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C 129/22 EN Official Journal of the European Union 3.6.

2003

Summary of Community decisions on marketing authorisations in respect of medicinal products


from 15 April 2003 to 15 May 2003

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2003/C 129/06)

— Issuing, maintenance or modification of a national marketing authorisation

Name(s) of the Holder(s) of the Date of


Date of the decision Member State concerned
medicinal product marketing authorisation notification

13.5.2003 Fluoxetine See Annex I See Annex I 14.5.2003

16.4.2003 Orbax See Annex II See Annex II 25.4.2003

— Suspension of a national marketing authorisation

Name(s) of the Holder(s) of the Date of


Date of the decision Member State concerned
medicinal product marketing authorisation notification

22.4.2003 Benzathine See Annex III See Annex III 24.4.2003


Benzylpenicillin

(1) OJ L 311, 28.11.2001, p. 67.


(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTES OF ADMINISTRATION,


MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES OF THE MEDICINAL
PRODUCT IN THE MEMBER STATES

FLUOXETINE-CONTAINING MEDICINAL PRODUCTS — ELI LILLY MARKETING AUTHORISATIONS IN THE


EUROPEAN UNION

Route of administration
Member State Marketing Authorisation Holder Invented Name Strength Packaging/Package size
+ Pharmaceutical form

AUSTRIA Eli Lilly Ges.mbH Fluctine 20 mg/5 ml Oral Solution Bottle 70 ml


Barichgasse 40-41
A-1030 Wien

Eli Lilly Ges.mbH Fluoxetine 20 mg/5 ml Oral Solution Bottle 70 ml


Barichgasse 40-41
A-1030 Wien

Eli Lilly Ges.mbH Fluctine 20 mg Oral Capsule Blister packs 14 and


Barichgasse 40-41 28
A-1030 Wien

Eli Lilly Ges.mbH Fluoxetine 20 mg Oral Capsule Blister packs 14 and


Barichgasse 40-41 28
A-1030 Wien

Eli Lilly Ges.mbH Fluctine 20 mg Oral Tablet Blister packs 14 and


Barichgasse 40-41 Dispersible 28
A-1030 Wien

Eli Lilly Ges.mbH Fluoxetine 20 mg Oral Tablet Blister packs 14 and


Barichgasse 40-41 Dispersible 28
A-1030 Wien
3.6.2003 EN Official Journal of the European Union C 129/23

Route of administration
Member State Marketing Authorisation Holder Invented Name Strength Packaging/Package size
+ Pharmaceutical form

BELGIUM Eli Lilly Benelux SA Prozac 20 mg/5 ml Oral Solution Bottles 70 and
Rue de l'Etuve, 52-Bte 1 140 ml
B-1000 Brussels

Eli Lilly Benelux SA Fontex 20 mg Oral Capsule Blister packs 14, 28,
Rue de l'Etuve, 52-Bte 1 56
B-1000 Brussels Unit-dose Pulvule

Eli Lilly Benelux SA Prozac 20 mg Oral Capsule Blister packs 14, 28,
Rue de l'Etuve, 52-Bte 1 56
B-1000 Brussels Unit-dose Pulvule

Eli Lilly Benelux SA Prozac 30 mg Oral Capsule Blister pack 21


Rue de l'Etuve, 52-Bte 1 Unit-dose Pulvule
B-1000 Brussels

Eli Lilly Benelux SA Fluoxetine ‘Lilly’ 20 mg Oral Capsule Blister packs 14, 28,
Rue de l'Etuve, 52-Bte 1 Green and Cream 56
B-1000 Brussels Unit-dose Pulvule

Eli Lilly Benelux SA Fluoxetine ‘Lilly’ 20 mg Oral Capsule Blister packs 14, 28,
Rue de l'Etuve, 52-Bte 1 Blue and White 56
B-1000 Brussels Unit-dose Pulvule

Eli Lilly Benelux SA Fluoxetine ‘Dista’ 20 mg Oral Capsule Blister packs 14, 28,
Rue de l'Etuve, 52-Bte 1 56
B-1000 Brussels Unit-dose Pulvule

Eli Lilly Benelux SA Prozac 40 mg Oral Capsule Blister packs 14


Rue de l'Etuve, 52-Bte 1 Pulvule
B-1000 Brussels

Eli Lilly Benelux SA Prozac 60 mg Oral Capsule Blister packs 14


Rue de l'Etuve, 52-Bte 1 Pulvule
B-1000 Brussels

Eli Lilly Benelux SA Prozac 20 mg Oral Tablet Blister packs 14, 28,
Rue de l'Etuve, 52-Bte 1 Dispersible 56
B-1000 Brussels Unit-dose

Eli Lilly Benelux SA Fontex 20 mg Oral Tablet Blister packs 14, 28,
Rue de l'Etuve, 52-Bte 1 Dispersible 56
B-1000 Brussels Unit-dose

DENMARK Eli Lilly Danmark A/S Fontex 20 mg/5 ml Oral Solution Bottle 70 ml
Nybrovej 110
DK-2800 Lyngby

Eli Lilly Danmark A/S Fontex 20 mg Oral Capsule N/A


Nybrovej 110
DK-2800 Lyngby

Eli Lilly Danmark A/S Fonzac 20 mg Oral Capsule Blister packs 30,
Nybrovej 110 100
DK-2800 Lyngby

Eli Lilly Danmark A/S Fontex 20 mg Oral Tablet Blister packs 30,
Nybrovej 110 Dispersible 100
DK-2800 Lyngby
C 129/24 EN Official Journal of the European Union 3.6.2003

Route of administration
Member State Marketing Authorisation Holder Invented Name Strength Packaging/Package size
+ Pharmaceutical form

FINLAND Oy Eli Lilly Ab Fontex 20 mg/5 ml Oral Solution Bottle 70 ml


Rajatorpantie 41 C
FIN-01640 Vantaa

Oy Eli Lilly Ab Fontex 20 mg Oral Capsule Blister packs 10, 30,


Rajatorpantie 41 C 100
FIN-01640 Vantaa

Oy Eli Lilly Ab Fontex 20 mg Oral Tablet Blister packs 14, 28,


Rajatorpantie 41 C Dispersible 56 and 100
FIN-01640 Vantaa

FRANCE Lilly France SA Prozac 20 mg/5 ml Oral Solution Vials with pipette
203, Bureaux de la Colline 70 ml
F-92213 Saint-Cloud

Lilly France SA Elindra 20 mg Oral Capsule Blister packs 7, 14,


203, Bureaux de la Colline 28 and 70
F-92213 Saint-Cloud

Lilly France SA Fluoxétine Elsa 20 mg Oral Capsule Blister packs 7, 14,


203, Bureaux de la Colline 28 and 70
F-92213 Saint-Cloud

Lilly France SA Fluoxétine RPG 20 mg Oral Capsule Blister packs 7, 14,


203, Bureaux de la Colline 28 and 70
F-92213 Saint-Cloud

Lilly France SA Fluoxétine Lilly 20 mg Oral Capsule Blister packs 7, 14,


203, Bureaux de la Colline 28 and 70
F-92213 Saint-Cloud

Lilly France SA Fontex 20 mg Oral Capsule Blister packs 7, 14,


203, Bureaux de la Colline 28 and 70
F-92213 Saint-Cloud

Lilly France SA Prozac 20 mg Oral Capsule Blister packs 7, 14,


203, Bureaux de la Colline 70
F-92213 Saint-Cloud

Lilly France SA Fluctine 20 mg Oral Tablet Blister packs 14, 28,


203, Bureaux de la Colline Dispersible 70
F-92213 Saint-Cloud

Lilly France SA Fluoxétine Lilly 20 mg Oral Tablet Blister packs 14, 28,
203, Bureaux de la Colline Dispersible 70
F-92213 Saint-Cloud

Lilly France SA Prozac 20 mg Oral Tablet Blister packs 14, 28,


203, Bureaux de la Colline Dispersible 70
F-92213 Saint-Cloud

GERMANY Lilly Deutschland GmbH Fluctin 20 mg/5 ml Oral Solution Bottle 70 ml


Teichweig 3
D-35396 Gießen

Lilly Deutschland GmbH Prozac 20 mg/5 ml Oral Solution Bottle 70 ml


Teichweig 3
D-35396 Gießen
3.6.2003 EN Official Journal of the European Union C 129/25

Route of administration
Member State Marketing Authorisation Holder Invented Name Strength Packaging/Package size
+ Pharmaceutical form

GERMANY Lilly Deutschland GmbH Prozac 20 mg/5 ml Oral Solution Bottle 70 ml


(cont’d) Teichweig 3
D-35396 Gießen

Lilly Deutschland GmbH Prozac 20 mg/5 ml Oral Solution Bottle 70 ml


Teichweig 3
D-35396 Gießen

Lilly Deutschland GmbH Fluctin 20 mg Oral Capsule Blister packs 20, 50,
Teichweig 3 100
D-35396 Gießen

Lilly Deutschland GmbH Prozac 20 mg Oral Capsule Blister packs 20, 50,
Teichweig 3 100
D-35396 Gießen

Lilly Deutschland GmbH Prozac 20 mg Oral Capsule Blister packs 20, 50,
Teichweig 3 100
D-35396 Gießen

Lilly Deutschland GmbH Prozac 20 mg Oral Capsule Blister packs 20, 50,
Teichweig 3 100
D-35396 Gießen

Lilly Deutschland GmbH Prozac 20 mg Oral Capsule Blister packs 20, 50,
Teichweig 3 100
D-35396 Gießen

Lilly Deutschland GmbH Prozac 20 mg Oral Capsule Blister packs 20, 50,
Teichweig 3 100
D-35396 Gießen

Lilly Deutschland GmbH Prozac 20 mg Oral Capsule Blister packs 20, 50,
Teichweig 3 100
D-35396 Gießen

Lilly Deutschland GmbH Fluctin 20 mg Oral Tablet Blister packs 20, 50,
Teichweig 3 Dispersible 100
D-35396 Gießen

GREECE Pharmabrand SACI Ladose 20 mg/5 ml Oral Solution Bottle 70 ml


15o KLM road Athens-Lamia,
GR-145 64 Kifissia

Pharmabrand SACI Ladose 20 mg Oral Capsule Blister 12 caps


15o KLM road Athens-Lamia,
GR-145 64 Kifissia

Pharmaserve-Lilly SACI Ladose 20 mg Oral Tablet Blister 14 tabs


15o KLM road Athens-Lamia, Dispersible
GR-145 64 Kifissia

Pharmaserve-Lilly SACI Ladose 20 mg Oral Tablet Blister 28 tabs


15o KLM road Athens-Lamia, Dispersible
GR-145 64 Kifissia

Pharmabrand SACI Fonzac 20 mg/5 ml Oral Solution Bottle 70 ml


15o KLM road Athens-Lamia,
GR-145 64 Kifissia
C 129/26 EN Official Journal of the European Union 3.6.2003

Route of administration
Member State Marketing Authorisation Holder Invented Name Strength Packaging/Package size
+ Pharmaceutical form

GREECE Pharmabrand SACI Fonzac 20 mg Oral Capsule Blister 12 caps


(cont’d) 15o KLM road Athens-Lamia,
GR-145 64 Kifissia

ICELAND Eli Lilly Danmark A/S Fontex 20 mg/5 ml Oral Solution Bottle 70 ml
Nybrovej 110
IS-2800 Lyngby

Eli Lilly Danmark A/S Fontex 20 mg Oral Capsule Blisters 30, 100
Nybrovej 110
IS-2800 Lyngby

Eli Lilly Danmark A/S Prozac 20 mg Oral Capsule Blisters 30, 100
Nybrovej 110
IS-2800 Lyngby

Eli Lilly Danmark A/S Fontex 20 mg Oral Tablet Blisters 30, 100
Nybrovej 110 Dispersible
IS-2800 Lyngby

Eli Lilly Danmark A/S Fluoxin 20 mg Oral Tablet Blisters 30, 100
Nybrovej 110 Dispersible
IS-2800 Lyngby

IRELAND Eli Lilly and Co Ltd Prozac 20 mg/5 ml Oral Solution Bottle 70 ml
Kingsclere road
Basingstoke
Hampshire RG21 6XA

Eli Lilly and Co Ltd Prozac 20 mg Oral Capsule Blister Packs 2, 28,
Kingsclere road 30, 98
Basingstoke Bottles 28, 30, 98
Hampshire RG21 6XA

Eli Lilly and Co Ltd Prozac 60 mg Oral Capsule Blisters 7, 14, 28,
Kingsclere road 30, 56, 60, 98
Basingstoke Bottles 28
Hampshire RG21 6XA

Dista Products Ltd Prozac 20 mg Oral Tablet Blister strips 2, 28,


Kingsclere road Dispersible 30, 100
Basingstoke
Hampshire RG21 6XA

ITALY Eli Lilly Italia SpA Prozac 20 mg/5 ml Oral Solution Bottles 60 ml
Via Gramsci, 731
I-50019 Sesto Fiorentino (FI)

Eli Lilly Italia SpA Prozac 20 mg Oral Capsule Blisters 12, 28


Via Gramsci, 731
I-50019 Sesto Fiorentino (FI)

Eli Lilly Italia SpA Prozac 20 mg Oral Tablet Blisters 12, 28


Via Gramsci, 731 Dispersible
I-50019 Sesto Fiorentino (FI)

LUXEMBOURG Eli Lilly Benelux SA Prozac 20 mg Oral Capsule Blisters 14, 28, 56
Rue de l'Etuve, 52-Bte 1 pulvules, Unit-dose
B-1000 Brussels
3.6.2003 EN Official Journal of the European Union C 129/27

Route of administration
Member State Marketing Authorisation Holder Invented Name Strength Packaging/Package size
+ Pharmaceutical form

LUXEMBOURG Eli Lilly Benelux SA Fontex 20 mg Oral Capsule Blister packs 14, 28,
(cont’d) Rue de l'Etuve, 52-Bte 1 56
B-1000 Brussels Unit-dose Pulvule

Eli Lilly Benelux SA Prozac 30 mg Oral Capsule Blisters 21 pulvules


Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA Prozac 40 mg Oral Capsule Blisters 14 pulvules


Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA Prozac 60 mg Oral Capsule Blisters 14 pulvules


Rue de l'Etuve, 52-Bte 1
B-1000 Brussels

Eli Lilly Benelux SA Prozac 20 mg Oral Tablet Blisters 14, 28


Rue de l'Etuve, 52-Bte 1 Dispersible Unit-dose
B-1000 Brussels

Eli Lilly Benelux SA Fontex 20 mg Oral Tablet Blister packs 14, 28,
Rue de l'Etuve, 52-Bte 1 Dispersible 56
B-1000 Brussels Unit-dose

Eli Lilly Benelux SA Prozac 20 mg/5 ml Oral Solution Bottles 70 ml,


Rue de l'Etuve, 52-Bte 1 140 ml
B-1000 Brussels

NETHERLANDS Eli Lilly Nederland BV Prozac 20 mg/5 ml Oral Solution Bottle with pipette
Grootslag 1-5 70 ml
3991 RA Houten
Netherlands

Eli Lilly Nederland BV Prozac 20 mg Oral Capsule Blister Strip 30, 60,
Grootslag 1-5 90
3991 RA Houten EAV-packaging 50
Netherlands

Eli Lilly Nederland BV Prozac 20 mg Oral Tablet Blister Strip. 28, 56


Grootslag 1-5 Dispersible
3991 RA Houten
Netherlands

NORWAY Eli Lilly Norway AS Fluoxetin 20 mg Oral Capsule 30 blister


Grenseveien 99 100 blister
N-0601 Oslo

Eli Lilly Norway AS Fontex 20 mg Oral Tablet 30 blister


Grenseveien 99 Dispersible 100 blister
N-0601 Oslo

PORTUGAL Lilly Farma, Produtos Prozac 20 mg/5 ml Oral Solution Bottles 70 ml,
Farmaceuticos, Lda 140 ml
rua Dr. Antonio Borges no 4 —
Piso 3,
Arquiparque – Miraflores
1495-131 Alges
C 129/28 EN Official Journal of the European Union 3.6.2003

Route of administration
Member State Marketing Authorisation Holder Invented Name Strength Packaging/Package size
+ Pharmaceutical form

PORTUGAL Lilly Farma, Produtos Prozac 20 mg Oral Capsule Blister packs 14, 28
(cont’d) Farmaceuticos, Lda
rua Dr. Antonio Borges no 4 —
Piso 3,
Arquiparque – Miraflores
1495-131 Alges

SPAIN Dista SA Prozac 20 mg/5 ml Oral Solution Bottles 70 and


Avda. de la Industria, 30 140 ml
Zona Industrial
E-28108 Alcobendas — Madrid

Dista SA Prozac 20 mg/5 ml Oral Powder 14, 28


Avda. de la Industria, 30 For Suspension
Zona Industrial
E-28108 Alcobendas — Madrid

Dista SA Prozac 20 mg Oral Capsule Blister packs 14, 28


Avda. de la Industria, 30
Zona Industrial
E-28108 Alcobendas — Madrid

Dista SA Prozac 20 mg Oral Tablet Blister packs 14, 28


Avda. de la Industria, 30 Dispersible
Zona Industrial
E-28108 Alcobendas — Madrid

SWEDEN Eli Lilly Sweden AB Fontex 20 mg/5 ml Oral Solution Bottle 70 ml


Box 30037
S-104 25 Stockholm

Eli Lilly Sweden AB Fontex 20 mg Oral Capsule Blister Packs 98×1


Box 30037 (single-dose)
S-104 25 Stockholm

Eli Lilly Sweden AB Fonzac 20 mg Oral Capsule Blister Packs 30×1


Box 30037 100×1 (single-dose)
S-104 25 Stockholm

Eli Lilly Sweden AB Fontex 20 mg Oral Tablet Blister Packs 10, 28,
Box 30037 Dispersible 100
S-104 25 Stockholm 100×1 (single-dose)

UNITED KINGDOM Eli Lilly and Co Ltd Prozac 20 mg/5 ml Oral Solution Bottle 70 ml
Kingsclere road
Basingstoke
Hampshire RG21 6XA

Eli Lilly and Co Ltd Prozac 20 mg Oral Capsule Blister Strip 2, 28,
Kingsclere road 30, 98
Basingstoke
Hampshire RG21 6XA

Eli Lilly and Co Ltd Prozac 60 mg Oral Capsule Blister Strip 7, 14,
Kingsclere road 28, 30, 56, 98
Basingstoke
Hampshire RG21 6XA
3.6.2003 EN Official Journal of the European Union C 129/29

ANNEX II

LIST OF THE PHARMACEUTICAL FORMS, STRENGTHS, ROUTES OF ADMINISTRATION, PACKAGING


AND PACKAGE SIZES OF THE VETERINARY MEDICINAL PRODUCT IN THE MEMBER STATES

Marketing Authorisation Holder (Name and address):

Reference Member State:

UNITED KINGDOM
Schering-Plough Ltd
Schering-Plough House
Shire Park
Welwyn Garden City
Herts AL7 1TW
United Kingdom

Concerned Member States:

AUSTRIA GREECE
Essex Tierarznei Schering-Plough SA
Ndl. der Essex Pharma GmbH 63, Agiou Dimitriou Str.
Thomas-Dehler-Str. 27 G-17455 Alimos
D-81737 München Athens

IRELAND
Schering-Plough Ltd
BELGIUM Schering-Plough House
Schering-Plough NV/SA Shire Park
Rue de Stallesstraat 73 Welwyn Garden City
B-1180 Brussels Herts AL7 1TW
United Kingdom

DENMARK LUXEMBOURG
Schering-Plough A/S Schering-Plough NV/SA
Hvedemarken 12 Rue de Stallesstraat 73
DK-3520 Farum B-1180 Brussels

PORTUGAL
Schering-Plough II-Veterinaria, Lda
FINLAND Casal Colaride, Agualva
Schering-Plough A/S P-2735 Cacem
Hvedemarken 12
DK-3520 Farum SPAIN
Schering-Plough SA
Km 36, Carretera Nacional I
E-28750 San Agustin de Guadalix
FRANCE
Madrid
Schering-Plough Veterinaire
92, rue Baudin
F-92300 Levallois-Perret SWEDEN
Schering-Plough A/S
Hvedemarken 12
DK-3520 Farum
GERMANY
Essex Tierarznei THE NETHERLANDS
Ndl. der Essex Pharma GmbH Schering-Plough NV/SA
Thomas-Dehler-Str. 27 Rue de Stallesstraat 73
D-81737 München B-1180 Brussels
C 129/30 EN Official Journal of the European Union 3.6.2003

Presentations:

Pharmaceutical Route of
Invented Name Strength Target Species Packaging Package size
Form administration

Orbax 6,25 mg Tablet Dog Oral Blister 10


(PVC/Alu)

Orbax 6,25 mg Tablet Dog Oral Blister 100


(PVC/Alu)

Orbax 25 mg Tablet Dog Oral Blister 10


(PVC/Alu)

Orbax 25 mg Tablet Dog Oral Blister 100


(PVC/Alu)

Orbax 75 mg Tablet Dog Oral Blister 8


(PVC/Alu)

Orbax 75 mg Tablet Dog Oral Blister 80


(PVC/Alu)

ANNEX III

LIST OF NAMES OF THE VETERINARY MEDICINAL PRODUCTS BASED ON BENZATHINE PENICILLIN FOR
FOOD PRODUCING ANIMALS AND MARKETING AUTHORISATION HOLDERS IN EU MEMBER STATES,
ICELAND AND NORWAY

Member State Product trade name Strength Company name Address

AUSTRIA Duphapen Benzathine benzylpenicillin 112,5 mg/ml Wyeth-Lederle Pharma Storchengasse 1


Procaine benzylpenicillin 150,00 mg/ml GmbH A-1150 Wien

Duplocillin Benzathine benzylpenicillin 128,75 mg/ml Intervet Siemensstr. 105


Procaine benzylpenicillin 154,43 mg/ml A-1210 Wien

Serocillin Depot Benzathine benzylpenicillin 112,5 mg/ml Norbrook Laboratories 105 Armagh Rd
Procaine benzylpenicillin 150,00 mg/ml Limited Newry BT35 6PU
County Down
Northern Ireland

Norocillin Long acting Benzathine benzylpenicillin 112,5 mg/ml Norbrook Laboratories 105 Armagh Road
Procaine benzylpenicillin 150,00 mg/ml Limited Newry BT35 6PU
County Down
Northern Ireland

BELGIUM Peni-Kel LA Benzathine benzylpenicillin 150,000 IU/ml Kela Laboratória NV St Lenaartseweg 48


Procaine benzylpenicillin 150,000 IU/ml B-2320 Hoogstraten

Retardpen Benzathine benzylpenicillin 150,000 IU/ml V.M.D. NV Berendonk 74


Procaine benzylpenicillin 150,000 IU/ml B-2370 Arendonk

Emdopen Benzathine benzylpenicillin 150,000 IU/ml Emdoka bvba J. Lijsenstraat 16


150 + 150 LA Procaine benzylpenicillin 150,000 IU/ml B-2321 Hoogstraten
Procaine hydrochloride 20 mg/ml

Duplocilline LA Benzathine benzylpenicillin 150,000 IU/ml Intervet Belgium Ragheno Park


Procaine benzylpenicillin 150,000 IU/ml Dellingstraat 32/1
B-2800 Mechelen
3.6.2003 EN Official Journal of the European Union C 129/31

Member State Product trade name Strength Company name Address

BELGIUM Duphapen LA Benzathine benzylpenicillin 150,000 IU/ml Fort Dodge Animal Health Van Houten
(cont’d) Procaine benzylpenicillin 150,000 IU/ml Benelux BV Industriepark 25
1381 MZ Weesp
The Netherlands

DENMARK Duplocillin Vet Benzathine benzylpenicillin 150,000 IU/ml Intervet International bv Wim de Körverstraat 35
Procaine benzylpenicillin 150,000 IU/ml PO Box 31
5830 AA Boxmeer
The Netherlands

FINLAND Duplocillin LA Benzathine benzylpenicillin 115 mg/ml Intervet Oy Tuupakantie 7 A


vet inj Procaine benzylpenicillin 150 mg/ml FIN-01740 Vantaa
(150 mg/ml)

FRANCE Uniject Benzathine benzylpenicillin 74 mg/ml Virbac SA 13ème rue — LID


Procaine benzylpenicillin 57 mg/ml BP 27
Dihydrostreptomycin sulphate 64 mg/ml F-06511 Carros Cedex

Duphapen LA Benzathine benzylpenicillin 15 mg/ml Fort Dodge Santé Animal 22-24 Ave Marcel Dassault
Procaine benzylpenicillin 15 mg/ml BP 440
F-37204 Tours Cedex 3

Duplocilline Benzathine benzylpenicillin 150,000 IU/ml Intervet Rue Olivier de Serres


Procaine benzylpenicillin 150,000 IU/ml Angers Technopole
F-49071 Beaucouzé

Dipene 5 + 5 Benzathine benzylpenicillin 100,000 IU/ml Virbac SA 13ème rue — LID


Procaine benzylpenicillin 100,000 IU/ml BP 27
F-06511 Carros Cedex

Shotapen Benzathine benzylpenicillin 100 mg/ml Virbac SA 13ème rue — LID


Procaine benzylpenicillin 100,000 IU/ml BP 27
Dihydrostreptomycin sulphate 16,4 mg/ml F-06511 Carros Cedex

GERMANY Strepdipend Benzathine benzylpenicillin 91,67 mg/ml Serumwerk Bernburg AG Hallesche Landstraße 105b
Suspension ölig Procaine benzylpenicillin 30,0 mg/ml D-06406 Bernburg
Dihydrostreptomycin sulphate
196,4 mg/ml

Strepdipend Benzathine benzylpenicillin 91,67 mg/ml Serumwerk Bernburg AG Hallesche Landstraße 105b
Suspension wässrig Dihydrostreptomycin sulphate D-06406 Bernburg
157,15 mg/ml

Veracin compositum Benzathine benzylpenicillin 76,19 mg/ml Albert Albrecht Hauptstraße 6—8
Procaine benzylpenicillin 120,00 mg/ml GmbH & Co. KG D-88326 Aulendorf
Dihydrostreptomycin sulphate
258,0 mg/ml
Procaine hydrochloride 20,0 mg/ml

Vetripen Depot N Benzathine benzylpenicillin 76,19 mg/ml CEVA Tiergesundheit GmbH Kanzlerstr. 4
Procaine benzylpenicillin 118,69 mg/ml D-40472 Düsseldorf
Dihydrostreptomycin sulphate
263,15 mg/ml

Langzeitpenicillin und Benzathine benzylpenicillin 76,19 mg/ml AniMedica GmbH Im Südfeld 9


Dihydrostreptomycin ad Procaine benzylpenicillin 120,00 mg/ml D-48308 Senden-Bösensell
us. vet Dihydrostreptomycin sulphate
258,0 mg/ml
C 129/32 EN Official Journal of the European Union 3.6.2003

Member State Product trade name Strength Company name Address

GERMANY Belamycin 300 Benzathine benzylpenicillin 127,0 mg/ml Bela-Pharm Lohner Str. 19
(cont’d) Procaine benzylpenicillin 149,9 mg/ml D-49377 Vechta

GREECE Fatromiycine — S Benzathine benzylpenicillin 150,000 IU/ml Fatro SpA Via Emilia 285
Procaine benzylpenicillin 150,000 IU/ml I-40064 Ozzano dell'Emilia —
Dihydrostreptomycin sulphate 200 mg/ml Bologna

Hipracillin retard Benzathine benzylpenicillin 100,000 IU/ml Laboratorios HIPRA SA Av. La Selva 135
Procaine benzylpenicillin 100,000 IU/ml E-17170 Amer (Girona)
Dihydrostreptomycin sulphate 250 mg/ml

IRELAND Norocillin LA Benzathine benzylpenicillin 112,5 mg/ml Norbrook Laboratories 105 Armagh Road
Procaine benzylpenicillin 150,0 mg/ml Limited Newry BT35 6PU
County Down
Northern Ireland

Duphapen LA Benzathine benzylpenicillin 112,5 mg/ml Fort Dodge Animal Health Flanders Road
Procaine benzylpenicillin 150,0 mg/ml Limited Hedge End
Southampton SO30 4QH
United Kingdom

ITALY Rubrocillina Benzathine benzylpenicillin 250,000 IU/ml Gellini Inter- Via Walter Tobagi, 7
Forte Veterinaria Dihydrostreptomycin sulphate 100 mg/ml national & Intervet Italy I-20068 Peschiera
Borromeo (MI)

Liquicil Liquicil 5 + 5: A.C.R.A.F. SpA — Aziende P.le della Stazione snc


(3 different pack sizes all Benzathine benzylpenicillin 200,000 IU/ml Chimiche Riunite Angelini I-00040 S. Palomba-Pomezia
with same strength) Streptomycin sulphate 200 mg/ml Francesco — Roma
Liquicil 20 + 20:
Benzathine benzylpenicillin 200,000 IU/ml
Streptomycin sulphate 200 mg/ml
Liquicil 50 + 50:
Benzathine benzylpenicillin 200,000 IU/ml
Streptomycin sulphate 200 mg/ml

Ritardomicina Benzathine benzylpenicillin Azienda Farmaceutica Via A. De Gasperi 47


6,000,000 IU/ml Italiana Srl I-21040 Sumirago (VA)
Dihydrostreptomycin sulphate 20 mg/ml
Streptomycin sulphate 20 mg/ml

Fatromicina Ritardo Strength 1 + 1: Fatro SpA Via Emilia 285


(3 strengths) Benzathine benzylpenicillin 5 000 IU/ml I-40064 Ozzano dell'Emilia —
Sodium benzylpenicillin 30,000 IU/ml Bologna
Procaine benzylpenicillin 20,000 IU/ml
Dihydrostreptomycin sulphate
133,5 mg/ml
Strength 3 + 2,5:
Benzathine benzylpenicillin 150,000 IU/ml
Sodium benzylpenicillin 75,000 IU/ml
Procaine benzylpenicillin 75,000 IU/ml
Dihydrostreptomycin sulphate
333,7 mg/ml
Strength 6 + 5:
Benzathine benzylpenicillin 150,000 IU/ml
Sodium benzylpenicillin 90,000 IU/ml
Procaine benzylpenicillin 60,000 IU/ml
Dihydrostreptomycin sulphate
333,75 mg/ml
3.6.2003 EN Official Journal of the European Union C 129/33

Member State Product trade name Strength Company name Address

ITALY Lugabiotic Flacone 1 + 1: Fatro SpA Via Emilia 285


(cont’d) (4 pack sizes — all with Benzathine benzylpenicillin 166,667 IU/ml I-40064 Ozzano dell'Emilia —
same strength) Sodium benzylpenicillin 66,667 IU/ml Bologna
Procaine benzylpenicillin 100,000 IU/ml
Streptomycin sulphate 333 mg/ml
Flacone 3 + 3:
Benzathine benzylpenicillin 166,667 IU/ml
Sodium benzylpenicillin 66,667 IU/ml
Procaine benzylpenicillin 100,000 IU/ml
Streptomycin sulphate 333 mg/ml
Flacone 6 + 6:
Benzathine benzylpenicillin 166,667 IU/ml
Sodium benzylpenicillin 66,667 IU/ml
Procaine benzylpenicillin 100,000 IU/ml
Streptomycin sulphate 333 mg/ml
Flacone 10 + 10:
Benzathine benzylpenicillin 166,667 IU/ml
Sodium benzylpenicillin 66,667 IU/ml
Procaine benzylpenicillin 100,000 IU/ml
Streptomycin sulphate 333 mg/ml

Neotardocillina 12,5 % Benzathine benzylpenicillin 125,000 IU/ml VAAS Industria Chimica Via Siena, 268
Streptomycin sulphate 50 mg/ml Farmaceutica Srl I-47032 Capocolle di
Bertinoro (FC)

Gentaplus Benzathine benzylpenicillin 200,000 IU/ml IZO Via Cremona 282


Gentamicin sulphate 30 mg/ml I-25124 Brescia

Bicormicina LA Benzathine benzylpenicillin 125,000 IU/ml Fatro SpA Via Emilia 285
Procaine benzylpenicillin 125,000 IU/ml I-40064 Ozzano dell'Emilia —
Dihydrostreptomicin sulphate 250 mg/ml Bologna
Dexamethasone sodium phosphate
200 µg/ml
Dexamethasone 21-isonicotinate
200 µg/ml

Liquibiotic iniettabile Tipo 5 + 5 Industria Italiana Integratori Via Pietro Bembo, 12


(3 pack sizes with same Benzathine benzylpenicillin 200,000 IU/ml TREI SpA I-41100 Modena
strength) Streptomycin sulphate 200 mg/ml
Tipo 20 + 20:
Benzathine benzylpenicillin 200,000 IU/ml
Streptomycin sulphate 200 mg/ml
Tipo 50 + 50:
Benzathine benzylpenicillin 200,000 IU/ml
Streptomycin sulphate 200 mg/ml

LUXEMBOURG Duplocilline LA inj. Benzathine benzylpenicillin 150,000 IU/ml Intervet International BV Ragheno Park
Procaine benzylpenicillin 150,000 IU/ml (NL) Dellingstraat 32/1
B-2800 Mechelen

Duphapen LA inj. Benzathine benzylpenicillin 600,000 IU/ml Fort Dodge Animal Health Van Houten Industriepark 25
Benelux BV 1381 MZ Weesp
The Netherlands

NETHERLANDS

PORTUGAL Bicormicina LA Benzathine benzylpenicillin 125,000 IU/ml Univete — Técnica Pécuária Rua D. Jerónimo
Procaine benzylpenicillin 125,000 IU/ml Comércio e Indústria, Lda Osório, 5-B
Dihydrostreptomicin sulphate 250 mg/ml P-1400-119 Lisboa
Dexamethasone sodium phosphate
200 µg/ml
Dexamethasone 21-isonicotinate
200 µg/ml
C 129/34 EN Official Journal of the European Union 3.6.2003

Member State Product trade name Strength Company name Address

PORTUGAL Duplocilina LA 150,000 IU/ml Intervet Portugal Saúde Estrada Nacional 249
(cont’d) Animal Km 14,2
Mem Martins

Peni-Kel LA 150,000 IU/ml Kela Laboratória NV St. Lenaartseweg 48


B-2320 Hoogstraten

Shotapen LA 100,000 IU/ml Virbac España SA Angel Guimerá 179 a 181


E-08950 Esplugues de
Llobregat, Barcelona

SPAIN Ivensalpen retardado Benzathine benzylpenicillin 200,000 IU/ml Laboratorios e Industrias Luis I, 56-58
Procaine benzylpenicillin 40,000 IU/ml IVEN, SA Polígono Industrial De
Benzylpenicillin 60,000 IU/ml Vallecas
E-28031 Madrid

Ivensalpen E Benzathine benzylpenicillin 50,000 IU/ml Laboratorios e Industrias Luis I, 56-58


(Ivensalpen sulfamidico) Procaine benzylpenicillin 50,000 IU/ml IVEN, SA Polígono Industrial De
Sulphamethoxypiridazine 200 mg/ml Vallecas
E-28031 Madrid

Zoobencil Estrepto 1 (Same composition as Zoobencil Estrepto Vétoquinol Especialidades Edificio Italia
(Product currently 2, different volume.) Veterinarias, SA Parque Empresarial San
suspended) Fernando
E-28830 San Fernando de
Henares, Madrid

Zoobencil Estrepto 2 Benzathine benzylpenicillin Vétoquinol Especialidades Edificio Italia


2,000,000 IU/ml Veterinarias, SA Parque Empresarial San
Streptomycin (sulphate) 200 mg/ml Fernando
E-28830 San Fernando de
Henares, Madrid

Zoobencil B12 Benzathine benzylpenicillin Vétoquinol Especialidades Edificio Italia


3,000,000 IU/ml Veterinarias, SA Parque Empresarial San
Vitamin B12: 37,5 µg/ml Fernando
E-28830 San Fernando de
Henares, Madrid

Dipen Suspensión retard Benzathine benzylpenicillin 100,000 IU/ml Chemical Iberica Crta Burgos-Portugal
Procaine benzylpenicillin 100,000 IU/ml km. 256
Dihydrostreptomycin 250 mg/ml E-37448 Calzada de Don
Diego, Salamanca

Hiprabenzatina — 1 Benzathine benzylpenicillin Laboratorios HIPRA SA Avda. La Selva, 135


1,000,000 IU/ml E-17170 Amer (Girona)
Dihydroxystreptomycin 1 000 mg/ml

Hipracilina retard Benzathine benzylpenicillin 100,000 IU/ml Laboratorios HIPRA SA Avda. La Selva, 135
Procaine benzylpenicillin 100,000 IU/ml E-17170 Amer (Girona)
Dihydrostreptomycin (sulphate) 50 mg/ml

Dipenisol retard Benzathine benzylpenicillin 100,000 IU/ml Química Farmacéutica Calabria, 268
Procaine benzylpenicillin 100,000 IU/ml Bayer, SA E-08029 Barcelona
Dihydrostreptomycin (sulphate)
200 mg/ml
3.6.2003 EN Official Journal of the European Union C 129/35

Member State Product trade name Strength Company name Address

SPAIN Shotapen LA 250 Benzathine benzylpenicillin 100,000 IU/ml Virbac España SA Angel Guimerá, 179-181
(cont’d) Procaine benzylpenicillin 100,000 IU/ml E-08950 Esplugues de
Dihydrostreptomycin (sulphate) Llobregat, Barcelona
200 mg/ml

Benzatard Benzathine benzylpenicillin 150,000 IU/ml Laboratorios SYVA, SA Avda. Párroco Pablo Díez,
Procaine benzylpenicillin 150,000 IU/ml 49-57
E-24010 León

Biosuspen retard Benzathine benzylpenicillin 75,000 IU/ml Laboratorios SYVA, SA Avda. Párroco Pablo Díez,
Procaine benzylpenicillin 125,000 IU/ml 49-57
Dihydrostreptomycin (sulphate) E-24010 León
250 mg/ml
Dexamethasone(21-Naphosphate)
250 µg/ml

Biochoc Benzathine benzylpenicillin Laboratorios SYVA, SA Avda. Párroco Pablo Díez,


1,000,000 IU/ml 49-57
Procaine benzylpenicillin 1,000,000 IU/ml E-24010 León
Sodium benzylpenicillin 500,000 IU/ml
Dihydrostreptomycin (sulphate)
5 000 mg/ml

Benzatina E Benzathine benzylpenicillin 75,000 IU/ml Laboratorios Ovejero, SA L-1 Crtra. León-Vilecha, 30
Potassium benzylpenicillin 25,000 IU/ml Apartado 321
Procaine benzylpenicillin 50,000 IU/ml E-24080 León
Streptomycin (sulphate) 250 mg/ml

Cyapen retard Benzathine benzylpenicillin 100,000 IU/ml Virbac España SA Angel Guimerá, 179-181
Procaine benzylpenicillin 100,000 IU/ml E-08950 Esplugues de
Dihydrostreptomycin (sulphate) Llobregat, Barcelona
200 mg/ml

SWEDEN

UNITED Duphapen LA Benzathine benzylpenicillin 112,5 mg/ml Fort Dodge Animal Health Flanders Road
KINGDOM Procaine benzylpenicillin 150,00 mg/ml Limited Hedge End
Southampton SO30 4QH
United Kingdom

Norocillin LA Benzathine benzylpenicillin 112,5 mg/ml Norbrook Laboratories Ltd 105 Armagh Road
Procaine benzylpenicillin 150,00 mg/ml Newry BT35 6PU
County Down
Northern Ireland

ICELAND Duplocillin L.A. vet Benzathine benzylpenicillin 115 mg/ml Intervet International B.V. Lynghals 13
Procaine benzylpenicillin 150 mg/ml IS-110-Reykjavik

NORWAY