Products for which the marketing authorisations are recommended for suspension by the CHMP on 22 January 2015
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- Domenic Greene
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1 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/ Churchill Place Canary Wharf London E14 5EU Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Esomeprazole magnesium Esomeprazol Arcana 20 mg magensaftresistente Hartkapseln 20 mg Gastro - resistant capsule, hard Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Esomeprazole magnesium Esomeprazol Arcana 40 mg magensaftresistente Hartkapseln 40 mg Gastro - resistant capsule, hard Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Esomeprazole magnesium Neximyl 20 mg magensaftresistente Hartkapseln 20 mg Gastro - resistant capsule, hard Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Esomeprazole magnesium Neximyl 40 mg magensaftresistente Hartkapseln 40 mg Gastro - resistant capsule, hard Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Candesartan cilexetil Candesartan Arcana 4mg Tabletten 4 mg Tablet Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Candesartan cilexetil Candesartan Arcana 8mg Tabletten 8mg Tablet EMA/52196/2015 Page 2/131
3 Austria Austria Austria Austria Austria Belgium Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Arcana Arzneimittel GmbH Huetteldorfer Straße Wien Austria Genericon Pharma GmbH Hafnerstr Graz Austria ratiopharm Arzneimittei- Vertriebs-GmbH Albert-Schweitzer-Gasse Wien Austria ratiopharm Arzneimittei- Vertriebs-GmbH Albert-Schweitzer-Gasse Wien Austria Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Netherlands Candesartan cilexetil Candesartan Arcana 16mg Tabletten 16 mg Tablet Candesartan Candesartan Arcana 32mg 32 mg Tablet cilexetil Tabletten Nebivolol Nebivolol Genericon 5 mg 5 mg Tablet Tabletten Desloratadine Desloratadin ratiopharm 2,5 mg Orodispersible 2,5 mg Schmelzten Desloratadine Desloratadin ratiopharm 5 5 mg Orodispersible mg Schmelzten Desloratadine Desloratadine Apotex 5 mg Film - coated EMA/52196/2015 Page 3/131
4 Belgium Belgium Belgium Belgium Belgium Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Donepezil Donepezil Odis Mylan 5 mg Orodispersible Donepezil Donepezil Odis Mylan 10 mg Orodispersible Repaglinide Repaglinide Mylan 0,5 mg 0,5 mg Tablet Pharma Repaglinide Repaglinide Mylan 1 mg 1 mg Tablet Pharma Repaglinide Repaglinide Mylan 2mg 2 mg Tablet Pharma Candesartan Candesartan Mylan 8 mg Tablet EMA/52196/2015 Page 4/131
5 Belgium Belgium Belgium Belgium Belgium Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Takeda Belgium Gentsesteenweg Brussels Belgium Teva Pharma Belgium NV Laarstraat Wilrijk Belgium Candesartan Candesartan Mylan 16 mg Tablet Candesartan Candesartan Mylan 32 mg Tablet Esomeprazole Esomeprazole Mylan 20 mg Gastro - resistant capsule, hard Esomeprazole Esomeprazole Mylan 40 mg Gastro - resistant capsule, hard Alendronic acid Alendromono 70 mg Tablet Desloratadine Desloratadine Teva 2,5 mg Orodispersible EMA/52196/2015 Page 5/131
6 Belgium Teva Pharma Belgium NV Laarstraat Wilrijk Belgium Desloratadine Desloratadine Teva 5 mg Orodispersible Bulgaria Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Ropinirole Ropinirole Accord 0,5 mg Film - coated Bulgaria Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Ropinirole Ropinirole Accord 1 mg Film - coated Bulgaria Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Ropinirole Ropinirole Accord 2 mg Film - coated Bulgaria Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Ropinirole Ropinirole Accord 5 mg Film - coated EMA/52196/2015 Page 6/131
7 Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Alkaloid - INT d.o.o. Šlandrova Ljubljana - Črnuče Slovenia Aquachim AD blvd. Prof. Tsvetan Lazarov 83 Sofia 1582 Bulgaria Aquachim AD blvd. Prof. Tsvetan Lazarov 83 Sofia 1582 Bulgaria Aquachim AD blvd. Prof. Tsvetan Lazarov 83 Sofia 1582 Bulgaria Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Cefpodoxime FOXERO 200 mg Tablet Quetiapine Aquatiapine 25 mg Film - coated Quetiapine Aquatiapine 100 mg Film - coated Quetiapine Aquatiapine 200 mg Film - coated Esomeprazole Esopragen 20 mg Gastro - resistant magnesium capsule, hard EMA/52196/2015 Page 7/131
8 Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Glenmark Pharmaceuticals s.r.o. Hvězdova 1716/2b Praha 4 Czech Republic Mylan SAS 117 allée des Parcs Saint-Priest Cedex Neo Balkanika EOOD 35 Zemliane Str. Sofia 1618 Bulgaria Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Tchaikapharma Highquality Medicines 1 G. M. Dimitrov Blvd. Sofia 1172 Bulgaria Esomeprazole magnesium Esopragen 40 mg Gastro - resistant capsule, hard Trimetazidine Apstar 35 mg 35 mg Prolonged - prolonged-release s release Trimetazidine Trimetazigen MR 35 mg Prolonged - release Nebivolol Bivolet 5 mg Tablet Trimetazidine Energotrim 35 mg Prolonged - release Bosentan Pulmohyperta 62,5 mg Film - coated EMA/52196/2015 Page 8/131
9 Bulgaria Tchaikapharma Highquality Medicines 1 G. M. Dimitrov Blvd. Sofia 1172 Bulgaria Bosentan Pulmohyperta 125 mg Film - coated Croatia Alkaloid d.o.o. Ulica grada Vukovara 226 F Zagreb Croatia Cefpodoxime Rexocef 200 mg filmom obložene e 200 mg Film - coated Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica Croatia Desloratadine Alerdin 2,5 mg raspadljive e za usta 2,5 mg Orodispersible Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica Croatia Desloratadine Alerdin 5 mg raspadljive e za usta 5 mg Orodispersible Croatia Fidifarm d.o.o. Obrtnička 37, Bestovje Rakitje Croatia Desloratadine Sinalerg 5 mg filmom obložene e 5 mg Film - coated EMA/52196/2015 Page 9/131
10 Croatia Jadran Galenski Laboratorij d.d. Svilno 20, Rijeka Croatia Desloratadine Escontral direkt 2,5 mg raspadljiva a za usta 2,5 mg Orodispersible Croatia Jadran Galenski Laboratorij d.d. Svilno 20, Rijeka Croatia Desloratadine Escontral direkt 5 mg raspadljiva a za usta 5 mg Orodispersible Croatia PharmaS d.o.o. Radnička cesta 47 Zagreb Croatia Tramadol/paraceta mol Tramadol/Paracetamol PharmaS 37,5 mg/ 325 mg filmom obložene e 37,5 mg/325 mg Film - coated Croatia PharmaS d.o.o. Radnička cesta 47 Zagreb Croatia Escitalopram Escitalopram PharmaS 10 mg filmom obložene e 10 mg Film - coated Croatia Sandoz d.o.o. Maksimirska 120 Zagreb Croatia Trimetazidine hydrochloride Vazidin 35 mg e s produljenim oslobađanjem 35 mg Prolonged - release EMA/52196/2015 Page 10/131
11 Cyprus Cyprus Cyprus Cyprus Cyprus Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Delorbis Pharmaceuticals Ltd 17 Athinon Street Ergates Industrial Area 2643 Ergates P.O. Box Lefkosia Cyprus Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli Athens Greece Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli Athens Greece Alendronic acid Alendronic Acid Accord 70 mg Tablet Entacapone Nobat 200 mg Film - coated Valsartan/hydrochl Valsartan/Hctz Fair-med 160 Film - coated orothiazide mg/12,5 mg Donepezil Donepezil/Generics 5 mg Orodispersible hydrochloride Donepezil Donepezil/Generics 10 mg Orodispersible hydrochloride EMA/52196/2015 Page 11/131
12 Cyprus Lambda Therapeutic Limited Sage House 319 Pinner Road, North Harrow Middlesex HA1 4HF Ropinirole hydrochloride Ropinirole Lambda 0,25 mg Film - coated Cyprus Lambda Therapeutic Limited Sage House 319 Pinner Road, North Harrow Middlesex HA1 4HF Ropinirole hydrochloride Ropinirole Lambda 0,5 mg Film - coated Cyprus Lambda Therapeutic Limited Sage House 319 Pinner Road, North Harrow Middlesex HA1 4HF Ropinirole hydrochloride Ropinirole Lambda 1 mg Film - coated Cyprus Lambda Therapeutic Limited Sage House 319 Pinner Road, North Harrow Middlesex HA1 4HF Ropinirole hydrochloride Ropinirole Lambda 2 mg Film - coated EMA/52196/2015 Page 12/131
13 Cyprus Lambda Therapeutic Limited Sage House 319 Pinner Road, North Harrow Middlesex HA1 4HF Ropinirole hydrochloride Ropinirole Lambda 5 mg Film - coated Cyprus Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF Clopidogrel hydrochloride Clopidogrel/Wockhardt 75 mg Film - coated Czech Republic Abbott Laboratories, s.r.o. Evropská 2591/33d Praha 6 - Hadovka Office Park Czech Republic Escitalopram oxalate Purcema 5 mg 5 mg Film - coated Czech Republic Abbott Laboratories, s.r.o. Evropská 2591/33d Praha 6 - Hadovka Office Park Czech Republic Escitalopram oxalate Purcema 10 mg 10 mg Film - coated Czech Republic Abbott Laboratories, s.r.o. Evropská 2591/33d Praha 6 - Hadovka Office Park Czech Republic Escitalopram oxalate Purcema 15 mg 15 mg Film - coated EMA/52196/2015 Page 13/131
14 Czech Republic Abbott Laboratories, s.r.o. Evropská 2591/33d Praha 6 - Hadovka Office Park Czech Republic Escitalopram oxalate Purcema 20 mg 20 mg Film - coated Czech Republic Actavis Group PTC ehf. Reykjavikurvegi Hafnarfjördur Iceland Metformin hydrochloride Metformin Actavis Retard 500 mg 500 mg Prolonged - release Czech Republic Actavis Group PTC ehf. Reykjavikurvegi Hafnarfjördur Iceland Metformin hydrochloride Metformin Actavis Retard 750 mg 750 mg Prolonged - release Czech Republic Alkaloid - INT d.o.o. Šlandrova Ljubljana - Črnuče Slovenia Cefpodoxime Forexo 200 mg potahované y 200 mg Film - coated Czech Republic Alvogen IPCo S.ar.l. Rue Heienhaff 5 L-1736 Senningerberg Luxembourg Desloratadine Desloratadin Alvogen 5 mg potahované y 5 mg Film - coated Czech Republic Apotex Europe B.V. Darwinweg 20 NL 2333 CR Leiden Netherlands Trimetazidine dihydrochloride Apo-trimetazidin 35 mg 35 mg Prolonged - release EMA/52196/2015 Page 14/131
15 Czech Republic Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Esomeprazole magnesium Esomylan 40 mg 40 mg Gastro - resistant capsule, hard Czech Republic Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Rizatriptan benzoate Rizatriptan Mylan 5 mg 5 mg Orodispersible Czech Republic Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Rizatriptan benzoate Rizatriptan Mylan 10 mg 10 mg Orodispersible Czech Republic Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Donepezil hydrochloride Donepezil Mylan 10 mg 10 mg Orodispersible Czech Republic Glenmark Pharmaceuticals s.r.o. Hvězdova 1716/2b Praha 4 Czech Republic Trimetazidine dihydrochloride Portora 35 mg y s prodlouženým uvolňováním 35 mg Prolonged - release Czech Republic GNR Czech s.r.o. Slavojova 579/ Praha 2 Czech Republic Desloratadine Geslora 5 mg 5 mg Film - coated EMA/52196/2015 Page 15/131
16 Czech Republic Labormed-Pharma, SA Theodor Pallady, 44B Bucharest Romania Desloratadine Desloratadin Labormed 2,5 mg y dispergovatelné v ústech 2,5 mg Orodispersible Czech Republic Labormed-Pharma, SA Theodor Pallady, 44B Bucharest Romania Desloratadine Desloratadin Labormed 5 mg y dispergovatelné v ústech 5 mg Orodispersible Czech Republic Mylan SAS 117 allée des Parcs Saint-Priest Cedex Trimetazidine Trimetazidin Mylan 35 mg 35 mg Prolonged - release Czech Republic SVUS Pharma a.s. Smetanovo nábřeží 1238/20a Hradec Králové Czech Republic Desloratadine Lotera 5 mg potahované y 5 mg Film - coated Denmark Actavis Group PTC ehf. Reykjavikurvegi Hafnarfjördur Iceland Metformin Metformin "Actavis PTC" 500 mg Prolonged - release Denmark Actavis Group PTC ehf. Reykjavikurvegi Hafnarfjördur Iceland Metformin Metformin "Actavis PTC" 750 mg Prolonged - release EMA/52196/2015 Page 16/131
17 Denmark Denmark Denmark Denmark Denmark Denmark Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Sweden Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Sweden Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Sweden Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Fluconazole Fluconazol "Bluefish" 50 mg Capsule, hard Fluconazole Fluconazol "Bluefish" 150 mg Capsule, hard Fluconazole Fluconazol "Bluefish" 200 mg Capsule, hard Valsartan/hydrochl Valsartan/hydrochlorthiazid 160 Film - coated orothiazide "Fair-Med" mg/12,5 mg Valsartan/hydrochl Valsartan/hydrochlorthiazid 320 Film - coated orothiazide "Fair-Med" mg/12,5 mg Valsartan/hydrochl Valsartan/hydrochlorthiazid 320 mg/25 Film - coated orothiazide "Fair-Med" mg EMA/52196/2015 Page 17/131
18 Denmark Mylan AB PO Box SE Stockholm Sweden Eletriptan Eletriptan Mylan 40 mg Film - coated Denmark Mylan AB PO Box SE Stockholm Sweden Esomeprazole Esomeprazol Mylan 20 mg Gastro - resistant capsule, hard Denmark Mylan AB PO Box SE Stockholm Sweden Esomeprazole Esomeprazol Mylan 40 mg Gastro - resistant capsule, hard Denmark Mylan AB PO Box SE Stockholm Sweden Rizatriptan Rizatriptan Mylan 10 mg Orodispersible Denmark Stadapharm GmbH Stadastr D Bad Vilbel Entacapone Entacapon STADA 200 mg Film - coated Estonia Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Alendronic acid ALENDRONIC ACID ACCORD 70mg 70 mg Tablet EMA/52196/2015 Page 18/131
19 Estonia Finland Finland Finland Finland Finland Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Actavis Group PTC ehf. Reykjavikurvegi Hafnarfjördur Iceland Actavis Group PTC ehf. Reykjavikurvegi Hafnarfjördur Iceland Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Sweden Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Sweden Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Sweden Trimetazidine ZIDMETIN 35 mg Modified - release Metformin Metformin Actavis 500 mg Prolonged - release Metformin Metformin Actavis 750 mg Prolonged - release Fluconazole Fluconazol Bluefish 50 mg Capsule, hard Fluconazole Fluconazol Bluefish 150 mg Capsule, hard Fluconazole Fluconazol Bluefish 200 mg Capsule, hard EMA/52196/2015 Page 19/131
20 Finland Finland Finland Finland Finland Finland Mylan AB PO Box SE Stockholm Sweden Mylan AB PO Box SE Stockholm Sweden Mylan AB PO Box SE Stockholm Sweden Mylan AB PO Box SE Stockholm Sweden Orion Corporation Orion Pharma PO BOX Espoo Finland Orion Corporation Orion Pharma PO BOX Espoo Finland Eletriptan Eletriptan Mylan 40 mg Film - coated Repaglinide Repaglinid Mylan 0,5 mg Tablet Repaglinide Repaglinid Mylan 1 mg Tablet Repaglinide Repaglinid Mylan 2 mg Tablet Valsartan VALSARTAN ORION 40 mg Film - coated Valsartan VALSARTAN ORION 80 mg Film - coated EMA/52196/2015 Page 20/131
21 Finland Orion Corporation Orion Pharma PO BOX Espoo Finland Valsartan VALSARTAN ORION 160 mg Film - coated Finland Orion Corporation Orion Pharma PO BOX Espoo Finland Valsartan VALSARTAN ORION 320 mg Film - coated Finland ratiopharm GmbH Graf-Arco-Strasse 3 D Ulm Desloratadine Desloratadine Ratiopharm 2,5 mg Orodispersible Finland ratiopharm GmbH Graf-Arco-Strasse 3 D Ulm Desloratadine Desloratadine Ratiopharm 5 mg Orodispersible Abbott Products SAS 42 rue Rouget de Lisle Suresnes Escitalopram ESCITALOPRAM ABBOTT 5mg, comprimé pelliculé 5 mg Film - coated Abbott Products SAS 42 rue Rouget de Lisle Suresnes Escitalopram ESCITALOPRAM ABBOTT 10mg, comprimé pelliculé 10 mg Film - coated EMA/52196/2015 Page 21/131
22 Abbott Products SAS 42 rue Rouget de Lisle Suresnes Escitalopram ESCITALOPRAM ABBOTT 15mg, comprimé pelliculé 15 mg Film - coated Abbott Products SAS 42 rue Rouget de Lisle Suresnes Escitalopram ESCITALOPRAM ABBOTT 20mg, comprimé pelliculé 20 mg Film - coated ACCORD HEALTHCARE SAS 45 Rue de Fbg de Roubaix Lille Ropinirole Ropinirole Accord 0,25mg, comprimé pelliculé 0,25 mg Film - coated ACCORD HEALTHCARE SAS 45 Rue de Fbg de Roubaix Lille Ropinirole Ropinirole Accord 0,5mg, comprimé pelliculé 0,5 mg Film - coated ACCORD HEALTHCARE SAS 45 Rue de Fbg de Roubaix Lille Ropinirole Ropinirole Accord 1mg, comprimé pelliculé 1 mg Film - coated EMA/52196/2015 Page 22/131
23 ACCORD HEALTHCARE SAS 45 Rue de Fbg de Roubaix Lille Ropinirole Ropinirole Accord 2mg, comprimé pelliculé 2 mg Film - coated ACCORD HEALTHCARE SAS 45 Rue de Fbg de Roubaix Lille Ropinirole Ropinirole Accord 5mg, comprimé pelliculé 5 mg Film - coated Brown & Burk UK, Ltd. 5, Marryat Close Hounslow TW4 5DQ Middlesex Escitalopram ESCITALOPRAM BROWN 5 mg, comprimé pelliculé sécable 5 mg Film - coated Brown & Burk UK, Ltd. 5, Marryat Close Hounslow TW4 5DQ Middlesex Escitalopram ESCITALOPRAM BROWN 10 mg, comprimé pelliculé sécable 10 mg Film - coated Brown & Burk UK, Ltd. 5, Marryat Close Hounslow TW4 5DQ Middlesex Escitalopram ESCITALOPRAM BROWN 15 mg, comprimé pelliculé sécable 15 mg Film - coated EMA/52196/2015 Page 23/131
24 Brown & Burk UK, Ltd. 5, Marryat Close Hounslow TW4 5DQ Middlesex Escitalopram ESCITALOPRAM BROWN 20 mg, comprimé pelliculé sécable 20 mg Film - coated Brown & Burk UK, Ltd. 5, Marryat Close Hounslow TW4 5DQ Middlesex Ebastine EBASTINE BROWN & BURK 10 mg, comprimé orodispersible 10 mg Orodispersible Cristers 22, quai Galliéni Suresnes Desloratadine DESLORATADINE CRISTERS 5 mg comprimé pelliculé 5 mg Film - coated Cristers 22, quai Galliéni Suresnes Ibuprofen IBUPROFENE CRISTERS 400 mg comprimé pelliculé 400 mg Film - coated Laboratoires Biogaran 15, boulevard Charles de Gaulle Colombes Cedex Ebastine EBASTINE BIOGARAN 10 mg comprimé pelliculé 10 mg Film - coated EMA/52196/2015 Page 24/131
25 Laboratoires Biogaran 15, boulevard Charles de Gaulle Colombes Cedex Ebastine EBASTINE BIOGARAN 10 mg comprimé orodispersible 10 mg Orodispersible Laboratoires GERDA 24 rue Erlanger PARIS Desloratadine DESLORATADINE ARROW 5 mg comprimé pelliculé 5 mg Film - coated Medipha Sante Les Fjords - Immeuble Oslo 19 avenue de Norvège Courtaboeuf Cedex Tramadol/paraceta mol TRAMADOL PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé 37,5 mg/325 mg Film - coated Medipha Sante Les Fjords - Immeuble Oslo 19 avenue de Norvège Courtaboeuf Cedex Desloratadine DESLORATADINE GNR 5 mg comprimé pelliculé 5 mg Film - coated Mylan SAS 117 allée des Parcs Saint-Priest Cedex Rizatriptan RIZATRIPTAN MYLAN 5mg, orodispersible 5 mg Orodispersible EMA/52196/2015 Page 25/131
26 Mylan SAS 117 allée des Parcs Saint-Priest Cedex Rizatriptan RIZATRIPTAN MYLAN 10 mg, orodispersible 10 mg Orodispersible Mylan SAS 117 allée des Parcs Saint-Priest Cedex Ebastine EBASTINE MYLAN 10mg, film-coated 10 mg Film - coated Mylan SAS 117 allée des Parcs Saint-Priest Cedex Ebastine EBASTINE MYLAN 10mg, orodispersible 10 mg Orodispersible Mylan SAS 117 allée des Parcs Saint-Priest Cedex Trimetazidine TRIMETAZIDINE MYLAN 35 mg Modified Release Tablets 35 mg Modified - release Mylan SAS 117 allée des Parcs Saint-Priest Cedex Candesartan CANDESARTAN MYLAN 32 mg, comprimé secable 32 mg Tablet Mylan SAS 117 allée des Parcs Saint-Priest Cedex Donepezil DONEPEZIL MYLAN 5 mg, orodispersible 5 mg Orodispersible EMA/52196/2015 Page 26/131
27 Mylan SAS 117 allée des Parcs Saint-Priest Cedex Donepezil DONEPEZIL MYLAN 10 mg, orodispersible 10 mg Orodispersible Mylan SAS 117 allée des Parcs Saint-Priest Cedex Esomeprazole ESOMEPRAZOLE MYLAN PHARMA 20mg, DR capsule 20 mg Gastro - resistant capsule, hard Mylan SAS 117 allée des Parcs Saint-Priest Cedex Esomeprazole ESOMEPRAZOLE MYLAN PHARMA 40mg, DR capsule 40 mg Gastro - resistant capsule, hard Mylan SAS 117 allée des Parcs Saint-Priest Cedex Desmopressin DESMOPRESSINE MYLAN 60 µg, orodispersible 0,06 mg Orodispersible Mylan SAS 117 allée des Parcs Saint-Priest Cedex Desmopressin DESMOPRESSINE MYLAN 120 µg, orodispersible 0,12 mg Orodispersible Mylan SAS 117 allée des Parcs Saint-Priest Cedex Desmopressin DESMOPRESSINE MYLAN 240 µg, orodispersible 0,24 mg Orodispersible EMA/52196/2015 Page 27/131
28 Ranbaxy Pharmacie Generiques Quai Dion Bouton Puteaux Aciclovir Aciclovir Ranbaxy 800 mg, comprimé 800 mg Tablet Ranbaxy Pharmacie Generiques Quai Dion Bouton Puteaux Aciclovir Aciclovir Ranbaxy 200 mg, comprimé 200 mg Tablet Ranbaxy Pharmacie Generiques Quai Dion Bouton Puteaux Aciclovir Aciclovir Almus 200 mg, comprimé 200 mg Tablet Ranbaxy Pharmacie Generiques Quai Dion Bouton Puteaux Alendronic acid Acide Alendronique Ranbaxy 70 mg, comprimé 70 mg Tablet Sanofi Aventis 1-13 bd Romain Rolland Paris Cedex 14 Ebastine EBASTINE ZENTIVA 10 mg comprimé pelliculé 10 mg Film - coated EMA/52196/2015 Page 28/131
29 Sanofi Aventis 1-13 bd Romain Rolland Paris Cedex 14 Ebastine EBASTINE ZENTIVA 10 mg comprimé orodispersible 10 mg Orodispersible Teva Sante Cœur Défense Esplanade du Général de Gaulle La Défense Cedex Desloratadine DESLORATADINE TEVA SANTE 5 mg comprimé pelliculé 5 mg Film - coated Venipharm SAS 4 Bureaux de la Colline Saint-Cloud Ebastine EBOUDA 10 mg comprimé pelliculé 10 mg Film - coated Venipharm SAS 4 Bureaux de la Colline Saint-Cloud Ebastine EBARREN 10 mg comprimé pelliculé 10 mg Film - coated Venipharm SAS 4 Bureaux de la Colline Saint-Cloud Ebastine EBONDE 10 mg comprimé pelliculé 10 mg Film - coated Venipharm SAS 4 Bureaux de la Colline Saint-Cloud Ebastine EBONTAN 10 mg comprimé orodispersible 10 mg Orodispersible EMA/52196/2015 Page 29/131
30 Venipharm SAS 4 Bureaux de la Colline Saint-Cloud Ebastine EBACHOI 10 mg comprimé orodispersible 10 mg Orodispersible Venipharm SAS 4 Bureaux de la Colline Saint-Cloud Ibuprofen IBUPROFENE ZYDUS FRANCE 200 mg comprimé pelliculé 200 mg Film - coated Zydus Zacles Hautes Patures 25 Rue des Peupliers Nanterre Cedes Ibuprofen IBUPROFENE ZYDUS FRANCE 400 mg comprimé pelliculé 400 mg Film - coated Zydus Zacles Hautes Patures 25 Rue des Peupliers Nanterre Cedes Tramadol/paraceta mol TRAMADOL PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé 37,5 mg/325 mg Film - coated Zydus Zacles Hautes Patures 25 Rue des Peupliers Nanterre Cedes Ibuprofen IBUPROFENE ZF 400 mg comprimé pelliculé 400 mg Film - coated EMA/52196/2015 Page 30/131
31 Zydus Zacles Hautes Patures 25 Rue des Peupliers Nanterre Cedes Desloratadine DESLORATADINE ZYDUS 5 mg comprimé pelliculé 5 mg Film - coated Zydus Zacles Hautes Patures 25 Rue des Peupliers Nanterre Cedes Escitalopram ESCITALOPRAM ZYDUS 5 mg, comprimé pelliculé 5 mg Film - coated Zydus Zacles Hautes Patures 25 Rue des Peupliers Nanterre Cedes Escitalopram ESCITALOPRAM ZYDUS 10 mg, comprimé pelliculé sécable 10 mg Film - coated Zydus Zacles Hautes Patures 25 Rue des Peupliers Nanterre Cedes Escitalopram ESCITALOPRAM ZYDUS 15 mg, comprimé pelliculé sécable 15 mg Film - coated EMA/52196/2015 Page 31/131
32 Zydus Zacles Hautes Patures 25 Rue des Peupliers Nanterre Cedes Escitalopram ESCITALOPRAM ZYDUS 20 mg, comprimé pelliculé sécable 20 mg Film - coated Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Alendronic acid ALENDRONIC ACID ACCORD 70MG 70 mg Tablet betapharm Arzneimittel GmbH Kobelweg 95 D Augsburg Levetiracetam Levetiracetam beta 250 mg, Filmten 250 mg Film - coated betapharm Arzneimittel GmbH Kobelweg 95 D Augsburg Levetiracetam Levetiracetam beta 500 mg, Filmten 500 mg Film - coated betapharm Arzneimittel GmbH Kobelweg 95 D Augsburg Levetiracetam Levetiracetam beta 750 mg, Filmten 750 mg Film - coated betapharm Arzneimittel GmbH Kobelweg 95 D Augsburg Levetiracetam Levetiracetam beta 1000 mg, Filmtabeltten 1000 mg Film - coated EMA/52196/2015 Page 32/131
33 Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Irbesartan Irbesartan Tablets 75mg 75 mg Film - coated Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Irbesartan Irbesartan Tablets 150mg 150 mg Film - coated Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Irbesartan Irbesartan Tablets 300 mg 300 mg Film - coated Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Irbesartan/hydroch lorothiazide Irbesartan HCTZ Fair-Med ,5 mg Filmten 150 mg/12,5 mg Film - coated Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Irbesartan/hydroch lorothiazide Irbesartan HCTZ Fair-Med ,5 mg Filmten 300 mg/12,5 mg Film - coated Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Irbesartan/hydroch lorothiazide Irbesartan HCTZ Fair-Med mg Filmten 300 mg/25 mg Film - coated EMA/52196/2015 Page 33/131
34 Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Valsartan/hydrochl orothiazide Valsartan/HCTZ Fair-Med Healthcare 160 mg/12.5 mg Filmten 160 mg/12,5 mg Film - coated Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Valsartan/hydrochl orothiazide Valsartan/HCTZ Fair-Med Healthcare 320 mg/12,5 mg Filmten 320 mg/12,5 mg Film - coated Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Valsartan/hydrochl orothiazide Valsartan/HCTZ Fair-Med Healthcare 320 mg/25 mg Filmten 320 mg/25 mg Film - coated Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Venlafaxine Venlafaxin Fair-Med 37,5 mg Hartkapseln, retardiert 37,5 mg Prolonged - release capsule, hard Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Venlafaxine Venlafaxin Fair-Med 75 mg Hartkapseln, retardiert 75 mg Prolonged - release capsule, hard Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Venlafaxine Venlafaxin Fair-Med 150 mg Hartkapseln, retardiert 150 mg Prolonged - release capsule, hard EMA/52196/2015 Page 34/131
35 Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Ciprofloxacin Ciprofloxacin Fair-Med Healthcare 500 mg Filmten 500 mg Film - coated Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Ciprofloxacin Ciprofloxacin Fair-Med Healthcare 750 mg Filmten 750 mg Film - coated Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Ciprofloxacin Ciprofloxacin Fair-Med Healthcare 250 mg Filmten 250 mg Film - coated Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Irbesartan Irbesartan Heumann 75 mg Filmten 75 mg Film - coated Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Irbesartan Irbesartan Heumann 150 mg Filmten 150 mg Film - coated EMA/52196/2015 Page 35/131
36 Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Irbesartan Irbesartan Heumann 300 mg Filmten 300 mg Film - coated Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Irbesartan/hydroch lorothiazide Irbesartan/Hydrochlorothia zid Heumann 150 mg/12.5 mg Filmten 150 mg/12,5 mg Film - coated Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Irbesartan/hydroch lorothiazide Irbesartan/Hydrochlorothia zid Heumann 300 mg/12.5 mg Filmten 300 mg/12,5 mg Film - coated Heumann Pharma GmbH & Co. Generica KG Südwestpark Nürnberg Irbesartan/hydroch lorothiazide Irbesartan/Hydrochlorothia zid Heumann 300 mg/25 mg Filmten 300 mg/25 mg Film - coated Hormosan Pharma GmbH Wilhelmshoeher Str. 106 D Frankfurt 06 Hessen Cefpodoxime proxetil Cefpodoxim- Hormosan 200mg Filmten 200 mg Film - coated EMA/52196/2015 Page 36/131
37 Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16 0PF Trimetazidine hydrochloride Lupamadazine 35 mg Retardten 35 mg Controlled - release Micro Labs GmbH Lyoner Str. 14 D Frankfurt/Main Escitalopram Escitalopram-Micro Labs 5 mg Filmten 5 mg Film - coated Micro Labs GmbH Lyoner Str. 14 D Frankfurt/Main Escitalopram Escitalopram-Micro Labs 10 mg Filmten 10 mg Film - coated Micro Labs GmbH Lyoner Str. 14 D Frankfurt/Main Escitalopram Escitalopram-Micro Labs 15 mg Filmten 15 mg Film - coated Micro Labs GmbH Lyoner Str. 14 D Frankfurt/Main Escitalopram Escitalopram-Micro Labs 20 mg Filmten 20 mg Film - coated Mylan dura GmBh Wittichstrasse Darmstadt Repaglinide Repaglinid Mylan 0,5 mg Tabletten 0,5 mg Tablet EMA/52196/2015 Page 37/131
38 Mylan dura GmBh Wittichstrasse Darmstadt Mylan dura GmBh Wittichstrasse Darmstadt Mylan dura GmBh Wittichstrasse Darmstadt Mylan dura GmBh Wittichstrasse Darmstadt Panacea Biotec GmbH Landshuter Allee 8-10 D München Panacea Biotec GmbH Landshuter Allee 8-10 D München Repaglinide Repaglinid Mylan 1 mg Tabletten 1 mg Tablet Repaglinide Repaglinid Mylan 2 mg 2 mg Tablet Tabletten Rizatriptan Rizatriptan Mylan dura 5 5 mg Orodispersible mg Schmelzten Rizatriptan Rizatriptan Mylan dura mg Orodispersible mg Schmelzten Tacrolimus Tacpan 0.5 mg Hartkapseln 0,5 mg Capsule, hard Tacrolimus Tacpan 1 mg Hartkapseln 1 mg Capsule, hard EMA/52196/2015 Page 38/131
39 Panacea Biotec GmbH Landshuter Allee 8-10 D München Stadapharm GmbH Stadastr D Bad Vilbel Tacrolimus Tacpan 5 mg Hartkapseln 5 mg Capsule, hard Entacapone Entacapon STADA 200 mg 200 mg Film - coated Filmten Unichem Laboratories Ltd. Studio 8B Ard Gaoithe Commercial Centre, Business Park Cashel Road Clonmel, Co Tipperary Ireland Irbesartan Irbesartan Unichem 150 mg Filmten 150 mg Film - coated Unichem Laboratories Ltd. Studio 8B Ard Gaoithe Commercial Centre, Business Park Cashel Road Clonmel, Co Tipperary Ireland Irbesartan Irbesartan Unichem 300 mg Filmten 300 mg Film - coated EMA/52196/2015 Page 39/131
40 Welding GmbH & Co. KG Esplanade 39 D Hamburg Irbesartan/hydroch lorothiazide Irbesartan + Hidroclorotiazida Welding 300 mg/12,5 mg Film - coated Welding GmbH & Co. KG Esplanade 39 D Hamburg Irbesartan/hydroch lorothiazide Irbesartan + Hidroclorotiazida Welding 150 mg/12,5 mg Film - coated Welding GmbH & Co. KG Esplanade 39 D Hamburg Irbesartan/hydroch lorothiazide Irbesartan + Hidroclorotiazida Welding 300 mg/25 mg Film - coated Welding GmbH & Co. KG Esplanade 39 D Hamburg Irbesartan Irbesartan Welding 75 mg Film - coated Welding GmbH & Co. KG Esplanade 39 D Hamburg Irbesartan Irbesartan Welding 150 mg Film - coated Welding GmbH & Co. KG Esplanade 39 D Hamburg Irbesartan Irbesartan Welding 300 mg Film - coated EMA/52196/2015 Page 40/131
41 Greece Abbott Laboratories Hellas ΑΒΕΕ Agiou Dimitriou 63 Alimos Greece Escitalopram oxalate Savandra 5 mg Film - coated Greece Abbott Laboratories Hellas ΑΒΕΕ Agiou Dimitriou 63 Alimos Greece Escitalopram oxalate Savandra 10 mg Film - coated Greece Abbott Laboratories Hellas ΑΒΕΕ Agiou Dimitriou 63 Alimos Greece Escitalopram oxalate Savandra 15 mg Film - coated Greece Abbott Laboratories Hellas ΑΒΕΕ Agiou Dimitriou 63 Alimos Greece Escitalopram oxalate Savandra 20 mg Film - coated Greece Genepharm S.A. 18 Km Marathon Avenue, Pallini Greece Desloratadine Desloratadine/Genepharm 5 mg δισκία επικαλυμμένα με υμένιο, 5 mg Film - coated EMA/52196/2015 Page 41/131
42 Greece Genepharm S.A. 18 Km Marathon Avenue, Pallini Greece Desloratadine Desloratadine/Genepharm 2,5 mg δισκία διασπειρόμενα στο στόμα 2,5 mg Orodispersible Greece Genepharm S.A. 18 Km Marathon Avenue, Pallini Greece Desloratadine Desloratadine/Genepharm 5 mg δισκία διασπειρόμενα στο στόμα 5 mg Orodispersible Greece Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli Athens Greece Donepezil hydrochloride Donepezil/ Generics 5 mg Orodispersible Greece Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli Athens Greece Donepezil hydrochloride Donepezil/ Generics 10 mg Orodispersible Greece Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli Athens Greece Esomeprazole magnesium Esomeprazole/ Generics 40 mg Prolonged - release capsule EMA/52196/2015 Page 42/131
43 Greece Sieger Pharma A.E. Marathonos Avenue 106 Pikermi Greece Desloratadine Desloratadine/Sieger 5 mg Film - coated Greece Sieger Pharma A.E. Marathonos Avenue 106 Pikermi Greece Desloratadine Desloratadine/Sieger 2,5 mg Orodispersible Greece Sieger Pharma A.E. Marathonos Avenue 106 Pikermi Greece Desloratadine Desloratadine/Sieger 5 mg Orodispersible Hungary Actavis Group PTC ehf. Reykjavikurvegi Hafnarfjördur Iceland Metformin hydrochloride Gluforlyn XR 500 mg retard ta 500 mg Prolonged - release Hungary Alvogen IPCo S.ar.l. Rue Heienhaff 5 L-1736 Senningerberg Luxembourg Desloratadine Alvotadin 5 mg filmta 5 mg Film - coated Hungary Alvogen IPCo S.ar.l. Rue Heienhaff 5 L-1736 Senningerberg Luxembourg Desloratadine Alvotadin 2.5 mg szájban diszpergálódó ta 2,5 mg Orodispersible EMA/52196/2015 Page 43/131
44 Hungary Alvogen IPCo S.ar.l. Rue Heienhaff 5 L-1736 Senningerberg Luxembourg Desloratadine Alvotadin 5 mg szájban diszpergálódó ta 5 mg Orodispersible Hungary Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Esomeprazole magnesium Esomeprazol Mylan 20 mg gyomornedv-ellenálló kemény kapszula 20 mg Gastro - resistant capsule, hard Hungary Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL Esomeprazole magnesium Esomeprazol Mylan 40 mg gyomornedv-ellenálló kemény kapszula 40 mg Gastro - resistant capsule, hard Hungary Glenmark Pharmaceuticals s.r.o. Hvězdova 1716/2b Praha 4 Czech Republic Trimetazidine dihydrochloride Apstar 35 mg retard ta 35 mg Prolonged - release Hungary Goodwill Pharma Kft. H-6724 Szeged Cserzy Mihály u. 32. Hungary Desloratadine Inaller 5 mg filmta 5 mg Film - coated Hungary Mylan SAS 117 allée des Parcs Saint-Priest Cedex Trimetazidine Trimetazidine Mylan 35 mg retard ta 35 mg Prolonged - release EMA/52196/2015 Page 44/131
45 Hungary Sandoz Hungária Kft. H-1114 Budapest Bartók Béla út Hungary Trimetazidine dihydrochloride Trimetazidine Sandoz 35 mg retard ta 35 mg Prolonged - release Hungary Teva Gyógyszergyár Zrt. H-4042 Debrecen Pallagi út 13. Hungary Desloratadine Desloratadin Teva 2.5 mg szájban diszpergálódó ta 2,5 mg Orodispersible Hungary Teva Gyógyszergyár Zrt. H-4042 Debrecen Pallagi út 13. Hungary Desloratadine Desloratadin Teva 5 mg szájban diszpergálódó ta 5 mg Orodispersible Iceland ratiopharm GmbH Graf-Arco-Strasse 3 D Ulm Desloratadine Desloratadine ratiopharm 5 mg Orodispersible Ireland Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Ropinirole hydrochloride Ropinirole 0.25 mg Filmcoated Tablets 0,25 mg Film - coated Ireland Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Ropinirole hydrochloride Ropinirole 0.5 mg Filmcoated Tablets 0,5 mg Film - coated EMA/52196/2015 Page 45/131
46 Ireland Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Ropinirole hydrochloride Ropinirole 1 mg Filmcoated Tablets 1 mg Film - coated Ireland Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Ropinirole hydrochloride Ropinirole 2 mg Filmcoated Tablets 2 mg Film - coated Ireland Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Ropinirole hydrochloride Ropinirole 5 mg Filmcoated Tablets 5 mg Film - coated Ireland Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Alendronic acid Alendronic Acid Once Weekly 70 mg Tablets 70 mg Tablet Ireland Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Valsartan/hydrochl orothiazide Valsartan/Hydrochlorothiaz ide Fair-Med 160 mg/12.5 mg film-coated s. 160 mg/12,5 mg Film - coated EMA/52196/2015 Page 46/131
47 Ireland Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Valsartan/hydrochl orothiazide Valsartan/Hydrochlorothiaz ide Fair-Med 320 mg/12.5 mg film-coated s 320 mg/12,5 mg Film - coated Ireland Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Valsartan/hydrochl orothiazide Valsartan/Hydrochlorothiaz ide Fair-Med 320 mg/25 mg film-coated s 320 mg/25 mg Film - coated Ireland Fannin (UK) Ltd Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT Fexofenadine hydrochloride Fexofenadine 120 mg filmcoated s 120 mg Film - coated Ireland Fannin (UK) Ltd Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT Fexofenadine hydrochloride Fexofenadine 180 mg filmcoated s 180 mg Film - coated Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Donepezil Aripil Orotab 5mg Orodispersible Tablet 5 mg Orodispersible EMA/52196/2015 Page 47/131
48 Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Donepezil Aripil Orotab 10mg Orodispersible Tablet 10 mg Orodispersible Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Esomeprazole Esomeprazole Mylan 20 mg Gastro-resistant Capsules, hard 20 mg Gastro - resistant capsule Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Esomeprazole Esomeprazole Mylan 40 mg Gastro-resistant Capsules, hard 40 mg Gastro - resistant capsule EMA/52196/2015 Page 48/131
49 Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Candesartan Candesartan Mylan 4mg Tablets 4 mg Tablet Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Candesartan Candesartan Mylan 8 mg Tablets 8 mg Tablet Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Candesartan Candesartan Mylan 16 mg Tablets 16 mg Tablet EMA/52196/2015 Page 49/131
50 Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Candesartan Candesartan Mylan 32 mg Tablets 32 mg Tablet Ireland Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA Phenoxymethyl penicillin Phenoxymethylpenicillin 250mg Film-coated Tablets 250 mg Film - coated Ireland Niche Generics Limited 1 The Cam Centre Wilbury Way, Hitchin Hertfordshire SG4 0TW Amlodipine besilate Amlodipine Niche 5mg s 5 mg Tablet Ireland Niche Generics Limited 1 The Cam Centre Wilbury Way, Hitchin Hertfordshire SG4 0TW Amlodipine besilate Amlodipine Niche 10mg Tablets 10 mg Tablet Ireland Niche Generics Limited 1 The Cam Centre Wilbury Way, Hitchin Hertfordshire SG4 0TW Irbesartan Irbesartan Niche 150mg film coated s 150 mg Film - coated EMA/52196/2015 Page 50/131
51 Ireland Niche Generics Limited 1 The Cam Centre Wilbury Way, Hitchin Hertfordshire SG4 0TW Irbesartan Irbesartan Niche 300mg film coated s 300 mg Film - coated Ireland Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF Clopidogrel hydrochloride Clopidogrel 75mg filmcoated s 75 mg Film - coated Italy Accord Healthcare Italia S.r.l. Largo Esterle, Monza Italy Metoclopramide METOCLOPRAMIDE ACCORD 10 mg Tablet Italy Italy Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Alendronic acid ALENDRONATO AHCL 10 mg Tablet Alendronic acid ALENDRONATO AHCL 70 mg Tablet EMA/52196/2015 Page 51/131
52 Italy Doc Generici SRL Via Turati, Milano Italy Desloratadine DESLORATADINA DOC GENERICI 5 mg Film - coated Italy Doc Generici SRL Via Turati, Milano Italy Desloratadine DESLORATADINA DOC GENERICI 2,5 mg Orodispersible Italy Doc Generici SRL Via Turati, Milano Italy Desloratadine DESLORATADINA DOC GENERICI 5 mg Orodispersible Italy Farmaceutici Caber S.P.A. Viale Citta' D'Europa, Rome Italy Valsartan VALSOTEN 40 mg Film - coated Italy Farmaceutici Caber S.P.A. Viale Citta' D'Europa, Rome Italy Valsartan VALSOTEN 80 mg Film - coated Italy Farmaceutici Caber S.P.A. Viale Citta' D'Europa, Rome Italy Valsartan VALSOTEN 160 mg Film - coated EMA/52196/2015 Page 52/131
53 Italy Farmaceutici Caber S.P.A. Viale Citta' D'Europa, Rome Italy Valsartan VALSOTEN 320 mg Film - coated Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Esomeprazole magnesium ESOMEPRAZOLO MYLAN 20 mg Gastro - resistant capsule, hard Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Esomeprazole magnesium ESOMEPRAZOLO MYLAN 40 mg Gastro - resistant capsule, hard Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Rizatriptan benzoate RIAZATRIPTAN MYLAN GENERICS 5 mg Orodispersible Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Rizatriptan benzoate RIAZATRIPTAN MYLAN GENERICS 10 mg Orodispersible Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Donepezil hydrochloride DONEPEZIL MYLAN GENERICS ITALIA 5 mg Orodispersible EMA/52196/2015 Page 53/131
54 Italy Italy Italy Italy Italy Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Mylan S.P.A. Via Vittor Pisani, Milan Italy Pensa Pharma S.P.A. Via Rossellini Ippolito, Milan Italy Ranbaxy Italia S.P.A. Piazza Filippo Meda, 4, Milano Italy Donepezil hydrochloride DONEPEZIL MYLAN GENERICS ITALIA 10 mg Orodispersible Repaglinide REPAGLINIDE MYLAN 0,5 mg Tablet Repaglinide REPAGLINIDE MYLAN 1 mg Tablet Repaglinide REPAGLINIDE MYLAN 2 mg Tablet Alendronic acid Alendronato Pensa 70 mg Tablet 70 mg compresse Alendronic acid ALENDRONATO RANBAXY 70 mg Tablet ITALIA EMA/52196/2015 Page 54/131
55 Latvia Lithuania Lithuania Lithuania Lithuania Sandoz Pharmaceuticals d.d. Verovskova 57 Ljubljana SI-1000 Slovenia Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex Lambda Therapeutic Limited Sage House 319 Pinner Road, North Harrow Middlesex HA1 4HF Lambda Therapeutic Limited Sage House 319 Pinner Road, North Harrow Middlesex HA1 4HF Lambda Therapeutic Limited Sage House 319 Pinner Road, North Harrow Middlesex HA1 4HF Trimetazidine dihydrochloride Zidmetin 35 mg Modified - release Alendronic acid Alendronic acid Accord 70 mg Tablet Ropinirole Ropinirole Lambada 0,5 mg Film - coated Ropinirole Ropinirole Lambada 1 mg Film - coated Ropinirole Ropinirole Lambada 2 mg Film - coated EMA/52196/2015 Page 55/131
56 Lithuania Lambda Therapeutic Limited Sage House 319 Pinner Road, North Harrow Middlesex HA1 4HF Ropinirole Ropinirole Lambada 5 mg Film - coated Lithuania Torrent Pharma GmbH Südwestpark Nürnberg Irbesartan Irbesartanas Torrent 75 mg Film - coated Lithuania Torrent Pharma GmbH Südwestpark Nürnberg Irbesartan Irbesartanas Torrent 150 mg Film - coated Lithuania Torrent Pharma GmbH Südwestpark Nürnberg Irbesartan Irbesartanas Torrent 300 mg Film - coated Lithuania Torrent Pharma GmbH Südwestpark Nürnberg Irbesartan/hydroch lorothiazide Irbesartanas/Hidrochlorotia zidas Torrent 150 mg/12,5 mg Film - coated Lithuania Torrent Pharma GmbH Südwestpark Nürnberg Irbesartan/hydroch lorothiazide Irbesartanas/Hidrochlorotia zidas Torrent 300 mg/12,5 mg Film - coated EMA/52196/2015 Page 56/131
57 Lithuania Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Torrent Pharma GmbH Südwestpark Nürnberg Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Irbesartan/hydroch lorothiazide Irbesartanas/Hidrochlorotia zidas Torrent 300 mg/25 mg Film - coated Repaglinide Repaglinide Mylan Pharma 0,5 mg Tablet 0,5 mg ten Repaglinide Repaglinide Mylan Pharma 1 mg Tablet 1 mg ten Repaglinide Repaglinide Mylan Pharma 2 mg Tablet 2 mg ten Esomeprazole Esomeprazole Mylan 20 mg Gastro - resistant capsule, hard Esomeprazole Esomeprazole Mylan 40 mg Gastro - resistant capsule, hard EMA/52196/2015 Page 57/131
58 Malta Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Valsartan/hydrochl orothiazide Valsartan/hydrochlorthiazid "Fair-Med" Coated s 160 mg/12,5 mg Film - coated Malta Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Valsartan/hydrochl orothiazide Valsartan/hydrochlorthiazid "Fair-Med" Coated s 320 mg/12,5 mg Film - coated Malta Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Valsartan/hydrochl orothiazide Valsartan/hydrochlorthiazid "Fair-Med" Coated s 320 mg/25 mg Film - coated Malta Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Ciprofloxacin Ciprofloxacin Fair-Med Coated Tablets 250 mg Film - coated Malta Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Ciprofloxacin Ciprofloxacin Fair-Med Coated Tablets 500 mg Film - coated Malta Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg irbesartan Irbesartan Fairmed 75mg Film-coated Tablets 75 mg Film - coated EMA/52196/2015 Page 58/131
59 Malta Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg irbesartan Irbesartan Fairmed 150mg Film-coated Tablets 150 mg Film - coated Malta Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg irbesartan Irbesartan Fairmed 300mg Film-coated Tablets 300 mg Film - coated Malta Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Irbesartan/hydroch lorothiazide Irbesartan/Hydrochlorothia zide Fairmed 150mg/12.5mg film-coated s 150 mg/12,5 mg Film - coated Malta Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Irbesartan/hydroch lorothiazide Irbesartan/Hydrochlorothia zide Fairmed 300mg/12.5mg film-coated s 300 mg/12,5 mg Film - coated Malta Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Irbesartan/hydroch lorothiazide Irbesartan/Hydrochlorothia zide Fairmed 300mg/25mg film-coated s 300 mg/25 mg Film - coated Malta Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Venlafaxine Venlafaxine Fair-Med 37,5 mg Prolonged - release capsule, hard EMA/52196/2015 Page 59/131
60 Malta Malta Malta Malta Norway Norway Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Fair-Med Healthcare GmbH Planckstrasse 13 DE Hamburg Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Sweden Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Sweden Venlafaxine Venlafaxine Fair-Med 75 mg Prolonged - release capsule, hard Venlafaxine Venlafaxine Fair-Med 150 mg Prolonged - release capsule, hard Clopidogrel Clopidogrel 75mg Filmcoated 75 mg Film - coated Tablets Clopidogrel Clopidogrel 75mg Coated 75 mg Film - coated Tablets Fluconazole Fluconazol Bluefish 50 mg Capsule, hard Fluconazole Fluconazol Bluefish 150 mg Capsule, hard EMA/52196/2015 Page 60/131
61 Norway Norway Norway Norway Norway Norway Bluefish Pharmaceuticals AB Torsgatan 11 SE Stockholm Sweden Mylan AB PO Box SE Stockholm Sweden Mylan AB PO Box SE Stockholm Sweden Mylan AB PO Box SE Stockholm Sweden Mylan AB PO Box SE Stockholm Sweden Mylan AB PO Box SE Stockholm Sweden Fluconazole Fluconazol Bluefish 200 mg Capsule, hard Esomeprazole Esomeprazol Mylan 20 mg Gastro - resistant capsule, hard Esomeprazole Esomeprazol Mylan 40 mg Gastro - resistant capsule, hard Eletriptan Eletriptan Mylan 20 mg Film - coated Eletriptan Eletriptan Mylan 40 mg Film - coated Candesartan Kandrozid 4 mg cilexetil EMA/52196/2015 Page 61/131
62 Norway Mylan AB PO Box SE Stockholm Sweden Candesartan cilexetil Kandrozid 8 mg Norway Mylan AB PO Box SE Stockholm Sweden Candesartan cilexetil Kandrozid 16 mg Norway Mylan AB PO Box SE Stockholm Sweden Candesartan cilexetil Kandrozid 32 mg Norway Mylan AB PO Box SE Stockholm Sweden Candesartan cilexetil Mylcande 8 mg Norway Mylan AB PO Box SE Stockholm Sweden Candesartan cilexetil Mylcande 16 mg Norway Mylan AB PO Box SE Stockholm Sweden Candesartan cilexetil Mylcande 32 mg EMA/52196/2015 Page 62/131
63 Norway Mylan AB PO Box SE Stockholm Sweden Rizatriptan RIZATRIPTAN MYLAN 10 mg, orodispersible 10 mg Orodispersible Norway ratiopharm GmbH Graf-Arco-Strasse 3 D Ulm Desloratadine Desloratadin Ratiopharm 2,5 mg Orodispersible Norway ratiopharm GmbH Graf-Arco-Strasse 3 D Ulm Desloratadine Desloratadin Ratiopharm 5 mg Orodispersible Abbott Laboratories Sp. z o.o. ul. Postępu 21B Warszawa Escitalopram Savandra 5 mg Film - coated Abbott Laboratories Sp. z o.o. ul. Postępu 21B Warszawa Escitalopram Savandra 10 mg Film - coated EMA/52196/2015 Page 63/131
Products for which the marketing authorisations are recommended for suspension by the CHMP on 21 May 2015
21 May 2015 EMA/344050/2015 Procedure Management and Committee Support Products for which the marketing authorisations are recommended for suspension by the CHMP on 21 May 2015 Article 31 of Directive
Products for which the marketing authorisations are recommended for suspension by the CHMP on 22 January 2015
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.
Please note that this draft Annex I may be updated to reflect further information on concerned products/mahs
2 May 2016 EMA/314147/2016 Corr. 7 Procedure Management and Committees Support Annex I List of the names, pharmaceutical s, strengths of the medicinal products, routes of, marketing authorisat s in the
INN Invented name Strength Pharmaceutical Form. 150 mg Retardkapseln. 75 mg Retardkapseln. 75mg Hartkapseln. 150mg Hartkapseln
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of, marketing authorisation holders in the Member States 1 Annex IA: Products for which the marketing authorisations
List of nationally authorised medicinal products
9 July 2015 EMA/483660/2015 Procedure Management and Committees Support Active substance: diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated), haemophilus type b conjugate
Invented name Name THIOCOLCHICOSIDE. THIOCOLCHICOSIDE ALMUS 4mg Tablet Oral use THIOCOLCHICOSIDE
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of, marketing authorisation holders in the member states 1 Czech Republic Czech Republic sanofi-aventis, s.r.o.
Name. Priligy 30 mg Filmtabletten. Priligy 60 mg Filmtabletten. Priligy 30 mg filmomhulde tablet. Priligy 60 mg filmomhulde tablet
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 1 Austria Janssen-Cilag Pharma
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