List of Products Pending Suspension

20 February 2015
EMA/52196/2015 rev. 1
Procedure Management and Business Support
Products for which the marketing authorisations are

recommended for suspension by the CHMP on 22 January
2015
Some of these medicinal products may be considered critical by the individual EU Member States. The
suspension of the concerned marketing authorisation(s) may be deferred by the period for which the
medicinal product is considered critical.
Article 31 of Directive 2001/83/EC
Procedure number: EMEA/H/A-31/1408
30 Churchill Place Canary Wharf London E14 5EU United Kingdom

Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.
Member State
Marketing Authorisation
(in EEA)
Holder
Austria
Arcana Arzneimittel GmbH
Esomeprazole
Esomeprazol Arcana 20 mg
Huetteldorfer Strae 299
magnesium
magensaftresistente
INN
1140 Wien
Invented name
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule, hard
Hartkapseln
Austria
Austria
Esomeprazole
Esomeprazol Arcana 40 mg
magnesium
magensaftresistente
1140 Wien
40 mg
Gastro - resistant
Oral use
capsule, hard
Hartkapseln
Austria
Austria
Esomeprazole
Neximyl 20 mg
magnesium
magensaftresistente
1140 Wien
20 mg
Gastro - resistant
Oral use
capsule, hard
Hartkapseln
Austria
Austria
Esomeprazole
Neximyl 40 mg
magnesium
magensaftresistente
1140 Wien
40 mg
Gastro - resistant
Oral use
capsule, hard
Hartkapseln
Austria
Austria
Candesartan
Candesartan Arcana 4mg
cilexetil
Tabletten
Candesartan
cilexetil
Tabletten
4 mg
Tablet
Oral use
8mg
Tablet
Oral use
1140 Wien
Austria
Austria
1140 Wien
Austria
GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015
Page 2/131
Member State
(in EEA)
Holder
Austria
Candesartan
cilexetil
Tabletten
Candesartan
cilexetil
Tabletten
Nebivolol
Nebivolol Genericon 5 mg
INN
Invented name
Pharmaceutical
Route of
Form
administration
16 mg
Tablet
Oral use
32 mg
Tablet
Oral use
5 mg
Tablet
Oral use
2,5 mg
Orodispersible
Oral use
Strength
1140 Wien
Austria
Austria
1140 Wien
Austria
Austria
Genericon Pharma GmbH

Hafnerstr. 211
Tabletten
8054 Graz
Austria
Austria
ratiopharm Arzneimittei-
Desloratadine
Vertriebs-GmbH
Desloratadin ratiopharm
2,5 mg Schmelztabletten
tablet
Albert-Schweitzer-Gasse 3
1140 Wien
Austria
Austria
ratiopharm Arzneimittei-
Desloratadine
Vertriebs-GmbH
Desloratadin ratiopharm 5
5 mg
mg Schmelztabletten
Orodispersible
Oral use
tablet
Albert-Schweitzer-Gasse 3
1140 Wien
Austria
Belgium
Apotex Europe B.V.
Desloratadine
Desloratadine Apotex
Darwinweg 20
5 mg
Film - coated
Oral use
tablet
NL 2333 CR Leiden
Netherlands
EMA/52196/2015
Page 3/131
Member State
(in EEA)
Holder
Belgium
Mylan bvba/sprl
INN
Donepezil
Invented name
Donepezil Odis Mylan
Strength
5 mg
Terhulpsesteenweg 6A
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Donepezil
Donepezil Odis Mylan
10 mg
Orodispersible
Oral use
tablet
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Repaglinide
Repaglinide Mylan 0,5 mg
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
8 mg
Tablet
Oral use
Pharma
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Repaglinide
Repaglinide Mylan 1 mg
Pharma
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Repaglinide
Repaglinide Mylan 2mg

Pharma
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Candesartan
Candesartan Mylan
1560 Hoeilaart
Belgium
EMA/52196/2015
Page 4/131
Member State
(in EEA)
Holder
Belgium
Mylan bvba/sprl
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Candesartan
Candesartan Mylan
16 mg
Tablet
Oral use
Candesartan
Candesartan Mylan
32 mg
Tablet
Oral use
Esomeprazole
Esomeprazole Mylan
20 mg
Gastro - resistant
Oral use
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
capsule, hard
1560 Hoeilaart
Belgium
Belgium
Mylan bvba/sprl
Esomeprazole
Esomeprazole Mylan
40 mg
Gastro - resistant
Oral use
capsule, hard
1560 Hoeilaart
Belgium
Belgium
Takeda Belgium
Alendronic acid
Alendromono
70 mg
Tablet
Oral use
Desloratadine
Desloratadine Teva
2,5 mg
Orodispersible
Oral use
Gentsesteenweg 615
1080 Brussels
Belgium
Belgium
Teva Pharma Belgium NV

Laarstraat 16
tablet
2610 Wilrijk
Belgium
EMA/52196/2015
Page 5/131
Member State
(in EEA)
Holder
Belgium
Teva Pharma Belgium NV
INN
Desloratadine
Invented name
Desloratadine Teva
Strength
5 mg
Laarstraat 16
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
2610 Wilrijk
Belgium
Bulgaria
Accord Healthcare Limited
Ropinirole
Ropinirole Accord
0,5 mg
Sage House, 319 Pinner Road
Film - coated
Oral use
tablet
North Harrow HA1 4HF

Middlesex
United Kingdom
Bulgaria
Ropinirole
Ropinirole Accord
1 mg
Film - coated
Oral use
tablet

Middlesex
United Kingdom
Bulgaria
Ropinirole
Ropinirole Accord
2 mg
Film - coated
Oral use
tablet

Middlesex
United Kingdom
Bulgaria
Ropinirole
Ropinirole Accord
5 mg
Film - coated
Oral use
tablet

Middlesex
United Kingdom
EMA/52196/2015
Page 6/131
Member State
(in EEA)
Holder
Bulgaria
Alkaloid - INT d.o.o.
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Cefpodoxime
FOXERO
200 mg
Tablet
Oral use
Quetiapine
Aquatiapine
25 mg
Film - coated
Oral use
landrova 4
1231 Ljubljana - rnue
Slovenia
Bulgaria
Aquachim AD
blvd. Prof. Tsvetan Lazarov
tablet
83
Sofia 1582
Bulgaria
Bulgaria
Aquachim AD
Quetiapine
Aquatiapine
100 mg
Film - coated
Oral use
tablet
83
Sofia 1582
Bulgaria
Bulgaria
Aquachim AD
Quetiapine
Aquatiapine
200 mg
Film - coated
Oral use
tablet
83
Sofia 1582
Bulgaria
Bulgaria
Generics (UK) Ltd
Esomeprazole
Station Close, Potters Bar
magnesium
Esopragen
20 mg
Gastro - resistant
Oral use
capsule, hard
Hertfordshire, EN6 1TL

United Kingdom
EMA/52196/2015
Page 7/131
Member State
(in EEA)
Holder
Bulgaria
Generics (UK) Ltd
Esomeprazole
magnesium
INN
Invented name
Esopragen
Strength
40 mg
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule, hard

United Kingdom
Bulgaria
Glenmark Pharmaceuticals
Trimetazidine
s.r.o.
Apstar 35 mg
35 mg
prolonged-release tablets
Prolonged -
Oral use
release tablet
Hvzdova 1716/2b
14078 Praha 4
Czech Republic
Bulgaria
Mylan SAS
Trimetazidine
Trimetazigen MR
35 mg
117 alle des Parcs
Prolonged -
Oral use
release tablet
69792 Saint-Priest Cedex

France
Bulgaria
Neo Balkanika EOOD
Nebivolol
Bivolet
5 mg
Tablet
Oral use
Trimetazidine
Energotrim
35 mg
Prolonged -
Oral use
35 Zemliane Str.
Sofia 1618
Bulgaria
Bulgaria
Sandoz Pharmaceuticals d.d.

Verovskova 57
release tablet
Ljubljana SI-1000
Slovenia
Bulgaria
Tchaikapharma Highquality
Bosentan
Pulmohyperta
Medicines
62,5 mg
Film - coated
Oral use
tablet
1 G. M. Dimitrov Blvd.
Sofia 1172
Bulgaria
EMA/52196/2015
Page 8/131
Member State
(in EEA)
Holder
Bulgaria
Tchaikapharma Highquality
INN
Bosentan
Invented name
Pulmohyperta
Strength
125 mg
Medicines
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
1 G. M. Dimitrov Blvd.
Sofia 1172
Bulgaria
Croatia
Alkaloid d.o.o.
Cefpodoxime
Ulica grada Vukovara 226 F
Rexocef 200 mg filmom
200 mg
obloene tablete
Film - coated
Oral use
tablet
Zagreb 10000
Croatia
Croatia
Belupo, lijekovi i kozmetika
Desloratadine
d.d.
Alerdin 2,5 mg raspadljive
2,5 mg
tablete za usta
Orodispersible
Oral use
tablet
Ulica Danica 5
Koprivnica 48000
Croatia
Croatia
Belupo, lijekovi i kozmetika
Desloratadine
d.d.
Alerdin 5 mg raspadljive
5 mg
tablete za usta
Orodispersible
Oral use
tablet
Ulica Danica 5
Koprivnica 48000
Croatia
Croatia
Fidifarm d.o.o.
Obrtnika 37, Bestovje
Desloratadine
Sinalerg 5 mg filmom
obloene tablete
5 mg
Film - coated
Oral use
tablet
Rakitje 10437
Croatia
EMA/52196/2015
Page 9/131
Member State
(in EEA)
Holder
Croatia
Jadran Galenski Laboratorij
INN
Desloratadine
d.d.
Invented name
Escontral direkt 2,5 mg
Strength
2,5 mg
raspadljiva tableta za usta
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
Svilno 20, Rijeka

51000
Croatia
Croatia
Jadran Galenski Laboratorij
Desloratadine
d.d.
Escontral direkt 5 mg
5 mg
raspadljiva tableta za usta
Orodispersible
Oral use
tablet
Svilno 20, Rijeka

51000
Croatia
Croatia
Croatia
PharmaS d.o.o.
Tramadol/paraceta
Tramadol/Paracetamol
37,5
Film - coated
Radnika cesta 47
mol
PharmaS 37,5 mg/
mg/325 mg
tablet
10 mg
Film - coated
Zagreb 10000
325 mg filmom obloene
Croatia
tablete
PharmaS d.o.o.
Escitalopram
Escitalopram PharmaS 10
Radnika cesta 47
mg filmom
Zagreb 10000
obloene tablete
Oral use
Oral use
tablet
Croatia
Croatia
Sandoz d.o.o.
Trimetazidine
Vazidin 35 mg tablete s
Maksimirska 120
hydrochloride
produljenim oslobaanjem
35 mg
Prolonged -
Oral use
release tablet
Zagreb 10000
Croatia
EMA/52196/2015
Page 10/131
Member State
(in EEA)
Holder
Cyprus
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Alendronic acid
Alendronic Acid Accord
70 mg
Tablet
Oral use
Entacapone
Nobat
200 mg
Film - coated
Oral use

Middlesex
United Kingdom
Cyprus
Delorbis Pharmaceuticals Ltd

17 Athinon Street
tablet
Ergates Industrial Area

2643 Ergates
P.O. Box 28629
2081 Lefkosia
Cyprus
Cyprus
Fair-Med Healthcare GmbH
Valsartan/hydrochl
Planckstrasse 13
orothiazide
Valsartan/Hctz Fair-med
DE-22765 Hamburg
160
Film - coated
mg/12,5
tablet
Oral use
mg
Germany
Cyprus
Generics Pharma Hellas Ltd
Donepezil
577a Vouliagmenis Avenue
hydrochloride
Donepezil/Generics
5 mg
Orodispersible
Oral use
tablet
Argyroupoli
164-51 Athens
Greece
Cyprus
Donepezil
hydrochloride
Donepezil/Generics
10 mg
Orodispersible
Oral use
tablet
Argyroupoli
164-51 Athens
Greece
EMA/52196/2015
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Member State
(in EEA)
Holder
Cyprus
Lambda Therapeutic Limited
Ropinirole
Sage House
hydrochloride
INN
Invented name
Ropinirole Lambda
Strength
0,25 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
319 Pinner Road, North

Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus
Ropinirole
Sage House
hydrochloride
Ropinirole Lambda
0,5 mg
Film - coated
Oral use
tablet

Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus
Ropinirole
Sage House
hydrochloride
Ropinirole Lambda
1 mg
Film - coated
Oral use
tablet

Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus
Ropinirole
Sage House
hydrochloride
Ropinirole Lambda
2 mg
Film - coated
Oral use
tablet

Harrow
Middlesex HA1 4HF
United Kingdom
EMA/52196/2015
Page 12/131
Member State
(in EEA)
Holder
Cyprus
Ropinirole
Sage House
hydrochloride
INN
Invented name
Ropinirole Lambda
Strength
5 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus
Wockhardt UK Limited
Clopidogrel
Ash Road North
hydrochloride
Clopidogrel/Wockhardt
75 mg
Film - coated
Oral use
tablet
Wrexham Industrial Estate

Wrexham LL13 9UF
United Kingdom
Czech Republic
Abbott Laboratories, s.r.o.
Escitalopram
Evropsk 2591/33d
oxalate
Purcema 5 mg
5 mg
Film - coated
Oral use
tablet
160 00 Praha 6 - Hadovka

Office Park
Czech Republic
Czech Republic
Escitalopram
Evropsk 2591/33d
oxalate
Purcema 10 mg
10 mg
Film - coated
Oral use
tablet

Office Park
Czech Republic
Czech Republic
Escitalopram
Evropsk 2591/33d
oxalate
Purcema 15 mg
15 mg
Film - coated
Oral use
tablet

Office Park
Czech Republic
EMA/52196/2015
Page 13/131
Member State
(in EEA)
Holder
Czech Republic
Escitalopram
Evropsk 2591/33d
oxalate
INN
Invented name
Purcema 20 mg
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

Office Park
Czech Republic
Czech Republic
Actavis Group PTC ehf.
Metformin
Metformin Actavis Retard
Reykjavikurvegi 76-78
hydrochloride
500 mg
Metformin
Metformin Actavis Retard
hydrochloride
750 mg
Cefpodoxime
Forexo 200 mg potahovan
500 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjrdur
Iceland
Czech Republic
750 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjrdur
Iceland
Czech Republic

landrova 4
200 mg
tablety
Film - coated
Oral use
tablet

Slovenia
Czech Republic
Alvogen IPCo S.ar.l.
Desloratadine
Rue Heienhaff 5
Desloratadin Alvogen 5 mg
5 mg
potahovan tablety
Film - coated
Oral use
tablet
L-1736 Senningerberg
Luxembourg
Czech Republic
Apotex Europe B.V.
Trimetazidine
Darwinweg 20
dihydrochloride
Apo-trimetazidin 35 mg
35 mg
Prolonged -
Oral use
release tablet
NL 2333 CR Leiden
Netherlands
EMA/52196/2015
Page 14/131
Member State
(in EEA)
Holder
Czech Republic
Generics (UK) Ltd
Esomeprazole
magnesium
INN
Invented name
Esomylan 40 mg
Strength
40 mg
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule, hard

United Kingdom
Czech Republic
Generics (UK) Ltd
Rizatriptan
benzoate
Rizatriptan Mylan 5 mg
5 mg
Orodispersible
Oral use
tablet

United Kingdom
Czech Republic
Generics (UK) Ltd
Rizatriptan
benzoate
10 mg
Orodispersible
Oral use
tablet

United Kingdom
Czech Republic
Generics (UK) Ltd
Donepezil
hydrochloride
Donepezil Mylan 10 mg
10 mg
Orodispersible
Oral use
tablet

United Kingdom
Czech Republic
Trimetazidine
Portora 35 mg tablety s
s.r.o.
dihydrochloride
prodlouenm uvolovnm
Desloratadine
Geslora 5 mg
35 mg
Prolonged -
Oral use
release tablet
Hvzdova 1716/2b
14078 Praha 4
Czech Republic
Czech Republic
GNR Czech s.r.o.

Slavojova 579/9
5 mg
Film - coated
Oral use
tablet
128 00 Praha 2
Czech Republic
EMA/52196/2015
Page 15/131
Member State
(in EEA)
Holder
Czech Republic
Labormed-Pharma, SA
INN
Desloratadine
Invented name
Desloratadin Labormed 2,5
Theodor Pallady, 44B
mg tablety dispergovateln
032266 Bucharest
v stech
Strength
2,5 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
Romania
Czech Republic
Labormed-Pharma, SA
Desloratadine
Desloratadin Labormed 5
mg tablety dispergovateln
032266 Bucharest
v stech
5 mg
Orodispersible
Oral use
tablet
Romania
Czech Republic
Mylan SAS
Trimetazidine
Trimetazidin Mylan 35 mg
35 mg
117 alle des Parcs
Prolonged -
Oral use
release tablet

France
Czech Republic
SVUS Pharma a.s.
Desloratadine
Smetanovo nbe 1238/20a
Lotera 5 mg potahovan
5 mg
tablety
Film - coated
Oral use
tablet
500 02 Hradec Krlov

Czech Republic
Denmark
Metformin
Metformin "Actavis PTC"
500 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjrdur
Iceland
Denmark
Metformin
Metformin "Actavis PTC"
750 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjrdur
Iceland
EMA/52196/2015
Page 16/131
Member State
(in EEA)
Holder
Denmark
Bluefish Pharmaceuticals AB
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Fluconazole
Fluconazol "Bluefish"
50 mg
Capsule, hard
Oral use
Fluconazole
150 mg
Capsule, hard
Oral use
Fluconazole
200 mg
Capsule, hard
Oral use
Valsartan/hydrochl
Valsartan/hydrochlorthiazid
160
Film - coated
Oral use
Planckstrasse 13
orothiazide
"Fair-Med"
mg/12,5
tablet
Torsgatan 11
SE-11123 Stockholm
Sweden
Denmark
Torsgatan 11
SE-11123 Stockholm
Sweden
Denmark
Torsgatan 11
SE-11123 Stockholm
Sweden
Denmark
DE-22765 Hamburg
mg
Germany
Denmark
Valsartan/hydrochl
320
Film - coated
Planckstrasse 13
orothiazide
"Fair-Med"
mg/12,5
tablet
DE-22765 Hamburg
Oral use
mg
Germany
Denmark
Valsartan/hydrochl
320 mg/25
Film - coated
Planckstrasse 13
orothiazide
"Fair-Med"
mg
tablet
Oral use
DE-22765 Hamburg
Germany
EMA/52196/2015
Page 17/131
Member State
(in EEA)
Holder
Denmark
Mylan AB
INN
Eletriptan
Invented name
Eletriptan Mylan
Strength
40 mg
PO Box 230 33
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
SE-104 35 Stockholm
Sweden
Denmark
Mylan AB
Esomeprazole
Esomeprazol Mylan
20 mg
PO Box 230 33
Gastro - resistant
Oral use
capsule, hard
SE-104 35 Stockholm
Sweden
Denmark
Mylan AB
Esomeprazole
Esomeprazol Mylan
40 mg
PO Box 230 33
Gastro - resistant
Oral use
capsule, hard
SE-104 35 Stockholm
Sweden
Denmark
Mylan AB
Rizatriptan
Rizatriptan Mylan
10 mg
PO Box 230 33
Orodispersible
Oral use
tablet
SE-104 35 Stockholm
Sweden
Denmark
Stadapharm GmbH
Entacapone
Entacapon STADA
200 mg
Stadastr. 2-18
Film - coated
Oral use
tablet
D-61118 Bad Vilbel

Germany
Estonia

Alendronic acid
ALENDRONIC ACID
70 mg
Tablet
Oral use
ACCORD 70mg

Middlesex
United Kingdom
EMA/52196/2015
Page 18/131
Member State
(in EEA)
Holder
Estonia
INN
Trimetazidine
Invented name
ZIDMETIN
Strength
35 mg
Verovskova 57
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
tablet
Ljubljana SI-1000
Slovenia
Finland
Metformin
Metformin Actavis
500 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjrdur
Iceland
Finland
Metformin
Metformin Actavis
750 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjrdur
Iceland
Finland
Fluconazole
Fluconazol Bluefish
50 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
150 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
200 mg
Capsule, hard
Oral use
Torsgatan 11
SE-11123 Stockholm
Sweden
Finland
Torsgatan 11
SE-11123 Stockholm
Sweden
Finland
Torsgatan 11
SE-11123 Stockholm
Sweden
EMA/52196/2015
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Member State
(in EEA)
Holder
Finland
Mylan AB
INN
Eletriptan
Invented name
Eletriptan Mylan
Strength
40 mg
PO Box 230 33
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
SE-104 35 Stockholm
Sweden
Finland
Mylan AB
Repaglinide
Repaglinid Mylan
0,5 mg
Tablet
Oral use
Repaglinide
Repaglinid Mylan
1 mg
Tablet
Oral use
Repaglinide
Repaglinid Mylan
2 mg
Tablet
Oral use
Valsartan
VALSARTAN ORION
40 mg
Film - coated
Oral use
PO Box 230 33
SE-104 35 Stockholm
Sweden
Finland
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
Finland
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
Finland
Orion Corporation
Orion Pharma
tablet
PO BOX 65
02101 Espoo
Finland
Finland
Orion Corporation
Valsartan
VALSARTAN ORION
Orion Pharma
80 mg
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
EMA/52196/2015
Page 20/131
Member State
(in EEA)
Holder
Finland
Orion Corporation
INN
Valsartan
Invented name
VALSARTAN ORION
Strength
160 mg
Orion Pharma
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Finland
Orion Corporation
Valsartan
VALSARTAN ORION
320 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Finland
ratiopharm GmbH
Desloratadine
Desloratadine Ratiopharm
2,5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm
Germany
Finland
ratiopharm GmbH
Desloratadine
Desloratadine Ratiopharm
5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm
Germany
France
Abbott Products SAS
Escitalopram
42 rue Rouget de Lisle
ESCITALOPRAM ABBOTT
5 mg
5mg, comprim pellicul
Film - coated
Oral use
tablet
92150 Suresnes
France
France
Abbott Products SAS

Escitalopram
ESCITALOPRAM ABBOTT
10 mg
Film - coated
Oral use
tablet
92150 Suresnes
France
EMA/52196/2015
Page 21/131
Member State
(in EEA)
Holder
France
Abbott Products SAS
INN
Escitalopram
Invented name
ESCITALOPRAM ABBOTT
Strength
15 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
92150 Suresnes
France
France
Abbott Products SAS
Escitalopram
ESCITALOPRAM ABBOTT
20 mg
Film - coated
Oral use
tablet
92150 Suresnes
France
France
ACCORD HEALTHCARE France
Ropinirole
SAS
Ropinirole Accord 0,25mg,
0,25 mg
comprim pellicul
Film - coated
Oral use
tablet
45 Rue de Fbg de Roubaix

59000 Lille
France
France
Ropinirole
SAS
Ropinirole Accord 0,5mg,
0,5 mg
comprim pellicul
Film - coated
Oral use
tablet

59000 Lille
France
France

SAS
Ropinirole
Ropinirole Accord 1mg,

comprim pellicul
1 mg
Film - coated
Oral use
tablet

59000 Lille
France
EMA/52196/2015
Page 22/131
Member State
(in EEA)
Holder
France
INN
Ropinirole
SAS
Invented name
Strength
2 mg
comprim pellicul
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

59000 Lille
France
France
Ropinirole
SAS
5 mg
comprim pellicul
Film - coated
Oral use
tablet

59000 Lille
France
France
Brown & Burk UK, Ltd.
Escitalopram
ESCITALOPRAM BROWN 5
5, Marryat Close
mg, comprim pellicul
Hounslow
scable
5 mg
Film - coated
Oral use
tablet
TW4 5DQ Middlesex

United Kingdom
France
Escitalopram
5, Marryat Close
Hounslow
scable
10 mg
Film - coated
Oral use
tablet
TW4 5DQ Middlesex

United Kingdom
France
Escitalopram
5, Marryat Close
Hounslow
scable
15 mg
Film - coated
Oral use
tablet
TW4 5DQ Middlesex

United Kingdom
EMA/52196/2015
Page 23/131
Member State
(in EEA)
Holder
France
INN
Escitalopram
Invented name
5, Marryat Close
Hounslow
scable
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
TW4 5DQ Middlesex

United Kingdom
France
Ebastine
EBASTINE BROWN & BURK
5, Marryat Close
10 mg, comprim
Hounslow
orodispersible
10 mg
Orodispersible
Oral use
tablet
TW4 5DQ Middlesex

United Kingdom
France
France
Cristers
Desloratadine
DESLORATADINE
22, quai Gallini
CRISTERS
92150 Suresnes
5 mg
France
comprim pellicul
Cristers
Ibuprofen
IBUPROFENE CRISTERS
22, quai Gallini
400 mg
92150 Suresnes
comprim pellicul
5 mg
Film - coated
Oral use
tablet
400 mg
Film - coated
Oral use
tablet
France
France
Laboratoires Biogaran
15, boulevard Charles de
Ebastine
EBASTINE BIOGARAN 10
mg comprim pellicul
10 mg
Film - coated
Oral use
tablet
Gaulle
92707 Colombes Cedex
France
EMA/52196/2015
Page 24/131
Member State
(in EEA)
Holder
France
Laboratoires Biogaran
INN
Ebastine
Invented name
EBASTINE BIOGARAN 10
15, boulevard Charles de
mg comprim
Gaulle
orodispersible
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
92707 Colombes Cedex

France
France
Laboratoires GERDA
Desloratadine
DESLORATADINE ARROW
24 rue Erlanger
5 mg
75016 PARIS
comprim pellicul
5 mg
Film - coated
Oral use
tablet
France
France
Medipha Sante
Tramadol/paraceta
TRAMADOL PARACETAMOL
37,5
Film - coated
Les Fjords - Immeuble Oslo
mol
NIALEX 37,5 mg/325 mg
mg/325 mg
tablet
5 mg
Film - coated
19 avenue de Norvge
Oral use
comprim pellicul
91953 Courtaboeuf Cedex

France
France
Medipha Sante
Desloratadine
DESLORATADINE GNR
Les Fjords - Immeuble Oslo
5 mg
19 avenue de Norvge
comprim pellicul
Oral use
tablet
91953 Courtaboeuf Cedex

France
France
Mylan SAS
117 alle des Parcs
Rizatriptan
RIZATRIPTAN MYLAN 5mg,

orodispersible tablet
5 mg
Orodispersible
Oral use
tablet

France
EMA/52196/2015
Page 25/131
Member State
(in EEA)
Holder
France
Mylan SAS
INN
Rizatriptan
117 alle des Parcs
Invented name
RIZATRIPTAN MYLAN 10
Strength
10 mg
mg, orodispersible tablet
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet

France
France
Mylan SAS
Ebastine
117 alle des Parcs
EBASTINE MYLAN 10mg,
10 mg
film-coated tablet
Film - coated
Oral use
tablet

France
France
Mylan SAS
Ebastine
117 alle des Parcs
EBASTINE MYLAN 10mg,
10 mg
Orodispersible
Oral use
tablet

France
France
Mylan SAS
Trimetazidine
TRIMETAZIDINE MYLAN 35
117 alle des Parcs
mg Modified Release
Tablets
35 mg
Modified - release
Oral use
tablet
France
France
Mylan SAS
Candesartan
117 alle des Parcs
CANDESARTAN MYLAN 32
32 mg
Tablet
Oral use
5 mg
Orodispersible
Oral use
mg, comprim secable

France
France
Mylan SAS
117 alle des Parcs
Donepezil
DONEPEZIL MYLAN 5 mg,

tablet

France
EMA/52196/2015
Page 26/131
Member State
(in EEA)
Holder
France
Mylan SAS
INN
Donepezil
117 alle des Parcs
Invented name
DONEPEZIL MYLAN 10
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet

France
France
Mylan SAS
Esomeprazole
117 alle des Parcs
ESOMEPRAZOLE MYLAN
20 mg
PHARMA 20mg, DR capsule
Gastro - resistant
Oral use
capsule, hard

France
France
Mylan SAS
Esomeprazole
117 alle des Parcs
ESOMEPRAZOLE MYLAN
40 mg
PHARMA 40mg, DR capsule
Gastro - resistant
Oral use
capsule, hard

France
France
Mylan SAS
Desmopressin
117 alle des Parcs
DESMOPRESSINE MYLAN
0,06 mg
60 g, orodispersible tablet
Orodispersible
Oral use
tablet

France
France
Mylan SAS
Desmopressin
DESMOPRESSINE MYLAN
117 alle des Parcs
120 g, orodispersible
tablet
0,12 mg
Orodispersible
Oral use
tablet
France
France
Mylan SAS
Desmopressin
DESMOPRESSINE MYLAN
117 alle des Parcs
240 g, orodispersible
tablet
0,24 mg
Orodispersible
Oral use
tablet
France
EMA/52196/2015
Page 27/131
Member State
(in EEA)
Holder
France
Ranbaxy Pharmacie
INN
Aciclovir
Generiques
Invented name
Aciclovir Ranbaxy 800 mg,
Pharmaceutical
Route of
Form
administration
800 mg
Tablet
Oral use
200 mg
Tablet
Oral use
200 mg
Tablet
Oral use
70 mg
Tablet
Oral use
10 mg
Film - coated
Oral use
Strength
comprim
11-15 Quai Dion Bouton

92800 Puteaux
France
France
Ranbaxy Pharmacie
Aciclovir
Generiques
Aciclovir Ranbaxy 200 mg,

comprim

92800 Puteaux
France
France
Ranbaxy Pharmacie
Aciclovir
Generiques
Aciclovir Almus 200 mg,

comprim

92800 Puteaux
France
France
Ranbaxy Pharmacie
Alendronic acid
Generiques
Acide Alendronique
Ranbaxy 70 mg, comprim

92800 Puteaux
France
France
Sanofi Aventis France

1-13 bd Romain Rolland
Ebastine
EBASTINE ZENTIVA 10 mg
comprim pellicul
tablet
75159 Paris Cedex 14

France
EMA/52196/2015
Page 28/131
Member State
(in EEA)
Holder
France
Sanofi Aventis France
INN
Ebastine
1-13 bd Romain Rolland
Invented name
EBASTINE ZENTIVA 10 mg
Strength
10 mg
comprim orodispersible
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
75159 Paris Cedex 14

France
France
Teva Sante
Desloratadine
DESLORATADINE TEVA
Cur Dfense - 100-110
SANTE
Esplanade du Gnral de
5 mg
Gaulle
comprim pellicul
5 mg
Film - coated
Oral use
tablet
92931 La Dfense Cedex

France
France
Venipharm SAS
Ebastine
4 Bureaux de la Colline
EBOUDA 10 mg comprim
10 mg
pellicul
Film - coated
Oral use
tablet
92213 Saint-Cloud
France
France
Venipharm SAS
Ebastine
EBARREN 10 mg comprim
10 mg
pellicul
Film - coated
Oral use
tablet
92213 Saint-Cloud
France
France
Venipharm SAS
Ebastine
EBONDE 10 mg comprim
10 mg
pellicul
Film - coated
Oral use
tablet
92213 Saint-Cloud
France
France
Venipharm SAS
Ebastine
EBONTAN 10 mg comprim
orodispersible
10 mg
Orodispersible
Oral use
tablet
92213 Saint-Cloud
France
EMA/52196/2015
Page 29/131
Member State
(in EEA)
Holder
France
Venipharm SAS
INN
Ebastine
Invented name
Strength
EBACHOI 10 mg comprim
10 mg
orodispersible
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
92213 Saint-Cloud
France
France
Venipharm SAS
Ibuprofen
IBUPROFENE ZYDUS
FRANCE 200 mg comprim
92213 Saint-Cloud
pellicul
200 mg
Film - coated
Oral use
tablet
France
France
Zydus France
Ibuprofen
IBUPROFENE ZYDUS
Zacles Hautes Patures
FRANCE 400 mg comprim
25 Rue des Peupliers
pellicul
400 mg
Film - coated
Oral use
tablet
92752 Nanterre Cedes

France
France
Zydus France
Tramadol/paraceta
TRAMADOL PARACETAMOL
37,5
Film - coated
mol
ZYDUS FRANCE
mg/325 mg
tablet
400 mg
Film - coated
37,5
mg/325 mg comprim
pellicul
Oral use
France
France
Zydus France
Ibuprofen
IBUPROFENE ZF 400 mg
comprim pellicul
Oral use
tablet

France
EMA/52196/2015
Page 30/131
Member State
(in EEA)
Holder
France
Zydus France
INN
Desloratadine
Invented name
DESLORATADINE ZYDUS 5
Strength
5 mg
mg comprim pellicul
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

France
France
Zydus France
Escitalopram
ESCITALOPRAM ZYDUS 5
5 mg
Film - coated
Oral use
tablet

France
France
Zydus France
Escitalopram
scable
10 mg
Film - coated
Oral use
tablet

France
France
Zydus France
Escitalopram
scable
15 mg
Film - coated
Oral use
tablet

France
EMA/52196/2015
Page 31/131
Member State
(in EEA)
Holder
France
Zydus France
INN
Escitalopram
Invented name
scable
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

France
Germany
Alendronic acid
ALENDRONIC ACID
70 mg
Tablet
Oral use
250 mg
Film - coated
Oral use
ACCORD 70MG

Middlesex
United Kingdom
Germany
betapharm Arzneimittel GmbH
Levetiracetam
Kobelweg 95
Levetiracetam beta 250

mg, Filmtabletten
tablet
D-86156 Augsburg
Germany
Germany
Levetiracetam
Kobelweg 95
500 mg
mg, Filmtabletten
Film - coated
Oral use
tablet
D-86156 Augsburg
Germany
Germany
Levetiracetam
Kobelweg 95
750 mg
mg, Filmtabletten
Film - coated
Oral use
tablet
D-86156 Augsburg
Germany
Germany

Kobelweg 95
Levetiracetam

mg, Filmtabeltten
1000 mg
Film - coated
Oral use
tablet
D-86156 Augsburg
Germany
EMA/52196/2015
Page 32/131
Member State
(in EEA)
Holder
Germany
INN
Irbesartan
Planckstrasse 13
Invented name
Irbesartan Tablets
Strength
75 mg
75mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Germany
Irbesartan
Planckstrasse 13
Irbesartan Tablets
150 mg
150mg
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Germany
Irbesartan
Planckstrasse 13
Irbesartan Tablets
300 mg
300 mg
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Germany
Irbesartan/hydroch
Irbesartan HCTZ Fair-Med
150
Film - coated
Planckstrasse 13
lorothiazide
150+12,5 mg Filmtabletten
mg/12,5
tablet
DE-22765 Hamburg
Oral use
mg
Germany
Germany
Irbesartan/hydroch
300
Film - coated
Planckstrasse 13
lorothiazide
300+12,5 mg Filmtabletten
mg/12,5
tablet
DE-22765 Hamburg
Oral use
mg
Germany
Germany
Irbesartan/hydroch
Planckstrasse 13
lorothiazide

300+25 mg Filmtabletten
300 mg/25
Film - coated
mg
tablet
Oral use
DE-22765 Hamburg
Germany
EMA/52196/2015
Page 33/131
Member State
(in EEA)
Holder
Germany
Valsartan/hydrochl
Valsartan/HCTZ Fair-Med
Planckstrasse 13
orothiazide
INN
DE-22765 Hamburg
Pharmaceutical
Route of
Form
administration
160
Film - coated
Oral use
Healthcare 160 mg/12.5
mg/12,5
tablet
mg Filmtabletten
mg
Invented name
Strength
Germany
Germany
Valsartan/hydrochl
320
Film - coated
Planckstrasse 13
orothiazide
Healthcare 320 mg/12,5
mg/12,5
tablet
mg Filmtabletten
mg
DE-22765 Hamburg
Oral use
Germany
Germany
Valsartan/hydrochl
320 mg/25
Film - coated
Planckstrasse 13
orothiazide
Healthcare 320 mg/25 mg
mg
tablet
37,5 mg
Prolonged -
DE-22765 Hamburg
Oral use
Filmtabletten
Germany
Germany
Venlafaxine
Planckstrasse 13
Venlafaxin Fair-Med 37,5

mg Hartkapseln, retardiert
Oral use
release capsule,
DE-22765 Hamburg
hard
Germany
Germany
Venlafaxine
Planckstrasse 13
Venlafaxin Fair-Med 75 mg
75 mg
Hartkapseln, retardiert
Prolonged -
Oral use
release capsule,
DE-22765 Hamburg
hard
Germany
Germany

Planckstrasse 13
Venlafaxine
Venlafaxin Fair-Med 150

mg Hartkapseln, retardiert
DE-22765 Hamburg
150 mg
Prolonged -
Oral use
release capsule,
hard
Germany
EMA/52196/2015
Page 34/131
Member State
(in EEA)
Holder
Germany
INN
Ciprofloxacin
Invented name
Ciprofloxacin Fair-Med
Planckstrasse 13
Healthcare 500 mg
DE-22765 Hamburg
Filmtabletten
Strength
500 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Germany
Germany
Ciprofloxacin
Planckstrasse 13
Healthcare 750 mg
DE-22765 Hamburg
Filmtabletten
750 mg
Film - coated
Oral use
tablet
Germany
Germany
Ciprofloxacin
Planckstrasse 13
Healthcare 250 mg
DE-22765 Hamburg
Filmtabletten
250 mg
Film - coated
Oral use
tablet
Germany
Germany
Heumann Pharma GmbH &
Irbesartan
Co. Generica KG
Irbesartan Heumann 75
75 mg
mg Filmtabletten
Film - coated
Oral use
tablet
Sdwestpark 50
90449 Nrnberg
Germany
Germany

Co. Generica KG
Irbesartan

mg Filmtabletten
150 mg
Film - coated
Oral use
tablet
Sdwestpark 50
90449 Nrnberg
Germany
EMA/52196/2015
Page 35/131
Member State
(in EEA)
Holder
Germany
INN
Irbesartan
Co. Generica KG
Invented name
Strength
300 mg
mg Filmtabletten
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Sdwestpark 50
90449 Nrnberg
Germany
Germany
Irbesartan/hydroch
Irbesartan/Hydrochlorothia
150
Film - coated
Co. Generica KG
lorothiazide
zid Heumann 150 mg/12.5
mg/12,5
tablet
mg Filmtabletten
mg
Sdwestpark 50
Oral use
90449 Nrnberg
Germany
Germany
Irbesartan/hydroch
300
Film - coated
Co. Generica KG
lorothiazide
zid Heumann 300 mg/12.5
mg/12,5
tablet
mg Filmtabletten
mg
Sdwestpark 50
Oral use
90449 Nrnberg
Germany
Germany
Irbesartan/hydroch
300 mg/25
Film - coated
Co. Generica KG
lorothiazide
zid Heumann 300 mg/25
mg
tablet
200 mg
Film - coated
Sdwestpark 50
Oral use
mg Filmtabletten
90449 Nrnberg
Germany
Germany
Hormosan Pharma GmbH
Cefpodoxime
Cefpodoxim-
Wilhelmshoeher Str. 106
proxetil
Hormosan
D-60389 Frankfurt
200mg
06 Hessen
Filmtabletten
Oral use
tablet
Germany
EMA/52196/2015
Page 36/131
Member State
(in EEA)
Holder
Germany
Lupin (Europe) Limited
Trimetazidine
Lupamadazine 35 mg
Victoria Court, Bexton Road
hydrochloride
Retardtabletten
Escitalopram
Escitalopram-Micro Labs 5
INN
Invented name
Strength
35 mg
Pharmaceutical
Route of
Form
administration
Controlled -
Oral use
release tablet
Knutsford, Cheshire WA16

0PF
United Kingdom
Germany
Micro Labs GmbH

Lyoner Str. 14
5 mg
mg Filmtabletten
Film - coated
Oral use
tablet
D-60528 Frankfurt/Main
Germany
Germany
Micro Labs GmbH
Escitalopram
Lyoner Str. 14
10 mg
mg Filmtabletten
Film - coated
Oral use
tablet
Germany
Germany
Micro Labs GmbH
Escitalopram
Lyoner Str. 14
15 mg
mg Filmtabletten
Film - coated
Oral use
tablet
Germany
Germany
Micro Labs GmbH
Escitalopram
Lyoner Str. 14
20 mg
mg Filmtabletten
Film - coated
Oral use
tablet
Germany
Germany
Mylan dura GmBh

Wittichstrasse 6
Repaglinide
Repaglinid Mylan 0,5 mg
0,5 mg
Tablet
Oral use
Tabletten
64295 Darmstadt
Germany
EMA/52196/2015
Page 37/131
Member State
(in EEA)
Holder
Germany
Mylan dura GmBh
INN
Repaglinide
Wittichstrasse 6
Invented name
Repaglinid Mylan 1 mg
Pharmaceutical
Route of
Form
administration
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
5 mg
Orodispersible
Oral use
Strength
Tabletten
64295 Darmstadt
Germany
Germany
Mylan dura GmBh
Repaglinide
Wittichstrasse 6
Repaglinid Mylan 2 mg
Tabletten
64295 Darmstadt
Germany
Germany
Mylan dura GmBh
Rizatriptan
Wittichstrasse 6
Rizatriptan Mylan dura 5

mg Schmelztabletten
tablet
64295 Darmstadt
Germany
Germany
Mylan dura GmBh
Rizatriptan
Wittichstrasse 6
Rizatriptan Mylan dura 10
10 mg
mg Schmelztabletten
Orodispersible
Oral use
tablet
64295 Darmstadt
Germany
Germany
Panacea Biotec Germany
Tacrolimus
Tacpan 0.5 mg Hartkapseln
0,5 mg
Capsule, hard
Oral use
Tacrolimus
Tacpan 1 mg Hartkapseln
1 mg
Capsule, hard
Oral use
GmbH
Landshuter Allee 8-10
D-80637 Mnchen
Germany
Germany

GmbH
D-80637 Mnchen
Germany
EMA/52196/2015
Page 38/131
Member State
(in EEA)
Holder
Germany
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Tacrolimus
Tacpan 5 mg Hartkapseln
5 mg
Capsule, hard
Oral use
Entacapone
Entacapon STADA 200 mg
200 mg
Film - coated
Oral use
GmbH
D-80637 Mnchen
Germany
Germany
Stadapharm GmbH
Stadastr. 2-18
Filmtabletten
tablet
D-61118 Bad Vilbel

Germany
Germany
Unichem Laboratories Ltd.
Irbesartan
Studio 8B Ard Gaoithe
Irbesartan Unichem 150
150 mg
mg Filmtabletten
Film - coated
Oral use
tablet
Commercial Centre, Business

Park
Cashel Road Clonmel,
Co Tipperary
Ireland
Germany

Irbesartan

mg Filmtabletten
300 mg
Film - coated
Oral use
tablet

Park
Co Tipperary
Ireland
EMA/52196/2015
Page 39/131
Member State
(in EEA)
Holder
Germany
Welding GmbH & Co. KG
Irbesartan/hydroch
Irbesartan +
Esplanade 39
lorothiazide
Hidroclorotiazida Welding
INN
Invented name
D-20354 Hamburg
Pharmaceutical
Route of
Form
administration
300
Film - coated
Oral use
mg/12,5
tablet
Strength
mg
Germany
Germany
Irbesartan/hydroch
Irbesartan +
150
Film - coated
Esplanade 39
lorothiazide
mg/12,5
tablet
D-20354 Hamburg
Oral use
mg
Germany
Germany
Irbesartan/hydroch
Irbesartan +
300 mg/25
Film - coated
Esplanade 39
lorothiazide
mg
tablet
Irbesartan
Irbesartan Welding
75 mg
Film - coated
Oral use
D-20354 Hamburg
Germany
Germany

Esplanade 39
Oral use
tablet
D-20354 Hamburg
Germany
Germany
Irbesartan
Irbesartan Welding
150 mg
Esplanade 39
Film - coated
Oral use
tablet
D-20354 Hamburg
Germany
Germany
Irbesartan
Irbesartan Welding
Esplanade 39
300 mg
Film - coated
Oral use
tablet
D-20354 Hamburg
Germany
EMA/52196/2015
Page 40/131
Member State
(in EEA)
Holder
Greece
Abbott Laboratories
Escitalopram
Hellas
oxalate
INN
Invented name
Savandra
Strength
5 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Agiou Dimitriou 63
Alimos 17456
Greece
Greece
Abbott Laboratories
Escitalopram
Hellas
oxalate
Savandra
10 mg
Film - coated
Oral use
tablet
Agiou Dimitriou 63
Alimos 17456
Greece
Greece
Abbott Laboratories
Escitalopram
Hellas
oxalate
Savandra
15 mg
Film - coated
Oral use
tablet
Agiou Dimitriou 63
Alimos 17456
Greece
Greece
Abbott Laboratories
Escitalopram
Hellas
oxalate
Savandra
20 mg
Film - coated
Oral use
tablet
Agiou Dimitriou 63
Alimos 17456
Greece
Greece
Genepharm S.A.
Desloratadine
Desloratadine/Genepharm
18 Km Marathon Avenue,
5 mg
15351 Pallini
5 mg
Film - coated
Oral use
tablet
Greece
EMA/52196/2015
Page 41/131
Member State
(in EEA)
Holder
Greece
Genepharm S.A.
INN
Desloratadine
Invented name
2,5 mg
15351 Pallini
Strength
2,5 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
Greece
Greece
Genepharm S.A.
Desloratadine
5 mg
15351 Pallini
5 mg
Orodispersible
Oral use
tablet
Greece
Greece
Donepezil
hydrochloride
Donepezil/ Generics
5 mg
Orodispersible
Oral use
tablet
Argyroupoli
164-51 Athens
Greece
Greece
Donepezil
hydrochloride
Donepezil/ Generics
10 mg
Orodispersible
Oral use
tablet
Argyroupoli
164-51 Athens
Greece
Greece
Esomeprazole
magnesium
Esomeprazole/ Generics
40 mg
Prolonged -
Oral use
release capsule
Argyroupoli
164-51 Athens
Greece
EMA/52196/2015
Page 42/131
Member State
(in EEA)
Holder
Greece
Sieger Pharma A.E.
INN
Desloratadine
Invented name
Desloratadine/Sieger
Strength
5 mg
Marathonos Avenue 106
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Pikermi 19009
Greece
Greece
Sieger Pharma A.E.
Desloratadine
2,5 mg
Orodispersible
Oral use
tablet
Pikermi 19009
Greece
Greece
Sieger Pharma A.E.
Desloratadine
5 mg
Orodispersible
Oral use
tablet
Pikermi 19009
Greece
Hungary
Metformin
Gluforlyn XR 500 mg
hydrochloride
retard tabletta
Desloratadine
Alvotadin 5 mg filmtabletta
500 mg
Prolonged -
Oral use
release tablet
220 Hafnarfjrdur
Iceland
Hungary
5 mg
Rue Heienhaff 5
Film - coated
Oral use
tablet
Luxembourg
Hungary

Rue Heienhaff 5
Desloratadine
Alvotadin 2.5 mg szjban

diszpergld tabletta
2,5 mg
Orodispersible
Oral use
tablet
Luxembourg
EMA/52196/2015
Page 43/131
Member State
(in EEA)
Holder
Hungary
INN
Desloratadine
Rue Heienhaff 5
Invented name
Alvotadin 5 mg szjban
Strength
5 mg
diszpergld tabletta
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
Luxembourg
Hungary
Generics (UK) Ltd
Esomeprazole
magnesium
Esomeprazol Mylan 20 mg
20 mg
gyomornedv-ellenll
Gastro - resistant
Oral use
capsule, hard
kemny kapszula
United Kingdom
Hungary
Generics (UK) Ltd
Esomeprazole
magnesium
40 mg
gyomornedv-ellenll
Gastro - resistant
Oral use
capsule, hard
kemny kapszula
United Kingdom
Hungary
Trimetazidine
Apstar 35 mg retard
s.r.o.
dihydrochloride
tabletta
Desloratadine
Inaller 5 mg filmtabletta
35 mg
Prolonged -
Oral use
release tablet
Hvzdova 1716/2b
14078 Praha 4
Czech Republic
Hungary
Goodwill Pharma Kft.
5 mg
H-6724 Szeged
Film - coated
Oral use
tablet
Cserzy Mihly u. 32.

Hungary
Hungary
Mylan SAS
117 alle des Parcs
Trimetazidine
Trimetazidine Mylan 35 mg
retard tabletta
35 mg
Prolonged -
Oral use
release tablet

France
EMA/52196/2015
Page 44/131
Member State
(in EEA)
Holder
Hungary
Sandoz Hungria Kft.
Trimetazidine
Trimetazidine Sandoz 35
H-1114 Budapest
dihydrochloride
mg retard tabletta
Desloratadine
Desloratadin Teva 2.5 mg
INN
Invented name
Strength
35 mg
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
release tablet
Bartk Bla t 43-47.

Hungary
Hungary
Teva Gygyszergyr Zrt.

H-4042 Debrecen
szjban diszpergld
Pallagi t 13.
tabletta
2,5 mg
Orodispersible
Oral use
tablet
Hungary
Hungary
Teva Gygyszergyr Zrt.
Desloratadine
Desloratadin Teva 5 mg
H-4042 Debrecen
szjban diszpergld
Pallagi t 13.
tabletta
5 mg
Orodispersible
Oral use
tablet
Hungary
Iceland
ratiopharm GmbH
Desloratadine
Desloratadine ratiopharm
5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm
Germany
Ireland
Ropinirole
Ropinirole 0.25 mg Film-
hydrochloride
coated Tablets
Ropinirole
Ropinirole 0.5 mg Film-
hydrochloride
coated Tablets
0,25 mg
Film - coated
Oral use
tablet

Middlesex
United Kingdom
Ireland
0,5 mg
Film - coated
Oral use
tablet

Middlesex
United Kingdom
EMA/52196/2015
Page 45/131
Member State
(in EEA)
Holder
Ireland
Ropinirole
Ropinirole 1 mg Film-
hydrochloride
coated Tablets
Ropinirole
hydrochloride
coated Tablets
Ropinirole
hydrochloride
coated Tablets
Alendronic acid
Alendronic Acid Once
INN
Invented name
Strength
1 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

Middlesex
United Kingdom
Ireland
2 mg
Film - coated
Oral use
tablet

Middlesex
United Kingdom
Ireland
5 mg
Film - coated
Oral use
tablet

Middlesex
United Kingdom
Ireland

70 mg
Tablet
Oral use
Oral use
Weekly 70 mg Tablets

Middlesex
United Kingdom
Ireland
Valsartan/hydrochl
Valsartan/Hydrochlorothiaz
160
Film - coated
Planckstrasse 13
orothiazide
ide Fair-Med 160 mg/12.5
mg/12,5
tablet
mg film-coated tablets.
mg
DE-22765 Hamburg
Germany
EMA/52196/2015
Page 46/131
Member State
(in EEA)
Holder
Ireland
Valsartan/hydrochl
Planckstrasse 13
orothiazide
INN
DE-22765 Hamburg
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
320
Film - coated
tablet
ide Fair-Med 320 mg/12.5
mg/12,5
mg film-coated tablets
mg
320 mg/25
Film - coated
ide Fair-Med 320 mg/25
mg
tablet
120 mg
Film - coated
Germany
Ireland
Valsartan/hydrochl
Planckstrasse 13
orothiazide
DE-22765 Hamburg
Oral use
mg film-coated tablets
Germany
Ireland
Fannin (UK) Ltd
Fexofenadine
Fexofenadine 120 mg film-
42-46 Booth Drive
hydrochloride
coated tablets
Fannin (UK) Ltd
Fexofenadine
Fexofenadine 180 mg film-
42-46 Booth Drive
hydrochloride
coated tablets
Donepezil
Aripil Orotab 5mg
Oral use
tablet
Park Farm South

Wellingborough
Northamptonshire NN8 6GT
United Kingdom
Ireland
180 mg
Film - coated
Oral use
tablet
Park Farm South

Wellingborough
United Kingdom
Ireland
McDermott Laboratories Ltd

t/a Gerard Laboratories
Orodispersible Tablet
5 mg
Orodispersible
Oral use
tablet
35/36 Baldoyle Industrial

Estate
Grange Road
Dublin 13
Ireland
EMA/52196/2015
Page 47/131
Member State
(in EEA)
Holder
Ireland
INN
Donepezil
Invented name
Aripil Orotab 10mg
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet

Estate
Grange Road
Dublin 13
Ireland
Ireland
Esomeprazole
Esomeprazole Mylan 20 mg
Gastro-resistant Capsules,
hard
20 mg
Gastro - resistant
Oral use
capsule
Estate
Grange Road
Dublin 13
Ireland
Ireland
Esomeprazole
Esomeprazole Mylan 40 mg
hard
40 mg
Gastro - resistant
Oral use
capsule
Estate
Grange Road
Dublin 13
Ireland
EMA/52196/2015
Page 48/131
Member State
(in EEA)
Holder
Ireland
INN
Candesartan
Invented name
Candesartan Mylan 4mg
Pharmaceutical
Route of
Form
administration
4 mg
Tablet
Oral use
8 mg
Tablet
Oral use
16 mg
Tablet
Oral use
Strength
Tablets

Estate
Grange Road
Dublin 13
Ireland
Ireland
Candesartan
Candesartan Mylan 8 mg
Tablets

Estate
Grange Road
Dublin 13
Ireland
Ireland

Candesartan
Tablets

Estate
Grange Road
Dublin 13
Ireland
EMA/52196/2015
Page 49/131
Member State
(in EEA)
Holder
Ireland
INN
Candesartan
Invented name
Pharmaceutical
Route of
Form
administration
32 mg
Tablet
Oral use
250 mg
Film - coated
Oral use
Strength
Tablets

Estate
Grange Road
Dublin 13
Ireland
Ireland
Morningside Healthcare
Phenoxymethyl
Phenoxymethylpenicillin
Limited
penicillin
250mg Film-coated Tablets
Amlodipine besilate
Amlodipine Niche 5mg
tablet
115 Narborough Road

Leicester, LE3 0PA
United Kingdom
Ireland
Niche Generics Limited

1 The Cam Centre
5 mg
Tablet
Oral use
10 mg
Tablet
Oral use
150 mg
Film - coated
Oral use
tablets
Wilbury Way, Hitchin

Hertfordshire SG4 0TW
United Kingdom
Ireland
Amlodipine besilate
1 The Cam Centre
Amlodipine Niche 10mg

Tablets

United Kingdom
Ireland

1 The Cam Centre
Irbesartan
Irbesartan Niche 150mg

film coated tablets
tablet

United Kingdom
EMA/52196/2015
Page 50/131
Member State
(in EEA)
Holder
Ireland
INN
Irbesartan
1 The Cam Centre
Invented name
Strength
300 mg
film coated tablets
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

United Kingdom
Ireland
Clopidogrel
Clopidogrel 75mg film-
Ash Road North
hydrochloride
coated tablets
Metoclopramide
METOCLOPRAMIDE
75 mg
Film - coated
Oral use
tablet

Wrexham LL13 9UF
United Kingdom
Italy
Accord Healthcare Italia S.r.l.

Largo Esterle, 4
10 mg
Tablet
Oral use
ACCORD
20052 Monza
Italy
Italy
Alendronic acid
ALENDRONATO AHCL
10 mg
Tablet
Oral use
Alendronic acid
ALENDRONATO AHCL
70 mg
Tablet
Oral use

Middlesex
United Kingdom
Italy

Middlesex
United Kingdom
EMA/52196/2015
Page 51/131
Member State
(in EEA)
Holder
Italy
Doc Generici SRL
INN
Desloratadine
Via Turati, 40
Invented name
DESLORATADINA DOC
Strength
5 mg
GENERICI
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
20121 Milano
Italy
Italy
Doc Generici SRL
Desloratadine
Via Turati, 40
DESLORATADINA DOC
2,5 mg
GENERICI
Orodispersible
Oral use
tablet
20121 Milano
Italy
Italy
Doc Generici SRL
Desloratadine
Via Turati, 40
DESLORATADINA DOC
5 mg
GENERICI
Orodispersible
Oral use
tablet
20121 Milano
Italy
Italy
Farmaceutici Caber S.P.A.
Valsartan
VALSOTEN
40 mg
Viale Citta' D'Europa, 681
Film - coated
Oral use
tablet
00144 Rome
Italy
Italy
Valsartan
VALSOTEN
80 mg
Film - coated
Oral use
tablet
00144 Rome
Italy
Italy
Valsartan
VALSOTEN
160 mg
Film - coated
Oral use
tablet
00144 Rome
Italy
EMA/52196/2015
Page 52/131
Member State
(in EEA)
Holder
Italy
INN
Valsartan
Invented name
VALSOTEN
Strength
320 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
00144 Rome
Italy
Italy
Mylan S.P.A.
Esomeprazole
Via Vittor Pisani, 20
magnesium
ESOMEPRAZOLO MYLAN
20 mg
Gastro - resistant
Oral use
capsule, hard
20124 Milan
Italy
Italy
Mylan S.P.A.
Esomeprazole
magnesium
ESOMEPRAZOLO MYLAN
40 mg
Gastro - resistant
Oral use
capsule, hard
20124 Milan
Italy
Italy
Mylan S.P.A.
Rizatriptan
RIAZATRIPTAN MYLAN
benzoate
GENERICS
Mylan S.P.A.
Rizatriptan
RIAZATRIPTAN MYLAN
benzoate
GENERICS
Mylan S.P.A.
Donepezil
DONEPEZIL MYLAN
hydrochloride
GENERICS ITALIA
5 mg
Orodispersible
Oral use
tablet
20124 Milan
Italy
Italy
10 mg
Orodispersible
Oral use
tablet
20124 Milan
Italy
Italy
5 mg
Orodispersible
Oral use
tablet
20124 Milan
Italy
EMA/52196/2015
Page 53/131
Member State
(in EEA)
Holder
Italy
Mylan S.P.A.
Donepezil
DONEPEZIL MYLAN
hydrochloride
GENERICS ITALIA
Repaglinide
REPAGLINIDE MYLAN
0,5 mg
Tablet
Oral use
Repaglinide
REPAGLINIDE MYLAN
1 mg
Tablet
Oral use
Repaglinide
REPAGLINIDE MYLAN
2 mg
Tablet
Oral use
Alendronic acid
Alendronato Pensa
70 mg
Tablet
Oral use
70 mg
Tablet
Oral use
INN
Invented name
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
20124 Milan
Italy
Italy
Mylan S.P.A.
20124 Milan
Italy
Italy
Mylan S.P.A.
20124 Milan
Italy
Italy
Mylan S.P.A.
20124 Milan
Italy
Italy
Pensa Pharma S.P.A.

Via Rossellini Ippolito, 12
70 mg compresse
20124 Milan
Italy
Italy
Ranbaxy Italia S.P.A.

Piazza Filippo Meda, 4, 3
Alendronic acid
ALENDRONATO RANBAXY
ITALIA
20121 - Milano
Italy
EMA/52196/2015
Page 54/131
Member State
(in EEA)
Holder
Latvia
Trimetazidine
Verovskova 57
dihydrochloride
INN
Invented name
Zidmetin
Strength
35 mg
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
tablet
Ljubljana SI-1000
Slovenia
Lithuania
Alendronic acid
Alendronic acid Accord
70 mg
Tablet
Oral use
Ropinirole
Ropinirole Lambada
0,5 mg
Film - coated
Oral use

Middlesex
United Kingdom
Lithuania

Sage House
tablet

Harrow
Middlesex HA1 4HF
United Kingdom
Lithuania
Ropinirole
Ropinirole Lambada
1 mg
Sage House
Film - coated
Oral use
tablet

Harrow
Middlesex HA1 4HF
United Kingdom
Lithuania
Ropinirole
Ropinirole Lambada
Sage House
2 mg
Film - coated
Oral use
tablet

Harrow
Middlesex HA1 4HF
United Kingdom
EMA/52196/2015
Page 55/131
Member State
(in EEA)
Holder
Lithuania
INN
Ropinirole
Invented name
Ropinirole Lambada
Strength
5 mg
Sage House
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

Harrow
Middlesex HA1 4HF
United Kingdom
Lithuania
Torrent Pharma GmbH
Irbesartan
Irbesartanas Torrent
75 mg
Sdwestpark 50
Film - coated
Oral use
tablet
90449 Nrnberg
Germany
Lithuania
Torrent Pharma GmbH
Irbesartan
150 mg
Sdwestpark 50
Film - coated
Oral use
tablet
90449 Nrnberg
Germany
Lithuania
Torrent Pharma GmbH
Irbesartan
300 mg
Sdwestpark 50
Film - coated
Oral use
tablet
90449 Nrnberg
Germany
Lithuania
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartanas/Hidrochlorotia
150
Film - coated
Sdwestpark 50
lorothiazide
zidas Torrent
mg/12,5
tablet
90449 Nrnberg
Oral use
mg
Germany
Lithuania
Torrent Pharma GmbH
Irbesartan/hydroch
300
Film - coated
Sdwestpark 50
lorothiazide
zidas Torrent
mg/12,5
tablet
90449 Nrnberg
Oral use
mg
Germany
EMA/52196/2015
Page 56/131
Member State
(in EEA)
Holder
Lithuania
Torrent Pharma GmbH
Irbesartan/hydroch
Sdwestpark 50
lorothiazide
Repaglinide
INN
Pharmaceutical
Route of
Form
administration
300 mg/25
Film - coated
Oral use
zidas Torrent
mg
tablet
Repaglinide Mylan Pharma
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
20 mg
Gastro - resistant
Oral use
Invented name
Strength
90449 Nrnberg
Germany
Luxembourg
Mylan bvba/sprl
0,5 mg tabletten
1560 Hoeilaart
Belgium
Luxembourg
Mylan bvba/sprl
Repaglinide

1 mg tabletten
1560 Hoeilaart
Belgium
Luxembourg
Mylan bvba/sprl
Repaglinide

2 mg tabletten
1560 Hoeilaart
Belgium
Luxembourg
Mylan bvba/sprl
Esomeprazole
Esomeprazole Mylan
capsule, hard
1560 Hoeilaart
Belgium
Luxembourg
Mylan bvba/sprl
Esomeprazole
Esomeprazole Mylan
40 mg
Gastro - resistant
Oral use
capsule, hard
1560 Hoeilaart
Belgium
EMA/52196/2015
Page 57/131
Member State
(in EEA)
Holder
Malta
Valsartan/hydrochl
Planckstrasse 13
orothiazide
"Fair-Med" Coated tablets
INN
Invented name
DE-22765 Hamburg
Pharmaceutical
Route of
Form
administration
160
Film - coated
Oral use
mg/12,5
tablet
Strength
mg
Germany
Malta
Valsartan/hydrochl
320
Film - coated
Planckstrasse 13
orothiazide
mg/12,5
tablet
DE-22765 Hamburg
Oral use
mg
Germany
Malta
Valsartan/hydrochl
320 mg/25
Film - coated
Planckstrasse 13
orothiazide
mg
tablet
Ciprofloxacin
250 mg
Film - coated
Oral use
DE-22765 Hamburg
Germany
Malta

Planckstrasse 13
Coated Tablets
Oral use
tablet
DE-22765 Hamburg
Germany
Malta
Ciprofloxacin
Planckstrasse 13
500 mg
Coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Malta

Planckstrasse 13
irbesartan
Irbesartan Fairmed 75mg

Film-coated Tablets
75 mg
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
EMA/52196/2015
Page 58/131
Member State
(in EEA)
Holder
Malta
INN
irbesartan
Planckstrasse 13
Invented name
Strength
150 mg
Film-coated Tablets
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Malta
irbesartan
Planckstrasse 13
300 mg
Film-coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Malta
Malta
Malta
Irbesartan/hydroch
150
Film - coated
Planckstrasse 13
lorothiazide
tablet
zide Fairmed
mg/12,5
DE-22765 Hamburg
150mg/12.5mg film-coated
mg
Germany
tablets
Irbesartan/hydroch
300
Film - coated
Planckstrasse 13
lorothiazide
zide Fairmed
mg/12,5
tablet
DE-22765 Hamburg
300mg/12.5mg film-coated
mg
Germany
tablets
Irbesartan/hydroch
300 mg/25
Film - coated
Planckstrasse 13
lorothiazide
zide Fairmed 300mg/25mg
mg
tablet
37,5 mg
Prolonged -
DE-22765 Hamburg
Oral use
Oral use
Oral use
film-coated tablets
Germany
Malta
Venlafaxine
Venlafaxine Fair-Med
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany
EMA/52196/2015
Page 59/131
Member State
(in EEA)
Holder
Malta
INN
Venlafaxine
Invented name
Strength
75 mg
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Germany
Malta
Venlafaxine
150 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany
Malta
Clopidogrel
Ash Road North
Clopidogrel 75mg Film-
75 mg
coated Tablets
Film - coated
Oral use
tablet

Wrexham LL13 9UF
United Kingdom
Malta
Clopidogrel
Ash Road North
Clopidogrel 75mg Coated
75 mg
Tablets
Film - coated
Oral use
tablet

Wrexham LL13 9UF
United Kingdom
Norway
Fluconazole
Fluconazol Bluefish
50 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
150 mg
Capsule, hard
Oral use
Torsgatan 11
SE-11123 Stockholm
Sweden
Norway
Torsgatan 11
SE-11123 Stockholm
Sweden
EMA/52196/2015
Page 60/131
Member State
(in EEA)
Holder
Norway
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Fluconazole
Fluconazol Bluefish
200 mg
Capsule, hard
Oral use
Esomeprazole
Esomeprazol Mylan
20 mg
Gastro - resistant
Oral use
Torsgatan 11
SE-11123 Stockholm
Sweden
Norway
Mylan AB
PO Box 230 33
capsule, hard
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Esomeprazole
Esomeprazol Mylan
40 mg
PO Box 230 33
Gastro - resistant
Oral use
capsule, hard
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Eletriptan
Eletriptan Mylan
20 mg
PO Box 230 33
Film - coated
Oral use
tablet
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Eletriptan
Eletriptan Mylan
40 mg
PO Box 230 33
Film - coated
Oral use
tablet
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
Kandrozid
4 mg
tablet
Oral use
SE-104 35 Stockholm
Sweden
EMA/52196/2015
Page 61/131
Member State
(in EEA)
Holder
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Kandrozid
8 mg
tablet
Oral use
Kandrozid
16 mg
tablet
Oral use
Kandrozid
32 mg
tablet
Oral use
Mylcande
8 mg
tablet
Oral use
Mylcande
16 mg
tablet
Oral use
Mylcande
32 mg
tablet
Oral use
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm
Sweden
Norway
Mylan AB
Candesartan
PO Box 230 33
cilexetil
SE-104 35 Stockholm
Sweden
EMA/52196/2015
Page 62/131
Member State
(in EEA)
Holder
Norway
Mylan AB
INN
Rizatriptan
PO Box 230 33
Invented name
RIZATRIPTAN MYLAN 10
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
SE-104 35 Stockholm
Sweden
Norway
ratiopharm GmbH
Desloratadine
Desloratadin Ratiopharm
2,5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm
Germany
Norway
ratiopharm GmbH
Desloratadine
Desloratadin Ratiopharm
5 mg
Graf-Arco-Strasse 3
Orodispersible
Oral use
tablet
D-89079 Ulm
Germany
Poland
Abbott Laboratories Poland
Escitalopram
Savandra
5 mg
Sp. z o.o.
Film - coated
Oral use
tablet
ul. Postpu 21B

02-676 Warszawa
Poland
Poland
Escitalopram
Savandra
Sp. z o.o.
10 mg
Film - coated
Oral use
tablet
ul. Postpu 21B

02-676 Warszawa
Poland
EMA/52196/2015
Page 63/131
Member State
(in EEA)
Holder
Poland
INN
Escitalopram
Invented name
Savandra
Strength
15 mg
Sp. z o.o.
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
ul. Postpu 21B

02-676 Warszawa
Poland
Poland
Escitalopram
Savandra
20 mg
Sp. z o.o.
Film - coated
Oral use
tablet
ul. Postpu 21B

02-676 Warszawa
Poland
Poland
Metformin
Metformin SR Actavis
500 mg
Film - coated
Oral use
tablet
220 Hafnarfjrdur
Iceland
Poland
Metformin
Metformin SR Actavis
750 mg
Film - coated
Oral use
tablet
220 Hafnarfjrdur
Iceland
Poland
Adamed Sp. z o.o.
Desloratadine
Desada
5 mg
Piekw 149
Orodispersible
Oral use
tablet
05-152 Czosnw k. Warszawy

Poland
Poland
Adamed Sp. z o.o.
Desloratadine
Hitaxa Fast
Piekw 149
2,5 mg
Orodispersible
Oral use
tablet

Poland
EMA/52196/2015
Page 64/131
Member State
(in EEA)
Holder
Poland
Adamed Sp. z o.o.
INN
Desloratadine
Invented name
Hitaxa
Strength
2,5 mg
Piekw 149
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet

Poland
Poland
Adamed Sp. z o.o.
Desloratadine
Hitaxa
5 mg
Piekw 149
Orodispersible
Oral use
tablet

Poland
Poland
Aflofarm Farmacja Polska Sp.
Desloratadine
Teslor
5 mg
z o.o.
Film - coated
Oral use
tablet
ul. Partyzancka 133/151

95-200 Pabianice
Poland
Poland
Desloratadine
Teslor fast
5 mg
z o.o.
Orodispersible
Oral use
tablet

95-200 Pabianice
Poland
Poland
Desloratadine
Teslor fast junior
z o.o.
2,5 mg
Orodispersible
Oral use
tablet

95-200 Pabianice
Poland
EMA/52196/2015
Page 65/131
Member State
(in EEA)
Holder
Poland
Apotex Europe B.V.
INN
Trimetazidine
Invented name
ApoTrimet PR
Strength
35 mg
Darwinweg 20
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
release tablet
NL 2333 CR Leiden
Netherlands
Poland
Bio-Profil Polska Sp. z o.o.
Desloratadine
Desloratadine Peseri
5 mg
Trakt Lubelski 135
Film - coated
Oral use
tablet
04-790 Warszawa
Poland
Poland
Valsartan/hydrochl
Planckstrasse 13
orothiazide
Valsartan HCT Fair-Med
DE-22765 Hamburg
320
Film - coated
mg/12,5
tablet
Oral use
mg
Germany
Poland
Valsartan/hydrochl
Planckstrasse 13
orothiazide
320 mg/25
Film - coated
mg
tablet
250 mg
Film - coated
Oral use
DE-22765 Hamburg
Germany
Poland
Ciprofloxacin
Planckstrasse 13
Oral use
tablet
DE-22765 Hamburg
Germany
Poland
Ciprofloxacin
Planckstrasse 13
500 mg
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
EMA/52196/2015
Page 66/131
Member State
(in EEA)
Holder
Poland
INN
Irbesartan
Invented name
Irbesartan Fair-Med
Strength
75 mg
Planckstrasse 13
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Poland
Irbesartan
Irbesartan Fair-Med
150 mg
Planckstrasse 13
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Poland
Irbesartan
Irbesartan Fair-Med
300 mg
Planckstrasse 13
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
Poland
Irbesartan/hydroch
Planckstrasse 13
lorothiazide
Irbesartan HCT Fair-Med
DE-22765 Hamburg
150
Film - coated
mg/12,5
tablet
Oral use
mg
Germany
Poland
Irbesartan/hydroch
Planckstrasse 13
lorothiazide
DE-22765 Hamburg
300
Film - coated
mg/12,5
tablet
Oral use
mg
Germany
Poland
Irbesartan/hydroch
Planckstrasse 13
lorothiazide
300 mg/25
Film - coated
mg
tablet
Oral use
DE-22765 Hamburg
Germany
EMA/52196/2015
Page 67/131
Member State
(in EEA)
Holder
Poland
Valsartan/hydrochl
Planckstrasse 13
orothiazide
INN
Invented name
DE-22765 Hamburg
Pharmaceutical
Route of
Form
administration
160
Film - coated
Oral use
mg/12,5
tablet
Strength
mg
Germany
Poland
Venlafaxine
VENLAFAXINE FAIR-MED
37,5 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany
Poland
Venlafaxine
75 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany
Poland
Venlafaxine
150 mg
Prolonged -
Planckstrasse 13
release capsule,
DE-22765 Hamburg
hard
Oral use
Germany
Poland
Generics (UK) Ltd
Candesartan
cilexetil
Kangen
8 mg
Tablet
Oral use
Kangen
16 mg
Tablet
Oral use

United Kingdom
Poland
Generics (UK) Ltd
Candesartan
cilexetil

United Kingdom
EMA/52196/2015
Page 68/131
Member State
(in EEA)
Holder
Poland
Labormed-Pharma, SA
INN
Desloratadine
Invented name
Desloratadine Labormed
Strength
2,5 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
032266 Bucharest
Romania
Poland
Labormed-Pharma, SA
Desloratadine
5 mg
Orodispersible
Oral use
tablet
032266 Bucharest
Romania
Poland
Medicplast Polska Sp. z o.o
Desloratadine
Desalergo
5 mg
ul. Wlczyska 232
Film - coated
Oral use
tablet
01-919 Warszawa
Poland
Poland
Desloratadine
Desalergo
2,5 mg
ul. Wlczyska 232
Orodispersible
Oral use
tablet
01-919 Warszawa
Poland
Poland
Desloratadine
Desalergo
5 mg
ul. Wlczyska 232
Orodispersible
Oral use
tablet
01-919 Warszawa
Poland
Poland
Orion Corporation
Valsartan
Valsartan Orion
Orion Pharma
40 mg
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
EMA/52196/2015
Page 69/131
Member State
(in EEA)
Holder
Poland
Orion Corporation
INN
Valsartan
Invented name
Valsartan Orion
Strength
80 mg
Orion Pharma
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Poland
Orion Corporation
Valsartan
Valsartan Orion
160 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Poland
Orion Corporation
Valsartan
Valsartan Orion
320 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Poland
Peseri Trading Limited
Desloratadine
2,5 mg
20 Queen Frederica Street
Orodispersible
Oral use
tablet
El-Greco House, office 301

1066 Nicosia
Cyprus
Poland
Desloratadine
5 mg
Orodispersible
Oral use
tablet

1066 Nicosia
Cyprus
EMA/52196/2015
Page 70/131
Member State
(in EEA)
Holder
Poland
Ranbaxy (Poland) Sp. z o.o.
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Alendronic acid
Alendran 70
70 mg
Tablet
Oral use
Trimetazidine
Dimesar
35 mg
Prolonged -
Oral use
Kubickiego 11
02-954 Warszawa
Poland
Poland
Sandoz GmbH
Biochemiestrasse 10
release tablet
A-6250 Kundl
Austria
Poland
S-Lab Sp. z o.o.
Desloratadine
Suprodeslon
5 mg
ul. Kieczowska 2
Film - coated
Oral use
tablet
55-095 Mirkw
Poland
Poland
S-Lab Sp. z o.o.
Desloratadine
Suprodeslon
2,5 mg
ul. Kieczowska 2
Orodispersible
Oral use
tablet
55-095 Mirkw
Poland
Poland
S-Lab Sp. z o.o.
Desloratadine
Suprodeslon
5 mg
ul. Kieczowska 2
Orodispersible
Oral use
tablet
55-095 Mirkw
Poland
Poland
SymPhar Sp. z o.o.
Desloratadine
Symdes
ul. Woska 1
5 mg
Film - coated
Oral use
tablet
00-777 Warszawa
Poland
EMA/52196/2015
Page 71/131
Member State
(in EEA)
Holder
Poland
Tactica Pharmaceuticals sp. z
INN
Desloratadine
Invented name
Goldesin
Strength
5 mg
o.o.
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
ul. Bankowa 4
44-100 Gliwice
Poland
Poland
US Pharmacia Sp. z o.o.
Desloratadine
Aleric Deslo
5 mg
ul.Zibicka 40
Film - coated
Oral use
tablet
50-507 Wrocaw
Poland
Poland
Desloratadine
Aleric Deslo
2,5 mg
ul.Zibicka 40
Orodispersible
Oral use
tablet
50-507 Wrocaw
Poland
Poland
Desloratadine
Aleric Deslo Active
5 mg
ul.Zibicka 40
Orodispersible
Oral use
tablet
50-507 Wrocaw
Poland
Poland
Clopidogrel
Clopidogrel Wockhardt
Ash Road North
75 mg
Film - coated
Oral use
tablet

Wrexham LL13 9UF
United Kingdom
EMA/52196/2015
Page 72/131
Member State
(in EEA)
Holder
Portugal
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Alendronic acid
cido alendrnico Accord
70 mg
tablet
Oral use
Cefpodoxime
Cefpodoxima Alkaloid
200 mg
Tablet
Oral use
Tramadol/paraceta
Tramadol + Paracetamol
37,5
Film - coated
Oral use
5, Marryat Close
mol
Brown
mg/325 mg
tablet
Trimetazidine
Trimetazidina Brown
35 mg

Middlesex
United Kingdom
Portugal

landrova 4
Slovenia
Portugal
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal

5, Marryat Close
Modified - release
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal
Escitalopram
Escitalopram Brown
5, Marryat Close
10 mg
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
EMA/52196/2015
Page 73/131
Member State
(in EEA)
Holder
Portugal
INN
Escitalopram
Invented name
Escitalopram Brown
Strength
15 mg
5, Marryat Close
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal
Escitalopram
Escitalopram Brown
5 mg
5, Marryat Close
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal
Escitalopram
Escitalopram Brown
20 mg
5, Marryat Close
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal
Ebastine
Ebastina Brown
10 mg
5, Marryat Close
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal
Ebastine
Ebastina Brown
5, Marryat Close
20 mg
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
EMA/52196/2015
Page 74/131
Member State
(in EEA)
Holder
Portugal
Daquimed - Comrcio de
INN
Quetiapine
Invented name
Quetiapina Daquimed
Strength
25 mg
Produtos Farmacuticos, S.A.
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Av. Associao Comercial e

Industrial de Gondomar, 330
- Zona Industrial da
Portelinha
4510-688 Fnzeres
Portugal
Portugal
Quetiapine
Quetiapina Daquimed
100 mg
Film - coated
Oral use
tablet

Portelinha
4510-688 Fnzeres
Portugal
Portugal
Quetiapine
Quetiapina Daquimed
150 mg
Film - coated
Oral use
tablet

Portelinha
4510-688 Fnzeres
Portugal
EMA/52196/2015
Page 75/131
Member State
(in EEA)
Holder
Portugal
INN
Quetiapine
Invented name
Quetiapina Daquimed
Strength
200 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

Portelinha
4510-688 Fnzeres
Portugal
Portugal
Quetiapine
Quetiapina Daquimed
300 mg
Film - coated
Oral use
tablet

Portelinha
4510-688 Fnzeres
Portugal
Portugal
Generis Farmacutica, S. A.
Levodopa/carbidop
Levodopa + Carbidopa +
50 mg/12,5
Film - coated
Rua Joo de Deus, 19
a/entacapone
Entacapona Generis
mg/200 mg
tablet
Levodopa/carbidop
75
Film - coated
Rua Joo de Deus, 19
a/entacapone
Entacapona Generis
mg/18,75
tablet
Oral use
2700-487 Amadora
Portugal
Portugal
2700-487 Amadora
Oral use
mg/200 mg
Portugal
EMA/52196/2015
Page 76/131
Member State
Pharmaceutical
Route of
(in EEA)
Holder
Form
administration
Portugal
Levodopa/carbidop
100 mg/25
Film - coated
Oral use
Rua Joo de Deus, 19
a/entacapone
Entacapona Generis
mg/200 mg
tablet
Levodopa/carbidop
125
Film - coated
Rua Joo de Deus, 19
a/entacapone
Entacapona Generis
mg/31,250
tablet
INN
Invented name
Strength
2700-487 Amadora
Portugal
Portugal
2700-487 Amadora
Oral use
mg/200 mg
Portugal
Portugal
Levodopa/carbidop
150
Film - coated
Rua Joo de Deus, 19
a/entacapone
Entacapona Generis
mg/37,5
tablet
2700-487 Amadora
Oral use
mg/200 mg
Portugal
Portugal
Levodopa/carbidop
175
Film - coated
Rua Joo de Deus, 19
a/entacapone
Entacapona Generis
mg/43,75
tablet
2700-487 Amadora
Oral use
mg/200 mg
Portugal
Portugal
Levodopa/carbidop
Rua Joo de Deus, 19
a/entacapone
Entacapona Generis
mg/200 mg
200 mg/50
Film - coated
tablet
Entacapone
Entacapona Generis
200 mg
Film - coated
Oral use
2700-487 Amadora
Portugal
Portugal
Rua Joo de Deus, 19
Oral use
tablet
2700-487 Amadora
Portugal
EMA/52196/2015
Page 77/131
Member State
(in EEA)
Holder
Portugal
Labesfal, Genricos, S.A.
INN
Desloratadine
Invented name
Desloratadina Labesfal OD
Strength
2,5 mg
Av. Dr. Afonso Costa, n 1370
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
3465-051 Campo de Besteiros

Portugal
Portugal
Desloratadine
Desloratadina Labesfal OD
5 mg
Orodispersible
Oral use
tablet

Portugal
Portugal
Alendronic acid
cido alendrnico Labesfal
70 mg
tablet
Oral use
Donepezil
Donepezilo Anova
5 mg
Orodispersible
Oral use

Portugal
Portugal
Laboratrios Anova - Produtos

Farmacuticos, Lda.
tablet
Rua Doutor Antnio Loureiro

Borges
Edficio Arquiparque 1, R/C
Esq
1499-016 Algs
Portugal
EMA/52196/2015
Page 78/131
Member State
(in EEA)
Holder
Portugal
INN
Donepezil
Invented name
Donepezilo Anova
Strength
10 mg
Farmacuticos, Lda.
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet

Borges
Esq
1499-016 Algs
Portugal
Portugal
Esomeprazole
Esomeprazol Anova
20 mg
Farmacuticos, Lda.
Gastro - resistant
Oral use
capsule, hard

Borges
Esq
1499-016 Algs
Portugal
Portugal
Esomeprazole
Esomeprazol Anova
Farmacuticos, Lda.
40 mg
Gastro - resistant
Oral use
capsule, hard

Borges
Esq
1499-016 Algs
Portugal
EMA/52196/2015
Page 79/131
Member State
(in EEA)
Holder
Portugal
Laboratrios Azevedos -
INN
Venlafaxine
Invented name
Venlafaxina Azevedos
Strength
37,5 mg
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
Indstria Farmacutica, S.A.
release capsule,
Edifcios Azevedos - Estrada
hard
Nacional 117-2, Alfragide

2614-504 Amadora
Portugal
Portugal
Venlafaxine
75 mg
Prolonged -
release capsule,
hard
Oral use

2614-504 Amadora
Portugal
Portugal
Venlafaxine
150 mg
Prolonged -
release capsule,
hard
Oral use

2614-504 Amadora
Portugal
Portugal
Laboratrios Basi - Indstria
Fluconazole
Fluconazol Basi
50 mg
Capsule
Oral use
Farmacutica, S.A
Parque Industrial Manuel
Loureno Ferreira, Lote 15
3450-232 Mortgua
Portugal
EMA/52196/2015
Page 80/131
Member State
(in EEA)
Holder
Portugal
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Fluconazole
Fluconazol Basi
150 mg
Capsule
Oral use
Fluconazole
Fluconazol Basi
200 mg
Capsule
Oral use
Desloratadine
Desloratadina Labormed
5 mg
Orodispersible
Oral use
Farmacutica, S.A
3450-232 Mortgua
Portugal
Portugal

Farmacutica, S.A
3450-232 Mortgua
Portugal
Portugal
Labormed-Pharma, SA
tablet
032266 Bucharest
Romania
Portugal
Labormed-Pharma, SA
Desloratadine
Desloratadina Labormed
2,5 mg
Orodispersible
Oral use
tablet
032266 Bucharest
Romania
Portugal
Cefpodoxime
Cefpodoxima Lupin
200 mg
Film - coated
Oral use
tablet

0PF
United Kingdom
EMA/52196/2015
Page 81/131
Member State
(in EEA)
Holder
Portugal
Mylan, Lda.
INN
Esomeprazole
Invented name
Esomeprazol Mylan
Strength
20 mg
Parque Expo, Edifcio Atlantis,
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule, hard
Avenida D. Joo II, Lote

1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Esomeprazole
Esomeprazol Mylan
40 mg
Gastro - resistant
Oral use
capsule, hard

1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Atorvastatin
Atorvastatina Anova
10 mg
Film - coated
Oral use
tablet

1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Atorvastatin
Atorvastatina Anova
20 mg
Film - coated
Oral use
tablet

1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
EMA/52196/2015
Page 82/131
Member State
(in EEA)
Holder
Portugal
Mylan, Lda.
INN
Atorvastatin
Invented name
Atorvastatina Anova
Strength
40 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Atorvastatin
Atorvastatina Anova
80 mg
Film - coated
Oral use
tablet

1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Donepezil
Donepezilo Mylan
5 mg
Orodispersible
Oral use
tablet

1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Donepezil
Donepezilo Mylan
10 mg
Orodispersible
Oral use
tablet

1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
EMA/52196/2015
Page 83/131
Member State
(in EEA)
Holder
Portugal
Mylan, Lda.
INN
Trimetazidine
Invented name
Trimetazidina Mylan
Strength
35 mg
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
tablet

1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
Candesartan
Candesartan Mylan
4 mg
Tablet
Oral use
Candesartan
Candesartan Mylan
8 mg
Tablet
Oral use
Candesartan
Candesartan Mylan
16 mg
Tablet
Oral use

1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal
Mylan, Lda.
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
EMA/52196/2015
Page 84/131
Member State
(in EEA)
Holder
Portugal
Mylan, Lda.
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Candesartan
Candesartan Mylan
32 mg
Tablet
Oral use
Desloratadine
Desloratadina Peseri
5 mg
Film - coated
Oral use

1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal

tablet

1066 Nicosia
Cyprus
Portugal
Desloratadine
5 mg
Orodispersible
Oral use
tablet

1066 Nicosia
Cyprus
Portugal
Desloratadine
2,5 mg
Orodispersible
Oral use
tablet

1066 Nicosia
Cyprus
EMA/52196/2015
Page 85/131
Member State
(in EEA)
Holder
Portugal
Pharmakern Portugal -
INN
Trimetazidine
Invented name
Trimetazidina Pharmakern
Strength
35 mg
Produtos Farmacuticos,
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
tablet
Sociedade Unipessoal, Lda.

Edifcio Atlas II, Av. Jos
Gomes Ferreira, N. 11 - 3,
Sala 31 - Miraflores
1495-139 Algs
Portugal
Portugal
Ratiopharm - Comrcio e
Desloratadine
Desloratadina Ratiopharm
2,5 mg
Indstria de Produtos
Orodispersible
Oral use
tablet
Farmacuticos, Lda.
Lagoas Park, Edifcio 5 A, Piso
2
2740-245 Porto Salvo
Portugal
Portugal
Ratiopharm - Comrcio e
Desloratadine
Desloratadina Ratiopharm
Indstria de Produtos
5 mg
Orodispersible
Oral use
tablet
Farmacuticos, Lda.
Lagoas Park, Edifcio 5 A, Piso
2
Portugal
EMA/52196/2015
Page 86/131
Member State
(in EEA)
Holder
Portugal
Sandoz Farmaceutica Lda.
INN
Trimetazidine
Invented name
Trimetazidina Itraxel
Strength
35 mg
Avenida Professor Doutor
Pharmaceutical
Route of
Form
administration
Prolonged -
Oral use
release tablet
Cavaco Silva, n. 10E

Taguspark
Portugal
Portugal
Teva Pharma - Produtos
Desloratadine
Desloratadina Teva
2,5 mg
Farmacuticos,Lda.
Orodispersible
Oral use
tablet
Edificio Tejo, Rua Quinta do

Pinheiro, 16 - 6
2790-143 Carnaxide
Portugal
Portugal
Teva Pharma - Produtos
Desloratadine
Desloratadina Teva
5 mg
Farmacuticos,Lda.
Orodispersible
Oral use
tablet
Edificio Tejo, Rua Quinta do

Pinheiro, 16 - 6
2790-143 Carnaxide
Portugal
Romania
Abbott Products SAS
Escitalopram
SAVANDRA 5 mg
5 mg
comprimate filmate
Film - coated
Oral use
tablet
92150 Suresnes
France
Romania
Abbott Products SAS

Escitalopram
SAVANDRA 10 mg
comprimate filmate
10 mg
Film - coated
Oral use
tablet
92150 Suresnes
France
EMA/52196/2015
Page 87/131
Member State
(in EEA)
Holder
Romania
Abbott Products SAS
INN
Escitalopram
Invented name
SAVANDRA 15 mg
Strength
15 mg
comprimate filmate
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
92150 Suresnes
France
Romania
Abbott Products SAS
Escitalopram
SAVANDRA 20 mg
20 mg
comprimate filmate
Film - coated
Oral use
tablet
92150 Suresnes
France
Romania
Cefpodoxime
landrova 4
Forexo 200 mg
200 mg
Tablet
Oral use
5 mg
Film - coated
Oral use
comprimate filmate

Slovenia
Romania
Desloratadine
Rue Heienhaff 5
Desloratadina Alvogen 5
mg comprimate filmate
tablet
Luxembourg
Romania
Dr. Reddys Laboratories
Levetiracetam
Levetiracetam Dr. Reddys,
Romania SRL
250 mg, comprimate
71st-73rd Nicolae Caramfil,
filmate
250 mg
Tablet
Oral use
500 mg
Tablet
Oral use
Floor 5, Space 10, Sector 1,

Bucuresti, Romania
Romania
Levetiracetam
Romania SRL
500mg, comprimate
filmate

Bucuresti, Romania
EMA/52196/2015
Page 88/131
Member State
(in EEA)
Holder
Romania
INN
Levetiracetam
Invented name
Romania SRL
750 mg, comprimate
filmate
Pharmaceutical
Route of
Form
administration
750 mg
Tablet
Oral use
1000 mg
Tablet
Oral use
40 mg
Tablet
Oral use
80 mg
Tablet
Oral use
Tablet
Oral use
Strength

Bucuresti, Romania
Romania
Levetiracetam
Romania SRL
1000 mg, comprimate
filmate

Bucuresti, Romania
Romania
Telmisartan
Romania SRL
Telmisartan Dr. Reddy's 40

mg comprimate

Bucuresti, Romania
Romania
Telmisartan
Romania SRL
Telmisartan Dr. Reddy's 80

mg comprimate

Bucuresti, Romania
Romania
Telmisartan/
Telmisartan HCT Dr.
40 mg/12,5
Romania SRL
hydrochlorothiazide
Reddys 40 mg/12,5 mg
mg
comprimate

Bucuresti, Romania
EMA/52196/2015
Page 89/131
Member State
(in EEA)
Holder
Romania
Telmisartan/
Telmisartan HCT Dr.
80 mg/12,5
Romania SRL
hydrochlorothiazide
Reddys 80 mg/12,5 mg
mg
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Tablet
Oral use
Tablet
Oral use
Gastro - resistant
Oral use
comprimate

Bucuresti, Romania
Romania
Telmisartan/
Telmisartan HCT Dr.
80 mg/25
Romania SRL
hydrochlorothiazide
Reddys 80 mg/25 mg
mg
comprimate

Bucuresti, Romania
Romania
Generics (UK) Ltd
Esomeprazole
magnesium
capsule gastrorezistente
Generics (UK) Ltd
Esomeprazole
magnesium
capsule gastrorezistente
Generics (UK) Ltd
Donepezil
hydrochloride
comprimate
20 mg
capsule, hard

United Kingdom
Romania
40 mg
Gastro - resistant
Oral use
capsule, hard

United Kingdom
Romania
5 mg
Orodispersible
Oral use
tablet
orodispersabile
United Kingdom
Romania
Generics (UK) Ltd
Donepezil
hydrochloride
comprimate
10 mg
Orodispersible
Oral use
tablet
orodispersabile
United Kingdom
EMA/52196/2015
Page 90/131
Member State
(in EEA)
Holder
Romania
Generics (UK) Ltd
INN
Repaglinide
Invented name
Repaglinida Generics 0.5
Pharmaceutical
Route of
Form
administration
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
4 mg
Tablet
Oral use
8 mg
Tablet
Oral use
16 mg
Tablet
Oral use
Strength
mg comprimate

United Kingdom
Romania
Generics (UK) Ltd
Repaglinide
Repaglinida Genericsl 1 mg
comprimate

United Kingdom
Romania
Generics (UK) Ltd
Repaglinide
Repaglinida Generics 2 mg
comprimate

United Kingdom
Romania
Generics (UK) Ltd
Candesartan
cilexetil
comprimate
Generics (UK) Ltd
Candesartan
cilexetil
comprimate
Generics (UK) Ltd
Candesartan
cilexetil
comprimate

United Kingdom
Romania

United Kingdom
Romania

United Kingdom
EMA/52196/2015
Page 91/131
Member State
(in EEA)
Holder
Romania
Generics (UK) Ltd
Rizatriptan
benzoate
comprimate
INN
Invented name
Strength
5 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
orrodispersabile
United Kingdom
Romania
Generics (UK) Ltd
Rizatriptan
benzoate
comprimate
10 mg
Orodispersible
Oral use
tablet
orrodispersabile
United Kingdom
Romania
Trimetazidine
Apstar 35mg
s.r.o.
Comprimate cu
Hvzdova 1716/2b
eliberare
14078 Praha 4
prelungit
35 mg
Modified - release
Oral use
tablet
Czech Republic
Romania
Labormed Pharma SA
Desloratadine
Bd. Theodor Pallady nr. 44 B
2.5 mg comprimate
032266, sector 3, Bucureti
orodispersabile
2,5 mg
Orodispersible
Oral use
tablet
Romnia
Romania
Labormed Pharma SA
Desloratadine
Desloratadine Labormed 5
Bd. Theodor Pallady nr. 44 B
mg comprimate
032266, sector 3, Bucureti
orodispersabile
5 mg
Orodispersible
Oral use
tablet
Romnia
Romania
Mylan SAS
Trimetazidine
Trimetazidina Mylan 35 mg
117 alle des Parcs
comprimate filmate cu
eliberare prelungita
35 mg
Prolonged -
Oral use
release tablet
France
EMA/52196/2015
Page 92/131
Member State
(in EEA)
Holder
Romania
Sandoz Pharma Services SRL
INN
Trimetazidine
Invented name
Trimeluzine Limited 35 mg
Calea Floreasca Street
comprimate filmate cu
No 169A, district 2
eliberare modificata
Strength
35 mg
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
tablet
Bucharest
Romania
Romania
STADA Hemofarm S.R.L.
Entacapone
Calea Torontalului km 6 -
ENTTANIDA 200
200 mg
comprimate filmate
Film - coated
Oral use
tablet
PITT
300633 Timioara
Romania
Romania
Teva Pharmaceuticals S.R.L.
Desloratadine
Desloratadina Teva 5 mg
Str. Domnia Ruxandra nr.
comprimate
12, parter, sector 2,
orodispersabile
5 mg
Orodispersible
Oral use
tablet
Bucureti, Romnia
Romania
Torrent Pharma SRL
Irbesartan
Irbesartan Torrent 75 mg
Str. Stirbei Voda nr. 36
comprimate
et. 2, biroul A, sector 1
filmate
75 mg
Film - coated
Oral use
tablet
Bucharest
Romania
Romania
Torrent Pharma SRL
Irbesartan
comprimate
filmate
150 mg
Film - coated
Oral use
tablet
Bucharest
Romania
EMA/52196/2015
Page 93/131
Member State
(in EEA)
Holder
Romania
Torrent Pharma SRL
INN
Irbesartan
Invented name
comprimate
filmate
Strength
300 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Bucharest
Romania
Romania
Torrent Pharma SRL
Irbesartan/hydroch
Irbesartan Torrent
150
Film - coated
lorothiazide
Hidrochlorotiazida
mg/12,5
tablet
150/12,5mg comprimate
mg
Bucharest
filmate
Oral use
Romania
Romania
Torrent Pharma SRL
Irbesartan/hydroch
Irbesartan Torrent
300
Film - coated
lorothiazide
tablet
Hidrochlorotiazida
mg/12,5
300/12,5mg comprimate
mg
Bucharest
filmate
Oral use
Romania
Romania
Torrent Pharma SRL
Irbesartan/hydroch
Irbesartan Torrent
300 mg/25
Film - coated
lorothiazide
Hidrochlorotiazida
mg
tablet
200 mg
Film - coated
300/25 mg comprimate
Bucharest
filmate
Oral use
Romania
Slovak Republic

landrova 4
Cefpodoxime
FOREXO 200 mg filmom

obalen tablety
Oral use
tablet

Slovenia
EMA/52196/2015
Page 94/131
Member State
(in EEA)
Holder
Slovak Republic
Alvogen IPCo S.r.l.
INN
Desloratadine
412F Route d'Esch
Invented name
Dezloratadin Alvogen 5 mg
Strength
5 mg
filmom obalen tablety
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
L - 2086
Luxembourg
Slovak Republic
Genericon s.r.o.,
Desloratadine
GESLORA 5 mg
5 mg
Anny Letensk 1108/15,
Film - coated
Oral use
tablet
120 00 Praha 2 - Vinohrady

Czech Republic
Slovak Republic
Generics (UK) Ltd
Donepezil
hydrochloride
orodispergovaten tablety
Generics (UK) Ltd
Donepezil
hydrochloride
orodispergovaten tablety
Generics (UK) Ltd
Rizatriptan
benzoate
5 mg
Orodispersible
Oral use
tablet

United Kingdom
Slovak Republic
10 mg
Orodispersible
Oral use
tablet

United Kingdom
Slovak Republic
10 mg
Orodispersible
Oral use
tablet

United Kingdom
Slovak Republic
s.r.o.
Trimetazidine
Apstar 35 mg tablety s
predenm uvoovanm
35 mg
Modified - release
Oral use
tablet
Hvzdova 1716/2b
14078 Praha 4
Czech Republic
EMA/52196/2015
Page 95/131
Member State
(in EEA)
Holder
Slovak Republic
Mylan SAS
INN
Trimetazidine
Invented name
Trimetazidin Mylan 35 mg
Strength
35 mg
117 alle des Parcs
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
tablet

France
Slovak Republic
SVUS Pharma a.s.
Desloratadine
Smetanovo nbe 1238/20a
LOTERA 5 mg filmom
5 mg
obalen tablety
Film - coated
Oral use
tablet
500 02 Hradec Krlov

Czech Republic
Slovak Republic
Teva Pharmaceuticals
Desloratadine
Slovakia s.r.o.
Dezloratadin Teva OROTAB
2,5 mg
2,5 mg
Orodispersible
Oral use
tablet
Teslova 26
821 02 Bratislava
Slovak Republic
Slovak Republic
Teva Pharmaceuticals
Desloratadine
Slovakia s.r.o.
Dezloratadin Teva OROTAB
5 mg
5 mg
Orodispersible
Oral use
tablet
Teslova 26
821 02 Bratislava
Slovak Republic
Slovenia
Cefpodoxime
landrova 4
Trexodo 200 mg filmsko
200 mg
obloene tablete
Film - coated
Oral use
tablet

Slovenia
Slovenia
Generics (UK) Ltd
Esomeprazole
magnesium
trde gastrorezistentne
20 mg
Gastro - resistant
Oral use
capsule, hard
kapsule
United Kingdom
EMA/52196/2015
Page 96/131
Member State
(in EEA)
Holder
Slovenia
Generics (UK) Ltd
Esomeprazole
magnesium
trde gastrorezistentne
INN
Invented name
Strength
40 mg
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule, hard
kapsule
United Kingdom
Slovenia
Generics (UK) Ltd
Donepezil
hydrochloride
orodisperzibilne tablete
Generics (UK) Ltd
Donepezil
hydrochloride
orodisperzibilne tablete
Lek farmacevtska druba d.d.
Trimetazidine
Trimeluzine 35 mg tablete
Verovkova 57
hydrochloride
s podaljanim sproanjem
Metoclopramide
METOCLOPRAMIDA
5 mg
Orodispersible
Oral use
tablet

United Kingdom
Slovenia
10 mg
Orodispersible
Oral use
tablet

United Kingdom
Slovenia
35 mg
Prolonged -
Oral use
release tablet
1526 Ljubljana
Slovenia
Spain
Accord Healthcare, S.L.U.

Moll de Barcelona s/n. World
ACCORD 10 mg
Trade Center. Edifici Est 6
COMPRIMIDOS EFG
10 mg
Tablet
Oral use
Film - coated
Oral use
planta,
8039 Barcelona
Spain
Spain
Apotex Europe B.V.
Desloratadine
DESLORATADINA APOTEX
Darwinweg 20
5 mg COMPRIMIDOS
NL 2333 CR Leiden
RECUBIERTOS CON
Netherlands
PELICULA EFG
EMA/52196/2015
5 mg
tablet
Page 97/131
Member State
(in EEA)
Holder
Spain
INN
Ebastine
Invented name
EBASTINA BROWN 10 mg
5, Marryat Close
COMPRIMIDOS
Hounslow
BUCODISPERSABLES EFG
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
TW4 5DQ Middlesex

United Kingdom
Spain
Farmalider, S.A.
Valsartan/hydrochl
VALSARTAN/HIDROCLORO
160
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL 160
mg/12,5
tablet
28108 Madrid
MG/12,5 mg
mg
Spain
COMPRIMIDOS
Oral use
RECUBIERTOS CON
PELICULA EFG
Spain
Farmalider, S.A.
Valsartan/hydrochl
160 mg/25
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL
mg
tablet
28108 Madrid
160/25 mg COMPRIMIDOS
Spain
RECUBIERTOS CON
Oral use
PELICULA EFG
Spain
Farmalider, S.A.
Valsartan/hydrochl
320
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL
mg/12,5
tablet
28108 Madrid
320/12.5 mg
mg
Spain
COMPRIMIDOS
Oral use
RECUBIERTOS CON
PELICULA EFG
Spain
Farmalider, S.A.
Valsartan/hydrochl
320 mg/25
Film - coated
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL
mg
tablet
28108 Madrid
320/25 mg COMPRIMIDOS
Spain
RECUBIERTOS CON
Oral use
PELICULA EFG
EMA/52196/2015
Page 98/131
Member State
(in EEA)
Holder
Spain
Farmalider, S.A.
Valsartan/hydrochl
Aragoneses 15
orothiazide
TIAZIDA CODRAMOL
INN
Invented name
28108 Madrid
80/12.5 mg COMPRIMIDOS
Spain
RECUBIERTOS CON
Pharmaceutical
Route of
Form
administration
80 mg/12,5
Film - coated
Oral use
mg
tablet
5 mg
Film - coated
Strength
PELICULA EFG
Spain
Laboratorios Combix, S.L.U.
Desloratadine
DESLORATADINA COMBIX
C/ Badajoz 2, Edificio 2
5 mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELCULA EFG
Oral use
tablet
Spain
Spain
Desloratadine
DESLORATADINA FLAS
COMBIX 5 mg
Pozuelo de Alarcon
COMPRIMIDOS
Madrid 28223
5 mg
Film - coated
Oral use
tablet
Spain
Spain
Escitalopram
ESCITALOPRAM COMBIX
10 mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELICULA EFG
10 mg
Film - coated
Oral use
tablet
Spain
Spain
Escitalopram
ESCITALOPRAM COMBIX
15 mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELICULA EFG
15 mg
Film - coated
Oral use
tablet
Spain
EMA/52196/2015
Page 99/131
Member State
(in EEA)
Holder
Spain
INN
Escitalopram
Invented name
ESCITALOPRAM COMBIX
20 mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELICULA EFG
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Spain
Spain
Escitalopram
ESCITALOPRAM COMBIX 5
mg COMPRIMIDOS
Pozuelo de Alarcon
RECUBIERTOS CON
Madrid 28223
PELICULA EFG
5 mg
Film - coated
Oral use
tablet
Spain
Spain
Laboratorios Ranbaxy, S. L U.
Alendronic acid
ACIDO ALENDRONICO
Paseig de Gracia 9
SEMANAL RANBAXY 70 mg
7a Pl
COMPRIMIDOS EFG
70 mg
Tablet
Oral use
10 mg
Orodispersible
Oral use
Barcelona 08007
Spain
Spain
Mylan Pharmaceuticals, S.L.
Donepezil
Plom 2-4, 5 Planta
PHARMACEUTICALS 10 mg
8038 Barcelona
COMPRIMIDOS
Spain
Spain
DONEPEZILO FLAS MYLAN
tablet
Donepezil
DONEPEZILO FLAS MYLAN
Plom 2-4, 5 Planta
PHARMACEUTICALS 5 mg
8038 Barcelona
COMPRIMIDOS
Spain
EMA/52196/2015
5 mg
Orodispersible
Oral use
tablet
Page 100/131
Member State
(in EEA)
Holder
Spain
INN
Esomeprazole
mg CAPSULAS
8038 Barcelona
GASTRORRESISTENTES
ESOMEPRAZOL MYLAN 40
Plom 2-4, 5 Planta
mg CAPSULAS
8038 Barcelona
GASTRORRESISTENTES
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule
EFG
Esomeprazole
Spain
Spain
ESOMEPRAZOL MYLAN 20
Plom 2-4, 5 Planta

Spain
Spain
Invented name
40 mg
Gastro - resistant
Oral use
capsule
EFG
Repaglinide
Plom 2-4, 5 Planta
REPAGLINIDA MYLAN 0,5
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
10 mg
Orodispersible
Oral use
mg COMPRIMIDOS EFG
8038 Barcelona
Spain
Spain
Repaglinide
Plom 2-4, 5 Planta
REPAGLINIDA MYLAN 1 mg
COMPRIMIDOS EFG
8038 Barcelona
Spain
Spain
Repaglinide
Plom 2-4, 5 Planta
REPAGLINIDA MYLAN 2 mg
COMPRIMIDOS EFG
8038 Barcelona
Spain
Spain
Rizatriptan
RIZATRIPTAN MAX MYLAN
Plom 2-4, 5 Planta
10 mg COMPRIMIDOS
8038 Barcelona
tablet
Spain
EMA/52196/2015
Page 101/131
Member State
(in EEA)
Holder
Spain
PENSA PHARMA, S.A.U
INN
Alendronic acid
Invented name
ACIDO ALENDRONICO
Jorge Comn (mdico
SEMANAL PENSA 70 mg
pediatra)
COMPRIMIDOS EFG
Pharmaceutical
Route of
Form
administration
70 mg
Tablet
Oral use
2,5 mg
Orodispersible
Oral use
Strength
3 - bajos
46015 Valencia (Valencia)
Spain
Spain
Pharmagenus, S.A.,
Desloratadine
DESLORATADINA
Avda. Cam Real, 51-57,
PHARMAGENUS 2,5 mg
08184 Palau-solita i
COMPRIMIDOS
Plegamans (Barcelona)
tablet
Spain
Spain
Pharmagenus, S.A.,
Desloratadine
DESLORATADINA
Avda. Cam Real, 51-57,
PHARMAGENUS 5 mg
08184 Palau-solita i
COMPRIMIDOS
Plegamans (Barcelona)
5 mg
Orodispersible
Oral use
tablet
Spain
Spain
Teva Pharma S.L.U.
Desloratadine
DESLORATADINA TEVA 5
C/ Anabel Segura, 11
mg COMPRIMIDOS
Edificio Albatros B, 1 planta
5 mg
Orodispersible
Oral use
tablet
Madrid 28108
Spain
Spain
Irbesartan
IRBESARTAN/HIDROCLOR
150
Film - coated
Esplanade 39
OTIAZIDA WELDING 150
mg/12,5
tablet
D-20354 Hamburg
mg/12.5 mg
mg
Germany
COMPRIMIDOS
Oral use
RECUBIERTOS CON
PELICULA EFG
EMA/52196/2015
Page 102/131
Member State
(in EEA)
Holder
Spain
INN
Irbesartan
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Oral use
300
Film - coated
Esplanade 39
mg/12,5
tablet
D-20354 Hamburg
mg/12.5 mg
mg
Germany
COMPRIMIDOS
RECUBIERTOS CON
PELICULA EFG
Spain
Irbesartan
300 mg/25
Film - coated
Oral use
Esplanade 39
mg
tablet
D-20354 Hamburg
mg/25 mg COMPRIMIDOS
Germany
RECUBIERTOS CON
70 mg
Tablet
Oral use
Clindamycin Alternova
150 mg
Capsule, hard
Oral use
Fluconazol Bluefish
50 mg
Capsule, hard
Oral use
PELICULA EFG
Sweden
Alendronic acid
Alendronat Accord
Veckotablett

Middlesex
United Kingdom
Sweden
Alternova A/S
Clindamycin
Lodshusvej 11
hydrochloride
DK-4230 Sklskr
Denmark
Sweden
Fluconazole
Torsgatan 11
SE-11123 Stockholm
Sweden
EMA/52196/2015
Page 103/131
Member State
(in EEA)
Holder
Sweden
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Fluconazole
Fluconazol Bluefish
150 mg
Capsule, hard
Oral use
Fluconazole
Fluconazol Bluefish
200 mg
Capsule, hard
Oral use
Generics (UK) Ltd
Donepezil
Donezil
5 mg
Orodispersible
Oral use
hydrochloride
Torsgatan 11
SE-11123 Stockholm
Sweden
Sweden
Torsgatan 11
SE-11123 Stockholm
Sweden
Sweden
tablet

United Kingdom
Sweden
Generics (UK) Ltd
Donepezil
hydrochloride
Donezil
10 mg
Orodispersible
Oral use
tablet

United Kingdom
Sweden
Mylan AB
Donepezil
Donepezil Mylan
5 mg
PO Box 230 33
Orodispersible
Oral use
tablet
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
Donepezil
Donepezil Mylan
PO Box 230 33
10 mg
Orodispersible
Oral use
tablet
SE-104 35 Stockholm
Sweden
EMA/52196/2015
Page 104/131
Member State
(in EEA)
Holder
Sweden
Mylan AB
INN
Rizatriptan
Invented name
Rizatriptan Mylan
Strength
10 mg
PO Box 230 33
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
Repaglinide
Repaglinid Mylan
0,5 mg
Tablet
Oral use
Repaglinide
Repaglinid Mylan
1 mg
Tablet
Oral use
Repaglinide
Repaglinid Mylan
2 mg
Tablet
Oral use
Esomeprazole
Esomeprazol Mylan
20 mg
Gastro - resistant
Oral use
PO Box 230 33
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
PO Box 230 33
capsule, hard
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
Esomeprazole
Esomeprazol Mylan
PO Box 230 33
40 mg
Gastro - resistant
Oral use
capsule, hard
SE-104 35 Stockholm
Sweden
EMA/52196/2015
Page 105/131
Member State
(in EEA)
Holder
Sweden
Mylan AB
INN
Eletriptan
Invented name
Eletriptan Mylan
Strength
20 mg
PO Box 230 33
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
SE-104 35 Stockholm
Sweden
Sweden
Mylan AB
Eletriptan
Eletriptan Mylan
40 mg
PO Box 230 33
Film - coated
Oral use
tablet
SE-104 35 Stockholm
Sweden
Sweden
Orion Corporation
Valsartan
Valsartan Orion
40 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Sweden
Orion Corporation
Valsartan
Valsartan Orion
80 mg
Orion Pharma
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Sweden
Orion Corporation
Valsartan
Valsartan Orion
Orion Pharma
160 mg
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
EMA/52196/2015
Page 106/131
Member State
(in EEA)
Holder
Sweden
Orion Corporation
INN
Valsartan
Invented name
Valsartan Orion
Strength
320 mg
Orion Pharma
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
PO BOX 65
02101 Espoo
Finland
Sweden
Ranbaxy UK Ltd.
Alendronic acid
Alendronat Ranbaxy
Building 4, Chiswick Park
Veckotablett 70 mg
566 Chiswick High Road
tabletter
70 mg
Tablet
Oral use
200 mg
Film - coated
Oral use
London, W4 5YE
Untied Kingdom
Sweden
Stada Arzneimittel AG
Entacapone
Entakapon STADA
Stadastrasse 2-18
tablet
DE-61118 Bad Vilbel

Germany
The
Netherlands
Ropinirole
Ropinirol Accord 5 mg,
5 mg
filmomhulde tabletten
Film - coated
Oral use
tablet

Middlesex
United Kingdom
The
Netherlands
Ropinirole
Ropinirol Accord 0,25 mg

0,25 mg
Film - coated
Oral use
tablet

Middlesex
United Kingdom
EMA/52196/2015
Page 107/131
Member State
(in EEA)
Holder
The
Netherlands
INN
Ropinirole
Invented name
Ropinirol Accord 0,5 mg
Strength
0,5 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

Middlesex
United Kingdom
The
Netherlands
Ropinirole
Ropinirol Accord 1 mg
1 mg
Film - coated
Oral use
tablet

Middlesex
United Kingdom
The
Netherlands
Ropinirole
Ropinirol Accord 2 mg
2 mg
Film - coated
Oral use
tablet

Middlesex
United Kingdom
The
Netherlands
Alendronic acid
Alendroninezuur Accord
10 mg
Tablet
Oral use
70 mg
Tablet
Oral use
10mg Tabletten

Middlesex
United Kingdom
The
Netherlands
Alendronic acid
Alendroninezuur Accord
70mg Tabletten

Middlesex
United Kingdom
EMA/52196/2015
Page 108/131
Member State
(in EEA)
Holder
The
Metoclopramide
Metoclopramidemonohydro
Netherlands
hydrochloride
chloride Accord 10 mg,
INN
Invented name
Pharmaceutical
Route of
Form
administration
10 mg
Tablet
Oral use
37,5 mg
Prolonged -
Oral use
Strength
Tabletten
Middlesex
United Kingdom
The
Alembic Pharmaceuticals
Netherlands
Europe Limited
Alembic 37,5 mg, capsule
release capsule,
Palazzo Pietro Stiges, 103,
met verlengde afgifte, hard
hard
Venlafaxine
Venlafaxine HCl Retard
Strait Street
VLT 1436 Valletta
Malta
The
Netherlands
Europe Limited
Alembic 75 mg, capsule
release capsule,
hard
Venlafaxine
75 mg
Prolonged -
Oral use
Strait Street
VLT 1436 Valletta
Malta
The
Netherlands
Europe Limited
Alembic 150 mg, capsule
release capsule,
hard
Venlafaxine
150 mg
Prolonged -
Oral use
Strait Street
VLT 1436 Valletta
Malta
EMA/52196/2015
Page 109/131
Member State
(in EEA)
Holder
The
Netherlands
5, Marryat Close
orodispergeerbare
Hounslow
tabletten
INN
Ebastine
Invented name
Ebastine BB 10 mg
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
TW4 5DQ Middlesex

United Kingdom
The
Centrafarm B.V.
Netherlands
Nieuwe Donk 3
Entacapone
Entacapone CF 200 mg,
200 mg
filmomhulde tablet
Film - coated
Oral use
tablet
4879 AC Etten Leur

The Netherlands
The
Netherlands
Planckstrasse 13
Ciprofloxacin
Ciprofloxacine Fair-Med
250 mg, filmomhulde
DE-22765 Hamburg
tabletten
250 mg
Film - coated
Oral use
tablet
Germany
The
Ciprofloxacin
Netherlands
Planckstrasse 13
500 mg, filmomhulde
DE-22765 Hamburg
tabletten
500 mg
Film - coated
Oral use
tablet
Germany
The
Ciprofloxacin
Netherlands
Planckstrasse 13
750 mg, filmomhulde
DE-22765 Hamburg
tabletten
750 mg
Film - coated
Oral use
tablet
Germany
The
Valsartan/hydrochl
160
Film - coated
Netherlands
Planckstrasse 13
orothiazide
160 mg/12,5 mg,
mg/12,5
tablet
mg
DE-22765 Hamburg
Oral use
Germany
EMA/52196/2015
Page 110/131
Member State
(in EEA)
Holder
The
Valsartan/hydrochl
Netherlands
Planckstrasse 13
orothiazide
INN
DE-22765 Hamburg
Pharmaceutical
Route of
Form
administration
320
Film - coated
Oral use
320 mg/12,5 mg,
mg/12,5
tablet
mg
Invented name
Strength
Germany
The
Valsartan/hydrochl
320 mg/25
Film - coated
Netherlands
Planckstrasse 13
orothiazide
320 mg/25 mg,
mg
tablet
37,5 mg
Prolonged -
DE-22765 Hamburg
Oral use
Germany
The
Venlafaxine
Venlafaxine Fair-Med 37,5
Netherlands
Planckstrasse 13
mg capsules met verlengde
release capsule,
DE-22765 Hamburg
afgifte, hard
hard
Oral use
Germany
The
Netherlands
Planckstrasse 13
Venlafaxine
Venlafaxine Fair-Med 75
75 mg
Prolonged release capsule,
DE-22765 Hamburg
afgifte, hard
hard
Oral use
Germany
The
Netherlands
Planckstrasse 13
Venlafaxine
Venlafaxine Fair-Med 150
150 mg
Prolonged release capsule,
DE-22765 Hamburg
afgifte, hard
hard
Oral use
Germany
The
Mylan B.V.
Esomeprazole
Esomeprazol Mylan 20 mg,
Netherlands
Dieselweg 25
maagsapresistente
3752 LB Bunschoten
capsules, hard
20 mg
Gastro - resistant
Oral use
capsule, hard
The Netherlands
EMA/52196/2015
Page 111/131
Member State
(in EEA)
Holder
The
Mylan B.V.
Netherlands
Dieselweg 25
maagsapresistente
3752 LB Bunschoten
capsules, hard
INN
Esomeprazole
Invented name
Esomeprazol Mylan 40 mg,
Strength
40 mg
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
capsule, hard
The Netherlands
The
Mylan B.V.
Rizatriptan
Rizatriptan SmeltTab Mylan
Netherlands
Dieselweg 25
5 mg, orodispergeerbare
3752 LB Bunschoten
tabletten
5 mg
Orodispersible
Oral use
tablet
The Netherlands
The
Mylan B.V.
Rizatriptan
Rizatriptan SmeltTab Mylan
Netherlands
Dieselweg 25
10 mg, orodispergeerbare
3752 LB Bunschoten
tabletten
10 mg
Orodispersible
Oral use
tablet
The Netherlands
The
Ranbaxy UK Ltd.
Netherlands
Alendronic acid
Alendroninezuur 70
70 mg
Tablet
Oral use
0,5 mg
Tablet
Oral use
2 mg
Tablet
Oral use
Ranbaxy, tabletten 70 mg

London, W4 5YE
Untied Kingdom
The
Sandoz B.V.
Netherlands
Veluwezoom 22
Clonazepam
Clonazepam Sandoz 0,5

mg, tabletten
1327 AH Almere
The Netherlands
The
Sandoz B.V.
Netherlands
Veluwezoom 22
Clonazepam
Clonazepam Sandoz 2 mg,

tabletten
1327 AH Almere
The Netherlands
EMA/52196/2015
Page 112/131
Member State
(in EEA)
Holder
The
Sandoz B.V.
Netherlands
Veluwezoom 22
INN
Clobazam
Invented name
Clobazam Sandoz 10 mg,
Pharmaceutical
Route of
Form
administration
10 mg
Tablet
Oral use
2,5 mg
Orodispersible
Oral use
Strength
tabletten
1327 AH Almere
The Netherlands
The
Teva Nederland B.V.
Desloratadine
Netherlands
Swensweg 5
2,5 mg Teva,
2031 GA Haarlem
orodispergeerbare
The Netherlands
Desloratadine Smelttablet
tabletten
The
Teva Nederland B.V.
Netherlands
Swensweg 5
5 mg Teva,
2031 GA Haarlem
orodispergeerbare
The Netherlands
tabletten
The
TioFarma b.v.
Netherlands
Benjamin Franklinstraat 5-10
tablet
Desloratadine
Clonazepam
Desloratadine Smelttablet
Clonazepam TioFarma 0,5
5 mg
Orodispersible
Oral use
tablet
0,5 mg
Tablet
Oral use
2 mg
Tablet
Oral use
10 mg
Tablet
Oral use
mg tabletten, tabletten
3261 LW Oud-Beyerland
The Netherlands
The
TioFarma b.v.
Netherlands
Clonazepam
Clonazepam TioFarma 2
mg tabletten, tabletten
The Netherlands
The
TioFarma b.v.
Netherlands
Clobazam
Clobazam TioFarma 10 mg,

tabletten
The Netherlands
EMA/52196/2015
Page 113/131
Member State
(in EEA)
Holder
The
TioFarma b.v.
Netherlands
INN
Clobazam
Invented name
Clobazam TioFarma 20 mg,
Pharmaceutical
Route of
Form
administration
20 mg
Tablet
Oral use
75 mg
Film - coated
Oral use
Strength
tabletten
The Netherlands
The
Torrent Pharma GmbH
Netherlands
Sdwestpark 50
irbesartan
tablet
90449 Nrnberg
Germany
The
Torrent Pharma GmbH
Netherlands
Sdwestpark 50
irbesartan
150 mg
Film - coated
Oral use
tablet
90449 Nrnberg
Germany
The
Torrent Pharma GmbH
Netherlands
Sdwestpark 50
irbesartan
300 mg
Film - coated
Oral use
tablet
90449 Nrnberg
Germany
The
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartan
150
Film - coated
Netherlands
Sdwestpark 50
lorothiazide
Hydrochloorthiazide
mg/12,5
tablet
90449 Nrnberg
Torrent 150 mg/12,5 mg
mg
Germany
The
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartan
300
Film - coated
Netherlands
Sdwestpark 50
lorothiazide
Hydrochloorthiazide
mg/12,5
tablet
90449 Nrnberg
Torrent 300 mg/12,5 mg
mg
Germany
EMA/52196/2015
Oral use
Oral use
Page 114/131
Member State
(in EEA)
Holder
The
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartan
Netherlands
Sdwestpark 50
lorothiazide
Hydrochloorthiazide
INN
90449 Nrnberg
Netherlands
Pharmaceutical
Route of
Form
administration
300 mg/25
Film - coated
Oral use
mg
tablet
150 mg
Film - coated
Strength
Torrent 300 mg/25 mg
Germany
The
Invented name
irbesartan

mg filmomhulde tabletten
Oral use
tablet

Park
Co Tipperary
Ireland
The
Netherlands
irbesartan
300 mg
mg filmomhulde tabletten
Film - coated
Oral use
tablet

Park
Co Tipperary
Ireland
United
Kingdom
Ropinirole
Ropinirole 0.25mg filmcoated tablets
0,25 mg
Film - coated
Oral use
tablet

Middlesex
United Kingdom
EMA/52196/2015
Page 115/131
Member State
(in EEA)
Holder
United
Kingdom
INN
Ropinirole
Invented name
Ropinirole 0.5mg film-
Strength
0,5 mg
coated tablets
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

Middlesex
United Kingdom
United
Kingdom
Ropinirole
Ropinirole 1mg film-coated
1 mg
tablets
Film - coated
Oral use
tablet

Middlesex
United Kingdom
United
Kingdom
Ropinirole
2 mg
tablets
Film - coated
Oral use
tablet

Middlesex
United Kingdom
United
Kingdom
Alendronic acid
alendronic acid 10mg
10 mg
Tablet
Oral use
70 mg
Tablet
Oral use
Tablets

Middlesex
United Kingdom
United
Kingdom
Alendronic acid
alendronic acid 70mg Once

Daily Tablets

Middlesex
United Kingdom
EMA/52196/2015
Page 116/131
Member State
(in EEA)
Holder
United
Metoclopramide
metoclopramide
Kingdom
hydrochloride
hydrochloride 10mg tablets
Ropinirole
INN
Invented name
Pharmaceutical
Route of
Form
administration
10 mg
Tablet
Oral use
5 mg
Film - coated
Oral use
Strength

Middlesex
United Kingdom
United
Kingdom
tablets
tablet

Middlesex
United Kingdom
United
Aptil Pharma Limited
Kingdom
9th Floor, CP House
Fluconazole
Fluconazole 50mg capsules
50 mg
Capsule, hard
Oral use
Fluconazole
Fluconazole 150mg
150 mg
Capsule, hard
Oral use
200 mg
Capsule, hard
Oral use
97-107 Uxbridge Road

London W5 5TL
United Kingdom
United
Kingdom
9th Floor, CP House
capsules

London W5 5TL
United Kingdom
United
Kingdom
9th Floor, CP House
Fluconazole
Fluconazole 200mg
capsules

London W5 5TL
United Kingdom
EMA/52196/2015
Page 117/131
Member State
(in EEA)
Holder
United
Auden McKenzie Limited
Kingdom
McKenzie House
INN
Dexamethasone
Pharmaceutical
Route of
Form
administration
2 mg
Tablet
Oral use
Tyvera 50mg Tablets
50 mg
Tablet
Oral use
Tyvera 100mg Tablets
100 mg
Tablet
Oral use
Clonazepam 500mcg
0,5 mg
Tablet
Oral use
2 mg
Tablet
Oral use
Invented name
Dexamethasone 2mg
Strength
Tablets
Bury Street, Ruislip

Middlesex HA4 7TL
United Kingdom
United
Thiamine
Kingdom
McKenzie House
hydrochloride

Middlesex HA4 7TL
United Kingdom
United
Thiamine
Kingdom
McKenzie House
hydrochloride

Middlesex HA4 7TL
United Kingdom
United
Kingdom
McKenzie House
Clonazepam
Tablet

Middlesex HA4 7TL
United Kingdom
United
Kingdom
McKenzie House
Clonazepam
Clonazepam 2mg Tablet

Middlesex HA4 7TL
United Kingdom
EMA/52196/2015
Page 118/131
Member State
(in EEA)
Holder
United
Kingdom
McKenzie House
INN
Clobazam
Invented name
CLOBAZAM AUDEN 10mg
Pharmaceutical
Route of
Form
administration
10 mg
Tablet
Oral use
250 mg
Film - coated
Oral use
Strength
TABLETS

Middlesex HA4 7TL
United Kingdom
United
Phenoxymethyl
Kingdom
5, Marryat Close
penicillin
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Escitalopram
Escitalopram 5mg Film-
Kingdom
5, Marryat Close
oxalate
coated tablets
5 mg
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Escitalopram
Kingdom
5, Marryat Close
oxalate
coated tablets
10 mg
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Escitalopram
Kingdom
5, Marryat Close
oxalate
coated tablets
15 mg
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
EMA/52196/2015
Page 119/131
Member State
(in EEA)
Holder
United
Escitalopram
Kingdom
5, Marryat Close
oxalate
coated tablets
INN
Invented name
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Tramadol
Aceon 100mg Prolonged-
Kingdom
5, Marryat Close
hydrochloride
release tablets
100 mg
Prolonged -
Oral use
release tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Tramadol
Kingdom
5, Marryat Close
hydrochloride
release tablets
150 mg
Prolonged -
Oral use
release tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Tramadol
Kingdom
5, Marryat Close
hydrochloride
release tablets
Valsartan
Valsartan 40mg Capsules
200 mg
Prolonged -
Oral use
release tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United
Dr Reddy's Laboratories (UK)
Kingdom
Limited
40 mg
Capsule
Oral use
6 Riverview Road, Beverley

East Yorkshire HU17 0LD
United Kingdom
EMA/52196/2015
Page 120/131
Member State
(in EEA)
Holder
United
Kingdom
Limited
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Valsartan
80 mg
Capsule
Oral use
Valsartan
160 mg
Capsule
Oral use
Valsartan
320 mg
Capsule
Oral use
Levetiracetam
Levetiracetam 250mg film-
250 mg
Film - coated
Oral use

United Kingdom
United
Kingdom
Limited
United Kingdom
United
Kingdom
Limited
United Kingdom
United
Kingdom
Limited
coated tablets
tablet

United Kingdom
United
Kingdom
Limited
Levetiracetam
Levetiracetam 500mg filmcoated tablets
500 mg
Film - coated
Oral use
tablet

United Kingdom
EMA/52196/2015
Page 121/131
Member State
(in EEA)
Holder
United
Kingdom
Limited
INN
Levetiracetam
Invented name
Levetiracetam 750mg film-
Strength
750 mg
coated tablets
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet

United Kingdom
United
Kingdom
Limited
Levetiracetam
Levetiracetam 1000mg
1000 mg
film-coated tablets
Film - coated
Oral use
tablet

United Kingdom
United
Kingdom
Limited
Pioglitazone
Pioglitazone 15mg Tablets
15 mg
Tablet
Oral use
Pioglitazone
30 mg
Tablet
Oral use
Pioglitazone
45 mg
Tablet
Oral use

United Kingdom
United
Kingdom
Limited
United Kingdom
United
Kingdom
Limited
United Kingdom
EMA/52196/2015
Page 122/131
Member State
(in EEA)
Holder
United
Kingdom
Limited
INN
Dipyridamole
Invented name
Attia 200mg Modified
Strength
200 mg
Release Capsules
Pharmaceutical
Route of
Form
administration
Modified - release
Oral use
capsule, hard

United Kingdom
United
Kingdom
Limited
Telmisartan
Telmisartan 20mg Tablets
20 mg
Tablet
Oral use
Telmisartan
40 mg
Tablet
Oral use
Telmisartan
80 mg
Tablet
Oral use
Tablet
Oral use

United Kingdom
United
Kingdom
Limited
United Kingdom
United
Kingdom
Limited
United Kingdom
United
Telmisartan/
Telmisartan/Hydrochlorothi
40 mg/12,5
Kingdom
Limited
hydrochlorothiazide
azide 40mg/12.5mg
mg
Tablets

United Kingdom
EMA/52196/2015
Page 123/131
Member State
(in EEA)
Holder
United
Telmisartan/
80 mg/12,5
Kingdom
Limited
hydrochlorothiazide
azide 80mg/12.5mg
mg
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Tablet
Oral use
Tablet
Oral use
Film - coated
Oral use
Tablets

United Kingdom
United
Telmisartan/
80 mg/25
Kingdom
Limited
hydrochlorothiazide
azide 80mg/25mg Tablets
mg
irbesartan
Irbesartan 75mg Film-
75 mg

United Kingdom
United
Kingdom
Planckstrasse 13
coated Tablets
tablet
DE-22765 Hamburg
Germany
United
Kingdom
Planckstrasse 13
irbesartan
150 mg
coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
United
Kingdom
Planckstrasse 13
irbesartan
300 mg
coated Tablets
Film - coated
Oral use
tablet
DE-22765 Hamburg
Germany
United
Irbesartan/hydroch
150
Film - coated
Kingdom
Planckstrasse 13
lorothiazide
zide 150mg/12.5mg film-
mg/12,5
tablet
coated tablets
mg
DE-22765 Hamburg
Oral use
Germany
EMA/52196/2015
Page 124/131
Member State
(in EEA)
Holder
United
Irbesartan/hydroch
Kingdom
Planckstrasse 13
lorothiazide
INN
DE-22765 Hamburg
Pharmaceutical
Route of
Form
administration
300
Film - coated
Oral use
zide 300mg/12.5mg film-
mg/12,5
tablet
coated tablets
mg
Invented name
Strength
Germany
United
Irbesartan/hydroch
300 mg/25
Film - coated
Kingdom
Planckstrasse 13
lorothiazide
zide 300mg/25mg film-
mg
tablet
DE-22765 Hamburg
Oral use
coated tablets
Germany
United
Fannin (UK) Ltd
Kingdom
42-46 Booth Drive
Fluconazole
Fluconazole 150mg capsule
150 mg
Capsule, hard
Oral use
Fexofenadine
Fexofenadine 120mg film-
120 mg
Film - coated
Oral use
Park Farm South

Wellingborough
United Kingdom
United
Fannin (UK) Ltd
Kingdom
42-46 Booth Drive
coated tablets
tablet
Park Farm South

Wellingborough
United Kingdom
United
Fannin (UK) Ltd
Kingdom
42-46 Booth Drive
Fexofenadine
Fexofenadine 180mg filmcoated tablets
180 mg
Film - coated
Oral use
tablet
Park Farm South

Wellingborough
United Kingdom
EMA/52196/2015
Page 125/131
Member State
(in EEA)
Holder
United
FDC Pharma
Kingdom
Unit 6, Fulcrum 1, Solent Way
INN
Invented name
Strength
Pharmaceutical
Route of
Form
administration
Amlodipine
Amlodipine 5mg Tablets
5 mg
Tablet
Oral use
Amlodipine
Amlodipine 10mg Tablets
10 mg
Tablet
Oral use
Repaglinide
Repaglinide Mylan 0.5mg
0,5 mg
Tablet
Oral use
1 mg
Tablet
Oral use
2 mg
Tablet
Oral use
5 mg
Orodispersible
Oral use
Whiteley, Fareham
Hampshire PO15 7FE
United Kingdom
United
FDC Pharma
Kingdom
Unit 6, Fulcrum 1, Solent Way

Whiteley, Fareham
Hampshire PO15 7FE
United Kingdom
United
Generics (UK) Ltd
Kingdom
Tablets

United Kingdom
United
Generics (UK) Ltd
Kingdom
Repaglinide

Tablets

United Kingdom
United
Generics (UK) Ltd
Kingdom
Repaglinide

Tablets

United Kingdom
United
Generics (UK) Ltd
Donepezil
Donepezil Hydrochloride
Kingdom
hydrochloride
5mg Orodispersible Tables
tablet

United Kingdom
EMA/52196/2015
Page 126/131
Member State
(in EEA)
Holder
United
Generics (UK) Ltd
Donepezil
Donepezil Hydrochloride
Kingdom
hydrochloride
10mg Orodispersible
INN
Invented name
Strength
10 mg
Pharmaceutical
Route of
Form
administration
Orodispersible
Oral use
tablet
Tables
United Kingdom
United
Generics (UK) Ltd
Rizatriptan
Rizatriptan 10mg
Kingdom
benzoate
Esomeprazole 20mg
10 mg
Orodispersible
Oral use
tablet

United Kingdom
United
Generics (UK) Ltd
Esomeprazole
Kingdom
magnesium
20 mg
Gastro - resistant
Oral use
capsule
hard
United Kingdom
United
Generics (UK) Ltd
Esomeprazole
Esomeprazole 40mg
Kingdom
magnesium
40 mg
Gastro - resistant
Oral use
capsule
hard
United Kingdom
United
Generics (UK) Ltd
Levodopa/carbidop
Levodopa/Carbidopa/Entac
150
Film - coated
Kingdom
a/entacapone
apone film-coated tablets
mg/37,5
tablet
150/37.5/200mg
mg/200 mg
Pantoprazole 20mg Gastro-
20 mg
Oral use
United Kingdom
United
Kingdom
Pantoprazole
Resistant tablets
Gastro - resistant
Oral use
tablet

0PF
United Kingdom
EMA/52196/2015
Page 127/131
Member State
(in EEA)
Holder
United
Kingdom
INN
Pantoprazole
Invented name
Pantoprazole 40mg Gastro-
Strength
40 mg
Resistant tablets
Pharmaceutical
Route of
Form
administration
Gastro - resistant
Oral use
tablet

0PF
United Kingdom
United
Phenoxymethyl
Kingdom
Limited
penicillin
250 mg
Film - coated
Oral use
tablet
115 Narborough Road

Leicester, LE3 0PA
United Kingdom
United
Metformin
Bolamyn/Metabet SR
Kingdom
Limited
hydrochloride
1000mg Prolonged Release
115 Narborough Road
1000 mg
Prolonged -
Oral use
release tablet
Tablets
Leicester, LE3 0PA

United Kingdom
United
Kingdom
1 The Cam Centre
irbesartan
150 mg
film-coated tablets
Film - coated
Oral use
tablet

United Kingdom
United
Kingdom
1 The Cam Centre
irbesartan

film-coated tablets
150 mg
Film - coated
Oral use
tablet

United Kingdom
EMA/52196/2015
Page 128/131
Member State
(in EEA)
Holder
United
Ranbaxy UK Ltd.
Kingdom
INN
Alendronic acid
Invented name
Alendronic Acid 70mg
Strength
70 mg
Pharmaceutical
Route of
Form
administration
Tablet
Oral use
Oral use
Tablets

London, W4 5YE
Untied Kingdom
United
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartan
150
Film - coated
Kingdom
Sdwestpark 50
lorothiazide
Hydrochlorothiazide
mg/12,5
tablet
90449 Nrnberg
150mg/12.5mg Film-
mg
Germany
coated tablets
United
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartan
300
Film - coated
Kingdom
Sdwestpark 50
lorothiazide
Hydrochlorothiazide
mg/12,5
tablet
90449 Nrnberg
300mg/12.5mg Film-
mg
Germany
coated tablets
United
Torrent Pharma GmbH
Irbesartan/hydroch
Irbesartan
300 mg/25
Film - coated
Kingdom
Sdwestpark 50
lorothiazide
Hydrochlorothiazide
mg
tablet
75 mg
Film - coated
90449 Nrnberg
Torrent Pharma GmbH
Kingdom
Sdwestpark 50
Oral use
300mg/25mg Film-coated
Germany
United
Oral use
tablets
irbesartan
Irbesartan 75mg Filmcoated tablets
Oral use
tablet
90449 Nrnberg
Germany
United
Torrent Pharma GmbH
Kingdom
Sdwestpark 50
irbesartan
Irbesartan 150mg Filmcoated tablets
150 mg
Film - coated
Oral use
tablet
90449 Nrnberg
Germany
EMA/52196/2015
Page 129/131
Member State
(in EEA)
Holder
United
Torrent Pharma GmbH
Kingdom
Sdwestpark 50
INN
irbesartan
Invented name
Strength
300 mg
coated tablets
Pharmaceutical
Route of
Form
administration
Film - coated
Oral use
tablet
90449 Nrnberg
Germany
United
Waymade PLC
Venlafaxine
Venlasov XL 75mg Modified
Kingdom
Sovereign House
hydrochloride
Release Capsules
75 mg
Prolonged -
Oral use
release capsule,
Miles Grat Road, Basildon
hard
Essex SS14 3FR

United Kingdom
United
Waymade PLC
Venlafaxine
Venlasov XL 150mg
Kingdom
Sovereign House
hydrochloride
Modified Release Capsules
150 mg
Prolonged -
Oral use
release capsule,
Miles Grat Road, Basildon
hard
Essex SS14 3FR

United Kingdom
United
Kingdom
Ash Road North
Clopidogrel
Clopidogrel 75mg Film-
75 mg
coated Tablets
Film - coated
Oral use
tablet

Wrexham LL13 9UF
United Kingdom
United
YJBPort Limited
Kingdom
74 Briarwood Drive
Hydrocortisone
Hydrocortisone 10mg
10 mg
Tablet
Oral use
Tablets
Northwood Hills
Middlesex HA6 1PL
United Kingdom
EMA/52196/2015
Page 130/131
Member State
(in EEA)
Holder
United
YJBPort Limited
Kingdom
74 Briarwood Drive
INN
Hydrocortisone
Invented name
Hydrocortisone 20mg
Strength
20 mg
Pharmaceutical
Route of
Form
administration
Tablet
Oral use
Tablets
Northwood Hills
Middlesex HA6 1PL
United Kingdom
EMA/52196/2015
Page 131/131

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20 February 2015

Products for which the marketing authorisations are

Article 31 of Directive 2001/83/EC

Procedure number: EMEA/H/A-31/1408

30 Churchill Place Canary Wharf London E14 5EU United Kingdom

An agency of the European Union

Arcana Arzneimittel GmbH

Huetteldorfer Strae 299

Arcana Arzneimittel GmbH

Huetteldorfer Strae 299

Arcana Arzneimittel GmbH

Huetteldorfer Strae 299

Arcana Arzneimittel GmbH

Huetteldorfer Strae 299

Arcana Arzneimittel GmbH

Candesartan Arcana 4mg

Huetteldorfer Strae 299

Arcana Arzneimittel GmbH

Candesartan Arcana 8mg

Huetteldorfer Strae 299

Arcana Arzneimittel GmbH

Candesartan Arcana 16mg

Huetteldorfer Strae 299

Arcana Arzneimittel GmbH

Candesartan Arcana 32mg

Huetteldorfer Strae 299

Genericon Pharma GmbH

Apotex Europe B.V.

Donepezil Odis Mylan

Donepezil Odis Mylan

Repaglinide Mylan 0,5 mg

Repaglinide Mylan 2mg

Teva Pharma Belgium NV

Teva Pharma Belgium NV

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow HA1 4HF

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow HA1 4HF

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow HA1 4HF

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow HA1 4HF

Alkaloid - INT d.o.o.

blvd. Prof. Tsvetan Lazarov

blvd. Prof. Tsvetan Lazarov

Generics (UK) Ltd

Station Close, Potters Bar

Hertfordshire, EN6 1TL

Generics (UK) Ltd

Station Close, Potters Bar

Hertfordshire, EN6 1TL

117 alle des Parcs

69792 Saint-Priest Cedex

Neo Balkanika EOOD

Sandoz Pharmaceuticals d.d.

Ulica grada Vukovara 226 F

Rexocef 200 mg filmom

Belupo, lijekovi i kozmetika

Alerdin 2,5 mg raspadljive