Visszavont Gyogyszerek PDF

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 INN Invented name Strength Pharmaceutical Route of
(in EEA) Holder Form administration
Austria Arcana Arzneimittel GmbH Esomeprazole Esomeprazol Arcana 20 mg 20 mg Gastro - resistant Oral use
Huetteldorfer Straße 299 magnesium magensaftresistente capsule, hard
1140 Wien Hartkapseln
Austria
Austria Arcana Arzneimittel GmbH Esomeprazole Esomeprazol Arcana 40 mg 40 mg Gastro - resistant Oral use
Austria
Austria Arcana Arzneimittel GmbH Esomeprazole Neximyl 20 mg 20 mg Gastro - resistant Oral use
Austria
Austria Arcana Arzneimittel GmbH Esomeprazole Neximyl 40 mg 40 mg Gastro - resistant Oral use
Austria
Austria Arcana Arzneimittel GmbH Candesartan Candesartan Arcana 4mg 4 mg Tablet Oral use
Huetteldorfer Straße 299 cilexetil Tabletten
1140 Wien
Austria
Austria Arcana Arzneimittel GmbH Candesartan Candesartan Arcana 8mg 8mg Tablet Oral use
1140 Wien
Austria
GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1
EMA/52196/2015 Page 2/131
1140 Wien
Austria
1140 Wien
Austria
Austria Genericon Pharma GmbH Nebivolol Nebivolol Genericon 5 mg 5 mg Tablet Oral use
Hafnerstr. 211 Tabletten
8054 Graz
Austria
Austria ratiopharm Arzneimittei- Desloratadine Desloratadin ratiopharm 2,5 mg Orodispersible Oral use
Vertriebs-GmbH 2,5 mg Schmelztabletten tablet
Albert-Schweitzer-Gasse 3
1140 Wien
Austria
Austria ratiopharm Arzneimittei- Desloratadine Desloratadin ratiopharm 5 5 mg Orodispersible Oral use
Vertriebs-GmbH mg Schmelztabletten tablet
Albert-Schweitzer-Gasse 3
1140 Wien
Austria
Belgium Apotex Europe B.V. Desloratadine Desloratadine Apotex 5 mg Film - coated Oral use
Darwinweg 20 tablet
NL 2333 CR Leiden
Netherlands
EMA/52196/2015 Page 3/131
Belgium Mylan bvba/sprl Donepezil Donepezil Odis Mylan 5 mg Orodispersible Oral use
Terhulpsesteenweg 6A tablet
1560 Hoeilaart
Belgium
Belgium Mylan bvba/sprl Donepezil Donepezil Odis Mylan 10 mg Orodispersible Oral use
Terhulpsesteenweg 6A tablet
1560 Hoeilaart
Belgium
Belgium Mylan bvba/sprl Repaglinide Repaglinide Mylan 0,5 mg 0,5 mg Tablet Oral use
Terhulpsesteenweg 6A Pharma
1560 Hoeilaart
Belgium
Belgium Mylan bvba/sprl Repaglinide Repaglinide Mylan 1 mg 1 mg Tablet Oral use
1560 Hoeilaart
Belgium
Belgium Mylan bvba/sprl Repaglinide Repaglinide Mylan 2mg 2 mg Tablet Oral use
1560 Hoeilaart
Belgium
Belgium Mylan bvba/sprl Candesartan Candesartan Mylan 8 mg Tablet Oral use
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium
EMA/52196/2015 Page 4/131

1560 Hoeilaart
Belgium
1560 Hoeilaart
Belgium
Belgium Mylan bvba/sprl Esomeprazole Esomeprazole Mylan 20 mg Gastro - resistant Oral use
Terhulpsesteenweg 6A capsule, hard
1560 Hoeilaart
Belgium
Belgium Mylan bvba/sprl Esomeprazole Esomeprazole Mylan 40 mg Gastro - resistant Oral use
1560 Hoeilaart
Belgium
Belgium Takeda Belgium Alendronic acid Alendromono 70 mg Tablet Oral use
Gentsesteenweg 615
1080 Brussels
Belgium
Belgium Teva Pharma Belgium NV Desloratadine Desloratadine Teva 2,5 mg Orodispersible Oral use
Laarstraat 16 tablet
2610 Wilrijk
Belgium
EMA/52196/2015 Page 5/131
Belgium Teva Pharma Belgium NV Desloratadine Desloratadine Teva 5 mg Orodispersible Oral use
Laarstraat 16 tablet
2610 Wilrijk
Belgium
Bulgaria Accord Healthcare Limited Ropinirole Ropinirole Accord 0,5 mg Film - coated Oral use
Sage House, 319 Pinner Road tablet
North Harrow HA1 4HF
Middlesex
United Kingdom
Bulgaria Accord Healthcare Limited Ropinirole Ropinirole Accord 1 mg Film - coated Oral use
Middlesex
United Kingdom
Middlesex
United Kingdom
Middlesex
United Kingdom
EMA/52196/2015 Page 6/131
Bulgaria Alkaloid - INT d.o.o. Cefpodoxime FOXERO 200 mg Tablet Oral use
Šlandrova 4
1231 Ljubljana - Črnuče
Slovenia
Bulgaria Aquachim AD Quetiapine Aquatiapine 25 mg Film - coated Oral use
blvd. Prof. Tsvetan Lazarov tablet
83
Sofia 1582
Bulgaria
83
Sofia 1582
Bulgaria
83
Sofia 1582
Bulgaria
Bulgaria Generics (UK) Ltd Esomeprazole Esopragen 20 mg Gastro - resistant Oral use
Station Close, Potters Bar magnesium capsule, hard
Hertfordshire, EN6 1TL
United Kingdom
EMA/52196/2015 Page 7/131
Bulgaria Generics (UK) Ltd Esomeprazole Esopragen 40 mg Gastro - resistant Oral use
United Kingdom
Bulgaria Glenmark Pharmaceuticals Trimetazidine Apstar 35 mg 35 mg Prolonged - Oral use
s.r.o. prolonged-release tablets release tablet
Hvězdova 1716/2b
14078 Praha 4
Czech Republic
Bulgaria Mylan SAS Trimetazidine Trimetazigen MR 35 mg Prolonged - Oral use
117 allée des Parcs release tablet
69792 Saint-Priest Cedex
France
Bulgaria Neo Balkanika EOOD Nebivolol Bivolet 5 mg Tablet Oral use
35 Zemliane Str.
Sofia 1618
Bulgaria
Bulgaria Sandoz Pharmaceuticals d.d. Trimetazidine Energotrim 35 mg Prolonged - Oral use
Verovskova 57 release tablet
Ljubljana SI-1000
Slovenia
Bulgaria Tchaikapharma Highquality Bosentan Pulmohyperta 62,5 mg Film - coated Oral use
Medicines tablet
1 G. M. Dimitrov Blvd.
Sofia 1172
Bulgaria
EMA/52196/2015 Page 8/131
Bulgaria Tchaikapharma Highquality Bosentan Pulmohyperta 125 mg Film - coated Oral use
Medicines tablet
1 G. M. Dimitrov Blvd.
Sofia 1172
Bulgaria
Croatia Alkaloid d.o.o. Cefpodoxime Rexocef 200 mg filmom 200 mg Film - coated Oral use
Ulica grada Vukovara 226 F obložene tablete tablet
Zagreb 10000
Croatia
Croatia Belupo, lijekovi i kozmetika Desloratadine Alerdin 2,5 mg raspadljive 2,5 mg Orodispersible Oral use
d.d. tablete za usta tablet
Ulica Danica 5
Koprivnica 48000
Croatia
Croatia Belupo, lijekovi i kozmetika Desloratadine Alerdin 5 mg raspadljive 5 mg Orodispersible Oral use
d.d. tablete za usta tablet
Ulica Danica 5
Koprivnica 48000
Croatia
Croatia Fidifarm d.o.o. Desloratadine Sinalerg 5 mg filmom 5 mg Film - coated Oral use
Obrtnička 37, Bestovje obložene tablete tablet
Rakitje 10437
Croatia
EMA/52196/2015 Page 9/131
Croatia Jadran Galenski Laboratorij Desloratadine Escontral direkt 2,5 mg 2,5 mg Orodispersible Oral use
d.d. raspadljiva tableta za usta tablet
Svilno 20, Rijeka
51000
Croatia
Croatia Jadran Galenski Laboratorij Desloratadine Escontral direkt 5 mg 5 mg Orodispersible Oral use
d.d. raspadljiva tableta za usta tablet
Svilno 20, Rijeka
51000
Croatia
Croatia PharmaS d.o.o. Tramadol/paraceta Tramadol/Paracetamol 37,5 Film - coated Oral use
Radnička cesta 47 mol PharmaS 37,5 mg/ mg/325 mg tablet
Zagreb 10000 325 mg filmom obložene
Croatia tablete
Croatia PharmaS d.o.o. Escitalopram Escitalopram PharmaS 10 10 mg Film - coated Oral use
Radnička cesta 47 mg filmom tablet
Zagreb 10000 obložene tablete
Croatia
Croatia Sandoz d.o.o. Trimetazidine Vazidin 35 mg tablete s 35 mg Prolonged - Oral use
Maksimirska 120 hydrochloride produljenim oslobađanjem release tablet
Zagreb 10000
Croatia
EMA/52196/2015 Page 10/131
Cyprus Accord Healthcare Limited Alendronic acid Alendronic Acid Accord 70 mg Tablet Oral use
Sage House, 319 Pinner Road
Middlesex
United Kingdom
Cyprus Delorbis Pharmaceuticals Ltd Entacapone Nobat 200 mg Film - coated Oral use
17 Athinon Street tablet
Ergates Industrial Area
2643 Ergates
P.O. Box 28629
2081 Lefkosia
Cyprus
Cyprus Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/Hctz Fair-med 160 Film - coated Oral use
Planckstrasse 13 orothiazide mg/12,5 tablet
DE-22765 Hamburg mg
Germany
Cyprus Generics Pharma Hellas Ltd Donepezil Donepezil/Generics 5 mg Orodispersible Oral use
577a Vouliagmenis Avenue hydrochloride tablet
Argyroupoli
164-51 Athens
Greece
Cyprus Generics Pharma Hellas Ltd Donepezil Donepezil/Generics 10 mg Orodispersible Oral use
Argyroupoli
164-51 Athens
Greece
EMA/52196/2015 Page 11/131
Cyprus Lambda Therapeutic Limited Ropinirole Ropinirole Lambda 0,25 mg Film - coated Oral use
Sage House hydrochloride tablet
319 Pinner Road, North
Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus Lambda Therapeutic Limited Ropinirole Ropinirole Lambda 0,5 mg Film - coated Oral use
Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus Lambda Therapeutic Limited Ropinirole Ropinirole Lambda 1 mg Film - coated Oral use
Harrow
Middlesex HA1 4HF
United Kingdom
Harrow
Middlesex HA1 4HF
United Kingdom
EMA/52196/2015 Page 12/131
Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus Wockhardt UK Limited Clopidogrel Clopidogrel/Wockhardt 75 mg Film - coated Oral use
Ash Road North hydrochloride tablet
Wrexham Industrial Estate
Wrexham LL13 9UF
United Kingdom
Czech Republic Abbott Laboratories, s.r.o. Escitalopram Purcema 5 mg 5 mg Film - coated Oral use
Evropská 2591/33d oxalate tablet
160 00 Praha 6 - Hadovka
Office Park
Czech Republic
Office Park
Czech Republic
Office Park
Czech Republic
EMA/52196/2015 Page 13/131
Office Park
Czech Republic
Czech Republic Actavis Group PTC ehf. Metformin Metformin Actavis Retard 500 mg Prolonged - Oral use
Reykjavikurvegi 76-78 hydrochloride 500 mg release tablet
220 Hafnarfjördur
Iceland
Czech Republic Actavis Group PTC ehf. Metformin Metformin Actavis Retard 750 mg Prolonged - Oral use
Reykjavikurvegi 76-78 hydrochloride 750 mg release tablet
220 Hafnarfjördur
Iceland
Czech Republic Alkaloid - INT d.o.o. Cefpodoxime Forexo 200 mg potahované 200 mg Film - coated Oral use
Šlandrova 4 tablety tablet
Slovenia
Czech Republic Alvogen IPCo S.ar.l. Desloratadine Desloratadin Alvogen 5 mg 5 mg Film - coated Oral use
Rue Heienhaff 5 potahované tablety tablet
L-1736 Senningerberg
Luxembourg
Czech Republic Apotex Europe B.V. Trimetazidine Apo-trimetazidin 35 mg 35 mg Prolonged - Oral use
Darwinweg 20 dihydrochloride release tablet
NL 2333 CR Leiden
Netherlands
EMA/52196/2015 Page 14/131
Czech Republic Generics (UK) Ltd Esomeprazole Esomylan 40 mg 40 mg Gastro - resistant Oral use
United Kingdom
Czech Republic Generics (UK) Ltd Rizatriptan Rizatriptan Mylan 5 mg 5 mg Orodispersible Oral use
Station Close, Potters Bar benzoate tablet
United Kingdom
Czech Republic Generics (UK) Ltd Rizatriptan Rizatriptan Mylan 10 mg 10 mg Orodispersible Oral use
United Kingdom
Czech Republic Generics (UK) Ltd Donepezil Donepezil Mylan 10 mg 10 mg Orodispersible Oral use
Station Close, Potters Bar hydrochloride tablet
United Kingdom
Czech Republic Glenmark Pharmaceuticals Trimetazidine Portora 35 mg tablety s 35 mg Prolonged - Oral use
s.r.o. dihydrochloride prodlouženým uvolňováním release tablet
Hvězdova 1716/2b
14078 Praha 4
Czech Republic
Czech Republic GNR Czech s.r.o. Desloratadine Geslora 5 mg 5 mg Film - coated Oral use
Slavojova 579/9 tablet
128 00 Praha 2
Czech Republic
EMA/52196/2015 Page 15/131
Czech Republic Labormed-Pharma, SA Desloratadine Desloratadin Labormed 2,5 2,5 mg Orodispersible Oral use
Theodor Pallady, 44B mg tablety dispergovatelné tablet
032266 Bucharest v ústech
Romania
Czech Republic Labormed-Pharma, SA Desloratadine Desloratadin Labormed 5 5 mg Orodispersible Oral use

Theodor Pallady, 44B mg tablety dispergovatelné tablet
032266 Bucharest v ústech
Romania
Czech Republic Mylan SAS Trimetazidine Trimetazidin Mylan 35 mg 35 mg Prolonged - Oral use
117 allée des Parcs release tablet
France
Czech Republic SVUS Pharma a.s. Desloratadine Lotera 5 mg potahované 5 mg Film - coated Oral use
Smetanovo nábřeží 1238/20a tablety tablet
500 02 Hradec Králové
Czech Republic
Denmark Actavis Group PTC ehf. Metformin Metformin "Actavis PTC" 500 mg Prolonged - Oral use
Reykjavikurvegi 76-78 release tablet
220 Hafnarfjördur
Iceland
Denmark Actavis Group PTC ehf. Metformin Metformin "Actavis PTC" 750 mg Prolonged - Oral use
220 Hafnarfjördur
Iceland
EMA/52196/2015 Page 16/131
Denmark Bluefish Pharmaceuticals AB Fluconazole Fluconazol "Bluefish" 50 mg Capsule, hard Oral use
Torsgatan 11
SE-11123 Stockholm
Sweden
Torsgatan 11
SE-11123 Stockholm
Sweden
Torsgatan 11
SE-11123 Stockholm
Sweden
Denmark Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/hydrochlorthiazid 160 Film - coated Oral use
Planckstrasse 13 orothiazide "Fair-Med" mg/12,5 tablet
DE-22765 Hamburg mg
Germany
Denmark Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/hydrochlorthiazid 320 Film - coated Oral use
Planckstrasse 13 orothiazide "Fair-Med" mg/12,5 tablet
DE-22765 Hamburg mg
Germany
Denmark Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/hydrochlorthiazid 320 mg/25 Film - coated Oral use
Planckstrasse 13 orothiazide "Fair-Med" mg tablet
DE-22765 Hamburg
Germany
EMA/52196/2015 Page 17/131
Denmark Mylan AB Eletriptan Eletriptan Mylan 40 mg Film - coated Oral use

PO Box 230 33 tablet
SE-104 35 Stockholm
Sweden
Denmark Mylan AB Esomeprazole Esomeprazol Mylan 20 mg Gastro - resistant Oral use
PO Box 230 33 capsule, hard
SE-104 35 Stockholm
Sweden
Denmark Mylan AB Esomeprazole Esomeprazol Mylan 40 mg Gastro - resistant Oral use
SE-104 35 Stockholm
Sweden
Denmark Mylan AB Rizatriptan Rizatriptan Mylan 10 mg Orodispersible Oral use
SE-104 35 Stockholm
Sweden
Denmark Stadapharm GmbH Entacapone Entacapon STADA 200 mg Film - coated Oral use
Stadastr. 2-18 tablet
D-61118 Bad Vilbel
Germany
Estonia Accord Healthcare Limited Alendronic acid ALENDRONIC ACID 70 mg Tablet Oral use
Sage House, 319 Pinner Road ACCORD 70mg
Middlesex
United Kingdom
EMA/52196/2015 Page 18/131
Estonia Sandoz Pharmaceuticals d.d. Trimetazidine ZIDMETIN 35 mg Modified - release Oral use
Verovskova 57 tablet
Ljubljana SI-1000
Slovenia
Finland Actavis Group PTC ehf. Metformin Metformin Actavis 500 mg Prolonged - Oral use
220 Hafnarfjördur
Iceland
Finland Actavis Group PTC ehf. Metformin Metformin Actavis 750 mg Prolonged - Oral use
220 Hafnarfjördur
Iceland
Finland Bluefish Pharmaceuticals AB Fluconazole Fluconazol Bluefish 50 mg Capsule, hard Oral use
Torsgatan 11
SE-11123 Stockholm
Sweden
Torsgatan 11
SE-11123 Stockholm
Sweden
Torsgatan 11
SE-11123 Stockholm
Sweden
EMA/52196/2015 Page 19/131
Finland Mylan AB Eletriptan Eletriptan Mylan 40 mg Film - coated Oral use

SE-104 35 Stockholm
Sweden
Finland Mylan AB Repaglinide Repaglinid Mylan 0,5 mg Tablet Oral use
PO Box 230 33
SE-104 35 Stockholm
Sweden
Finland Mylan AB Repaglinide Repaglinid Mylan 1 mg Tablet Oral use
PO Box 230 33
SE-104 35 Stockholm
Sweden
Finland Mylan AB Repaglinide Repaglinid Mylan 2 mg Tablet Oral use
PO Box 230 33
SE-104 35 Stockholm
Sweden
Finland Orion Corporation Valsartan VALSARTAN ORION 40 mg Film - coated Oral use
Orion Pharma tablet
PO BOX 65
02101 Espoo
Finland
Orion Pharma tablet
PO BOX 65
02101 Espoo
Finland
EMA/52196/2015 Page 20/131
Orion Pharma tablet
PO BOX 65
02101 Espoo
Finland
Orion Pharma tablet
PO BOX 65
02101 Espoo
Finland
Finland ratiopharm GmbH Desloratadine Desloratadine Ratiopharm 2,5 mg Orodispersible Oral use
Graf-Arco-Strasse 3 tablet
D-89079 Ulm
Germany
Finland ratiopharm GmbH Desloratadine Desloratadine Ratiopharm 5 mg Orodispersible Oral use
D-89079 Ulm
Germany
France Abbott Products SAS Escitalopram ESCITALOPRAM ABBOTT 5 mg Film - coated Oral use
42 rue Rouget de Lisle 5mg, comprimé pelliculé tablet
92150 Suresnes
France
92150 Suresnes
France
EMA/52196/2015 Page 21/131
92150 Suresnes
France
92150 Suresnes
France
France ACCORD HEALTHCARE France Ropinirole Ropinirole Accord 0,25mg, 0,25 mg Film - coated Oral use
SAS comprimé pelliculé tablet
45 Rue de Fbg de Roubaix
59000 Lille
France
France ACCORD HEALTHCARE France Ropinirole Ropinirole Accord 0,5mg, 0,5 mg Film - coated Oral use
59000 Lille
France
France ACCORD HEALTHCARE France Ropinirole Ropinirole Accord 1mg, 1 mg Film - coated Oral use
59000 Lille
France
EMA/52196/2015 Page 22/131
59000 Lille
France
59000 Lille
France
France Brown & Burk UK, Ltd. Escitalopram ESCITALOPRAM BROWN 5 5 mg Film - coated Oral use
5, Marryat Close mg, comprimé pelliculé tablet
Hounslow sécable
TW4 5DQ Middlesex
United Kingdom
Hounslow sécable
TW4 5DQ Middlesex
United Kingdom
Hounslow sécable
TW4 5DQ Middlesex
United Kingdom
EMA/52196/2015 Page 23/131
Hounslow sécable
TW4 5DQ Middlesex
United Kingdom
France Brown & Burk UK, Ltd. Ebastine EBASTINE BROWN & BURK 10 mg Orodispersible Oral use
5, Marryat Close 10 mg, comprimé tablet
Hounslow orodispersible
TW4 5DQ Middlesex
United Kingdom
France Cristers Desloratadine DESLORATADINE 5 mg Film - coated Oral use
22, quai Galliéni CRISTERS tablet
92150 Suresnes 5 mg
France comprimé pelliculé
France Cristers Ibuprofen IBUPROFENE CRISTERS 400 mg Film - coated Oral use
22, quai Galliéni 400 mg tablet
92150 Suresnes comprimé pelliculé
France
France Laboratoires Biogaran Ebastine EBASTINE BIOGARAN 10 10 mg Film - coated Oral use
15, boulevard Charles de mg comprimé pelliculé tablet
Gaulle
92707 Colombes Cedex
France
EMA/52196/2015 Page 24/131
France Laboratoires Biogaran Ebastine EBASTINE BIOGARAN 10 10 mg Orodispersible Oral use

15, boulevard Charles de mg comprimé tablet
Gaulle orodispersible
92707 Colombes Cedex
France
France Laboratoires GERDA Desloratadine DESLORATADINE ARROW 5 mg Film - coated Oral use
24 rue Erlanger 5 mg tablet
75016 PARIS comprimé pelliculé
France
France Medipha Sante Tramadol/paraceta TRAMADOL PARACETAMOL 37,5 Film - coated Oral use
Les Fjords - Immeuble Oslo mol NIALEX 37,5 mg/325 mg mg/325 mg tablet
19 avenue de Norvège comprimé pelliculé
91953 Courtaboeuf Cedex
France
France Medipha Sante Desloratadine DESLORATADINE GNR 5 mg Film - coated Oral use
Les Fjords - Immeuble Oslo 5 mg tablet
19 avenue de Norvège comprimé pelliculé
91953 Courtaboeuf Cedex
France
France Mylan SAS Rizatriptan RIZATRIPTAN MYLAN 5mg, 5 mg Orodispersible Oral use
117 allée des Parcs orodispersible tablet tablet
France
EMA/52196/2015 Page 25/131
France Mylan SAS Rizatriptan RIZATRIPTAN MYLAN 10 10 mg Orodispersible Oral use

117 allée des Parcs mg, orodispersible tablet tablet
France
France Mylan SAS Ebastine EBASTINE MYLAN 10mg, 10 mg Film - coated Oral use
117 allée des Parcs film-coated tablet tablet
France
France Mylan SAS Ebastine EBASTINE MYLAN 10mg, 10 mg Orodispersible Oral use
France
France Mylan SAS Trimetazidine TRIMETAZIDINE MYLAN 35 35 mg Modified - release Oral use
117 allée des Parcs mg Modified Release tablet
69792 Saint-Priest Cedex Tablets
France
France Mylan SAS Candesartan CANDESARTAN MYLAN 32 32 mg Tablet Oral use
117 allée des Parcs mg, comprimé secable
France
France Mylan SAS Donepezil DONEPEZIL MYLAN 5 mg, 5 mg Orodispersible Oral use
France
EMA/52196/2015 Page 26/131
France Mylan SAS Donepezil DONEPEZIL MYLAN 10 10 mg Orodispersible Oral use

117 allée des Parcs mg, orodispersible tablet tablet
France
France Mylan SAS Esomeprazole ESOMEPRAZOLE MYLAN 20 mg Gastro - resistant Oral use
117 allée des Parcs PHARMA 20mg, DR capsule capsule, hard
France
France Mylan SAS Esomeprazole ESOMEPRAZOLE MYLAN 40 mg Gastro - resistant Oral use
117 allée des Parcs PHARMA 40mg, DR capsule capsule, hard
France
France Mylan SAS Desmopressin DESMOPRESSINE MYLAN 0,06 mg Orodispersible Oral use
117 allée des Parcs 60 µg, orodispersible tablet tablet
France
117 allée des Parcs 120 µg, orodispersible tablet
69792 Saint-Priest Cedex tablet
France
117 allée des Parcs 240 µg, orodispersible tablet
69792 Saint-Priest Cedex tablet
France
EMA/52196/2015 Page 27/131
France Ranbaxy Pharmacie Aciclovir Aciclovir Ranbaxy 800 mg, 800 mg Tablet Oral use
Generiques comprimé
11-15 Quai Dion Bouton
92800 Puteaux
France
France Ranbaxy Pharmacie Aciclovir Aciclovir Ranbaxy 200 mg, 200 mg Tablet Oral use
92800 Puteaux
France
France Ranbaxy Pharmacie Aciclovir Aciclovir Almus 200 mg, 200 mg Tablet Oral use
92800 Puteaux
France
France Ranbaxy Pharmacie Alendronic acid Acide Alendronique 70 mg Tablet Oral use
Generiques Ranbaxy 70 mg, comprimé
92800 Puteaux
France
France Sanofi Aventis France Ebastine EBASTINE ZENTIVA 10 mg 10 mg Film - coated Oral use
1-13 bd Romain Rolland comprimé pelliculé tablet
75159 Paris Cedex 14
France
EMA/52196/2015 Page 28/131
France Sanofi Aventis France Ebastine EBASTINE ZENTIVA 10 mg 10 mg Orodispersible Oral use
1-13 bd Romain Rolland comprimé orodispersible tablet
75159 Paris Cedex 14
France
France Teva Sante Desloratadine DESLORATADINE TEVA 5 mg Film - coated Oral use
Cœur Défense - 100-110 SANTE tablet
Esplanade du Général de 5 mg
Gaulle comprimé pelliculé
92931 La Défense Cedex
France
France Venipharm SAS Ebastine EBOUDA 10 mg comprimé 10 mg Film - coated Oral use
4 Bureaux de la Colline pelliculé tablet
92213 Saint-Cloud
France
France Venipharm SAS Ebastine EBARREN 10 mg comprimé 10 mg Film - coated Oral use
92213 Saint-Cloud
France
France Venipharm SAS Ebastine EBONDE 10 mg comprimé 10 mg Film - coated Oral use
92213 Saint-Cloud
France
France Venipharm SAS Ebastine EBONTAN 10 mg comprimé 10 mg Orodispersible Oral use
4 Bureaux de la Colline orodispersible tablet
92213 Saint-Cloud
France
EMA/52196/2015 Page 29/131
France Venipharm SAS Ebastine EBACHOI 10 mg comprimé 10 mg Orodispersible Oral use

4 Bureaux de la Colline orodispersible tablet
92213 Saint-Cloud
France
France Venipharm SAS Ibuprofen IBUPROFENE ZYDUS 200 mg Film - coated Oral use
4 Bureaux de la Colline FRANCE 200 mg comprimé tablet
92213 Saint-Cloud pelliculé
France
France Zydus France Ibuprofen IBUPROFENE ZYDUS 400 mg Film - coated Oral use
Zacles Hautes Patures FRANCE 400 mg comprimé tablet
25 Rue des Peupliers pelliculé
92752 Nanterre Cedes
France
France Zydus France Tramadol/paraceta TRAMADOL PARACETAMOL 37,5 Film - coated Oral use
Zacles Hautes Patures mol ZYDUS FRANCE 37,5 mg/325 mg tablet
25 Rue des Peupliers mg/325 mg comprimé
92752 Nanterre Cedes pelliculé
France
France Zydus France Ibuprofen IBUPROFENE ZF 400 mg 400 mg Film - coated Oral use
Zacles Hautes Patures comprimé pelliculé tablet
25 Rue des Peupliers
France
EMA/52196/2015 Page 30/131
France Zydus France Desloratadine DESLORATADINE ZYDUS 5 5 mg Film - coated Oral use
Zacles Hautes Patures mg comprimé pelliculé tablet
France
France Zydus France Escitalopram ESCITALOPRAM ZYDUS 5 5 mg Film - coated Oral use
Zacles Hautes Patures mg, comprimé pelliculé tablet
France
25 Rue des Peupliers sécable
France
France
EMA/52196/2015 Page 31/131
France
Germany Accord Healthcare Limited Alendronic acid ALENDRONIC ACID 70 mg Tablet Oral use
Sage House, 319 Pinner Road ACCORD 70MG
Middlesex
United Kingdom
Germany betapharm Arzneimittel GmbH Levetiracetam Levetiracetam beta 250 250 mg Film - coated Oral use
Kobelweg 95 mg, Filmtabletten tablet
D-86156 Augsburg
Germany
D-86156 Augsburg
Germany
D-86156 Augsburg
Germany
Kobelweg 95 mg, Filmtabeltten tablet
D-86156 Augsburg
Germany
EMA/52196/2015 Page 32/131
Germany Fair-Med Healthcare GmbH Irbesartan Irbesartan Tablets 75 mg Film - coated Oral use
Planckstrasse 13 75mg tablet
DE-22765 Hamburg
Germany
Planckstrasse 13 150mg tablet
DE-22765 Hamburg
Germany
Planckstrasse 13 300 mg tablet
DE-22765 Hamburg
Germany
Germany Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan HCTZ Fair-Med 150 Film - coated Oral use
Planckstrasse 13 lorothiazide 150+12,5 mg Filmtabletten mg/12,5 tablet
DE-22765 Hamburg mg
Germany
Germany Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan HCTZ Fair-Med 300 Film - coated Oral use
Planckstrasse 13 lorothiazide 300+12,5 mg Filmtabletten mg/12,5 tablet
DE-22765 Hamburg mg
Germany
Germany Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan HCTZ Fair-Med 300 mg/25 Film - coated Oral use
Planckstrasse 13 lorothiazide 300+25 mg Filmtabletten mg tablet
DE-22765 Hamburg
Germany
EMA/52196/2015 Page 33/131
Germany Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/HCTZ Fair-Med 160 Film - coated Oral use
Planckstrasse 13 orothiazide Healthcare 160 mg/12.5 mg/12,5 tablet
DE-22765 Hamburg mg Filmtabletten mg
Germany
Germany Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/HCTZ Fair-Med 320 Film - coated Oral use
Planckstrasse 13 orothiazide Healthcare 320 mg/12,5 mg/12,5 tablet
DE-22765 Hamburg mg Filmtabletten mg
Germany
Germany Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/HCTZ Fair-Med 320 mg/25 Film - coated Oral use
Planckstrasse 13 orothiazide Healthcare 320 mg/25 mg mg tablet
DE-22765 Hamburg Filmtabletten
Germany
Germany Fair-Med Healthcare GmbH Venlafaxine Venlafaxin Fair-Med 37,5 37,5 mg Prolonged - Oral use
Planckstrasse 13 mg Hartkapseln, retardiert release capsule,
DE-22765 Hamburg hard
Germany
Germany Fair-Med Healthcare GmbH Venlafaxine Venlafaxin Fair-Med 75 mg 75 mg Prolonged - Oral use
Planckstrasse 13 Hartkapseln, retardiert release capsule,
Germany
Germany Fair-Med Healthcare GmbH Venlafaxine Venlafaxin Fair-Med 150 150 mg Prolonged - Oral use
Planckstrasse 13 mg Hartkapseln, retardiert release capsule,
Germany
EMA/52196/2015 Page 34/131
Germany Fair-Med Healthcare GmbH Ciprofloxacin Ciprofloxacin Fair-Med 500 mg Film - coated Oral use
Planckstrasse 13 Healthcare 500 mg tablet
Germany
Germany
Germany
Germany Heumann Pharma GmbH & Irbesartan Irbesartan Heumann 75 75 mg Film - coated Oral use
Co. Generica KG mg Filmtabletten tablet
Südwestpark 50
90449 Nürnberg
Germany
Südwestpark 50
90449 Nürnberg
Germany
EMA/52196/2015 Page 35/131
Südwestpark 50
90449 Nürnberg
Germany
Germany Heumann Pharma GmbH & Irbesartan/hydroch Irbesartan/Hydrochlorothia 150 Film - coated Oral use
Co. Generica KG lorothiazide zid Heumann 150 mg/12.5 mg/12,5 tablet
Südwestpark 50 mg Filmtabletten mg
90449 Nürnberg
Germany
Germany Heumann Pharma GmbH & Irbesartan/hydroch Irbesartan/Hydrochlorothia 300 Film - coated Oral use
Co. Generica KG lorothiazide zid Heumann 300 mg/12.5 mg/12,5 tablet
Südwestpark 50 mg Filmtabletten mg
90449 Nürnberg
Germany
Germany Heumann Pharma GmbH & Irbesartan/hydroch Irbesartan/Hydrochlorothia 300 mg/25 Film - coated Oral use
Co. Generica KG lorothiazide zid Heumann 300 mg/25 mg tablet
Südwestpark 50 mg Filmtabletten
90449 Nürnberg
Germany
Germany Hormosan Pharma GmbH Cefpodoxime Cefpodoxim- 200 mg Film - coated Oral use
Wilhelmshoeher Str. 106 proxetil Hormosan tablet
D-60389 Frankfurt 200mg
06 Hessen Filmtabletten
Germany
EMA/52196/2015 Page 36/131
Germany Lupin (Europe) Limited Trimetazidine Lupamadazine 35 mg 35 mg Controlled - Oral use

Victoria Court, Bexton Road hydrochloride Retardtabletten release tablet
Knutsford, Cheshire WA16
0PF
United Kingdom
Germany Micro Labs GmbH Escitalopram Escitalopram-Micro Labs 5 5 mg Film - coated Oral use
Lyoner Str. 14 mg Filmtabletten tablet
D-60528 Frankfurt/Main
Germany
Germany
Germany
Germany
Germany Mylan dura GmBh Repaglinide Repaglinid Mylan 0,5 mg 0,5 mg Tablet Oral use
Wittichstrasse 6 Tabletten
64295 Darmstadt
Germany
EMA/52196/2015 Page 37/131
Germany Mylan dura GmBh Repaglinide Repaglinid Mylan 1 mg 1 mg Tablet Oral use
64295 Darmstadt
Germany
Germany Mylan dura GmBh Repaglinide Repaglinid Mylan 2 mg 2 mg Tablet Oral use
64295 Darmstadt
Germany
Germany Mylan dura GmBh Rizatriptan Rizatriptan Mylan dura 5 5 mg Orodispersible Oral use
Wittichstrasse 6 mg Schmelztabletten tablet
64295 Darmstadt
Germany
Germany Mylan dura GmBh Rizatriptan Rizatriptan Mylan dura 10 10 mg Orodispersible Oral use
Wittichstrasse 6 mg Schmelztabletten tablet
64295 Darmstadt
Germany
Germany Panacea Biotec Germany Tacrolimus Tacpan 0.5 mg Hartkapseln 0,5 mg Capsule, hard Oral use
GmbH
Landshuter Allee 8-10
D-80637 München
Germany
Germany Panacea Biotec Germany Tacrolimus Tacpan 1 mg Hartkapseln 1 mg Capsule, hard Oral use
GmbH
D-80637 München
Germany
EMA/52196/2015 Page 38/131
Germany Panacea Biotec Germany Tacrolimus Tacpan 5 mg Hartkapseln 5 mg Capsule, hard Oral use
GmbH
D-80637 München
Germany
Germany Stadapharm GmbH Entacapone Entacapon STADA 200 mg 200 mg Film - coated Oral use
Stadastr. 2-18 Filmtabletten tablet
D-61118 Bad Vilbel
Germany
Germany Unichem Laboratories Ltd. Irbesartan Irbesartan Unichem 150 150 mg Film - coated Oral use
Studio 8B Ard Gaoithe mg Filmtabletten tablet
Commercial Centre, Business
Park
Cashel Road Clonmel,
Co Tipperary
Ireland
Germany Unichem Laboratories Ltd. Irbesartan Irbesartan Unichem 300 300 mg Film - coated Oral use
Studio 8B Ard Gaoithe mg Filmtabletten tablet
Park
Co Tipperary
Ireland
EMA/52196/2015 Page 39/131
Germany Welding GmbH & Co. KG Irbesartan/hydroch Irbesartan + 300 Film - coated Oral use
Esplanade 39 lorothiazide Hidroclorotiazida Welding mg/12,5 tablet
D-20354 Hamburg mg
Germany
Germany Welding GmbH & Co. KG Irbesartan/hydroch Irbesartan + 150 Film - coated Oral use
Esplanade 39 lorothiazide Hidroclorotiazida Welding mg/12,5 tablet
D-20354 Hamburg mg
Germany
Germany Welding GmbH & Co. KG Irbesartan/hydroch Irbesartan + 300 mg/25 Film - coated Oral use
Esplanade 39 lorothiazide Hidroclorotiazida Welding mg tablet
D-20354 Hamburg
Germany
Germany Welding GmbH & Co. KG Irbesartan Irbesartan Welding 75 mg Film - coated Oral use
Esplanade 39 tablet
D-20354 Hamburg
Germany
Esplanade 39 tablet
D-20354 Hamburg
Germany
Esplanade 39 tablet
D-20354 Hamburg
Germany
EMA/52196/2015 Page 40/131
Greece Abbott Laboratories Escitalopram Savandra 5 mg Film - coated Oral use

Hellas ΑΒΕΕ oxalate tablet
Agiou Dimitriou 63
Alimos 17456
Greece
Agiou Dimitriou 63
Alimos 17456
Greece
Agiou Dimitriou 63
Alimos 17456
Greece
Agiou Dimitriou 63
Alimos 17456
Greece
Greece Genepharm S.A. Desloratadine Desloratadine/Genepharm 5 mg Film - coated Oral use
18 Km Marathon Avenue, 5 mg δισκία επικαλυμμένα tablet
15351 Pallini με υμένιο,
Greece
EMA/52196/2015 Page 41/131
Greece Genepharm S.A. Desloratadine Desloratadine/Genepharm 2,5 mg Orodispersible Oral use

18 Km Marathon Avenue, 2,5 mg δισκία tablet
15351 Pallini διασπειρόμενα στο στόμα
Greece
Greece Genepharm S.A. Desloratadine Desloratadine/Genepharm 5 mg Orodispersible Oral use
18 Km Marathon Avenue, 5 mg δισκία διασπειρόμενα tablet
15351 Pallini στο στόμα
Greece
Greece Generics Pharma Hellas Ltd Donepezil Donepezil/ Generics 5 mg Orodispersible Oral use
Argyroupoli
164-51 Athens
Greece
Greece Generics Pharma Hellas Ltd Donepezil Donepezil/ Generics 10 mg Orodispersible Oral use
Argyroupoli
164-51 Athens
Greece
Greece Generics Pharma Hellas Ltd Esomeprazole Esomeprazole/ Generics 40 mg Prolonged - Oral use
577a Vouliagmenis Avenue magnesium release capsule
Argyroupoli
164-51 Athens
Greece
EMA/52196/2015 Page 42/131
Greece Sieger Pharma A.E. Desloratadine Desloratadine/Sieger 5 mg Film - coated Oral use
Marathonos Avenue 106 tablet
Pikermi 19009
Greece
Greece Sieger Pharma A.E. Desloratadine Desloratadine/Sieger 2,5 mg Orodispersible Oral use
Pikermi 19009
Greece
Greece Sieger Pharma A.E. Desloratadine Desloratadine/Sieger 5 mg Orodispersible Oral use
Pikermi 19009
Greece
Hungary Actavis Group PTC ehf. Metformin Gluforlyn XR 500 mg 500 mg Prolonged - Oral use
Reykjavikurvegi 76-78 hydrochloride retard tabletta release tablet
220 Hafnarfjördur
Iceland
Hungary Alvogen IPCo S.ar.l. Desloratadine Alvotadin 5 mg filmtabletta 5 mg Film - coated Oral use
Rue Heienhaff 5 tablet
Luxembourg
Hungary Alvogen IPCo S.ar.l. Desloratadine Alvotadin 2.5 mg szájban 2,5 mg Orodispersible Oral use
Rue Heienhaff 5 diszpergálódó tabletta tablet
Luxembourg
EMA/52196/2015 Page 43/131
Hungary Alvogen IPCo S.ar.l. Desloratadine Alvotadin 5 mg szájban 5 mg Orodispersible Oral use
Rue Heienhaff 5 diszpergálódó tabletta tablet
Luxembourg
Hungary Generics (UK) Ltd Esomeprazole Esomeprazol Mylan 20 mg 20 mg Gastro - resistant Oral use
Station Close, Potters Bar magnesium gyomornedv-ellenálló capsule, hard
Hertfordshire, EN6 1TL kemény kapszula
United Kingdom
Hungary Generics (UK) Ltd Esomeprazole Esomeprazol Mylan 40 mg 40 mg Gastro - resistant Oral use
Station Close, Potters Bar magnesium gyomornedv-ellenálló capsule, hard
Hertfordshire, EN6 1TL kemény kapszula
United Kingdom
Hungary Glenmark Pharmaceuticals Trimetazidine Apstar 35 mg retard 35 mg Prolonged - Oral use
s.r.o. dihydrochloride tabletta release tablet
Hvězdova 1716/2b
14078 Praha 4
Czech Republic
Hungary Goodwill Pharma Kft. Desloratadine Inaller 5 mg filmtabletta 5 mg Film - coated Oral use
H-6724 Szeged tablet
Cserzy Mihály u. 32.
Hungary
Hungary Mylan SAS Trimetazidine Trimetazidine Mylan 35 mg 35 mg Prolonged - Oral use

117 allée des Parcs retard tabletta release tablet
France
EMA/52196/2015 Page 44/131
Hungary Sandoz Hungária Kft. Trimetazidine Trimetazidine Sandoz 35 35 mg Prolonged - Oral use
H-1114 Budapest dihydrochloride mg retard tabletta release tablet
Bartók Béla út 43-47.
Hungary
Hungary Teva Gyógyszergyár Zrt. Desloratadine Desloratadin Teva 2.5 mg 2,5 mg Orodispersible Oral use
H-4042 Debrecen szájban diszpergálódó tablet
Pallagi út 13. tabletta
Hungary
Hungary Teva Gyógyszergyár Zrt. Desloratadine Desloratadin Teva 5 mg 5 mg Orodispersible Oral use
H-4042 Debrecen szájban diszpergálódó tablet
Pallagi út 13. tabletta
Hungary
Iceland ratiopharm GmbH Desloratadine Desloratadine ratiopharm 5 mg Orodispersible Oral use
D-89079 Ulm
Germany
Ireland Accord Healthcare Limited Ropinirole Ropinirole 0.25 mg Film- 0,25 mg Film - coated Oral use
Sage House, 319 Pinner Road hydrochloride coated Tablets tablet
Middlesex
United Kingdom
Ireland Accord Healthcare Limited Ropinirole Ropinirole 0.5 mg Film- 0,5 mg Film - coated Oral use
Middlesex
United Kingdom
EMA/52196/2015 Page 45/131
Ireland Accord Healthcare Limited Ropinirole Ropinirole 1 mg Film- 1 mg Film - coated Oral use
Middlesex
United Kingdom
Middlesex
United Kingdom
Middlesex
United Kingdom
Ireland Accord Healthcare Limited Alendronic acid Alendronic Acid Once 70 mg Tablet Oral use
Sage House, 319 Pinner Road Weekly 70 mg Tablets
Middlesex
United Kingdom
Ireland Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/Hydrochlorothiaz 160 Film - coated Oral use
Planckstrasse 13 orothiazide ide Fair-Med 160 mg/12.5 mg/12,5 tablet
DE-22765 Hamburg mg film-coated tablets. mg
Germany
EMA/52196/2015 Page 46/131
Ireland Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/Hydrochlorothiaz 320 Film - coated Oral use
Planckstrasse 13 orothiazide ide Fair-Med 320 mg/12.5 mg/12,5 tablet
DE-22765 Hamburg mg film-coated tablets mg
Germany
Ireland Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/Hydrochlorothiaz 320 mg/25 Film - coated Oral use
Planckstrasse 13 orothiazide ide Fair-Med 320 mg/25 mg tablet
DE-22765 Hamburg mg film-coated tablets
Germany
Ireland Fannin (UK) Ltd Fexofenadine Fexofenadine 120 mg film- 120 mg Film - coated Oral use
42-46 Booth Drive hydrochloride coated tablets tablet
Park Farm South
Wellingborough
Northamptonshire NN8 6GT
United Kingdom
Ireland Fannin (UK) Ltd Fexofenadine Fexofenadine 180 mg film- 180 mg Film - coated Oral use
42-46 Booth Drive hydrochloride coated tablets tablet
Park Farm South
Wellingborough
United Kingdom
Ireland McDermott Laboratories Ltd Donepezil Aripil Orotab 5mg 5 mg Orodispersible Oral use
t/a Gerard Laboratories Orodispersible Tablet tablet
35/36 Baldoyle Industrial
Estate
Grange Road
Dublin 13
Ireland
EMA/52196/2015 Page 47/131
Ireland McDermott Laboratories Ltd Donepezil Aripil Orotab 10mg 10 mg Orodispersible Oral use
t/a Gerard Laboratories Orodispersible Tablet tablet
Estate
Grange Road
Dublin 13
Ireland
Ireland McDermott Laboratories Ltd Esomeprazole Esomeprazole Mylan 20 mg 20 mg Gastro - resistant Oral use
t/a Gerard Laboratories Gastro-resistant Capsules, capsule
35/36 Baldoyle Industrial hard
Estate
Grange Road
Dublin 13
Ireland
Ireland McDermott Laboratories Ltd Esomeprazole Esomeprazole Mylan 40 mg 40 mg Gastro - resistant Oral use
t/a Gerard Laboratories Gastro-resistant Capsules, capsule
35/36 Baldoyle Industrial hard
Estate
Grange Road
Dublin 13
Ireland
EMA/52196/2015 Page 48/131
Ireland McDermott Laboratories Ltd Candesartan Candesartan Mylan 4mg 4 mg Tablet Oral use
t/a Gerard Laboratories Tablets
Estate
Grange Road
Dublin 13
Ireland
Ireland McDermott Laboratories Ltd Candesartan Candesartan Mylan 8 mg 8 mg Tablet Oral use
Estate
Grange Road
Dublin 13
Ireland
Estate
Grange Road
Dublin 13
Ireland
EMA/52196/2015 Page 49/131
Estate
Grange Road
Dublin 13
Ireland
Ireland Morningside Healthcare Phenoxymethyl Phenoxymethylpenicillin 250 mg Film - coated Oral use
Limited penicillin 250mg Film-coated Tablets tablet
115 Narborough Road
Leicester, LE3 0PA
United Kingdom
Ireland Niche Generics Limited Amlodipine besilate Amlodipine Niche 5mg 5 mg Tablet Oral use
1 The Cam Centre tablets
Wilbury Way, Hitchin
Hertfordshire SG4 0TW
United Kingdom
Ireland Niche Generics Limited Amlodipine besilate Amlodipine Niche 10mg 10 mg Tablet Oral use
1 The Cam Centre Tablets
United Kingdom
Ireland Niche Generics Limited Irbesartan Irbesartan Niche 150mg 150 mg Film - coated Oral use
1 The Cam Centre film coated tablets tablet
United Kingdom
EMA/52196/2015 Page 50/131
Ireland Niche Generics Limited Irbesartan Irbesartan Niche 300mg 300 mg Film - coated Oral use
1 The Cam Centre film coated tablets tablet
United Kingdom
Ireland Wockhardt UK Limited Clopidogrel Clopidogrel 75mg film- 75 mg Film - coated Oral use
Ash Road North hydrochloride coated tablets tablet
Wrexham LL13 9UF
United Kingdom
Italy Accord Healthcare Italia S.r.l. Metoclopramide METOCLOPRAMIDE 10 mg Tablet Oral use
Largo Esterle, 4 ACCORD
20052 Monza
Italy
Italy Accord Healthcare Limited Alendronic acid ALENDRONATO AHCL 10 mg Tablet Oral use
Middlesex
United Kingdom
Italy Accord Healthcare Limited Alendronic acid ALENDRONATO AHCL 70 mg Tablet Oral use
Middlesex
United Kingdom
EMA/52196/2015 Page 51/131
Italy Doc Generici SRL Desloratadine DESLORATADINA DOC 5 mg Film - coated Oral use
Via Turati, 40 GENERICI tablet
20121 Milano
Italy
Italy Doc Generici SRL Desloratadine DESLORATADINA DOC 2,5 mg Orodispersible Oral use
20121 Milano
Italy
Italy Doc Generici SRL Desloratadine DESLORATADINA DOC 5 mg Orodispersible Oral use
20121 Milano
Italy
Italy Farmaceutici Caber S.P.A. Valsartan VALSOTEN 40 mg Film - coated Oral use
Viale Citta' D'Europa, 681 tablet
00144 Rome
Italy
00144 Rome
Italy
00144 Rome
Italy
EMA/52196/2015 Page 52/131
00144 Rome
Italy
Italy Mylan S.P.A. Esomeprazole ESOMEPRAZOLO MYLAN 20 mg Gastro - resistant Oral use
Via Vittor Pisani, 20 magnesium capsule, hard
20124 Milan
Italy
Italy Mylan S.P.A. Esomeprazole ESOMEPRAZOLO MYLAN 40 mg Gastro - resistant Oral use
Via Vittor Pisani, 20 magnesium capsule, hard
20124 Milan
Italy
Italy Mylan S.P.A. Rizatriptan RIAZATRIPTAN MYLAN 5 mg Orodispersible Oral use
Via Vittor Pisani, 20 benzoate GENERICS tablet
20124 Milan
Italy
Italy Mylan S.P.A. Rizatriptan RIAZATRIPTAN MYLAN 10 mg Orodispersible Oral use
Via Vittor Pisani, 20 benzoate GENERICS tablet
20124 Milan
Italy
Italy Mylan S.P.A. Donepezil DONEPEZIL MYLAN 5 mg Orodispersible Oral use
Via Vittor Pisani, 20 hydrochloride GENERICS ITALIA tablet
20124 Milan
Italy
EMA/52196/2015 Page 53/131
Italy Mylan S.P.A. Donepezil DONEPEZIL MYLAN 10 mg Orodispersible Oral use

Via Vittor Pisani, 20 hydrochloride GENERICS ITALIA tablet
20124 Milan
Italy
Italy Mylan S.P.A. Repaglinide REPAGLINIDE MYLAN 0,5 mg Tablet Oral use
Via Vittor Pisani, 20
20124 Milan
Italy
Italy Mylan S.P.A. Repaglinide REPAGLINIDE MYLAN 1 mg Tablet Oral use
20124 Milan
Italy
Italy Mylan S.P.A. Repaglinide REPAGLINIDE MYLAN 2 mg Tablet Oral use
20124 Milan
Italy
Italy Pensa Pharma S.P.A. Alendronic acid Alendronato Pensa 70 mg Tablet Oral use
Via Rossellini Ippolito, 12 70 mg compresse
20124 Milan
Italy
Italy Ranbaxy Italia S.P.A. Alendronic acid ALENDRONATO RANBAXY 70 mg Tablet Oral use
Piazza Filippo Meda, 4, 3 ITALIA
20121 - Milano
Italy
EMA/52196/2015 Page 54/131
Latvia Sandoz Pharmaceuticals d.d. Trimetazidine Zidmetin 35 mg Modified - release Oral use
Verovskova 57 dihydrochloride tablet
Ljubljana SI-1000
Slovenia
Lithuania Accord Healthcare Limited Alendronic acid Alendronic acid Accord 70 mg Tablet Oral use
Middlesex
United Kingdom
Lithuania Lambda Therapeutic Limited Ropinirole Ropinirole Lambada 0,5 mg Film - coated Oral use
Sage House tablet
Harrow
Middlesex HA1 4HF
United Kingdom
Lithuania Lambda Therapeutic Limited Ropinirole Ropinirole Lambada 1 mg Film - coated Oral use
Sage House tablet
Harrow
Middlesex HA1 4HF
United Kingdom
Sage House tablet
Harrow
Middlesex HA1 4HF
United Kingdom
EMA/52196/2015 Page 55/131
Sage House tablet
Harrow
Middlesex HA1 4HF
United Kingdom
Lithuania Torrent Pharma GmbH Irbesartan Irbesartanas Torrent 75 mg Film - coated Oral use
Südwestpark 50 tablet
90449 Nürnberg
Germany
90449 Nürnberg
Germany
90449 Nürnberg
Germany
Lithuania Torrent Pharma GmbH Irbesartan/hydroch Irbesartanas/Hidrochlorotia 150 Film - coated Oral use
Südwestpark 50 lorothiazide zidas Torrent mg/12,5 tablet
90449 Nürnberg mg
Germany
Lithuania Torrent Pharma GmbH Irbesartan/hydroch Irbesartanas/Hidrochlorotia 300 Film - coated Oral use
Südwestpark 50 lorothiazide zidas Torrent mg/12,5 tablet
90449 Nürnberg mg
Germany
EMA/52196/2015 Page 56/131
Lithuania Torrent Pharma GmbH Irbesartan/hydroch Irbesartanas/Hidrochlorotia 300 mg/25 Film - coated Oral use
Südwestpark 50 lorothiazide zidas Torrent mg tablet
90449 Nürnberg
Germany
Luxembourg Mylan bvba/sprl Repaglinide Repaglinide Mylan Pharma 0,5 mg Tablet Oral use
Terhulpsesteenweg 6A 0,5 mg tabletten
1560 Hoeilaart
Belgium
Luxembourg Mylan bvba/sprl Repaglinide Repaglinide Mylan Pharma 1 mg Tablet Oral use
Terhulpsesteenweg 6A 1 mg tabletten
1560 Hoeilaart
Belgium
Luxembourg Mylan bvba/sprl Repaglinide Repaglinide Mylan Pharma 2 mg Tablet Oral use
Terhulpsesteenweg 6A 2 mg tabletten
1560 Hoeilaart
Belgium
Luxembourg Mylan bvba/sprl Esomeprazole Esomeprazole Mylan 20 mg Gastro - resistant Oral use
1560 Hoeilaart
Belgium
Luxembourg Mylan bvba/sprl Esomeprazole Esomeprazole Mylan 40 mg Gastro - resistant Oral use
1560 Hoeilaart
Belgium
EMA/52196/2015 Page 57/131
Malta Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/hydrochlorthiazid 160 Film - coated Oral use
Planckstrasse 13 orothiazide "Fair-Med" Coated tablets mg/12,5 tablet
DE-22765 Hamburg mg
Germany
Malta Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/hydrochlorthiazid 320 Film - coated Oral use
Planckstrasse 13 orothiazide "Fair-Med" Coated tablets mg/12,5 tablet
DE-22765 Hamburg mg
Germany
Malta Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/hydrochlorthiazid 320 mg/25 Film - coated Oral use
Planckstrasse 13 orothiazide "Fair-Med" Coated tablets mg tablet
DE-22765 Hamburg
Germany
Malta Fair-Med Healthcare GmbH Ciprofloxacin Ciprofloxacin Fair-Med 250 mg Film - coated Oral use
Planckstrasse 13 Coated Tablets tablet
DE-22765 Hamburg
Germany
Malta Fair-Med Healthcare GmbH Ciprofloxacin Ciprofloxacin Fair-Med 500 mg Film - coated Oral use
Planckstrasse 13 Coated Tablets tablet
DE-22765 Hamburg
Germany
Malta Fair-Med Healthcare GmbH irbesartan Irbesartan Fairmed 75mg 75 mg Film - coated Oral use
Planckstrasse 13 Film-coated Tablets tablet
DE-22765 Hamburg
Germany
EMA/52196/2015 Page 58/131
DE-22765 Hamburg
Germany
DE-22765 Hamburg
Germany
Malta Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan/Hydrochlorothia 150 Film - coated Oral use
Planckstrasse 13 lorothiazide zide Fairmed mg/12,5 tablet
DE-22765 Hamburg 150mg/12.5mg film-coated mg
Germany tablets
Malta Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan/Hydrochlorothia 300 Film - coated Oral use
Planckstrasse 13 lorothiazide zide Fairmed mg/12,5 tablet
DE-22765 Hamburg 300mg/12.5mg film-coated mg
Germany tablets
Malta Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan/Hydrochlorothia 300 mg/25 Film - coated Oral use
Planckstrasse 13 lorothiazide zide Fairmed 300mg/25mg mg tablet
DE-22765 Hamburg film-coated tablets
Germany
Malta Fair-Med Healthcare GmbH Venlafaxine Venlafaxine Fair-Med 37,5 mg Prolonged - Oral use
Planckstrasse 13 release capsule,
Germany
EMA/52196/2015 Page 59/131
Malta Fair-Med Healthcare GmbH Venlafaxine Venlafaxine Fair-Med 75 mg Prolonged - Oral use
Germany
Malta Fair-Med Healthcare GmbH Venlafaxine Venlafaxine Fair-Med 150 mg Prolonged - Oral use
Germany
Malta Wockhardt UK Limited Clopidogrel Clopidogrel 75mg Film- 75 mg Film - coated Oral use
Ash Road North coated Tablets tablet
Wrexham LL13 9UF
United Kingdom
Malta Wockhardt UK Limited Clopidogrel Clopidogrel 75mg Coated 75 mg Film - coated Oral use
Ash Road North Tablets tablet
Wrexham LL13 9UF
United Kingdom
Norway Bluefish Pharmaceuticals AB Fluconazole Fluconazol Bluefish 50 mg Capsule, hard Oral use
Torsgatan 11
SE-11123 Stockholm
Sweden
Torsgatan 11
SE-11123 Stockholm
Sweden
EMA/52196/2015 Page 60/131
Torsgatan 11
SE-11123 Stockholm
Sweden
Norway Mylan AB Esomeprazole Esomeprazol Mylan 20 mg Gastro - resistant Oral use
SE-104 35 Stockholm
Sweden
Norway Mylan AB Esomeprazole Esomeprazol Mylan 40 mg Gastro - resistant Oral use
SE-104 35 Stockholm
Sweden
Norway Mylan AB Eletriptan Eletriptan Mylan 20 mg Film - coated Oral use
SE-104 35 Stockholm
Sweden
Norway Mylan AB Eletriptan Eletriptan Mylan 40 mg Film - coated Oral use
SE-104 35 Stockholm
Sweden
Norway Mylan AB Candesartan Kandrozid 4 mg tablet Oral use
PO Box 230 33 cilexetil
SE-104 35 Stockholm
Sweden
EMA/52196/2015 Page 61/131

SE-104 35 Stockholm
Sweden
SE-104 35 Stockholm
Sweden
SE-104 35 Stockholm
Sweden
Norway Mylan AB Candesartan Mylcande 8 mg tablet Oral use
SE-104 35 Stockholm
Sweden
SE-104 35 Stockholm
Sweden
SE-104 35 Stockholm
Sweden
EMA/52196/2015 Page 62/131
Norway Mylan AB Rizatriptan RIZATRIPTAN MYLAN 10 10 mg Orodispersible Oral use

PO Box 230 33 mg, orodispersible tablet tablet
SE-104 35 Stockholm
Sweden
Norway ratiopharm GmbH Desloratadine Desloratadin Ratiopharm 2,5 mg Orodispersible Oral use
D-89079 Ulm
Germany
Norway ratiopharm GmbH Desloratadine Desloratadin Ratiopharm 5 mg Orodispersible Oral use
D-89079 Ulm
Germany
Poland Abbott Laboratories Poland Escitalopram Savandra 5 mg Film - coated Oral use
Sp. z o.o. tablet
ul. Postępu 21B
02-676 Warszawa
Poland
Sp. z o.o. tablet
ul. Postępu 21B
02-676 Warszawa
Poland
EMA/52196/2015 Page 63/131
Sp. z o.o. tablet
ul. Postępu 21B
02-676 Warszawa
Poland
Sp. z o.o. tablet
ul. Postępu 21B
02-676 Warszawa
Poland
Poland Actavis Group PTC ehf. Metformin Metformin SR Actavis 500 mg Film - coated Oral use
Reykjavikurvegi 76-78 tablet
220 Hafnarfjördur
Iceland
Poland Actavis Group PTC ehf. Metformin Metformin SR Actavis 750 mg Film - coated Oral use
Reykjavikurvegi 76-78 tablet
220 Hafnarfjördur
Iceland
Poland Adamed Sp. z o.o. Desloratadine Desada 5 mg Orodispersible Oral use
Pieńków 149 tablet
05-152 Czosnów k. Warszawy
Poland
Poland Adamed Sp. z o.o. Desloratadine Hitaxa Fast 2,5 mg Orodispersible Oral use
Poland
EMA/52196/2015 Page 64/131
Poland Adamed Sp. z o.o. Desloratadine Hitaxa 2,5 mg Orodispersible Oral use
Poland
Poland Adamed Sp. z o.o. Desloratadine Hitaxa 5 mg Orodispersible Oral use
Poland
Poland Aflofarm Farmacja Polska Sp. Desloratadine Teslor 5 mg Film - coated Oral use
z o.o. tablet
ul. Partyzancka 133/151
95-200 Pabianice
Poland
Poland Aflofarm Farmacja Polska Sp. Desloratadine Teslor fast 5 mg Orodispersible Oral use
z o.o. tablet
95-200 Pabianice
Poland
Poland Aflofarm Farmacja Polska Sp. Desloratadine Teslor fast junior 2,5 mg Orodispersible Oral use
z o.o. tablet
95-200 Pabianice
Poland
EMA/52196/2015 Page 65/131
Poland Apotex Europe B.V. Trimetazidine ApoTrimet PR 35 mg Prolonged - Oral use

Darwinweg 20 release tablet
NL 2333 CR Leiden
Netherlands
Poland Bio-Profil Polska Sp. z o.o. Desloratadine Desloratadine Peseri 5 mg Film - coated Oral use
Trakt Lubelski 135 tablet
04-790 Warszawa
Poland
Poland Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan HCT Fair-Med 320 Film - coated Oral use
DE-22765 Hamburg mg
Germany
Poland Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan HCT Fair-Med 320 mg/25 Film - coated Oral use
Planckstrasse 13 orothiazide mg tablet
DE-22765 Hamburg
Germany
Poland Fair-Med Healthcare GmbH Ciprofloxacin Ciprofloxacin Fair-Med 250 mg Film - coated Oral use
Planckstrasse 13 tablet
DE-22765 Hamburg
Germany
Poland Fair-Med Healthcare GmbH Ciprofloxacin Ciprofloxacin Fair-Med 500 mg Film - coated Oral use
DE-22765 Hamburg
Germany
EMA/52196/2015 Page 66/131
Poland Fair-Med Healthcare GmbH Irbesartan Irbesartan Fair-Med 75 mg Film - coated Oral use
DE-22765 Hamburg
Germany
DE-22765 Hamburg
Germany
DE-22765 Hamburg
Germany
Poland Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan HCT Fair-Med 150 Film - coated Oral use
Planckstrasse 13 lorothiazide mg/12,5 tablet
DE-22765 Hamburg mg
Germany
Poland Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan HCT Fair-Med 300 Film - coated Oral use
Planckstrasse 13 lorothiazide mg/12,5 tablet
DE-22765 Hamburg mg
Germany
Poland Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan HCT Fair-Med 300 mg/25 Film - coated Oral use
Planckstrasse 13 lorothiazide mg tablet
DE-22765 Hamburg
Germany
EMA/52196/2015 Page 67/131
Poland Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan HCT Fair-Med 160 Film - coated Oral use
DE-22765 Hamburg mg
Germany
Poland Fair-Med Healthcare GmbH Venlafaxine VENLAFAXINE FAIR-MED 37,5 mg Prolonged - Oral use
Germany
Poland Fair-Med Healthcare GmbH Venlafaxine VENLAFAXINE FAIR-MED 75 mg Prolonged - Oral use
Germany
Poland Fair-Med Healthcare GmbH Venlafaxine VENLAFAXINE FAIR-MED 150 mg Prolonged - Oral use
Germany
Poland Generics (UK) Ltd Candesartan Kangen 8 mg Tablet Oral use
Station Close, Potters Bar cilexetil
United Kingdom
Poland Generics (UK) Ltd Candesartan Kangen 16 mg Tablet Oral use
Station Close, Potters Bar cilexetil
United Kingdom
EMA/52196/2015 Page 68/131
Poland Labormed-Pharma, SA Desloratadine Desloratadine Labormed 2,5 mg Orodispersible Oral use

Theodor Pallady, 44B tablet
032266 Bucharest
Romania
Poland Labormed-Pharma, SA Desloratadine Desloratadine Labormed 5 mg Orodispersible Oral use

032266 Bucharest
Romania
Poland Medicplast Polska Sp. z o.o Desloratadine Desalergo 5 mg Film - coated Oral use
ul. Wólczyńska 232 tablet
01-919 Warszawa
Poland
Poland Medicplast Polska Sp. z o.o Desloratadine Desalergo 2,5 mg Orodispersible Oral use
01-919 Warszawa
Poland
Poland Medicplast Polska Sp. z o.o Desloratadine Desalergo 5 mg Orodispersible Oral use
01-919 Warszawa
Poland
Poland Orion Corporation Valsartan Valsartan Orion 40 mg Film - coated Oral use
Orion Pharma tablet
PO BOX 65
02101 Espoo
Finland
EMA/52196/2015 Page 69/131
Orion Pharma tablet
PO BOX 65
02101 Espoo
Finland
Orion Pharma tablet
PO BOX 65
02101 Espoo
Finland
Orion Pharma tablet
PO BOX 65
02101 Espoo
Finland
Poland Peseri Trading Limited Desloratadine Desloratadine Peseri 2,5 mg Orodispersible Oral use
20 Queen Frederica Street tablet
El-Greco House, office 301
1066 Nicosia
Cyprus
Poland Peseri Trading Limited Desloratadine Desloratadine Peseri 5 mg Orodispersible Oral use
1066 Nicosia
Cyprus
EMA/52196/2015 Page 70/131
Poland Ranbaxy (Poland) Sp. z o.o. Alendronic acid Alendran 70 70 mg Tablet Oral use
Kubickiego 11
02-954 Warszawa
Poland
Poland Sandoz GmbH Trimetazidine Dimesar 35 mg Prolonged - Oral use
Biochemiestrasse 10 release tablet
A-6250 Kundl
Austria
Poland S-Lab Sp. z o.o. Desloratadine Suprodeslon 5 mg Film - coated Oral use
ul. Kiełczowska 2 tablet
55-095 Mirków
Poland
Poland S-Lab Sp. z o.o. Desloratadine Suprodeslon 2,5 mg Orodispersible Oral use
55-095 Mirków
Poland
Poland S-Lab Sp. z o.o. Desloratadine Suprodeslon 5 mg Orodispersible Oral use
55-095 Mirków
Poland
Poland SymPhar Sp. z o.o. Desloratadine Symdes 5 mg Film - coated Oral use
ul. Włoska 1 tablet
00-777 Warszawa
Poland
EMA/52196/2015 Page 71/131
Poland Tactica Pharmaceuticals sp. z Desloratadine Goldesin 5 mg Film - coated Oral use
o.o. tablet
ul. Bankowa 4
44-100 Gliwice
Poland
Poland US Pharmacia Sp. z o.o. Desloratadine Aleric Deslo 5 mg Film - coated Oral use
ul.Ziębicka 40 tablet
50-507 Wrocław
Poland
Poland US Pharmacia Sp. z o.o. Desloratadine Aleric Deslo 2,5 mg Orodispersible Oral use
50-507 Wrocław
Poland
Poland US Pharmacia Sp. z o.o. Desloratadine Aleric Deslo Active 5 mg Orodispersible Oral use
50-507 Wrocław
Poland
Poland Wockhardt UK Limited Clopidogrel Clopidogrel Wockhardt 75 mg Film - coated Oral use
Ash Road North tablet
Wrexham LL13 9UF
United Kingdom
EMA/52196/2015 Page 72/131
Portugal Accord Healthcare Limited Alendronic acid Ácido alendrónico Accord 70 mg tablet Oral use
Middlesex
United Kingdom
Portugal Alkaloid - INT d.o.o. Cefpodoxime Cefpodoxima Alkaloid 200 mg Tablet Oral use
Šlandrova 4
Slovenia
Portugal Brown & Burk UK, Ltd. Tramadol/paraceta Tramadol + Paracetamol 37,5 Film - coated Oral use
5, Marryat Close mol Brown mg/325 mg tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal Brown & Burk UK, Ltd. Trimetazidine Trimetazidina Brown 35 mg Modified - release Oral use
5, Marryat Close tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal Brown & Burk UK, Ltd. Escitalopram Escitalopram Brown 10 mg Film - coated Oral use
Hounslow
TW4 5DQ Middlesex
United Kingdom
EMA/52196/2015 Page 73/131
Hounslow
TW4 5DQ Middlesex
United Kingdom
Hounslow
TW4 5DQ Middlesex
United Kingdom
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal Brown & Burk UK, Ltd. Ebastine Ebastina Brown 10 mg Film - coated Oral use
Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal Brown & Burk UK, Ltd. Ebastine Ebastina Brown 20 mg Film - coated Oral use
Hounslow
TW4 5DQ Middlesex
United Kingdom
EMA/52196/2015 Page 74/131
Portugal Daquimed - Comércio de Quetiapine Quetiapina Daquimed 25 mg Film - coated Oral use
Produtos Farmacêuticos, S.A. tablet
Av. Associação Comercial e
Industrial de Gondomar, 330
- Zona Industrial da
Portelinha
4510-688 Fânzeres
Portugal
Portelinha
4510-688 Fânzeres
Portugal
Portelinha
4510-688 Fânzeres
Portugal
EMA/52196/2015 Page 75/131
Portelinha
4510-688 Fânzeres
Portugal
Portelinha
4510-688 Fânzeres
Portugal
Portugal Generis Farmacêutica, S. A. Levodopa/carbidop Levodopa + Carbidopa + 50 mg/12,5 Film - coated Oral use
Rua João de Deus, 19 a/entacapone Entacapona Generis mg/200 mg tablet
2700-487 Amadora
Portugal
Portugal Generis Farmacêutica, S. A. Levodopa/carbidop Levodopa + Carbidopa + 75 Film - coated Oral use
Rua João de Deus, 19 a/entacapone Entacapona Generis mg/18,75 tablet
2700-487 Amadora mg/200 mg
Portugal
EMA/52196/2015 Page 76/131
Portugal Generis Farmacêutica, S. A. Levodopa/carbidop Levodopa + Carbidopa + 100 mg/25 Film - coated Oral use
2700-487 Amadora
Portugal
Portugal
Portugal
Portugal
Portugal Generis Farmacêutica, S. A. Levodopa/carbidop Levodopa + Carbidopa + 200 mg/50 Film - coated Oral use
2700-487 Amadora
Portugal
Portugal Generis Farmacêutica, S. A. Entacapone Entacapona Generis 200 mg Film - coated Oral use
Rua João de Deus, 19 tablet
2700-487 Amadora
Portugal
EMA/52196/2015 Page 77/131
Portugal Labesfal, Genéricos, S.A. Desloratadine Desloratadina Labesfal OD 2,5 mg Orodispersible Oral use
Av. Dr. Afonso Costa, nº 1370 tablet
3465-051 Campo de Besteiros
Portugal
Portugal Labesfal, Genéricos, S.A. Desloratadine Desloratadina Labesfal OD 5 mg Orodispersible Oral use
Av. Dr. Afonso Costa, nº 1370 tablet
Portugal
Portugal Labesfal, Genéricos, S.A. Alendronic acid Ácido alendrónico Labesfal 70 mg tablet Oral use
Av. Dr. Afonso Costa, nº 1370
Portugal
Portugal Laboratórios Anova - Produtos Donepezil Donepezilo Anova 5 mg Orodispersible Oral use
Farmacêuticos, Lda. tablet
Rua Doutor António Loureiro
Borges
Edíficio Arquiparque 1, R/C
Esqº
1499-016 Algés
Portugal
EMA/52196/2015 Page 78/131
Portugal Laboratórios Anova - Produtos Donepezil Donepezilo Anova 10 mg Orodispersible Oral use
Farmacêuticos, Lda. tablet
Borges
Esqº
1499-016 Algés
Portugal
Portugal Laboratórios Anova - Produtos Esomeprazole Esomeprazol Anova 20 mg Gastro - resistant Oral use
Farmacêuticos, Lda. capsule, hard
Borges
Esqº
1499-016 Algés
Portugal
Portugal Laboratórios Anova - Produtos Esomeprazole Esomeprazol Anova 40 mg Gastro - resistant Oral use
Farmacêuticos, Lda. capsule, hard
Borges
Esqº
1499-016 Algés
Portugal
EMA/52196/2015 Page 79/131
Portugal Laboratórios Azevedos - Venlafaxine Venlafaxina Azevedos 37,5 mg Prolonged - Oral use
Indústria Farmacêutica, S.A. release capsule,
Edifícios Azevedos - Estrada hard
Nacional 117-2, Alfragide
2614-504 Amadora
Portugal
Portugal Laboratórios Azevedos - Venlafaxine Venlafaxina Azevedos 75 mg Prolonged - Oral use
2614-504 Amadora
Portugal
Portugal Laboratórios Azevedos - Venlafaxine Venlafaxina Azevedos 150 mg Prolonged - Oral use
2614-504 Amadora
Portugal
Portugal Laboratórios Basi - Indústria Fluconazole Fluconazol Basi 50 mg Capsule Oral use
Farmacêutica, S.A
Parque Industrial Manuel
Lourenço Ferreira, Lote 15
3450-232 Mortágua
Portugal
EMA/52196/2015 Page 80/131
Farmacêutica, S.A
3450-232 Mortágua
Portugal
Farmacêutica, S.A
3450-232 Mortágua
Portugal
Portugal Labormed-Pharma, SA Desloratadine Desloratadina Labormed 5 mg Orodispersible Oral use
032266 Bucharest
Romania
Portugal Labormed-Pharma, SA Desloratadine Desloratadina Labormed 2,5 mg Orodispersible Oral use

032266 Bucharest
Romania
Portugal Lupin (Europe) Limited Cefpodoxime Cefpodoxima Lupin 200 mg Film - coated Oral use
Victoria Court, Bexton Road tablet
0PF
United Kingdom
EMA/52196/2015 Page 81/131
Portugal Mylan, Lda. Esomeprazole Esomeprazol Mylan 20 mg Gastro - resistant Oral use
Parque Expo, Edifício Atlantis, capsule, hard
Avenida D. João 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
Parque Expo, Edifício Atlantis, 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
Parque Expo, Edifício Atlantis, tablet
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
EMA/52196/2015 Page 82/131
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
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
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
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
EMA/52196/2015 Page 83/131
Portugal Mylan, Lda. Trimetazidine Trimetazidina Mylan 35 mg Modified - release Oral use
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
Parque Expo, Edifício Atlantis,
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
EMA/52196/2015 Page 84/131

1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal Peseri Trading Limited Desloratadine Desloratadina Peseri 5 mg Film - coated Oral use
1066 Nicosia
Cyprus
Portugal Peseri Trading Limited Desloratadine Desloratadina Peseri 5 mg Orodispersible Oral use
1066 Nicosia
Cyprus
Portugal Peseri Trading Limited Desloratadine Desloratadina Peseri 2,5 mg Orodispersible Oral use
1066 Nicosia
Cyprus
EMA/52196/2015 Page 85/131
Portugal Pharmakern Portugal - Trimetazidine Trimetazidina Pharmakern 35 mg Modified - release Oral use
Produtos Farmacêuticos, tablet
Sociedade Unipessoal, Lda.
Edifício Atlas II, Av. José
Gomes Ferreira, N.º 11 - 3º,
Sala 31 - Miraflores
1495-139 Algés
Portugal
Portugal Ratiopharm - Comércio e Desloratadine Desloratadina Ratiopharm 2,5 mg Orodispersible Oral use
Indústria de Produtos tablet
Farmacêuticos, Lda.
Lagoas Park, Edifício 5 A, Piso
2
2740-245 Porto Salvo
Portugal
Portugal Ratiopharm - Comércio e Desloratadine Desloratadina Ratiopharm 5 mg Orodispersible Oral use
Indústria de Produtos tablet
Farmacêuticos, Lda.
Lagoas Park, Edifício 5 A, Piso
2
Portugal
EMA/52196/2015 Page 86/131
Portugal Sandoz Farmaceutica Lda. Trimetazidine Trimetazidina Itraxel 35 mg Prolonged - Oral use
Avenida Professor Doutor release tablet
Cavaco Silva, n. 10E
Taguspark
Portugal
Portugal Teva Pharma - Produtos Desloratadine Desloratadina Teva 2,5 mg Orodispersible Oral use
Farmacêuticos,Lda. tablet
Edificio Tejo, Rua Quinta do
Pinheiro, 16 - 6º
2790-143 Carnaxide
Portugal
Portugal Teva Pharma - Produtos Desloratadine Desloratadina Teva 5 mg Orodispersible Oral use
Farmacêuticos,Lda. tablet
Edificio Tejo, Rua Quinta do
Pinheiro, 16 - 6º
2790-143 Carnaxide
Portugal
Romania Abbott Products SAS Escitalopram SAVANDRA 5 mg 5 mg Film - coated Oral use
42 rue Rouget de Lisle comprimate filmate tablet
92150 Suresnes
France
92150 Suresnes
France
EMA/52196/2015 Page 87/131
92150 Suresnes
France
92150 Suresnes
France
Romania Alkaloid - INT d.o.o. Cefpodoxime Forexo 200 mg 200 mg Tablet Oral use
Šlandrova 4 comprimate filmate
Slovenia
Romania Alvogen IPCo S.ar.l. Desloratadine Desloratadina Alvogen 5 5 mg Film - coated Oral use
Rue Heienhaff 5 mg comprimate filmate tablet
Luxembourg
Romania Dr. Reddy’s Laboratories Levetiracetam Levetiracetam Dr. Reddy’s, 250 mg Tablet Oral use
Romania SRL 250 mg, comprimate
71st-73rd Nicolae Caramfil, filmate
Floor 5, Space 10, Sector 1,
Bucuresti, Romania
Romania SRL 500mg, comprimate
Bucuresti, Romania
EMA/52196/2015 Page 88/131
Bucuresti, Romania
Bucuresti, Romania
Romania Dr. Reddy’s Laboratories Telmisartan Telmisartan Dr. Reddy's 40 40 mg Tablet Oral use
Romania SRL mg comprimate
71st-73rd Nicolae Caramfil,
Bucuresti, Romania
Romania Dr. Reddy’s Laboratories Telmisartan Telmisartan Dr. Reddy's 80 80 mg Tablet Oral use
Romania SRL mg comprimate
71st-73rd Nicolae Caramfil,
Bucuresti, Romania
Romania Dr. Reddy’s Laboratories Telmisartan/ Telmisartan HCT Dr. 40 mg/12,5 Tablet Oral use
Romania SRL hydrochlorothiazide Reddy’s 40 mg/12,5 mg mg
71st-73rd Nicolae Caramfil, comprimate
Bucuresti, Romania
EMA/52196/2015 Page 89/131
Romania Dr. Reddy’s Laboratories Telmisartan/ Telmisartan HCT Dr. 80 mg/12,5 Tablet Oral use
Romania SRL hydrochlorothiazide Reddy’s 80 mg/12,5 mg mg
Bucuresti, Romania
Romania Dr. Reddy’s Laboratories Telmisartan/ Telmisartan HCT Dr. 80 mg/25 Tablet Oral use
Romania SRL hydrochlorothiazide Reddy’s 80 mg/25 mg mg
Bucuresti, Romania
Romania Generics (UK) Ltd Esomeprazole Esomeprazol Mylan 20 mg 20 mg Gastro - resistant Oral use
Station Close, Potters Bar magnesium capsule gastrorezistente capsule, hard
United Kingdom
Romania Generics (UK) Ltd Esomeprazole Esomeprazol Mylan 40 mg 40 mg Gastro - resistant Oral use
Station Close, Potters Bar magnesium capsule gastrorezistente capsule, hard
United Kingdom
Romania Generics (UK) Ltd Donepezil Donepezil Mylan 5 mg 5 mg Orodispersible Oral use
Station Close, Potters Bar hydrochloride comprimate tablet
Hertfordshire, EN6 1TL orodispersabile
United Kingdom
Romania Generics (UK) Ltd Donepezil Donepezil Mylan 10 mg 10 mg Orodispersible Oral use
Station Close, Potters Bar hydrochloride comprimate tablet
Hertfordshire, EN6 1TL orodispersabile
United Kingdom
EMA/52196/2015 Page 90/131
Romania Generics (UK) Ltd Repaglinide Repaglinida Generics 0.5 0,5 mg Tablet Oral use
Station Close, Potters Bar mg comprimate
United Kingdom
Romania Generics (UK) Ltd Repaglinide Repaglinida Genericsl 1 mg 1 mg Tablet Oral use
Station Close, Potters Bar comprimate
United Kingdom
Romania Generics (UK) Ltd Repaglinide Repaglinida Generics 2 mg 2 mg Tablet Oral use
Station Close, Potters Bar comprimate
United Kingdom
Romania Generics (UK) Ltd Candesartan Candesartan Mylan 4 mg 4 mg Tablet Oral use
Station Close, Potters Bar cilexetil comprimate
United Kingdom
United Kingdom
United Kingdom
EMA/52196/2015 Page 91/131
Romania Generics (UK) Ltd Rizatriptan Rizatriptan Mylan 5 mg 5 mg Orodispersible Oral use
Station Close, Potters Bar benzoate comprimate tablet
Hertfordshire, EN6 1TL orrodispersabile
United Kingdom
Romania Generics (UK) Ltd Rizatriptan Rizatriptan Mylan 10 mg 10 mg Orodispersible Oral use
Station Close, Potters Bar benzoate comprimate tablet
Hertfordshire, EN6 1TL orrodispersabile
United Kingdom
Romania Glenmark Pharmaceuticals Trimetazidine Apstar 35mg 35 mg Modified - release Oral use
s.r.o. Comprimate cu tablet
Hvězdova 1716/2b eliberare
14078 Praha 4 prelungită
Czech Republic
Romania Labormed Pharma SA Desloratadine Desloratadine Labormed 2,5 mg Orodispersible Oral use
Bd. Theodor Pallady nr. 44 B 2.5 mg comprimate tablet
032266, sector 3, Bucureşti orodispersabile
România
Romania Labormed Pharma SA Desloratadine Desloratadine Labormed 5 5 mg Orodispersible Oral use
Bd. Theodor Pallady nr. 44 B mg comprimate tablet
032266, sector 3, Bucureşti orodispersabile
România
Romania Mylan SAS Trimetazidine Trimetazidina Mylan 35 mg 35 mg Prolonged - Oral use
117 allée des Parcs comprimate filmate cu release tablet
69792 Saint-Priest Cedex eliberare prelungita
France
EMA/52196/2015 Page 92/131
Romania Sandoz Pharma Services SRL Trimetazidine Trimeluzine Limited 35 mg 35 mg Modified - release Oral use
Calea Floreasca Street comprimate filmate cu tablet
No 169A, district 2 eliberare modificata
Bucharest
Romania
Romania STADA Hemofarm S.R.L. Entacapone ENTTANIDA 200 200 mg Film - coated Oral use
Calea Torontalului km 6 - comprimate filmate tablet
PITT
300633 Timişoara
Romania
Romania Teva Pharmaceuticals S.R.L. Desloratadine Desloratadina Teva 5 mg 5 mg Orodispersible Oral use
Str. Domniţa Ruxandra nr. comprimate tablet
12, parter, sector 2, orodispersabile
Bucureşti, România
Romania Torrent Pharma SRL Irbesartan Irbesartan Torrent 75 mg 75 mg Film - coated Oral use
Str. Stirbei Voda nr. 36 comprimate tablet
et. 2, biroul A, sector 1 filmate
Bucharest
Romania
Bucharest
Romania
EMA/52196/2015 Page 93/131
Bucharest
Romania
Romania Torrent Pharma SRL Irbesartan/hydroch Irbesartan Torrent 150 Film - coated Oral use
Str. Stirbei Voda nr. 36 lorothiazide Hidrochlorotiazida mg/12,5 tablet
et. 2, biroul A, sector 1 150/12,5mg comprimate mg
Bucharest filmate
Romania
Romania Torrent Pharma SRL Irbesartan/hydroch Irbesartan Torrent 300 Film - coated Oral use
Str. Stirbei Voda nr. 36 lorothiazide Hidrochlorotiazida mg/12,5 tablet
et. 2, biroul A, sector 1 300/12,5mg comprimate mg
Bucharest filmate
Romania
Romania Torrent Pharma SRL Irbesartan/hydroch Irbesartan Torrent 300 mg/25 Film - coated Oral use
Str. Stirbei Voda nr. 36 lorothiazide Hidrochlorotiazida mg tablet
et. 2, biroul A, sector 1 300/25 mg comprimate
Bucharest filmate
Romania
Slovak Republic Alkaloid - INT d.o.o. Cefpodoxime FOREXO 200 mg filmom 200 mg Film - coated Oral use
Šlandrova 4 obalené tablety tablet
Slovenia
EMA/52196/2015 Page 94/131
Slovak Republic Alvogen IPCo S.àr.l. Desloratadine Dezloratadin Alvogen 5 mg 5 mg Film - coated Oral use
412F Route d'Esch filmom obalené tablety tablet
L - 2086
Luxembourg
Slovak Republic Genericon s.r.o., Desloratadine GESLORA 5 mg 5 mg Film - coated Oral use
Anny Letenské 1108/15, tablet
120 00 Praha 2 - Vinohrady
Czech Republic
Slovak Republic Generics (UK) Ltd Donepezil Donepezil Mylan 5 mg 5 mg Orodispersible Oral use
Station Close, Potters Bar hydrochloride orodispergovateľné tablety tablet
United Kingdom
Slovak Republic Generics (UK) Ltd Donepezil Donepezil Mylan 10 mg 10 mg Orodispersible Oral use
Station Close, Potters Bar hydrochloride orodispergovateľné tablety tablet
United Kingdom
Slovak Republic Generics (UK) Ltd Rizatriptan Rizatriptan Mylan 10 mg 10 mg Orodispersible Oral use
United Kingdom
Slovak Republic Glenmark Pharmaceuticals Trimetazidine Apstar 35 mg tablety s 35 mg Modified - release Oral use
s.r.o. predĺženým uvoľňovaním tablet
Hvězdova 1716/2b
14078 Praha 4
Czech Republic
EMA/52196/2015 Page 95/131
Slovak Republic Mylan SAS Trimetazidine Trimetazidin Mylan 35 mg 35 mg Modified - release Oral use
117 allée des Parcs tablet
France
Slovak Republic SVUS Pharma a.s. Desloratadine LOTERA 5 mg filmom 5 mg Film - coated Oral use
Smetanovo nábřeží 1238/20a obalené tablety tablet
500 02 Hradec Králové
Czech Republic
Slovak Republic Teva Pharmaceuticals Desloratadine Dezloratadin Teva OROTAB 2,5 mg Orodispersible Oral use
Slovakia s.r.o. 2,5 mg tablet
Teslova 26
821 02 Bratislava
Slovak Republic
Slovak Republic Teva Pharmaceuticals Desloratadine Dezloratadin Teva OROTAB 5 mg Orodispersible Oral use
Slovakia s.r.o. 5 mg tablet
Teslova 26
821 02 Bratislava
Slovak Republic
Slovenia Alkaloid - INT d.o.o. Cefpodoxime Trexodo 200 mg filmsko 200 mg Film - coated Oral use
Šlandrova 4 obložene tablete tablet
Slovenia
Slovenia Generics (UK) Ltd Esomeprazole Esomeprazol Mylan 20 mg 20 mg Gastro - resistant Oral use
Station Close, Potters Bar magnesium trde gastrorezistentne capsule, hard
Hertfordshire, EN6 1TL kapsule
United Kingdom
EMA/52196/2015 Page 96/131
Slovenia Generics (UK) Ltd Esomeprazole Esomeprazol Mylan 40 mg 40 mg Gastro - resistant Oral use
Station Close, Potters Bar magnesium trde gastrorezistentne capsule, hard
Hertfordshire, EN6 1TL kapsule
United Kingdom
Slovenia Generics (UK) Ltd Donepezil Donepezil Mylan 5 mg 5 mg Orodispersible Oral use
Station Close, Potters Bar hydrochloride orodisperzibilne tablete tablet
United Kingdom
Slovenia Generics (UK) Ltd Donepezil Donepezil Mylan 10 mg 10 mg Orodispersible Oral use
Station Close, Potters Bar hydrochloride orodisperzibilne tablete tablet
United Kingdom
Slovenia Lek farmacevtska družba d.d. Trimetazidine Trimeluzine 35 mg tablete 35 mg Prolonged - Oral use
Verovškova 57 hydrochloride s podaljšanim sproščanjem release tablet
1526 Ljubljana
Slovenia
Spain Accord Healthcare, S.L.U. Metoclopramide METOCLOPRAMIDA 10 mg Tablet Oral use

Moll de Barcelona s/n. World ACCORD 10 mg
Trade Center. Edifici Est 6ª COMPRIMIDOS EFG
planta,
8039 Barcelona
Spain
Spain Apotex Europe B.V. Desloratadine DESLORATADINA APOTEX 5 mg Film - coated Oral use
Darwinweg 20 5 mg COMPRIMIDOS tablet
NL 2333 CR Leiden RECUBIERTOS CON
Netherlands PELICULA EFG
EMA/52196/2015 Page 97/131
Spain Brown & Burk UK, Ltd. Ebastine EBASTINA BROWN 10 mg 10 mg Orodispersible Oral use
5, Marryat Close COMPRIMIDOS tablet
Hounslow BUCODISPERSABLES EFG
TW4 5DQ Middlesex
United Kingdom
Spain Farmalider, S.A. Valsartan/hydrochl VALSARTAN/HIDROCLORO 160 Film - coated Oral use
Aragoneses 15 orothiazide TIAZIDA CODRAMOL 160 mg/12,5 tablet
28108 Madrid MG/12,5 mg mg
Spain COMPRIMIDOS
RECUBIERTOS CON
PELICULA EFG
Spain Farmalider, S.A. Valsartan/hydrochl VALSARTAN/HIDROCLORO 160 mg/25 Film - coated Oral use
Aragoneses 15 orothiazide TIAZIDA CODRAMOL mg tablet
28108 Madrid 160/25 mg COMPRIMIDOS
Spain RECUBIERTOS CON
PELICULA EFG
Spain Farmalider, S.A. Valsartan/hydrochl VALSARTAN/HIDROCLORO 320 Film - coated Oral use
Aragoneses 15 orothiazide TIAZIDA CODRAMOL mg/12,5 tablet
28108 Madrid 320/12.5 mg mg
Spain COMPRIMIDOS
RECUBIERTOS CON
PELICULA EFG
Spain Farmalider, S.A. Valsartan/hydrochl VALSARTAN/HIDROCLORO 320 mg/25 Film - coated Oral use
28108 Madrid 320/25 mg COMPRIMIDOS
PELICULA EFG
EMA/52196/2015 Page 98/131
Spain Farmalider, S.A. Valsartan/hydrochl VALSARTAN/HIDROCLORO 80 mg/12,5 Film - coated Oral use
28108 Madrid 80/12.5 mg COMPRIMIDOS
PELICULA EFG
Spain Laboratorios Combix, S.L.U. Desloratadine DESLORATADINA COMBIX 5 mg Film - coated Oral use
C/ Badajoz 2, Edificio 2 5 mg COMPRIMIDOS tablet
Pozuelo de Alarcon RECUBIERTOS CON
Madrid 28223 PELÍCULA EFG
Spain
Spain Laboratorios Combix, S.L.U. Desloratadine DESLORATADINA FLAS 5 mg Film - coated Oral use
C/ Badajoz 2, Edificio 2 COMBIX 5 mg tablet
Pozuelo de Alarcon COMPRIMIDOS
Madrid 28223 BUCODISPERSABLES EFG
Spain
Spain Laboratorios Combix, S.L.U. Escitalopram ESCITALOPRAM COMBIX 10 mg Film - coated Oral use
Madrid 28223 PELICULA EFG
Spain
Spain
EMA/52196/2015 Page 99/131
Spain
Spain Laboratorios Combix, S.L.U. Escitalopram ESCITALOPRAM COMBIX 5 5 mg Film - coated Oral use
C/ Badajoz 2, Edificio 2 mg COMPRIMIDOS tablet
Spain
Spain Laboratorios Ranbaxy, S. L U. Alendronic acid ACIDO ALENDRONICO 70 mg Tablet Oral use
Paseig de Gracia 9 SEMANAL RANBAXY 70 mg
7a Pl COMPRIMIDOS EFG
Barcelona 08007
Spain
Spain Mylan Pharmaceuticals, S.L. Donepezil DONEPEZILO FLAS MYLAN 10 mg Orodispersible Oral use
Plom 2-4, 5º Planta PHARMACEUTICALS 10 mg tablet
8038 Barcelona COMPRIMIDOS
Spain BUCODISPERSABLES EFG
Spain Mylan Pharmaceuticals, S.L. Donepezil DONEPEZILO FLAS MYLAN 5 mg Orodispersible Oral use
Plom 2-4, 5º Planta PHARMACEUTICALS 5 mg tablet
8038 Barcelona COMPRIMIDOS
Spain BUCODISPERSABLES EFG
EMA/52196/2015 Page 100/131
Spain Mylan Pharmaceuticals, S.L. Esomeprazole ESOMEPRAZOL MYLAN 20 20 mg Gastro - resistant Oral use
Plom 2-4, 5º Planta mg CAPSULAS capsule
8038 Barcelona GASTRORRESISTENTES
Spain EFG
Spain Mylan Pharmaceuticals, S.L. Esomeprazole ESOMEPRAZOL MYLAN 40 40 mg Gastro - resistant Oral use
Plom 2-4, 5º Planta mg CAPSULAS capsule
8038 Barcelona GASTRORRESISTENTES
Spain EFG
Spain Mylan Pharmaceuticals, S.L. Repaglinide REPAGLINIDA MYLAN 0,5 0,5 mg Tablet Oral use
Plom 2-4, 5º Planta mg COMPRIMIDOS EFG
8038 Barcelona
Spain
Spain Mylan Pharmaceuticals, S.L. Repaglinide REPAGLINIDA MYLAN 1 mg 1 mg Tablet Oral use
Plom 2-4, 5º Planta COMPRIMIDOS EFG
8038 Barcelona
Spain
Spain Mylan Pharmaceuticals, S.L. Repaglinide REPAGLINIDA MYLAN 2 mg 2 mg Tablet Oral use
Plom 2-4, 5º Planta COMPRIMIDOS EFG
8038 Barcelona
Spain
Spain Mylan Pharmaceuticals, S.L. Rizatriptan RIZATRIPTAN MAX MYLAN 10 mg Orodispersible Oral use
Plom 2-4, 5º Planta 10 mg COMPRIMIDOS tablet
8038 Barcelona BUCODISPERSABLES EFG
Spain
EMA/52196/2015 Page 101/131
Spain PENSA PHARMA, S.A.U Alendronic acid ACIDO ALENDRONICO 70 mg Tablet Oral use
Jorge Comín (médico SEMANAL PENSA 70 mg
pediatra) COMPRIMIDOS EFG
3 - bajos
46015– Valencia (Valencia)
Spain
Spain Pharmagenus, S.A., Desloratadine DESLORATADINA 2,5 mg Orodispersible Oral use
Avda. Camí Real, 51-57, PHARMAGENUS 2,5 mg tablet
08184 Palau-solita i COMPRIMIDOS
Plegamans (Barcelona) BUCODISPERSABLES EFG
Spain
Spain Pharmagenus, S.A., Desloratadine DESLORATADINA 5 mg Orodispersible Oral use
Avda. Camí Real, 51-57, PHARMAGENUS 5 mg tablet
08184 Palau-solita i COMPRIMIDOS
Plegamans (Barcelona) BUCODISPERSABLES EFG
Spain
Spain Teva Pharma S.L.U. Desloratadine DESLORATADINA TEVA 5 5 mg Orodispersible Oral use
C/ Anabel Segura, 11 mg COMPRIMIDOS tablet
Edificio Albatros B, 1ª planta BUCODISPERSABLES EFG
Madrid 28108
Spain
Spain Welding GmbH & Co. KG Irbesartan IRBESARTAN/HIDROCLOR 150 Film - coated Oral use
Esplanade 39 OTIAZIDA WELDING 150 mg/12,5 tablet
D-20354 Hamburg mg/12.5 mg mg
Germany COMPRIMIDOS
RECUBIERTOS CON
PELICULA EFG
EMA/52196/2015 Page 102/131
Spain Welding GmbH & Co. KG Irbesartan IRBESARTAN/HIDROCLOR 300 Film - coated Oral use
Esplanade 39 OTIAZIDA WELDING 300 mg/12,5 tablet
D-20354 Hamburg mg/12.5 mg mg
Germany COMPRIMIDOS
RECUBIERTOS CON
PELICULA EFG
Spain Welding GmbH & Co. KG Irbesartan IRBESARTAN/HIDROCLOR 300 mg/25 Film - coated Oral use
Esplanade 39 OTIAZIDA WELDING 300 mg tablet
D-20354 Hamburg mg/25 mg COMPRIMIDOS
Germany RECUBIERTOS CON
PELICULA EFG
Sweden Accord Healthcare Limited Alendronic acid Alendronat Accord 70 mg Tablet Oral use
Sage House, 319 Pinner Road Veckotablett
Middlesex
United Kingdom
Sweden Alternova A/S Clindamycin Clindamycin Alternova 150 mg Capsule, hard Oral use
Lodshusvej 11 hydrochloride
DK-4230 Skælskør
Denmark
Sweden Bluefish Pharmaceuticals AB Fluconazole Fluconazol Bluefish 50 mg Capsule, hard Oral use
Torsgatan 11
SE-11123 Stockholm
Sweden
EMA/52196/2015 Page 103/131
Torsgatan 11
SE-11123 Stockholm
Sweden
Torsgatan 11
SE-11123 Stockholm
Sweden
Sweden Generics (UK) Ltd Donepezil Donezil 5 mg Orodispersible Oral use
United Kingdom
Sweden Generics (UK) Ltd Donepezil Donezil 10 mg Orodispersible Oral use
United Kingdom
Sweden Mylan AB Donepezil Donepezil Mylan 5 mg Orodispersible Oral use
SE-104 35 Stockholm
Sweden
Sweden Mylan AB Donepezil Donepezil Mylan 10 mg Orodispersible Oral use
SE-104 35 Stockholm
Sweden
EMA/52196/2015 Page 104/131
Sweden Mylan AB Rizatriptan Rizatriptan Mylan 10 mg Orodispersible Oral use

SE-104 35 Stockholm
Sweden
Sweden Mylan AB Repaglinide Repaglinid Mylan 0,5 mg Tablet Oral use
PO Box 230 33
SE-104 35 Stockholm
Sweden
Sweden Mylan AB Repaglinide Repaglinid Mylan 1 mg Tablet Oral use
PO Box 230 33
SE-104 35 Stockholm
Sweden
Sweden Mylan AB Repaglinide Repaglinid Mylan 2 mg Tablet Oral use
PO Box 230 33
SE-104 35 Stockholm
Sweden
Sweden Mylan AB Esomeprazole Esomeprazol Mylan 20 mg Gastro - resistant Oral use
SE-104 35 Stockholm
Sweden
Sweden Mylan AB Esomeprazole Esomeprazol Mylan 40 mg Gastro - resistant Oral use
SE-104 35 Stockholm
Sweden
EMA/52196/2015 Page 105/131
Sweden Mylan AB Eletriptan Eletriptan Mylan 20 mg Film - coated Oral use

SE-104 35 Stockholm
Sweden
Sweden Mylan AB Eletriptan Eletriptan Mylan 40 mg Film - coated Oral use
SE-104 35 Stockholm
Sweden
Sweden Orion Corporation Valsartan Valsartan Orion 40 mg Film - coated Oral use
Orion Pharma tablet
PO BOX 65
02101 Espoo
Finland
Orion Pharma tablet
PO BOX 65
02101 Espoo
Finland
Orion Pharma tablet
PO BOX 65
02101 Espoo
Finland
EMA/52196/2015 Page 106/131
Orion Pharma tablet
PO BOX 65
02101 Espoo
Finland
Sweden Ranbaxy UK Ltd. Alendronic acid Alendronat Ranbaxy 70 mg Tablet Oral use
Building 4, Chiswick Park Veckotablett 70 mg
566 Chiswick High Road tabletter
London, W4 5YE
Untied Kingdom
Sweden Stada Arzneimittel AG Entacapone Entakapon STADA 200 mg Film - coated Oral use
Stadastrasse 2-18 tablet
DE-61118 Bad Vilbel
Germany
The Accord Healthcare Limited Ropinirole Ropinirol Accord 5 mg, 5 mg Film - coated Oral use
Netherlands Sage House, 319 Pinner Road filmomhulde tabletten tablet
Middlesex
United Kingdom
The Accord Healthcare Limited Ropinirole Ropinirol Accord 0,25 mg 0,25 mg Film - coated Oral use
Middlesex
United Kingdom
EMA/52196/2015 Page 107/131
The Accord Healthcare Limited Ropinirole Ropinirol Accord 0,5 mg 0,5 mg Film - coated Oral use
Middlesex
United Kingdom
The Accord Healthcare Limited Ropinirole Ropinirol Accord 1 mg 1 mg Film - coated Oral use
Middlesex
United Kingdom
The Accord Healthcare Limited Ropinirole Ropinirol Accord 2 mg 2 mg Film - coated Oral use
Middlesex
United Kingdom
The Accord Healthcare Limited Alendronic acid Alendroninezuur Accord 10 mg Tablet Oral use
Netherlands Sage House, 319 Pinner Road 10mg Tabletten
Middlesex
United Kingdom
The Accord Healthcare Limited Alendronic acid Alendroninezuur Accord 70 mg Tablet Oral use
Netherlands Sage House, 319 Pinner Road 70mg Tabletten
Middlesex
United Kingdom
EMA/52196/2015 Page 108/131
The Accord Healthcare Limited Metoclopramide Metoclopramidemonohydro 10 mg Tablet Oral use

Netherlands Sage House, 319 Pinner Road hydrochloride chloride Accord 10 mg,
North Harrow HA1 4HF Tabletten
Middlesex
United Kingdom
The Alembic Pharmaceuticals Venlafaxine Venlafaxine HCl Retard 37,5 mg Prolonged - Oral use
Netherlands Europe Limited Alembic 37,5 mg, capsule release capsule,
Palazzo Pietro Stiges, 103, met verlengde afgifte, hard hard
Strait Street
VLT 1436 Valletta
Malta
The Alembic Pharmaceuticals Venlafaxine Venlafaxine HCl Retard 75 mg Prolonged - Oral use
Netherlands Europe Limited Alembic 75 mg, capsule release capsule,
Strait Street
VLT 1436 Valletta
Malta
The Alembic Pharmaceuticals Venlafaxine Venlafaxine HCl Retard 150 mg Prolonged - Oral use
Netherlands Europe Limited Alembic 150 mg, capsule release capsule,
Strait Street
VLT 1436 Valletta
Malta
EMA/52196/2015 Page 109/131
The Brown & Burk UK, Ltd. Ebastine Ebastine BB 10 mg 10 mg Orodispersible Oral use
Netherlands 5, Marryat Close orodispergeerbare tablet
Hounslow tabletten
TW4 5DQ Middlesex
United Kingdom
The Centrafarm B.V. Entacapone Entacapone CF 200 mg, 200 mg Film - coated Oral use
Netherlands Nieuwe Donk 3 filmomhulde tablet tablet
4879 AC Etten Leur
The Netherlands
The Fair-Med Healthcare GmbH Ciprofloxacin Ciprofloxacine Fair-Med 250 mg Film - coated Oral use
Netherlands Planckstrasse 13 250 mg, filmomhulde tablet
DE-22765 Hamburg tabletten
Germany
Germany
Germany
The Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/HCTZ Fair-Med 160 Film - coated Oral use
Netherlands Planckstrasse 13 orothiazide 160 mg/12,5 mg, mg/12,5 tablet
DE-22765 Hamburg filmomhulde tabletten mg
Germany
EMA/52196/2015 Page 110/131
The Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/HCTZ Fair-Med 320 Film - coated Oral use
Netherlands Planckstrasse 13 orothiazide 320 mg/12,5 mg, mg/12,5 tablet
DE-22765 Hamburg filmomhulde tabletten mg
Germany
The Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/HCTZ Fair-Med 320 mg/25 Film - coated Oral use
Netherlands Planckstrasse 13 orothiazide 320 mg/25 mg, mg tablet
DE-22765 Hamburg filmomhulde tabletten
Germany
The Fair-Med Healthcare GmbH Venlafaxine Venlafaxine Fair-Med 37,5 37,5 mg Prolonged - Oral use
Netherlands Planckstrasse 13 mg capsules met verlengde release capsule,
DE-22765 Hamburg afgifte, hard hard
Germany
The Fair-Med Healthcare GmbH Venlafaxine Venlafaxine Fair-Med 75 75 mg Prolonged - Oral use
Germany
The Fair-Med Healthcare GmbH Venlafaxine Venlafaxine Fair-Med 150 150 mg Prolonged - Oral use
Germany
The Mylan B.V. Esomeprazole Esomeprazol Mylan 20 mg, 20 mg Gastro - resistant Oral use
Netherlands Dieselweg 25 maagsapresistente capsule, hard
3752 LB Bunschoten capsules, hard
The Netherlands
EMA/52196/2015 Page 111/131
The Mylan B.V. Esomeprazole Esomeprazol Mylan 40 mg, 40 mg Gastro - resistant Oral use
Netherlands Dieselweg 25 maagsapresistente capsule, hard
3752 LB Bunschoten capsules, hard
The Netherlands
The Mylan B.V. Rizatriptan Rizatriptan SmeltTab Mylan 5 mg Orodispersible Oral use
Netherlands Dieselweg 25 5 mg, orodispergeerbare tablet
3752 LB Bunschoten tabletten
The Netherlands
The Mylan B.V. Rizatriptan Rizatriptan SmeltTab Mylan 10 mg Orodispersible Oral use
Netherlands Dieselweg 25 10 mg, orodispergeerbare tablet
3752 LB Bunschoten tabletten
The Netherlands
The Ranbaxy UK Ltd. Alendronic acid Alendroninezuur 70 70 mg Tablet Oral use
Netherlands Building 4, Chiswick Park Ranbaxy, tabletten 70 mg
566 Chiswick High Road
London, W4 5YE
Untied Kingdom
The Sandoz B.V. Clonazepam Clonazepam Sandoz 0,5 0,5 mg Tablet Oral use
Netherlands Veluwezoom 22 mg, tabletten
1327 AH Almere
The Netherlands
The Sandoz B.V. Clonazepam Clonazepam Sandoz 2 mg, 2 mg Tablet Oral use
Netherlands Veluwezoom 22 tabletten
1327 AH Almere
The Netherlands
EMA/52196/2015 Page 112/131
The Sandoz B.V. Clobazam Clobazam Sandoz 10 mg, 10 mg Tablet Oral use
Netherlands Veluwezoom 22 tabletten
1327 AH Almere
The Netherlands
The Teva Nederland B.V. Desloratadine Desloratadine Smelttablet 2,5 mg Orodispersible Oral use
Netherlands Swensweg 5 2,5 mg Teva, tablet
2031 GA Haarlem orodispergeerbare
The Netherlands tabletten
The Teva Nederland B.V. Desloratadine Desloratadine Smelttablet 5 mg Orodispersible Oral use
Netherlands Swensweg 5 5 mg Teva, tablet
2031 GA Haarlem orodispergeerbare
The Netherlands tabletten
The TioFarma b.v. Clonazepam Clonazepam TioFarma 0,5 0,5 mg Tablet Oral use
Netherlands Benjamin Franklinstraat 5-10 mg tabletten, tabletten
3261 LW Oud-Beyerland
The Netherlands
The TioFarma b.v. Clonazepam Clonazepam TioFarma 2 2 mg Tablet Oral use

Netherlands Benjamin Franklinstraat 5-10 mg tabletten, tabletten
The Netherlands
The TioFarma b.v. Clobazam Clobazam TioFarma 10 mg, 10 mg Tablet Oral use
Netherlands Benjamin Franklinstraat 5-10 tabletten
The Netherlands
EMA/52196/2015 Page 113/131
The TioFarma b.v. Clobazam Clobazam TioFarma 20 mg, 20 mg Tablet Oral use
Netherlands Benjamin Franklinstraat 5-10 tabletten
The Netherlands
The Torrent Pharma GmbH irbesartan Irbesartan Torrent 75 mg 75 mg Film - coated Oral use
Netherlands Südwestpark 50 filmomhulde tabletten tablet
90449 Nürnberg
Germany
90449 Nürnberg
Germany
90449 Nürnberg
Germany
The Torrent Pharma GmbH Irbesartan/hydroch Irbesartan 150 Film - coated Oral use
Netherlands Südwestpark 50 lorothiazide Hydrochloorthiazide mg/12,5 tablet
90449 Nürnberg Torrent 150 mg/12,5 mg mg
Germany filmomhulde tabletten
The Torrent Pharma GmbH Irbesartan/hydroch Irbesartan 300 Film - coated Oral use
Netherlands Südwestpark 50 lorothiazide Hydrochloorthiazide mg/12,5 tablet
90449 Nürnberg Torrent 300 mg/12,5 mg mg
EMA/52196/2015 Page 114/131
The Torrent Pharma GmbH Irbesartan/hydroch Irbesartan 300 mg/25 Film - coated Oral use
Netherlands Südwestpark 50 lorothiazide Hydrochloorthiazide mg tablet
90449 Nürnberg Torrent 300 mg/25 mg
The Unichem Laboratories Ltd. irbesartan Irbesartan Unichem 150 150 mg Film - coated Oral use
Netherlands Studio 8B Ard Gaoithe mg filmomhulde tabletten tablet
Park
Co Tipperary
Ireland
The Unichem Laboratories Ltd. irbesartan Irbesartan Unichem 300 300 mg Film - coated Oral use
Netherlands Studio 8B Ard Gaoithe mg filmomhulde tabletten tablet
Park
Co Tipperary
Ireland
United Accord Healthcare Limited Ropinirole Ropinirole 0.25mg film- 0,25 mg Film - coated Oral use
Kingdom Sage House, 319 Pinner Road coated tablets tablet
Middlesex
United Kingdom
EMA/52196/2015 Page 115/131
United Accord Healthcare Limited Ropinirole Ropinirole 0.5mg film- 0,5 mg Film - coated Oral use
Kingdom Sage House, 319 Pinner Road coated tablets tablet
Middlesex
United Kingdom
United Accord Healthcare Limited Ropinirole Ropinirole 1mg film-coated 1 mg Film - coated Oral use
Kingdom Sage House, 319 Pinner Road tablets tablet
Middlesex
United Kingdom
Middlesex
United Kingdom
United Accord Healthcare Limited Alendronic acid alendronic acid 10mg 10 mg Tablet Oral use
Kingdom Sage House, 319 Pinner Road Tablets
Middlesex
United Kingdom
United Accord Healthcare Limited Alendronic acid alendronic acid 70mg Once 70 mg Tablet Oral use
Kingdom Sage House, 319 Pinner Road Daily Tablets
Middlesex
United Kingdom
EMA/52196/2015 Page 116/131
United Accord Healthcare Limited Metoclopramide metoclopramide 10 mg Tablet Oral use

Kingdom Sage House, 319 Pinner Road hydrochloride hydrochloride 10mg tablets
Middlesex
United Kingdom
Middlesex
United Kingdom
United Aptil Pharma Limited Fluconazole Fluconazole 50mg capsules 50 mg Capsule, hard Oral use
Kingdom 9th Floor, CP House
97-107 Uxbridge Road
London W5 5TL
United Kingdom
United Aptil Pharma Limited Fluconazole Fluconazole 150mg 150 mg Capsule, hard Oral use
Kingdom 9th Floor, CP House capsules
London W5 5TL
United Kingdom
United Aptil Pharma Limited Fluconazole Fluconazole 200mg 200 mg Capsule, hard Oral use
Kingdom 9th Floor, CP House capsules
London W5 5TL
United Kingdom
EMA/52196/2015 Page 117/131
United Auden McKenzie Limited Dexamethasone Dexamethasone 2mg 2 mg Tablet Oral use
Kingdom McKenzie House Tablets
Bury Street, Ruislip
Middlesex HA4 7TL
United Kingdom
United Auden McKenzie Limited Thiamine Tyvera 50mg Tablets 50 mg Tablet Oral use
Kingdom McKenzie House hydrochloride
Middlesex HA4 7TL
United Kingdom
United Auden McKenzie Limited Thiamine Tyvera 100mg Tablets 100 mg Tablet Oral use
Kingdom McKenzie House hydrochloride
Middlesex HA4 7TL
United Kingdom
United Auden McKenzie Limited Clonazepam Clonazepam 500mcg 0,5 mg Tablet Oral use
Kingdom McKenzie House Tablet
Middlesex HA4 7TL
United Kingdom
United Auden McKenzie Limited Clonazepam Clonazepam 2mg Tablet 2 mg Tablet Oral use
Kingdom McKenzie House
Middlesex HA4 7TL
United Kingdom
EMA/52196/2015 Page 118/131
United Auden McKenzie Limited Clobazam CLOBAZAM AUDEN 10mg 10 mg Tablet Oral use
Kingdom McKenzie House TABLETS
Middlesex HA4 7TL
United Kingdom
United Brown & Burk UK, Ltd. Phenoxymethyl Phenoxymethylpenicillin 250 mg Film - coated Oral use
Kingdom 5, Marryat Close penicillin 250mg Film-coated Tablets tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
United Brown & Burk UK, Ltd. Escitalopram Escitalopram 5mg Film- 5 mg Film - coated Oral use
Kingdom 5, Marryat Close oxalate coated tablets tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Hounslow
TW4 5DQ Middlesex
United Kingdom
Hounslow
TW4 5DQ Middlesex
United Kingdom
EMA/52196/2015 Page 119/131
Hounslow
TW4 5DQ Middlesex
United Kingdom
United Brown & Burk UK, Ltd. Tramadol Aceon 100mg Prolonged- 100 mg Prolonged - Oral use
Kingdom 5, Marryat Close hydrochloride release tablets release tablet
Hounslow
TW4 5DQ Middlesex
United Kingdom
Hounslow
TW4 5DQ Middlesex
United Kingdom
Hounslow
TW4 5DQ Middlesex
United Kingdom
United Dr Reddy's Laboratories (UK) Valsartan Valsartan 40mg Capsules 40 mg Capsule Oral use
Kingdom Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom
EMA/52196/2015 Page 120/131
Kingdom Limited
United Kingdom
Kingdom Limited
United Kingdom
Kingdom Limited
United Kingdom
United Dr Reddy's Laboratories (UK) Levetiracetam Levetiracetam 250mg film- 250 mg Film - coated Oral use
Kingdom Limited coated tablets tablet
United Kingdom
United Kingdom
EMA/52196/2015 Page 121/131
United Kingdom
United Dr Reddy's Laboratories (UK) Levetiracetam Levetiracetam 1000mg 1000 mg Film - coated Oral use
Kingdom Limited film-coated tablets tablet
United Kingdom
United Dr Reddy's Laboratories (UK) Pioglitazone Pioglitazone 15mg Tablets 15 mg Tablet Oral use
Kingdom Limited
United Kingdom
Kingdom Limited
United Kingdom
Kingdom Limited
United Kingdom
EMA/52196/2015 Page 122/131
United Dr Reddy's Laboratories (UK) Dipyridamole Attia 200mg Modified 200 mg Modified - release Oral use
Kingdom Limited Release Capsules capsule, hard
United Kingdom
United Dr Reddy's Laboratories (UK) Telmisartan Telmisartan 20mg Tablets 20 mg Tablet Oral use
Kingdom Limited
United Kingdom
Kingdom Limited
United Kingdom
Kingdom Limited
United Kingdom
United Dr Reddy's Laboratories (UK) Telmisartan/ Telmisartan/Hydrochlorothi 40 mg/12,5 Tablet Oral use
Kingdom Limited hydrochlorothiazide azide 40mg/12.5mg mg
6 Riverview Road, Beverley Tablets
United Kingdom
EMA/52196/2015 Page 123/131
United Dr Reddy's Laboratories (UK) Telmisartan/ Telmisartan/Hydrochlorothi 80 mg/12,5 Tablet Oral use
Kingdom Limited hydrochlorothiazide azide 80mg/12.5mg mg
6 Riverview Road, Beverley Tablets
United Kingdom
United Dr Reddy's Laboratories (UK) Telmisartan/ Telmisartan/Hydrochlorothi 80 mg/25 Tablet Oral use
Kingdom Limited hydrochlorothiazide azide 80mg/25mg Tablets mg
United Kingdom
United Fair-Med Healthcare GmbH irbesartan Irbesartan 75mg Film- 75 mg Film - coated Oral use
Kingdom Planckstrasse 13 coated Tablets tablet
DE-22765 Hamburg
Germany
DE-22765 Hamburg
Germany
DE-22765 Hamburg
Germany
United Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan/Hydrochlorothia 150 Film - coated Oral use
Kingdom Planckstrasse 13 lorothiazide zide 150mg/12.5mg film- mg/12,5 tablet
DE-22765 Hamburg coated tablets mg
Germany
EMA/52196/2015 Page 124/131
United Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan/Hydrochlorothia 300 Film - coated Oral use
Kingdom Planckstrasse 13 lorothiazide zide 300mg/12.5mg film- mg/12,5 tablet
DE-22765 Hamburg coated tablets mg
Germany
United Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan/Hydrochlorothia 300 mg/25 Film - coated Oral use
Kingdom Planckstrasse 13 lorothiazide zide 300mg/25mg film- mg tablet
DE-22765 Hamburg coated tablets
Germany
United Fannin (UK) Ltd Fluconazole Fluconazole 150mg capsule 150 mg Capsule, hard Oral use
Kingdom 42-46 Booth Drive
Park Farm South
Wellingborough
United Kingdom
United Fannin (UK) Ltd Fexofenadine Fexofenadine 120mg film- 120 mg Film - coated Oral use
Kingdom 42-46 Booth Drive coated tablets tablet
Park Farm South
Wellingborough
United Kingdom
United Fannin (UK) Ltd Fexofenadine Fexofenadine 180mg film- 180 mg Film - coated Oral use
Kingdom 42-46 Booth Drive coated tablets tablet
Park Farm South
Wellingborough
United Kingdom
EMA/52196/2015 Page 125/131
United FDC Pharma Amlodipine Amlodipine 5mg Tablets 5 mg Tablet Oral use
Kingdom Unit 6, Fulcrum 1, Solent Way
Whiteley, Fareham
Hampshire PO15 7FE
United Kingdom
United FDC Pharma Amlodipine Amlodipine 10mg Tablets 10 mg Tablet Oral use
Kingdom Unit 6, Fulcrum 1, Solent Way
Whiteley, Fareham
Hampshire PO15 7FE
United Kingdom
United Generics (UK) Ltd Repaglinide Repaglinide Mylan 0.5mg 0,5 mg Tablet Oral use
Kingdom Station Close, Potters Bar Tablets
United Kingdom
United Generics (UK) Ltd Repaglinide Repaglinide Mylan 1mg 1 mg Tablet Oral use
United Kingdom
United Generics (UK) Ltd Repaglinide Repaglinide Mylan 2mg 2 mg Tablet Oral use
United Kingdom
United Generics (UK) Ltd Donepezil Donepezil Hydrochloride 5 mg Orodispersible Oral use
Kingdom Station Close, Potters Bar hydrochloride 5mg Orodispersible Tables tablet
United Kingdom
EMA/52196/2015 Page 126/131
United Generics (UK) Ltd Donepezil Donepezil Hydrochloride 10 mg Orodispersible Oral use
Kingdom Station Close, Potters Bar hydrochloride 10mg Orodispersible tablet
Hertfordshire, EN6 1TL Tables
United Kingdom
United Generics (UK) Ltd Rizatriptan Rizatriptan 10mg 10 mg Orodispersible Oral use
Kingdom Station Close, Potters Bar benzoate Orodispersible Tablet tablet
United Kingdom
United Generics (UK) Ltd Esomeprazole Esomeprazole 20mg 20 mg Gastro - resistant Oral use
Kingdom Station Close, Potters Bar magnesium Gastro-resistant Capsules, capsule
Hertfordshire, EN6 1TL hard
United Kingdom
United Generics (UK) Ltd Esomeprazole Esomeprazole 40mg 40 mg Gastro - resistant Oral use
Kingdom Station Close, Potters Bar magnesium Gastro-resistant Capsules, capsule
Hertfordshire, EN6 1TL hard
United Kingdom
United Generics (UK) Ltd Levodopa/carbidop Levodopa/Carbidopa/Entac 150 Film - coated Oral use
Kingdom Station Close, Potters Bar a/entacapone apone film-coated tablets mg/37,5 tablet
Hertfordshire, EN6 1TL 150/37.5/200mg mg/200 mg
United Kingdom
United Lupin (Europe) Limited Pantoprazole Pantoprazole 20mg Gastro- 20 mg Gastro - resistant Oral use
Kingdom Victoria Court, Bexton Road Resistant tablets tablet
0PF
United Kingdom
EMA/52196/2015 Page 127/131
United Lupin (Europe) Limited Pantoprazole Pantoprazole 40mg Gastro- 40 mg Gastro - resistant Oral use
Kingdom Victoria Court, Bexton Road Resistant tablets tablet
0PF
United Kingdom
United Morningside Healthcare Phenoxymethyl Phenoxymethylpenicillin 250 mg Film - coated Oral use
Kingdom Limited penicillin 250mg Film-coated Tablets tablet
115 Narborough Road
Leicester, LE3 0PA
United Kingdom
United Morningside Healthcare Metformin Bolamyn/Metabet SR 1000 mg Prolonged - Oral use
Kingdom Limited hydrochloride 1000mg Prolonged Release release tablet
115 Narborough Road Tablets
Leicester, LE3 0PA
United Kingdom
United Niche Generics Limited irbesartan Irbesartan Niche 150mg 150 mg Film - coated Oral use
Kingdom 1 The Cam Centre film-coated tablets tablet
United Kingdom
United Niche Generics Limited irbesartan Irbesartan Niche 150mg 150 mg Film - coated Oral use
Kingdom 1 The Cam Centre film-coated tablets tablet
United Kingdom
EMA/52196/2015 Page 128/131
United Ranbaxy UK Ltd. Alendronic acid Alendronic Acid 70mg 70 mg Tablet Oral use
Kingdom Building 4, Chiswick Park Tablets
566 Chiswick High Road
London, W4 5YE
Untied Kingdom
United Torrent Pharma GmbH Irbesartan/hydroch Irbesartan 150 Film - coated Oral use
Kingdom Südwestpark 50 lorothiazide Hydrochlorothiazide mg/12,5 tablet
90449 Nürnberg 150mg/12.5mg Film- mg
Germany coated tablets
United Torrent Pharma GmbH Irbesartan/hydroch Irbesartan 300 Film - coated Oral use
Kingdom Südwestpark 50 lorothiazide Hydrochlorothiazide mg/12,5 tablet
90449 Nürnberg 300mg/12.5mg Film- mg
Germany coated tablets
United Torrent Pharma GmbH Irbesartan/hydroch Irbesartan 300 mg/25 Film - coated Oral use
Kingdom Südwestpark 50 lorothiazide Hydrochlorothiazide mg tablet
90449 Nürnberg 300mg/25mg Film-coated
Germany tablets
United Torrent Pharma GmbH irbesartan Irbesartan 75mg Film- 75 mg Film - coated Oral use
Kingdom Südwestpark 50 coated tablets tablet
90449 Nürnberg
Germany
90449 Nürnberg
Germany
EMA/52196/2015 Page 129/131
90449 Nürnberg
Germany
United Waymade PLC Venlafaxine Venlasov XL 75mg Modified 75 mg Prolonged - Oral use
Kingdom Sovereign House hydrochloride Release Capsules release capsule,
Miles Grat Road, Basildon hard
Essex SS14 3FR
United Kingdom
United Waymade PLC Venlafaxine Venlasov XL 150mg 150 mg Prolonged - Oral use
Kingdom Sovereign House hydrochloride Modified Release Capsules release capsule,
Miles Grat Road, Basildon hard
Essex SS14 3FR
United Kingdom
United Wockhardt UK Limited Clopidogrel Clopidogrel 75mg Film- 75 mg Film - coated Oral use
Kingdom Ash Road North coated Tablets tablet
Wrexham LL13 9UF
United Kingdom
United YJBPort Limited Hydrocortisone Hydrocortisone 10mg 10 mg Tablet Oral use
Kingdom 74 Briarwood Drive Tablets
Northwood Hills
Middlesex HA6 1PL
United Kingdom
EMA/52196/2015 Page 130/131
United YJBPort Limited Hydrocortisone Hydrocortisone 20mg 20 mg Tablet Oral use

Kingdom 74 Briarwood Drive 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

Belgium Mylan bvba/sprl Candesartan Candesartan Mylan 16 mg Tablet Oral use

Czech Republic Labormed-Pharma, SA Desloratadine Desloratadin Labormed 5 5 mg Orodispersible Oral use

Denmark Mylan AB Eletriptan Eletriptan Mylan 40 mg Film - coated Oral use

Finland Mylan AB Eletriptan Eletriptan Mylan 40 mg Film - coated Oral use

France Laboratoires Biogaran Ebastine EBASTINE BIOGARAN 10 10 mg Orodispersible Oral use

France Mylan SAS Rizatriptan RIZATRIPTAN MYLAN 10 10 mg Orodispersible Oral use

France Mylan SAS Donepezil DONEPEZIL MYLAN 10 10 mg Orodispersible Oral use

France Venipharm SAS Ebastine EBACHOI 10 mg comprimé 10 mg Orodispersible Oral use

Germany Lupin (Europe) Limited Trimetazidine Lupamadazine 35 mg 35 mg Controlled - Oral use

Greece Abbott Laboratories Escitalopram Savandra 5 mg Film - coated Oral use

Greece Genepharm S.A. Desloratadine Desloratadine/Genepharm 2,5 mg Orodispersible Oral use

Hungary Mylan SAS Trimetazidine Trimetazidine Mylan 35 mg 35 mg Prolonged - Oral use

Italy Mylan S.P.A. Donepezil DONEPEZIL MYLAN 10 mg Orodispersible Oral use

Norway Mylan AB Candesartan Kandrozid 8 mg tablet Oral use

Norway Mylan AB Rizatriptan RIZATRIPTAN MYLAN 10 10 mg Orodispersible Oral use

Poland Apotex Europe B.V. Trimetazidine ApoTrimet PR 35 mg Prolonged - Oral use

Poland Labormed-Pharma, SA Desloratadine Desloratadine Labormed 2,5 mg Orodispersible Oral use

Poland Labormed-Pharma, SA Desloratadine Desloratadine Labormed 5 mg Orodispersible Oral use

Portugal Labormed-Pharma, SA Desloratadine Desloratadina Labormed 2,5 mg Orodispersible Oral use

Portugal Mylan, Lda. Candesartan Candesartan Mylan 32 mg Tablet Oral use

Spain Accord Healthcare, S.L.U. Metoclopramide METOCLOPRAMIDA 10 mg Tablet Oral use

Sweden Mylan AB Rizatriptan Rizatriptan Mylan 10 mg Orodispersible Oral use

Sweden Mylan AB Eletriptan Eletriptan Mylan 20 mg Film - coated Oral use

The Accord Healthcare Limited Metoclopramide Metoclopramidemonohydro 10 mg Tablet Oral use

The TioFarma b.v. Clonazepam Clonazepam TioFarma 2 2 mg Tablet Oral use

United Accord Healthcare Limited Metoclopramide metoclopramide 10 mg Tablet Oral use

United YJBPort Limited Hydrocortisone Hydrocortisone 20mg 20 mg Tablet Oral use

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