Only application
for dogs Vetmedica Medicine as (Article 13(3) of
GmbH defined in Directive No
relevant national 2001/82/EC)
legislation

Vetmedin 2.5 mg Boehringer VPA10454/023/ 2.5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use
chewable tablets Ingelheim 002 Prescription Only application
for dogs Vetmedica Medicine as (Article 13(1) of
GmbH defined in Directive No
relevant national 2001/82/EC)
legislation

Vetmedin 5 mg Boehringer VPA10454/021/ 5 milligram(s) Capsule, hard - QC01CE90 POM: - Pimobendan Full application - Oral use
capsules Ingelheim 001 Prescription Only (Article 12(3) of
Vetmedica Medicine as Directive No
GmbH defined in 2001/82/EC)
relevant national
legislation

Vetmedin 5 mg Boehringer VPA10454/023/ 5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use
chewable tablets Ingelheim 003 Prescription Only application
for dogs Vetmedica Medicine as (Article 13(1) of
GmbH defined in Directive No
relevant national 2001/82/EC)
legislation

Vetmedin Chew Boehringer VPA10454/024/ 1.25 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use
1.25 mg Ingelheim 001 Prescription Only application
chewable tablets Vetmedica Medicine as (Article 13(1) of
for dogs. GmbH defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 193 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Vetmedin Chew Boehringer VPA10454/024/ 10 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use
10 mg chewable Ingelheim 004 Prescription Only application
tablets for dogs Vetmedica Medicine as (Article 13(3) of
GmbH defined in Directive No
relevant national 2001/82/EC)
legislation

Vetmedin Chew Boehringer VPA10454/024/ 2.5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use
2.5 mg chewable Ingelheim 002 Prescription Only application
tablets for dogs Vetmedica Medicine as (Article 13(3) of
GmbH defined in Directive No
relevant national 2001/82/EC)
legislation

Vetmedin Chew Boehringer VPA10454/024/ 5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use
5 mg chewable Ingelheim 003 Prescription Only application
tablets for dogs Vetmedica Medicine as (Article 13(1) of
GmbH defined in Directive No
relevant national 2001/82/EC)
legislation

Vetmulin 100 Huvepharma NV VPA10782/005/ 100 Premix for - QJ01XQ01 POM: - Tiamulin - Oral use
g/kg premix for 002 gram(s)/kilogra medicated Prescription Only hydrogen
medicated m(s) feeding stuff Medicine as fumarate
feeding stuff for defined in
pigs, chickens, relevant national
turkeys and legislation
rabbits
Vetmulin 100 Huvepharma NV VPA10782/010/ 100 Granules - QJ01XQ01 POM: - Tiamulin - Oral use
mg/g oral 001 milligram(s)/gra Prescription Only hydrogen
granules for pigs m Medicine as fumarate
defined in
relevant national
legislation

VETMULIN 125 Huvepharma NV VPA10782/009/ 125 Solution for use - QJ01XQ01 POM: - Tiamulin Generic - In drinking
mg/ml Solution 002 milligram(s)/millil in drinking water Prescription Only hydrogen application water use
for use in itre Medicine as fumarate (Article 13(1) of
drinking water for defined in Directive No
pigs and relevant national 2001/82/EC)
chickens legislation

VETMULIN 162 Huvepharma NV VPA10782/008/ 162 Solution for - QJ01XQ01 POM: - Tiamulin 13(1) generic - Intra-Muscular
mg/ml Solution 001 milligram(s)/millil injection Prescription Only
for Injection for itre Medicine as
pigs defined in
relevant national
legislation

Vetmulin 20 g/kg Huvepharma NV VPA10782/005/ 20 Premix for - QJ01XQ01 POM: - Tiamulin - Oral use
premix for 001 gram(s)/kilogra medicated Prescription Only hydrogen
medicated m(s) feeding stuff Medicine as fumarate
feeding stuff for defined in
pigs, chickens, relevant national
turkeys and legislation
rabbits
Vetmulin 450 Huvepharma NV VPA10782/002/ 450 Granules - QJ01XQ01 POM: - Tiamulin Generic - In drinking
mg/g granules 001 milligram(s)/gra Prescription Only hydrogen application water use
for use in m Medicine as fumarate (Article 13(1) of - Oral use
drinking water for defined in Directive No
pigs, chickens relevant national 2001/82/EC)
and turkeys legislation

Vetofol 10 mg/ml Norbrook VPA22664/109/ 10 Emulsion for - QN01AX10 VPO: Veterinary - Propofol Generic - Intravenous
Emulsion for Laboratories 001 milligram(s)/millil injection Practitioner Only application use
Injection for Cats (Ireland) Limited itre as defined in (Article 13(1) of
and Dogs relevant national Directive No
legislation 2001/82/EC)

Veterinary Medicines Authorised/Transfer Pending Products Page 194 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Vetoryl 10 mg Dechra VPA22622/023/ 10 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Full application - Oral use
hard capsules for Regulatory B.V. 001 capsule Prescription Only (Article 12(3) of
dogs Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Vetoryl 120 mg Dechra VPA22622/023/ 120 Milligrams Capsule, hard - QH02CA01 POM: - Trilostane Full application - Oral use
hard capsules Regulatory B.V. 004 per capsule Prescription Only (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Vetoryl 30 mg Dechra VPA22622/023/ 30 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Full application - Oral use
hard capsules Regulatory B.V. 002 capsule Prescription Only (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Vetoryl 60 mg Dechra VPA22622/023/ 60 Milligrams per Capsule, hard - QH02CA01 POM: - Trilostane Full application - Oral use
hard capsules Regulatory B.V. 003 capsule Prescription Only (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Vetrimoxin Ceva Santé VPA10815/049/ 50 Premix for - QJ01CA04 POM: - Amoxicillin Generic - Oral use
50mg/g Premix Animale 001 milligram(s)/gra medicated Prescription Only application
for medicated m feeding stuff Medicine as (Article 13(1) of
feeding stuff for defined in Directive No
pigs relevant national 2001/82/EC)
legislation

Vetrisul Powder Eurovet Animal VPA10989/031/ 40 Powder for oral - QJ01EW10 POM: - Trimethoprim - Oral use
Health B.V. 001 milligram(s)/gra administration Prescription Only - Sulfadiazine
m Medicine as
defined in
relevant national
legislation

Vidalta 10 mg Intervet Ireland VPA10996/263/ 10 mg/tablet Tablet - QH03BB01 POM: - Carbimazole Full application - Oral use
prolonged- Limited 001 Prescription Only (Article 12(3) of
release tablets Medicine as Directive No
for cats defined in 2001/82/EC)
relevant national
legislation

Vidalta 15 mg Intervet Ireland VPA10996/263/ 15 mg/tablet Tablet - QH03BB01 POM: - Carbimazole Full application - Oral use
prolonged- Limited 002 Prescription Only (Article 12(3) of
release tablets Medicine as Directive No
for cats defined in 2001/82/EC)
relevant national
legislation

Vigophos 100 LIVISTO Int'l, VPA10425/007/ 100, 0.05 Solution for - QA12CX91 POM: - Butafosfan Generic - Intravenous
mg / ml + 0.05 S.L. 001 milligram(s)/millil injection Prescription Only - application use
mg / ml solution itre Medicine as Cyanocobalamin (Article 13(1) of
for injection for defined in Directive No
cattle relevant national 2001/82/EC)
legislation

VIMCO emulsion Laboratorios VPA10846/016/ . Emulsion for - QI03AB POM: - Staphylococcus Full application - Intramuscular
for injection for Hipra S.A. 001 injection Prescription Only aureus SP140 (Article 12(3) of use
ewes and female Medicine as CP8 strain, Directive No
goats defined in inactivated, 2001/82/EC)
relevant national expressing
legislation biofilm
components

Veterinary Medicines Authorised/Transfer Pending Products Page 195 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
VIRBAGEST 4 Virbac S.A. VPA10988/086/ 4 Oral solution - QG03DX90 POM: - Altrenogest Generic - Oral use
mg/ml oral 001 milligram(s)/millil Prescription Only application
solution for pigs itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Virbamec Virbac S.A. VPA10988/105/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
Injectable 001 milligram(s)/millil injection Merchant as application use
Solution 10 itre defined in (Article 13(1) of
mg/ml relevant national Directive No
legislation 2001/82/EC)

Virbamec Virbac S.A. VPA10988/107/ 10 Solution for - QP54AA01 LM: Licensed - Ivermectin Generic - Subcutaneous
Injectable 001 milligram(s)/millil injection Merchant as application use
Solution for itre defined in (Article 13(1) of
Cattle, Swine relevant national Directive No
and Sheep 10 legislation 2001/82/EC)
mg/ml
VIRBAMEC Virbac S.A. VPA10988/106/ 5 Pour-on solution - QP54AA01 LM: Licensed - Ivermectin - Topical use
Pour-On solution 001 milligram(s)/millil Merchant as
for cattle 5 mg/m itre defined in
relevant national
legislation

Virbamec Super Virbac S.A. VPA10988/108/ 10, 100 Solution for - QP54AA51 LM: Licensed - Ivermectin Full application - Subcutaneous
Solution For 001 milligram(s)/millil injection Merchant as - Clorsulon (Article 12(3) of use
Injection itre defined in Directive No
relevant national 2001/82/EC)
legislation

Vitamin B1 100 Bimeda Animal VPA22033/047/ 100 Solution for - QA11DA01 POM: - Thiamine - Intramuscular
mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only hydrochloride use
for Injection itre Medicine as - Intravenous
defined in use
relevant national
legislation

Vitamin K1 10 Bimeda Animal VPA22033/048/ 10 Solution for - QB02 POM: - - Intramuscular


mg/ml Solution Health Limited 001 milligram(s)/millil injection Prescription Only Phytomenadione use
for Injection itre Medicine as (Vitamin K1) - Intravenous
defined in use
relevant national - Subcutaneous
legislation use

VITBPLEX Chem-Pharm VPA10823/018/ . Solution for - QA11E LM: Licensed - Thiamine Informed - Intramuscular
Solution for 001 injection Merchant as hydrochloride consent use
Injection defined in - Riboflavin application - Subcutaneous
relevant national sodium (Article 13c of use
legislation phosphate Directive No
- Pyridoxine 2001/82/EC)
hydrochloride
- Nicotinamide
- Ascorbic acid
Vitesel Norbrook VPA22664/034/ 68, 1.5 Suspension for - QA11J POM (E): - all-rac-a- - Intramuscular
Suspension for Laboratories 001 milligram(s)/millil injection Prescription Only Tocopheryl use
Injection (Ireland) Limited itre Exempt as acetate - Subcutaneous
defined in - Selenium use
relevant national
legislation

Vitofyllin 100 mg WDT - VPA10660/002/ 100 mg/tablet Film-coated - QC04AD90 POM: - Propentofylline Generic - Oral use
film-coated Wirtschaftsgeno 002 tablet Prescription Only application
tablets for dogs ssenschaft Medicine as (Article 13(1) of
deutscher defined in Directive No
Tierarzte eG relevant national 2001/82/EC)
legislation

Vitofyllin 50 mg WDT - VPA10660/002/ 50 mg/tablet Film-coated - QC04AD90 POM: - Propentofylline Generic - Oral use
film-coated Wirtschaftsgeno 001 tablet Prescription Only application
tablets for dogs ssenschaft Medicine as (Article 13(1) of
deutscher defined in Directive No
Tierarzte eG relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 196 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Vivitonin 100 mg Intervet Ireland VPA10996/127/ 100 mg/tablet Tablet - QC04AD90 POM: - Propentofylline Full application - Oral use
film-coated Limited 002 Prescription Only (Article 12(3) of
tablets Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Vivitonin 50 mg Intervet Ireland VPA10996/127/ 50 mg/tablet Film-coated - QC04AD90 POM: - Propentofylline Full application - Oral use
film-coated Limited 001 tablet Prescription Only (Article 12(3) of
tablets Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Voxical Plus Chanelle VPA10987/090/ 50,50,150 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use
Tablets for dogs Pharmaceuticals 001 mg/tablet Companion - Pyrantel application
Manufacturing Animal Medicine - Febantel (Article 13(3) of
Limited as defined in Directive No
relevant national 2001/82/EC)
legislation

Voxical Plus XL Chanelle VPA10987/090/ 175,504,525 Tablet - QP52AA51 CAM: - Praziquantel Hybrid - Oral use
Tablets For Dog Pharmaceuticals 002 mg/tablet Companion - Pyrantel application
Manufacturing Animal Medicine embonate (Article 13(3) of
Limited as defined in - Febantel Directive No
relevant national 2001/82/EC)
legislation

Vulketan 2.5 AUDEVARD VPA10481/003/ 2.5 Gel - QD03AX90 POM: - Ketanserin Generic - Cutaneous use
mg/g gel for 001 milligram(s)/gra Prescription Only tartrate application
horses m Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Wellplus Divasa-Farmavic VPA10505/003/ 150, 144, 50 Tablet - QP52AA30 CAM: - Febantel Generic - Oral use
Flavoured tablets S.A. 001 mg/tablet Companion - Pyrantel application
for Dogs Animal Medicine embonate (Article 13(1) of
as defined in - Praziquantel Directive No
relevant national 2001/82/EC)
legislation

Winter Dip Hygeia VPA10203/001/ 10 percent Concentrate for - QP53AF03 LM: Licensed - Diazinon Well-established - Topical use
Concentrate for Chemicals Ltd 001 weight/volume dip emulsion Merchant as (dimpylate) use application
dip emulsion defined in (Article 13a of
relevant national Directive No
legislation 2001/82/EC)

WORMALL Coyle Veterinary VPA10889/002/ 2.265 percent Oral suspension - QP52AC02 LM: Licensed - Oxfendazole Informed - Oral use
2.265%w/v Oral Products Ltd. 001 weight/volume Merchant as consent
Suspension defined in application
relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Xylapan 20 Vetoquinol VPA10983/061/ 20 Solution for - QN05CM92 VPO: Veterinary - Xylazine - Intramuscular
mg/ml Solution Ireland Limited 001 milligram(s)/millil injection Practitioner Only use
for Injection itre as defined in - Intravenous
relevant national use
legislation - Subcutaneous
use

Young's Vector Elanco GmbH VPA22020/027/ 12.5 Pour-on solution - QP53AC LM: Licensed - Cypermethrin Full application - Topical use
12.5 mg/ml Pour- 001 milligram(s)/millil Merchant as tech. (cis: trans / (Article 12(3) of
on Solution itre defined in 80:20) Directive No
relevant national 2001/82/EC)
legislation

Zanil Fluke Intervet Ireland VPA10996/262/ 3.4 percent Oral suspension - QP52A LM: Licensed - Oxyclozanide - Oral use
Drench Limited 001 weight/volume Merchant as
defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 197 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
ZANTEL Chanelle VPA10987/060/ 50/500 mg/tablet Tablet - QP52AA51 CAM: - Praziquantel - Oral use
Pharmaceuticals 001 Companion - Fenbendazole
Manufacturing Animal Medicine
Limited as defined in
relevant national
legislation

Zantel Cat and Chanelle VPA10987/052/ 50/500 mg/tablet Tablet - QP52AA51 CAM: - Praziquantel - Oral use
Dog Tablets Pharmaceuticals 001 - QP52AC13 Companion - Fenbendazole
Manufacturing Animal Medicine
Limited as defined in
relevant national
legislation

Zantel Cat and Chanelle VPA10987/052/ 50/500 mg/tablet Tablet - QP52AA51 CAM: - Praziquantel - Oral use
Dog Tablets Pharmaceuticals 001 - QP52AC13 Companion - Fenbendazole
Manufacturing Animal Medicine
Limited as defined in
relevant national
legislation

Zelys 1.25 mg Ceva Santé VPA10815/046/ 1.25 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use
chewable tablets Animale 001 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Zelys 10 mg Ceva Santé VPA10815/046/ 10 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Hybrid - Oral use
chewable tablets Animale 003 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Zelys 5 mg Ceva Santé VPA10815/046/ 5 mg/tablet Chewable tablet - QC01CE90 POM: - Pimobendan Generic - Oral use
chewable tablets Animale 002 Prescription Only application
for dogs Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Zerofen 10% Chanelle VPA10987/017/ 10 percent Oral suspension - QP52AC13 LM: Licensed - Fenbendazole - Oral use
Oral Suspension Pharmaceuticals 001 weight/volume Merchant as
Manufacturing defined in
Limited relevant national
legislation

Zerofen 2.5% Chanelle VPA10987/017/ 2.5 percent Oral suspension - QP52AC13 LM: Licensed - Fenbendazole Informed - Oral use
Oral Suspension Pharmaceuticals 002 weight/volume Merchant as consent
Manufacturing defined in application
Limited relevant national (Article 13c of
legislation Directive No
2001/82/EC)
Zerofen 22 % Chanelle VPA10987/140/ 22 percent Granules - QP52AC13 CAM: - Fenbendazole - Oral use
Granules Pharmaceuticals 001 weight/weight Companion
Manufacturing Animal Medicine
Limited as defined in
relevant national
legislation

Zerofen 4 % Chanelle VPA10987/143/ 4 percent Premix for - QP52AC13 POM: - Fenbendazole - Oral use
Premix for Pharmaceuticals 001 weight/weight medicated Prescription Only
medicated Manufacturing feeding stuff Medicine as
feeding stuff Limited defined in
relevant national
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 198 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Zeromast 600 Bimeda Animal VPA22033/033/ 600 mg/syringe Intramammary - QJ01C POM: - Cloxacillin - Intramammary
mg/syringe Health Limited 001 suspension Prescription Only use
Intramammary Medicine as
Suspension defined in
relevant national
legislation

Zeromectin 5 Chanelle VPA10987/109/ 5 Pour-on solution - QP54AA04 LM: Licensed - Eprinomectin Generic, hybrid - Topical use
mg/ml Pour-on Pharmaceuticals 001 milligram(s)/millil Merchant as or similar
Solution for beef Manufacturing itre defined in biological
and dairy cattle Limited relevant national application
legislation (Article 13 of
Directive No
2001/82/EC)
Zeronil 134 mg Chanelle VPA10987/093/ 134 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 002 Prescription Only application
for medium dogs Manufacturing Medicine as (Article 13(3) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Zeronil 268 mg Chanelle VPA10987/093/ 268 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 003 Prescription Only application
for large dogs Manufacturing Medicine as (Article 13(3) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Zeronil 402 mg Chanelle VPA10987/093/ 402 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 004 Prescription Only application
for extra large Manufacturing Medicine as (Article 13(3) of
dogs Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Zeronil 50 mg Chanelle VPA10987/094/ 50 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 001 Prescription Only application
for cats Manufacturing Medicine as (Article 13(3) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Zeronil 67 mg Chanelle VPA10987/093/ 67 mg/pipette Spot-on solution - QP53AX15 POM: - Fipronil Hybrid - Topical use
Spot-on Solution Pharmaceuticals 001 Prescription Only application
for small dogs Manufacturing Medicine as (Article 13(3) of
Limited defined in Directive No
relevant national 2001/82/EC)
legislation

Zeronil Combo Chanelle VPA10987/126/ 134, 120.6 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
134 mg/120.6 Pharmaceuticals 002 mg/pipette Prescription Only - (S)-methoprene application
mg Spot-on Manufacturing Medicine as (Article 13(3) of
Solution for Limited defined in Directive No
Medium Dogs relevant national 2001/82/EC)
legislation

Zeronil Combo Chanelle VPA10987/126/ 268, 241.2 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
268 mg/241.2 Pharmaceuticals 003 mg/pipette Prescription Only - (S)-methoprene application
mg Spot-on Manufacturing Medicine as (Article 13(3) of
Solution for Limited defined in Directive No
Large Dogs. relevant national 2001/82/EC)
legislation

Zeronil Combo Chanelle VPA10987/126/ 402, 361.8 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
402 mg/361.8 Pharmaceuticals 004 mg/pipette Prescription Only - (S)-methoprene application
mg Spot-on Manufacturing Medicine as (Article 13(3) of
Solution for Extra Limited defined in Directive No
Large Dogs. relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 199 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
Zeronil Combo Chanelle VPA10987/125/ 50, 60 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
50 mg/60 mg Pharmaceuticals 001 mg/pipette Prescription Only - (S)-methoprene application
Spot-on Solution Manufacturing Medicine as (Article 13(3) of
for Cats and Limited defined in Directive No
Ferrets relevant national 2001/82/EC)
legislation

Zeronil Combo Chanelle VPA10987/126/ 67, 60.3 Spot-on solution - QP53AX65 POM: - Fipronil Hybrid - Spot-on use
67 mg/60.3 mg Pharmaceuticals 001 mg/pipette Prescription Only - (S)-methoprene application
Spot-on Solution Manufacturing Medicine as (Article 13(3) of
for Small Dogs Limited defined in Directive No
relevant national 2001/82/EC)
legislation

ZincoTec Zinc Provimi Ltd VPA10446/001/ 100 percent Premix for - QA07XA91 POM: - Zinc oxide Full application - Oral use
Oxide 100% 001 medicated Prescription Only (Article 12(3) of
Premix for feeding stuff Medicine as Directive No
medicated defined in 2001/82/EC)
Feeding Stuff relevant national
legislation

Zitac vet 100 mg Intervet Ireland VPA10996/202/ 100 mg/tablet Tablet - QA02BA01 POM: - Cimetidine Full application - Oral use
tablets for dogs Limited 002 Prescription Only (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Zitac vet 200 mg Intervet Ireland VPA10996/202/ 200 mg/tablet Tablet - QA02BA01 POM: - Cimetidine Full application - Oral use
tablets for dogs Limited 003 Prescription Only (Article 12(3) of
Medicine as Directive No
defined in 2001/82/EC)
relevant national
legislation

Z-Itch Floris Holding VPA22969/001/ 40 Pour-on solution - QP53AC04 POM: - Permethrin Generic - Topical use
BV 001 milligram(s)/millil Prescription Only (80:20) technical application
itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Zodon 150 mg Ceva Santé VPA10815/040/ 150 mg/tablet Chewable tablet - QJ01FF01 POM: - Clindamycin Generic - Oral use
chewable tablets Animale 002 Prescription Only application
for dogs. Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Zodon 25 mg/ml Ceva Santé VPA10815/038/ 25 Oral solution - QJ01FF01 POM: - Clindamycin Generic - Oral use
oral solution for Animale 001 milligram(s)/millil Prescription Only application
cats and dogs itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Zodon 264 mg Ceva Santé VPA10815/040/ 264 mg/tablet Chewable tablet - QJ01FF01 POM: - Clindamycin Hybrid - Oral use
chewable tablets Animale 003 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Zodon 88 mg Ceva Santé VPA10815/040/ 88 mg/tablet Chewable tablet - QJ01FF01 POM: - Clindamycin Hybrid - Oral use
chewable tablets Animale 001 Prescription Only application
for dogs Medicine as (Article 13(3) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 200 of 201


Trade Name Licence Licence Strength Dosage Form ATC Legal Status Active Legal Basis Routes of
Holder Number Ingredients Administration
ZOLETIL 100 Virbac S.A. VPA10988/099/ 100 Lyophilisate and - QN01AX99 VPO: Veterinary - Tiletamine Generic - Intramuscular
(50 mg/ml + 50 002 milligram(s)/millil solvent for Practitioner Only - Zolazepam application use
mg/ml) itre solution for as defined in (Article 13(1) of - Intravenous
lyophilisate and injection relevant national Directive No use
solvent for legislation 2001/82/EC)
solution for
injection for dogs
and cats
ZOLETIL 50 (25 Virbac S.A. VPA10988/099/ 50 Lyophilisate and - QN01AX99 VPO: Veterinary - Tiletamine Generic - Intramuscular
mg/ml + 25 001 milligram(s)/millil solvent for Practitioner Only - Zolazepam application use
mg/ml) itre solution for as defined in (Article 13(1) of - Intravenous
lyophilisate and injection relevant national Directive No use
solvent for legislation 2001/82/EC)
solution for
injection for dogs
and cats
ZORABEL 50 Vetpharma VPA10516/024/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Hybrid - Oral use
mg/ml Oral Animal Health, 001 milligram(s)/millil Prescription Only application
Suspension for S.L. itre Medicine as (Article 13(3) of
pigs defined in Directive No
relevant national 2001/82/EC)
legislation

Zuritol 25 mg/ml LABORATORIO VPA10665/004/ 25 Oral solution - QP51AJ01 POM: - Toltrazuril Generic - Oral use
solution for use S CALIER S.A. 001 milligram(s)/millil Prescription Only application
in drinking water itre Medicine as (Article 13(1) of
for chickens defined in Directive No
relevant national 2001/82/EC)
legislation

Zuritol 50 mg/ml LABORATORIO VPA10665/007/ 50 Oral suspension - QP51AJ01 POM: - Toltrazuril Generic - Oral use
oral suspension S CALIER S.A. 001 milligram(s)/millil Prescription Only application
for pigs. itre Medicine as (Article 13(1) of
defined in Directive No
relevant national 2001/82/EC)
legislation

Veterinary Medicines Authorised/Transfer Pending Products Page 201 of 201

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