Products for which the marketing authorisations are recommended for suspension by the CHMP on 22 January 2015 Some of these medicinal products may be considered critical by the individual EU Member States. The suspension of the concerned marketing authorisation(s) may be deferred by the period for which the medicinal product is considered critical. Article 31 of Directive 2001/83/EC Procedure number: EMEA/H/A-31/1408 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged. Member State Marketing Authorisation (in EEA) Holder Austria Arcana Arzneimittel GmbH Esomeprazole Esomeprazol Arcana 20 mg Huetteldorfer Straße 299 magnesium magensaftresistente INN 1140 Wien Invented name Strength 20 mg Pharmaceutical Route of Form administration Gastro - resistant Oral use capsule, hard Hartkapseln Austria Austria Arcana Arzneimittel GmbH Esomeprazole Esomeprazol Arcana 40 mg Huetteldorfer Straße 299 magnesium magensaftresistente 1140 Wien 40 mg Gastro - resistant Oral use capsule, hard Hartkapseln Austria Austria Arcana Arzneimittel GmbH Esomeprazole Neximyl 20 mg Huetteldorfer Straße 299 magnesium magensaftresistente 1140 Wien 20 mg Gastro - resistant Oral use capsule, hard Hartkapseln Austria Austria Arcana Arzneimittel GmbH Esomeprazole Neximyl 40 mg Huetteldorfer Straße 299 magnesium magensaftresistente 1140 Wien 40 mg Gastro - resistant Oral use capsule, hard Hartkapseln Austria Austria Arcana Arzneimittel GmbH Candesartan Candesartan Arcana 4mg Huetteldorfer Straße 299 cilexetil Tabletten Arcana Arzneimittel GmbH Candesartan Candesartan Arcana 8mg Huetteldorfer Straße 299 cilexetil Tabletten 4 mg Tablet Oral use 8mg Tablet Oral use 1140 Wien Austria Austria 1140 Wien Austria GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 2/133 Member State Marketing Authorisation (in EEA) Holder Austria Arcana Arzneimittel GmbH Candesartan Candesartan Arcana 16mg Huetteldorfer Straße 299 cilexetil Tabletten Arcana Arzneimittel GmbH Candesartan Candesartan Arcana 32mg Huetteldorfer Straße 299 cilexetil Tabletten Nebivolol Nebivolol Genericon 5 mg INN Invented name Pharmaceutical Route of Form administration 16 mg Tablet Oral use 32 mg Tablet Oral use 5 mg Tablet Oral use 2,5 mg Orodispersible Oral use Strength 1140 Wien Austria Austria 1140 Wien Austria Austria Genericon Pharma GmbH Hafnerstr. 211 Tabletten 8054 Graz Austria Austria ratiopharm Arzneimittei- Desloratadine Vertriebs-GmbH Desloratadin ratiopharm 2,5 mg Schmelztabletten tablet Albert-Schweitzer-Gasse 3 1140 Wien Austria Austria ratiopharm Arzneimittei- Desloratadine Vertriebs-GmbH Desloratadin ratiopharm 5 5 mg mg Schmelztabletten Orodispersible Oral use tablet Albert-Schweitzer-Gasse 3 1140 Wien Austria Belgium Apotex Europe B.V. Desloratadine Desloratadine Apotex Darwinweg 20 5 mg Film - coated Oral use tablet NL 2333 CR Leiden Netherlands GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 3/133 Member State Marketing Authorisation (in EEA) Holder Belgium Mylan bvba/sprl INN Donepezil Invented name Donepezil Odis Mylan Strength 5 mg Terhulpsesteenweg 6A Pharmaceutical Route of Form administration Orodispersible Oral use tablet 1560 Hoeilaart Belgium Belgium Mylan bvba/sprl Donepezil Donepezil Odis Mylan 10 mg Terhulpsesteenweg 6A Orodispersible Oral use tablet 1560 Hoeilaart Belgium Belgium Mylan bvba/sprl Repaglinide Terhulpsesteenweg 6A Repaglinide Mylan 0,5 mg 0,5 mg Tablet Oral use 1 mg Tablet Oral use 2 mg Tablet Oral use 8 mg Tablet Oral use Pharma 1560 Hoeilaart Belgium Belgium Mylan bvba/sprl Repaglinide Terhulpsesteenweg 6A Repaglinide Mylan 1 mg Pharma 1560 Hoeilaart Belgium Belgium Mylan bvba/sprl Repaglinide Terhulpsesteenweg 6A Repaglinide Mylan 2mg Pharma 1560 Hoeilaart Belgium Belgium Mylan bvba/sprl Candesartan Candesartan Mylan Terhulpsesteenweg 6A 1560 Hoeilaart Belgium GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 4/133 Member State Marketing Authorisation (in EEA) Holder Belgium Mylan bvba/sprl INN Invented name Strength Pharmaceutical Route of Form administration Candesartan Candesartan Mylan 16 mg Tablet Oral use Candesartan Candesartan Mylan 32 mg Tablet Oral use Esomeprazole Esomeprazole Mylan 20 mg Gastro - resistant Oral use Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Belgium Mylan bvba/sprl Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Belgium Mylan bvba/sprl Terhulpsesteenweg 6A capsule, hard 1560 Hoeilaart Belgium Belgium Mylan bvba/sprl Esomeprazole Esomeprazole Mylan 40 mg Terhulpsesteenweg 6A Gastro - resistant Oral use capsule, hard 1560 Hoeilaart Belgium Belgium Takeda Belgium Alendronic acid Alendromono 70 mg Tablet Oral use Desloratadine Desloratadine Teva 2,5 mg Orodispersible Oral use Gentsesteenweg 615 1080 Brussels Belgium Belgium Teva Pharma Belgium NV Laarstraat 16 tablet 2610 Wilrijk Belgium GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 5/133 Member State Marketing Authorisation (in EEA) Holder Belgium Teva Pharma Belgium NV INN Desloratadine Invented name Desloratadine Teva Strength 5 mg Laarstraat 16 Pharmaceutical Route of Form administration Orodispersible Oral use tablet 2610 Wilrijk Belgium Bulgaria Accord Healthcare Limited Ropinirole Ropinirole Accord 0,5 mg Sage House, 319 Pinner Road Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom Bulgaria Accord Healthcare Limited Ropinirole Ropinirole Accord 1 mg Sage House, 319 Pinner Road Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom Bulgaria Accord Healthcare Limited Ropinirole Ropinirole Accord 2 mg Sage House, 319 Pinner Road Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom Bulgaria Accord Healthcare Limited Ropinirole Ropinirole Accord Sage House, 319 Pinner Road 5 mg Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 6/133 Member State Marketing Authorisation (in EEA) Holder Bulgaria Alkaloid - INT d.o.o. INN Invented name Strength Pharmaceutical Route of Form administration Cefpodoxime FOXERO 200 mg Tablet Oral use Quetiapine Aquatiapine 25 mg Film - coated Oral use Šlandrova 4 1231 Ljubljana - Črnuče Slovenia Bulgaria Aquachim AD blvd. Prof. Tsvetan Lazarov tablet 83 Sofia 1582 Bulgaria Bulgaria Aquachim AD Quetiapine Aquatiapine 100 mg blvd. Prof. Tsvetan Lazarov Film - coated Oral use tablet 83 Sofia 1582 Bulgaria Bulgaria Aquachim AD Quetiapine Aquatiapine 200 mg blvd. Prof. Tsvetan Lazarov Film - coated Oral use tablet 83 Sofia 1582 Bulgaria Bulgaria Generics (UK) Ltd Esomeprazole Station Close, Potters Bar magnesium Esopragen 20 mg Gastro - resistant Oral use capsule, hard Hertfordshire, EN6 1TL United Kingdom Bulgaria Generics (UK) Ltd Esomeprazole Station Close, Potters Bar magnesium Esopragen 40 mg Gastro - resistant Oral use capsule, hard Hertfordshire, EN6 1TL United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 7/133 Member State Marketing Authorisation (in EEA) Holder Bulgaria Glenmark Pharmaceuticals INN Trimetazidine s.r.o. Invented name Apstar 35 mg Strength 35 mg prolonged-release tablets Pharmaceutical Route of Form administration Prolonged - Oral use release tablet Hvězdova 1716/2b 14078 Praha 4 Czech Republic Bulgaria Mylan SAS Trimetazidine Trimetazigen MR 35 mg 117 allée des Parcs Prolonged - Oral use release tablet 69792 Saint-Priest Cedex France Bulgaria Neo Balkanika EOOD Nebivolol Bivolet 5 mg Tablet Oral use Trimetazidine Energotrim 35 mg Prolonged - Oral use 35 Zemliane Str. Sofia 1618 Bulgaria Bulgaria Sandoz Pharmaceuticals d.d. Verovskova 57 release tablet Ljubljana SI-1000 Slovenia Bulgaria Tchaikapharma Highquality Bosentan Pulmohyperta 62,5 mg Medicines Film - coated Oral use tablet 1 G. M. Dimitrov Blvd. Sofia 1172 Bulgaria Bulgaria Tchaikapharma Highquality Bosentan Pulmohyperta Medicines 125 mg Film - coated Oral use tablet 1 G. M. Dimitrov Blvd. Sofia 1172 Bulgaria GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 8/133 Member State Marketing Authorisation (in EEA) Holder Croatia Alkaloid d.o.o. INN Cefpodoxime Ulica grada Vukovara 226 F Invented name Rexocef 200 mg filmom Strength 200 mg obložene tablete Pharmaceutical Route of Form administration Film - coated Oral use tablet Zagreb 10000 Croatia Croatia Belupo, lijekovi i kozmetika Desloratadine d.d. Alerdin 2,5 mg raspadljive 2,5 mg tablete za usta Orodispersible Oral use tablet Ulica Danica 5 Koprivnica 48000 Croatia Croatia Belupo, lijekovi i kozmetika Desloratadine d.d. Alerdin 5 mg raspadljive 5 mg tablete za usta Orodispersible Oral use tablet Ulica Danica 5 Koprivnica 48000 Croatia Croatia Fidifarm d.o.o. Desloratadine Obrtnička 37, Bestovje Sinalerg 5 mg filmom 5 mg obložene tablete Film - coated Oral use tablet Rakitje 10437 Croatia Croatia Jadran Galenski Laboratorij d.d. Desloratadine Escontral direkt 2,5 mg raspadljiva tableta za usta 2,5 mg Orodispersible Oral use tablet Svilno 20, Rijeka 51000 Croatia GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 9/133 Member State Marketing Authorisation (in EEA) Holder Croatia Jadran Galenski Laboratorij INN Desloratadine d.d. Invented name Escontral direkt 5 mg Strength 5 mg raspadljiva tableta za usta Pharmaceutical Route of Form administration Orodispersible Oral use tablet Svilno 20, Rijeka 51000 Croatia Croatia Croatia PharmaS d.o.o. Tramadol/paraceta Tramadol/Paracetamol 37,5 Film - coated Radnička cesta 47 mol PharmaS 37,5 mg/ mg/325 mg tablet 10 mg Film - coated Zagreb 10000 325 mg filmom obložene Croatia tablete PharmaS d.o.o. Escitalopram Escitalopram PharmaS 10 Radnička cesta 47 mg filmom Zagreb 10000 obložene tablete Oral use Oral use tablet Croatia Croatia Sandoz d.o.o. Trimetazidine Vazidin 35 mg tablete s Maksimirska 120 hydrochloride produljenim oslobađanjem Alendronic acid Alendronic Acid Accord 35 mg Prolonged - Oral use release tablet Zagreb 10000 Croatia Cyprus Accord Healthcare Limited 70 mg Tablet Oral use Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 10/133 Member State Marketing Authorisation (in EEA) Holder Cyprus Delorbis Pharmaceuticals Ltd INN Entacapone Invented name Nobat Strength 200 mg 17 Athinon Street Pharmaceutical Route of Form administration Film - coated Oral use tablet Ergates Industrial Area 2643 Ergates P.O. Box 28629 2081 Lefkosia Cyprus Cyprus Fair-Med Healthcare GmbH Valsartan/hydrochl Planckstrasse 13 orothiazide Valsartan/Hctz Fair-med DE-22765 Hamburg 160 Film - coated mg/12,5 tablet Oral use mg Germany Cyprus Generics Pharma Hellas Ltd Donepezil 577a Vouliagmenis Avenue hydrochloride Donepezil/Generics 5 mg Orodispersible Oral use tablet Argyroupoli 164-51 Athens Greece Cyprus Generics Pharma Hellas Ltd Donepezil 577a Vouliagmenis Avenue hydrochloride Donepezil/Generics 10 mg Orodispersible Oral use tablet Argyroupoli 164-51 Athens Greece Cyprus Lambda Therapeutic Limited Ropinirole Sage House hydrochloride Ropinirole Lambda 0,25 mg Film - coated Oral use tablet 319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 11/133 Member State Marketing Authorisation (in EEA) Holder Cyprus Lambda Therapeutic Limited Ropinirole Sage House hydrochloride INN Invented name Ropinirole Lambda Strength 0,5 mg Pharmaceutical Route of Form administration Film - coated Oral use tablet 319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Cyprus Lambda Therapeutic Limited Ropinirole Sage House hydrochloride Ropinirole Lambda 1 mg Film - coated Oral use tablet 319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Cyprus Lambda Therapeutic Limited Ropinirole Sage House hydrochloride Ropinirole Lambda 2 mg Film - coated Oral use tablet 319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Cyprus Lambda Therapeutic Limited Ropinirole Sage House hydrochloride Ropinirole Lambda 5 mg Film - coated Oral use tablet 319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 12/133 Member State Marketing Authorisation (in EEA) Holder Cyprus Wockhardt UK Limited Clopidogrel Ash Road North hydrochloride INN Invented name Clopidogrel/Wockhardt Strength 75 mg Pharmaceutical Route of Form administration Film - coated Oral use tablet Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom Czech Republic Abbott Laboratories, s.r.o. Escitalopram Evropská 2591/33d oxalate Purcema 5 mg 5 mg Film - coated Oral use tablet 160 00 Praha 6 - Hadovka Office Park Czech Republic Czech Republic Abbott Laboratories, s.r.o. Escitalopram Evropská 2591/33d oxalate Purcema 10 mg 10 mg Film - coated Oral use tablet 160 00 Praha 6 - Hadovka Office Park Czech Republic Czech Republic Abbott Laboratories, s.r.o. Escitalopram Evropská 2591/33d oxalate Purcema 15 mg 15 mg Film - coated Oral use tablet 160 00 Praha 6 - Hadovka Office Park Czech Republic Czech Republic Abbott Laboratories, s.r.o. Escitalopram Evropská 2591/33d oxalate Purcema 20 mg 20 mg Film - coated Oral use tablet 160 00 Praha 6 - Hadovka Office Park Czech Republic GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 13/133 Member State Marketing Authorisation (in EEA) Holder Czech Republic Actavis Group PTC ehf. Metformin Metformin Actavis Retard Reykjavikurvegi 76-78 hydrochloride 500 mg Actavis Group PTC ehf. Metformin Metformin Actavis Retard Reykjavikurvegi 76-78 hydrochloride 750 mg Actavis Group PTC ehf. Metformin Metformin Actavis Retard Reykjavikurvegi 76-78 hydrochloride 1000 mg Cefpodoxime Forexo 200 mg potahované INN Invented name Strength 500 mg Pharmaceutical Route of Form administration Prolonged - Oral use release tablet 220 Hafnarfjördur Iceland Czech Republic 750 mg Prolonged - Oral use release tablet 220 Hafnarfjördur Iceland Czech Republic 1000 mg Prolonged - Oral use release tablet 220 Hafnarfjördur Iceland Czech Republic Alkaloid - INT d.o.o. Šlandrova 4 200 mg tablety Film - coated Oral use tablet 1231 Ljubljana - Črnuče Slovenia Czech Republic Alvogen IPCo S.ar.l. Desloratadine Rue Heienhaff 5 Desloratadin Alvogen 5 mg 5 mg potahované tablety Film - coated Oral use tablet L-1736 Senningerberg Luxembourg Czech Republic Alvogen IPCo S.ar.l. Rue Heienhaff 5 Desloratadine Desloratadin Alvogen 0,5 0,5 mg/ml Oral solution Oral use mg/ml perorální roztok L-1736 Senningerberg Luxembourg GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 14/133 Member State Marketing Authorisation (in EEA) Holder Czech Republic Apotex Europe B.V. Trimetazidine Darwinweg 20 dihydrochloride INN Invented name Apo-trimetazidin 35 mg Strength 35 mg Pharmaceutical Route of Form administration Prolonged - Oral use release tablet NL 2333 CR Leiden Netherlands Czech Republic Generics (UK) Ltd Esomeprazole Station Close, Potters Bar magnesium Esomylan 40 mg 40 mg Gastro - resistant Oral use capsule, hard Hertfordshire, EN6 1TL United Kingdom Czech Republic Generics (UK) Ltd Rizatriptan Station Close, Potters Bar benzoate Rizatriptan Mylan 5 mg 5 mg Orodispersible Oral use tablet Hertfordshire, EN6 1TL United Kingdom Czech Republic Generics (UK) Ltd Rizatriptan Station Close, Potters Bar benzoate Rizatriptan Mylan 10 mg 10 mg Orodispersible Oral use tablet Hertfordshire, EN6 1TL United Kingdom Czech Republic Generics (UK) Ltd Donepezil Station Close, Potters Bar hydrochloride Donepezil Mylan 10 mg 10 mg Orodispersible Oral use tablet Hertfordshire, EN6 1TL United Kingdom Czech Republic Glenmark Pharmaceuticals Trimetazidine Portora 35 mg tablety s s.r.o. dihydrochloride prodlouženým uvolňováním 35 mg Prolonged - Oral use release tablet Hvězdova 1716/2b 14078 Praha 4 Czech Republic GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 15/133 Member State Marketing Authorisation (in EEA) Holder Czech Republic GNR Czech s.r.o. INN Desloratadine Invented name Geslora 5 mg Strength 5 mg Slavojova 579/9 Pharmaceutical Route of Form administration Film - coated Oral use tablet 128 00 Praha 2 Czech Republic Czech Republic Labormed-Pharma, SA Desloratadine Desloratadin Labormed 2,5 Theodor Pallady, 44B mg tablety dispergovatelné 032266 Bucharest v ústech 2,5 mg Orodispersible Oral use tablet Romania Czech Republic Labormed-Pharma, SA Desloratadine Desloratadin Labormed 5 Theodor Pallady, 44B mg tablety dispergovatelné 032266 Bucharest v ústech 5 mg Orodispersible Oral use tablet Romania Czech Republic Mylan SAS Trimetazidine Trimetazidin Mylan 35 mg 35 mg 117 allée des Parcs Prolonged - Oral use release tablet 69792 Saint-Priest Cedex France Czech Republic SVUS Pharma a.s. Desloratadine Smetanovo nábřeží 1238/20a Lotera 5 mg potahované 5 mg tablety Film - coated Oral use tablet 500 02 Hradec Králové Czech Republic Denmark Actavis Group PTC ehf. Metformin Metformin "Actavis PTC" Reykjavikurvegi 76-78 500 mg Prolonged - Oral use release tablet 220 Hafnarfjördur Iceland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 16/133 Member State Marketing Authorisation (in EEA) Holder Denmark Actavis Group PTC ehf. INN Metformin Invented name Metformin "Actavis PTC" Strength 750 mg Reykjavikurvegi 76-78 Pharmaceutical Route of Form administration Prolonged - Oral use release tablet 220 Hafnarfjördur Iceland Denmark Actavis Group PTC ehf. Metformin Metformin "Actavis PTC" 1000 mg Reykjavikurvegi 76-78 Prolonged - Oral use release tablet 220 Hafnarfjördur Iceland Denmark Bluefish Pharmaceuticals AB Fluconazole Fluconazol "Bluefish" 50 mg Capsule, hard Oral use Fluconazole Fluconazol "Bluefish" 150 mg Capsule, hard Oral use Fluconazole Fluconazol "Bluefish" 200 mg Capsule, hard Oral use Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/hydrochlorthiazid 160 Film - coated Oral use Planckstrasse 13 orothiazide "Fair-Med" mg/12,5 tablet Torsgatan 11 SE-11123 Stockholm Sweden Denmark Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden Denmark Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden Denmark DE-22765 Hamburg mg Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 17/133 Member State Marketing Authorisation (in EEA) Holder Denmark Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/hydrochlorthiazid Planckstrasse 13 orothiazide "Fair-Med" INN Invented name DE-22765 Hamburg Pharmaceutical Route of Form administration 320 Film - coated Oral use mg/12,5 tablet Strength mg Germany Denmark Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/hydrochlorthiazid 320 mg/25 Film - coated Planckstrasse 13 orothiazide "Fair-Med" mg tablet Eletriptan Eletriptan Mylan 40 mg Film - coated Oral use DE-22765 Hamburg Germany Denmark Mylan AB PO Box 230 33 Oral use tablet SE-104 35 Stockholm Sweden Denmark Mylan AB Esomeprazole Esomeprazol Mylan 20 mg PO Box 230 33 Gastro - resistant Oral use capsule, hard SE-104 35 Stockholm Sweden Denmark Mylan AB Esomeprazole Esomeprazol Mylan 40 mg PO Box 230 33 Gastro - resistant Oral use capsule, hard SE-104 35 Stockholm Sweden Denmark Mylan AB Rizatriptan Rizatriptan Mylan PO Box 230 33 10 mg Orodispersible Oral use tablet SE-104 35 Stockholm Sweden GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 18/133 Member State Marketing Authorisation (in EEA) Holder Denmark Stadapharm GmbH INN Entacapone Invented name Entacapon STADA Strength 200 mg Stadastr. 2-18 Pharmaceutical Route of Form administration Film - coated Oral use tablet D-61118 Bad Vilbel Germany Estonia Accord Healthcare Limited Alendronic acid Sage House, 319 Pinner Road ALENDRONIC ACID 70 mg Tablet Oral use Modified - release Oral use ACCORD 70mg North Harrow HA1 4HF Middlesex United Kingdom Estonia Sandoz Pharmaceuticals d.d. Trimetazidine ZIDMETIN 35 mg Verovskova 57 tablet Ljubljana SI-1000 Slovenia Finland Actavis Group PTC ehf. Metformin Metformin Actavis 500 mg Reykjavikurvegi 76-78 Prolonged - Oral use release tablet 220 Hafnarfjördur Iceland Finland Actavis Group PTC ehf. Metformin Metformin Actavis 750 mg Reykjavikurvegi 76-78 Prolonged - Oral use release tablet 220 Hafnarfjördur Iceland Finland Actavis Group PTC ehf. Metformin Metformin Actavis Reykjavikurvegi 76-78 1000 mg Prolonged - Oral use release tablet 220 Hafnarfjördur Iceland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 19/133 Member State Marketing Authorisation (in EEA) Holder Finland Bluefish Pharmaceuticals AB INN Invented name Strength Pharmaceutical Route of Form administration Fluconazole Fluconazol Bluefish 50 mg Capsule, hard Oral use Fluconazole Fluconazol Bluefish 150 mg Capsule, hard Oral use Fluconazole Fluconazol Bluefish 200 mg Capsule, hard Oral use Eletriptan Eletriptan Mylan 40 mg Film - coated Oral use Torsgatan 11 SE-11123 Stockholm Sweden Finland Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden Finland Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden Finland Mylan AB PO Box 230 33 tablet SE-104 35 Stockholm Sweden Finland Mylan AB Repaglinide Repaglinid Mylan 0,5 mg Tablet Oral use Repaglinide Repaglinid Mylan 1 mg Tablet Oral use PO Box 230 33 SE-104 35 Stockholm Sweden Finland Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 20/133 Member State Marketing Authorisation (in EEA) Holder Finland Mylan AB INN Invented name Strength Pharmaceutical Route of Form administration Repaglinide Repaglinid Mylan 2 mg Tablet Oral use Valsartan VALSARTAN ORION 40 mg Film - coated Oral use PO Box 230 33 SE-104 35 Stockholm Sweden Finland Orion Corporation Orion Pharma tablet PO BOX 65 02101 Espoo Finland Finland Orion Corporation Valsartan VALSARTAN ORION 80 mg Orion Pharma Film - coated Oral use tablet PO BOX 65 02101 Espoo Finland Finland Orion Corporation Valsartan VALSARTAN ORION 160 mg Orion Pharma Film - coated Oral use tablet PO BOX 65 02101 Espoo Finland Finland Orion Corporation Valsartan VALSARTAN ORION Orion Pharma 320 mg Film - coated Oral use tablet PO BOX 65 02101 Espoo Finland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 21/133 Member State Marketing Authorisation (in EEA) Holder Finland ratiopharm GmbH INN Desloratadine Invented name Desloratadine Ratiopharm Strength 2,5 mg Graf-Arco-Strasse 3 Pharmaceutical Route of Form administration Orodispersible Oral use tablet D-89079 Ulm Germany Finland ratiopharm GmbH Desloratadine Desloratadine Ratiopharm 5 mg Graf-Arco-Strasse 3 Orodispersible Oral use tablet D-89079 Ulm Germany France Abbott Products SAS Escitalopram 42 rue Rouget de Lisle ESCITALOPRAM ABBOTT 5 mg 5mg, comprimé pelliculé Film - coated Oral use tablet 92150 Suresnes France France Abbott Products SAS Escitalopram 42 rue Rouget de Lisle ESCITALOPRAM ABBOTT 10 mg 10mg, comprimé pelliculé Film - coated Oral use tablet 92150 Suresnes France France Abbott Products SAS Escitalopram 42 rue Rouget de Lisle ESCITALOPRAM ABBOTT 15 mg 15mg, comprimé pelliculé Film - coated Oral use tablet 92150 Suresnes France France Abbott Products SAS 42 rue Rouget de Lisle Escitalopram ESCITALOPRAM ABBOTT 20mg, comprimé pelliculé 20 mg Film - coated Oral use tablet 92150 Suresnes France GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 22/133 Member State Marketing Authorisation (in EEA) Holder France ACCORD HEALTHCARE France INN Ropinirole SAS Invented name Ropinirole Accord 0,25mg, Strength 0,25 mg comprimé pelliculé Pharmaceutical Route of Form administration Film - coated Oral use tablet 45 Rue de Fbg de Roubaix 59000 Lille France France ACCORD HEALTHCARE France Ropinirole SAS Ropinirole Accord 0,5mg, 0,5 mg comprimé pelliculé Film - coated Oral use tablet 45 Rue de Fbg de Roubaix 59000 Lille France France ACCORD HEALTHCARE France Ropinirole SAS Ropinirole Accord 1mg, 1 mg comprimé pelliculé Film - coated Oral use tablet 45 Rue de Fbg de Roubaix 59000 Lille France France ACCORD HEALTHCARE France Ropinirole SAS Ropinirole Accord 2mg, 2 mg comprimé pelliculé Film - coated Oral use tablet 45 Rue de Fbg de Roubaix 59000 Lille France France ACCORD HEALTHCARE France SAS Ropinirole Ropinirole Accord 5mg, comprimé pelliculé 5 mg Film - coated Oral use tablet 45 Rue de Fbg de Roubaix 59000 Lille France GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 23/133 Member State Marketing Authorisation (in EEA) Holder France Brown & Burk UK, Ltd. INN Escitalopram Invented name ESCITALOPRAM BROWN 5 5, Marryat Close mg, comprimé pelliculé Hounslow sécable Strength 5 mg Pharmaceutical Route of Form administration Film - coated Oral use tablet TW4 5DQ Middlesex United Kingdom France Brown & Burk UK, Ltd. Escitalopram ESCITALOPRAM BROWN 10 5, Marryat Close mg, comprimé pelliculé Hounslow sécable 10 mg Film - coated Oral use tablet TW4 5DQ Middlesex United Kingdom France Brown & Burk UK, Ltd. Escitalopram ESCITALOPRAM BROWN 15 5, Marryat Close mg, comprimé pelliculé Hounslow sécable 15 mg Film - coated Oral use tablet TW4 5DQ Middlesex United Kingdom France Brown & Burk UK, Ltd. Escitalopram ESCITALOPRAM BROWN 20 5, Marryat Close mg, comprimé pelliculé Hounslow sécable 20 mg Film - coated Oral use tablet TW4 5DQ Middlesex United Kingdom France Brown & Burk UK, Ltd. Ebastine EBASTINE BROWN & BURK 5, Marryat Close 10 mg, comprimé Hounslow orodispersible 10 mg Orodispersible Oral use tablet TW4 5DQ Middlesex United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 24/133 Member State Marketing Authorisation (in EEA) Holder France Cristers France INN Desloratadine Invented name DESLORATADINE 22, quai Galliéni CRISTERS 92150 Suresnes 5 mg France comprimé pelliculé Cristers Ibuprofen IBUPROFENE CRISTERS 22, quai Galliéni 400 mg 92150 Suresnes comprimé pelliculé Strength 5 mg Pharmaceutical Route of Form administration Film - coated Oral use tablet 400 mg Film - coated Oral use tablet France France Laboratoires Biogaran Ebastine 15, boulevard Charles de EBASTINE BIOGARAN 10 10 mg mg comprimé pelliculé Film - coated Oral use tablet Gaulle 92707 Colombes Cedex France France Laboratoires Biogaran Ebastine EBASTINE BIOGARAN 10 15, boulevard Charles de mg comprimé Gaulle orodispersible 10 mg Orodispersible Oral use tablet 92707 Colombes Cedex France France Laboratoires GERDA Desloratadine DESLORATADINE ARROW 24 rue Erlanger 5 mg 75016 PARIS comprimé pelliculé 5 mg Film - coated Oral use tablet France GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 25/133 Member State Marketing Authorisation (in EEA) Holder France Medipha Sante Tramadol/paraceta TRAMADOL PARACETAMOL Les Fjords - Immeuble Oslo mol NIALEX 37,5 mg/325 mg INN 19 avenue de Norvège Invented name Pharmaceutical Route of Form administration 37,5 Film - coated Oral use mg/325 mg tablet 5 mg Film - coated Strength comprimé pelliculé 91953 Courtaboeuf Cedex France France Medipha Sante Desloratadine DESLORATADINE GNR Les Fjords - Immeuble Oslo 5 mg 19 avenue de Norvège comprimé pelliculé Oral use tablet 91953 Courtaboeuf Cedex France France Mylan SAS Rizatriptan 117 allée des Parcs RIZATRIPTAN MYLAN 5mg, 5 mg orodispersible tablet Orodispersible Oral use tablet 69792 Saint-Priest Cedex France France Mylan SAS Rizatriptan 117 allée des Parcs RIZATRIPTAN MYLAN 10 10 mg mg, orodispersible tablet Orodispersible Oral use tablet 69792 Saint-Priest Cedex France France Mylan SAS Ebastine 117 allée des Parcs EBASTINE MYLAN 10mg, 10 mg film-coated tablet Film - coated Oral use tablet 69792 Saint-Priest Cedex France France Mylan SAS 117 allée des Parcs Ebastine EBASTINE MYLAN 10mg, orodispersible tablet 10 mg Orodispersible Oral use tablet 69792 Saint-Priest Cedex France GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 26/133 Member State Marketing Authorisation (in EEA) Holder France Mylan SAS INN Trimetazidine Invented name TRIMETAZIDINE MYLAN 35 117 allée des Parcs mg Modified Release 69792 Saint-Priest Cedex Tablets Strength 35 mg Pharmaceutical Route of Form administration Modified - release Oral use tablet France France Mylan SAS Candesartan 117 allée des Parcs CANDESARTAN MYLAN 32 32 mg Tablet Oral use 5 mg Orodispersible Oral use mg, comprimé secable 69792 Saint-Priest Cedex France France Mylan SAS Donepezil 117 allée des Parcs DONEPEZIL MYLAN 5 mg, orodispersible tablet tablet 69792 Saint-Priest Cedex France France Mylan SAS Donepezil 117 allée des Parcs DONEPEZIL MYLAN 10 10 mg mg, orodispersible tablet Orodispersible Oral use tablet 69792 Saint-Priest Cedex France France Mylan SAS Esomeprazole 117 allée des Parcs ESOMEPRAZOLE MYLAN 20 mg PHARMA 20mg, DR capsule Gastro - resistant Oral use capsule, hard 69792 Saint-Priest Cedex France France Mylan SAS 117 allée des Parcs Esomeprazole ESOMEPRAZOLE MYLAN PHARMA 40mg, DR capsule 40 mg Gastro - resistant Oral use capsule, hard 69792 Saint-Priest Cedex France GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 27/133 Member State Marketing Authorisation (in EEA) Holder France Mylan SAS INN Desmopressin 117 allée des Parcs Invented name DESMOPRESSINE MYLAN Strength 0,06 mg 60 µg, orodispersible tablet Pharmaceutical Route of Form administration Orodispersible Oral use tablet 69792 Saint-Priest Cedex France France Mylan SAS Desmopressin DESMOPRESSINE MYLAN 117 allée des Parcs 120 µg, orodispersible 69792 Saint-Priest Cedex tablet 0,12 mg Orodispersible Oral use tablet France France Mylan SAS Desmopressin DESMOPRESSINE MYLAN 117 allée des Parcs 240 µg, orodispersible 69792 Saint-Priest Cedex tablet 0,24 mg Orodispersible Oral use tablet France France Ranbaxy Pharmacie Aciclovir Generiques Aciclovir Ranbaxy 800 mg, 800 mg Tablet Oral use 200 mg Tablet Oral use 200 mg Tablet Oral use comprimé 11-15 Quai Dion Bouton 92800 Puteaux France France Ranbaxy Pharmacie Aciclovir Generiques Aciclovir Ranbaxy 200 mg, comprimé 11-15 Quai Dion Bouton 92800 Puteaux France France Ranbaxy Pharmacie Generiques Aciclovir Aciclovir Almus 200 mg, comprimé 11-15 Quai Dion Bouton 92800 Puteaux France GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 28/133 Member State Marketing Authorisation (in EEA) Holder France Ranbaxy Pharmacie INN Alendronic acid Generiques Invented name Acide Alendronique Pharmaceutical Route of Form administration 70 mg Tablet Oral use 10 mg Film - coated Oral use Strength Ranbaxy 70 mg, comprimé 11-15 Quai Dion Bouton 92800 Puteaux France France Sanofi Aventis France Ebastine 1-13 bd Romain Rolland EBASTINE ZENTIVA 10 mg comprimé pelliculé tablet 75159 Paris Cedex 14 France France Sanofi Aventis France Ebastine 1-13 bd Romain Rolland EBASTINE ZENTIVA 10 mg 10 mg comprimé orodispersible Orodispersible Oral use tablet 75159 Paris Cedex 14 France France Teva Sante Desloratadine DESLORATADINE TEVA Cœur Défense - 100-110 SANTE Esplanade du Général de 5 mg Gaulle comprimé pelliculé 5 mg Film - coated Oral use tablet 92931 La Défense Cedex France France Venipharm SAS Ebastine 4 Bureaux de la Colline EBOUDA 10 mg comprimé 10 mg pelliculé Film - coated Oral use tablet 92213 Saint-Cloud France France Venipharm SAS 4 Bureaux de la Colline Ebastine EBARREN 10 mg comprimé pelliculé 10 mg Film - coated Oral use tablet 92213 Saint-Cloud France GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 29/133 Member State Marketing Authorisation (in EEA) Holder France Venipharm SAS INN Ebastine 4 Bureaux de la Colline Invented name Strength EBONDE 10 mg comprimé 10 mg pelliculé Pharmaceutical Route of Form administration Film - coated Oral use tablet 92213 Saint-Cloud France France Venipharm SAS Ebastine 4 Bureaux de la Colline EBONTAN 10 mg comprimé 10 mg orodispersible Orodispersible Oral use tablet 92213 Saint-Cloud France France Venipharm SAS Ebastine 4 Bureaux de la Colline EBACHOI 10 mg comprimé 10 mg orodispersible Orodispersible Oral use tablet 92213 Saint-Cloud France France Venipharm SAS Ibuprofen IBUPROFENE ZYDUS 4 Bureaux de la Colline FRANCE 200 mg comprimé 92213 Saint-Cloud pelliculé 200 mg Film - coated Oral use tablet France France Zydus France Ibuprofen IBUPROFENE ZYDUS Zacles Hautes Patures FRANCE 400 mg comprimé 25 Rue des Peupliers pelliculé 400 mg Film - coated Oral use tablet 92752 Nanterre Cedes France France Zydus France Tramadol/paraceta TRAMADOL PARACETAMOL 37,5 Film - coated Zacles Hautes Patures mol ZYDUS FRANCE mg/325 mg tablet 37,5 25 Rue des Peupliers mg/325 mg comprimé 92752 Nanterre Cedes pelliculé Oral use France GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 30/133 Member State Marketing Authorisation (in EEA) Holder France Zydus France INN Ibuprofen Zacles Hautes Patures Invented name IBUPROFENE ZF 400 mg Strength 400 mg comprimé pelliculé Pharmaceutical Route of Form administration Film - coated Oral use tablet 25 Rue des Peupliers 92752 Nanterre Cedes France France Zydus France Desloratadine Zacles Hautes Patures DESLORATADINE ZYDUS 5 5 mg mg comprimé pelliculé Film - coated Oral use tablet 25 Rue des Peupliers 92752 Nanterre Cedes France France Zydus France Escitalopram Zacles Hautes Patures ESCITALOPRAM ZYDUS 5 5 mg mg, comprimé pelliculé Film - coated Oral use tablet 25 Rue des Peupliers 92752 Nanterre Cedes France France Zydus France Escitalopram ESCITALOPRAM ZYDUS 10 Zacles Hautes Patures mg, comprimé pelliculé 25 Rue des Peupliers sécable 10 mg Film - coated Oral use tablet 92752 Nanterre Cedes France GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 31/133 Member State Marketing Authorisation (in EEA) Holder France Zydus France INN Escitalopram Invented name ESCITALOPRAM ZYDUS 15 Zacles Hautes Patures mg, comprimé pelliculé 25 Rue des Peupliers sécable Strength 15 mg Pharmaceutical Route of Form administration Film - coated Oral use tablet 92752 Nanterre Cedes France France Zydus France Escitalopram ESCITALOPRAM ZYDUS 20 Zacles Hautes Patures mg, comprimé pelliculé 25 Rue des Peupliers sécable 20 mg Film - coated Oral use tablet 92752 Nanterre Cedes France Germany Accord Healthcare Limited Alendronic acid Sage House, 319 Pinner Road ALENDRONIC ACID 70 mg Tablet Oral use 250 mg Film - coated Oral use ACCORD 70MG North Harrow HA1 4HF Middlesex United Kingdom Germany betapharm Arzneimittel GmbH Levetiracetam Kobelweg 95 Levetiracetam beta 250 mg, Filmtabletten tablet D-86156 Augsburg Germany Germany betapharm Arzneimittel GmbH Kobelweg 95 Levetiracetam Levetiracetam beta 500 mg, Filmtabletten 500 mg Film - coated Oral use tablet D-86156 Augsburg Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 32/133 Member State Marketing Authorisation (in EEA) Holder Germany betapharm Arzneimittel GmbH INN Levetiracetam Kobelweg 95 Invented name Levetiracetam beta 750 Strength 750 mg mg, Filmtabletten Pharmaceutical Route of Form administration Film - coated Oral use tablet D-86156 Augsburg Germany Germany betapharm Arzneimittel GmbH Levetiracetam Kobelweg 95 Levetiracetam beta 1000 1000 mg mg, Filmtabeltten Film - coated Oral use tablet D-86156 Augsburg Germany Germany Fair-Med Healthcare GmbH Irbesartan Planckstrasse 13 Irbesartan Tablets 75 mg 75mg Film - coated Oral use tablet DE-22765 Hamburg Germany Germany Fair-Med Healthcare GmbH Irbesartan Planckstrasse 13 Irbesartan Tablets 150 mg 150mg Film - coated Oral use tablet DE-22765 Hamburg Germany Germany Fair-Med Healthcare GmbH Irbesartan Planckstrasse 13 Irbesartan Tablets 300 mg 300 mg Film - coated Oral use tablet DE-22765 Hamburg Germany Germany Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan HCTZ Fair-Med 150 Film - coated Planckstrasse 13 lorothiazide 150+12,5 mg Filmtabletten mg/12,5 tablet DE-22765 Hamburg Oral use mg Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 33/133 Member State Marketing Authorisation (in EEA) Holder Germany Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan HCTZ Fair-Med Planckstrasse 13 lorothiazide 300+12,5 mg Filmtabletten INN Invented name DE-22765 Hamburg Pharmaceutical Route of Form administration 300 Film - coated Oral use mg/12,5 tablet Strength mg Germany Germany Fair-Med Healthcare GmbH Irbesartan/hydroch Planckstrasse 13 lorothiazide Fair-Med Healthcare GmbH Planckstrasse 13 Irbesartan HCTZ Fair-Med 300 mg/25 Film - coated 300+25 mg Filmtabletten mg tablet Valsartan/hydrochl Valsartan/HCTZ Fair-Med 160 Film - coated orothiazide Healthcare 160 mg/12.5 mg/12,5 tablet mg Filmtabletten mg Oral use DE-22765 Hamburg Germany Germany DE-22765 Hamburg Oral use Germany Germany Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/HCTZ Fair-Med 320 Film - coated Planckstrasse 13 orothiazide Healthcare 320 mg/12,5 mg/12,5 tablet mg Filmtabletten mg DE-22765 Hamburg Oral use Germany Germany Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/HCTZ Fair-Med 320 mg/25 Film - coated Planckstrasse 13 orothiazide Healthcare 320 mg/25 mg mg tablet 37,5 mg Prolonged - DE-22765 Hamburg Oral use Filmtabletten Germany Germany Fair-Med Healthcare GmbH Planckstrasse 13 Venlafaxine Venlafaxin Fair-Med 37,5 mg Hartkapseln, retardiert DE-22765 Hamburg Oral use release capsule, hard Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 34/133 Member State Marketing Authorisation (in EEA) Holder Germany Fair-Med Healthcare GmbH INN Venlafaxine Planckstrasse 13 Invented name Venlafaxin Fair-Med 75 mg Strength 75 mg Hartkapseln, retardiert Pharmaceutical Route of Form administration Prolonged - Oral use release capsule, DE-22765 Hamburg hard Germany Germany Fair-Med Healthcare GmbH Venlafaxine Planckstrasse 13 Venlafaxin Fair-Med 150 150 mg mg Hartkapseln, retardiert Prolonged - Oral use release capsule, DE-22765 Hamburg hard Germany Germany Fair-Med Healthcare GmbH Ciprofloxacin Ciprofloxacin Fair-Med Planckstrasse 13 Healthcare 500 mg DE-22765 Hamburg Filmtabletten 500 mg Film - coated Oral use tablet Germany Germany Fair-Med Healthcare GmbH Ciprofloxacin Ciprofloxacin Fair-Med Planckstrasse 13 Healthcare 750 mg DE-22765 Hamburg Filmtabletten 750 mg Film - coated Oral use tablet Germany Germany Fair-Med Healthcare GmbH Ciprofloxacin Ciprofloxacin Fair-Med Planckstrasse 13 Healthcare 250 mg DE-22765 Hamburg Filmtabletten 250 mg Film - coated Oral use tablet Germany Germany Heumann Pharma GmbH & Co. Generica KG Irbesartan Irbesartan Heumann 75 mg Filmtabletten 75 mg Film - coated Oral use tablet Südwestpark 50 90449 Nürnberg Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 35/133 Member State Marketing Authorisation (in EEA) Holder Germany Heumann Pharma GmbH & INN Irbesartan Co. Generica KG Invented name Irbesartan Heumann 150 Strength 150 mg mg Filmtabletten Pharmaceutical Route of Form administration Film - coated Oral use tablet Südwestpark 50 90449 Nürnberg Germany Germany Heumann Pharma GmbH & Irbesartan Co. Generica KG Irbesartan Heumann 300 300 mg mg Filmtabletten Film - coated Oral use tablet Südwestpark 50 90449 Nürnberg Germany Germany Heumann Pharma GmbH & Irbesartan/hydroch Irbesartan 150 Film - coated Co. Generica KG lorothiazide Hydrochloorthiazide mg/12,5 tablet Südwestpark 50 heumann 150mg/12,5mg mg 90449 Nürnberg Filmtabletten Oral use Germany Germany Heumann Pharma GmbH & Irbesartan/hydroch Irbesartan 300 Film - coated Co. Generica KG lorothiazide tablet Hydrochloorthiazide mg/12,5 Südwestpark 50 heumann 300mg/12,5mg mg 90449 Nürnberg Filmtabletten Oral use Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 36/133 Member State Marketing Authorisation (in EEA) Holder Germany Heumann Pharma GmbH & Irbesartan/hydroch Irbesartan Co. Generica KG lorothiazide Hydrochloorthiazide INN Invented name Südwestpark 50 heumann 300mg/25mg 90449 Nürnberg Filmtabletten Pharmaceutical Route of Form administration 300 mg/25 Film - coated Oral use mg tablet Strength Germany Germany Heumann Pharma GmbH & Irbesartan/hydroch Irbesartan/Hydrochlorothia 150 Film - coated Co. Generica KG lorothiazide zid Heumann 150 mg/12.5 mg/12,5 tablet mg Filmtabletten mg Südwestpark 50 Oral use 90449 Nürnberg Germany Germany Heumann Pharma GmbH & Irbesartan/hydroch Irbesartan/Hydrochlorothia 300 Film - coated Co. Generica KG lorothiazide zid Heumann 300 mg/12.5 mg/12,5 tablet mg Filmtabletten mg Südwestpark 50 Oral use 90449 Nürnberg Germany Germany Heumann Pharma GmbH & Irbesartan/hydroch Irbesartan/Hydrochlorothia 300 mg/25 Film - coated Co. Generica KG lorothiazide zid Heumann 300 mg/25 mg tablet 200 mg Film - coated Südwestpark 50 Oral use mg Filmtabletten 90449 Nürnberg Germany Germany Hormosan Pharma GmbH Cefpodoxime Cefpodoxim- Wilhelmshoeher Str. 106 proxetil Hormosan D-60389 Frankfurt 200mg 06 Hessen Filmtabletten Oral use tablet Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 37/133 Member State Marketing Authorisation (in EEA) Holder Germany Lupin (Europe) Limited Trimetazidine Lupamadazine 35 mg Victoria Court, Bexton Road hydrochloride Retardtabletten Escitalopram Escitalopram-Micro Labs 5 INN Invented name Strength 35 mg Pharmaceutical Route of Form administration Controlled - Oral use release tablet Knutsford, Cheshire WA16 0PF United Kingdom Germany Micro Labs GmbH Lyoner Str. 14 5 mg mg Filmtabletten Film - coated Oral use tablet D-60528 Frankfurt/Main Germany Germany Micro Labs GmbH Escitalopram Lyoner Str. 14 Escitalopram-Micro Labs 10 10 mg mg Filmtabletten Film - coated Oral use tablet D-60528 Frankfurt/Main Germany Germany Micro Labs GmbH Escitalopram Lyoner Str. 14 Escitalopram-Micro Labs 15 15 mg mg Filmtabletten Film - coated Oral use tablet D-60528 Frankfurt/Main Germany Germany Micro Labs GmbH Escitalopram Lyoner Str. 14 Escitalopram-Micro Labs 20 20 mg mg Filmtabletten Film - coated Oral use tablet D-60528 Frankfurt/Main Germany Germany Mylan dura GmBh Wittichstrasse 6 Repaglinide Repaglinid Mylan 0,5 mg 0,5 mg Tablet Oral use Tabletten 64295 Darmstadt Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 38/133 Member State Marketing Authorisation (in EEA) Holder Germany Mylan dura GmBh INN Repaglinide Wittichstrasse 6 Invented name Repaglinid Mylan 1 mg Pharmaceutical Route of Form administration 1 mg Tablet Oral use 2 mg Tablet Oral use 5 mg Orodispersible Oral use Strength Tabletten 64295 Darmstadt Germany Germany Mylan dura GmBh Repaglinide Wittichstrasse 6 Repaglinid Mylan 2 mg Tabletten 64295 Darmstadt Germany Germany Mylan dura GmBh Rizatriptan Wittichstrasse 6 Rizatriptan Mylan dura 5 mg Schmelztabletten tablet 64295 Darmstadt Germany Germany Mylan dura GmBh Rizatriptan Wittichstrasse 6 Rizatriptan Mylan dura 10 10 mg mg Schmelztabletten Orodispersible Oral use tablet 64295 Darmstadt Germany Germany Panacea Biotec Germany Tacrolimus Tacpan 0.5 mg Hartkapseln 0,5 mg Capsule, hard Oral use Tacrolimus Tacpan 1 mg Hartkapseln 1 mg Capsule, hard Oral use GmbH Landshuter Allee 8-10 D-80637 München Germany Germany Panacea Biotec Germany GmbH Landshuter Allee 8-10 D-80637 München Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 39/133 Member State Marketing Authorisation (in EEA) Holder Germany Panacea Biotec Germany INN Invented name Strength Pharmaceutical Route of Form administration Tacrolimus Tacpan 5 mg Hartkapseln 5 mg Capsule, hard Oral use Entacapone Entacapon STADA 200 mg 200 mg Film - coated Oral use GmbH Landshuter Allee 8-10 D-80637 München Germany Germany Stadapharm GmbH Stadastr. 2-18 Filmtabletten tablet D-61118 Bad Vilbel Germany Germany Unichem Laboratories Ltd. Irbesartan Studio 8B Ard Gaoithe Irbesartan Unichem 150 150 mg mg Filmtabletten Film - coated Oral use tablet Commercial Centre, Business Park Cashel Road Clonmel, Co Tipperary Ireland Germany Unichem Laboratories Ltd. Studio 8B Ard Gaoithe Irbesartan Irbesartan Unichem 300 mg Filmtabletten 300 mg Film - coated Oral use tablet Commercial Centre, Business Park Cashel Road Clonmel, Co Tipperary Ireland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 40/133 Member State Marketing Authorisation (in EEA) Holder Germany Welding GmbH & Co. KG Irbesartan/hydroch Irbesartan + Esplanade 39 lorothiazide Hidroclorotiazida Welding INN Invented name D-20354 Hamburg Pharmaceutical Route of Form administration 300 Film - coated Oral use mg/12,5 tablet Strength mg Germany Germany Welding GmbH & Co. KG Irbesartan/hydroch Irbesartan + 150 Film - coated Esplanade 39 lorothiazide Hidroclorotiazida Welding mg/12,5 tablet D-20354 Hamburg Oral use mg Germany Germany Welding GmbH & Co. KG Irbesartan/hydroch Irbesartan + 300 mg/25 Film - coated Esplanade 39 lorothiazide Hidroclorotiazida Welding mg tablet Irbesartan Irbesartan Welding 75 mg Film - coated Oral use D-20354 Hamburg Germany Germany Welding GmbH & Co. KG Esplanade 39 Oral use tablet D-20354 Hamburg Germany Germany Welding GmbH & Co. KG Irbesartan Irbesartan Welding 150 mg Esplanade 39 Film - coated Oral use tablet D-20354 Hamburg Germany Germany Welding GmbH & Co. KG Irbesartan Irbesartan Welding Esplanade 39 300 mg Film - coated Oral use tablet D-20354 Hamburg Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 41/133 Member State Marketing Authorisation (in EEA) Holder Greece Abbott Laboratories Escitalopram Hellas ΑΒΕΕ oxalate INN Invented name Savandra Strength 5 mg Pharmaceutical Route of Form administration Film - coated Oral use tablet Agiou Dimitriou 63 Alimos 17456 Greece Greece Abbott Laboratories Escitalopram Hellas ΑΒΕΕ oxalate Savandra 10 mg Film - coated Oral use tablet Agiou Dimitriou 63 Alimos 17456 Greece Greece Abbott Laboratories Escitalopram Hellas ΑΒΕΕ oxalate Savandra 15 mg Film - coated Oral use tablet Agiou Dimitriou 63 Alimos 17456 Greece Greece Abbott Laboratories Escitalopram Hellas ΑΒΕΕ oxalate Savandra 20 mg Film - coated Oral use tablet Agiou Dimitriou 63 Alimos 17456 Greece Greece Genepharm S.A. Desloratadine Desloratadine/Genepharm 18 Km Marathon Avenue, 5 mg δισκία επικαλυμμένα 15351 Pallini με υμένιο, 5 mg Film - coated Oral use tablet Greece GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 42/133 Member State Marketing Authorisation (in EEA) Holder Greece Genepharm S.A. INN Desloratadine Invented name Desloratadine/Genepharm 18 Km Marathon Avenue, 2,5 mg δισκία 15351 Pallini διασπειρόμενα στο στόμα Strength 2,5 mg Pharmaceutical Route of Form administration Orodispersible Oral use tablet Greece Greece Genepharm S.A. Desloratadine Desloratadine/Genepharm 18 Km Marathon Avenue, 5 mg δισκία διασπειρόμενα 15351 Pallini στο στόμα 5 mg Orodispersible Oral use tablet Greece Greece Generics Pharma Hellas Ltd Donepezil 577a Vouliagmenis Avenue hydrochloride Donepezil/ Generics 5 mg Orodispersible Oral use tablet Argyroupoli 164-51 Athens Greece Greece Generics Pharma Hellas Ltd Donepezil 577a Vouliagmenis Avenue hydrochloride Donepezil/ Generics 10 mg Orodispersible Oral use tablet Argyroupoli 164-51 Athens Greece Greece Generics Pharma Hellas Ltd Esomeprazole 577a Vouliagmenis Avenue magnesium Esomeprazole/ Generics 40 mg Prolonged - Oral use release capsule Argyroupoli 164-51 Athens Greece Greece Sieger Pharma A.E. Desloratadine Desloratadine/Sieger Marathonos Avenue 106 5 mg Film - coated Oral use tablet Pikermi 19009 Greece GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 43/133 Member State Marketing Authorisation (in EEA) Holder Greece Sieger Pharma A.E. INN Desloratadine Invented name Desloratadine/Sieger Strength 2,5 mg Marathonos Avenue 106 Pharmaceutical Route of Form administration Orodispersible Oral use tablet Pikermi 19009 Greece Greece Sieger Pharma A.E. Desloratadine Desloratadine/Sieger 5 mg Marathonos Avenue 106 Orodispersible Oral use tablet Pikermi 19009 Greece Hungary Actavis Group PTC ehf. Metformin Gluforlyn XR 500 mg Reykjavikurvegi 76-78 hydrochloride retard tabletta Desloratadine Alvotadin 5 mg filmtabletta 500 mg Prolonged - Oral use release tablet 220 Hafnarfjördur Iceland Hungary Alvogen IPCo S.ar.l. 5 mg Rue Heienhaff 5 Film - coated Oral use tablet L-1736 Senningerberg Luxembourg Hungary Alvogen IPCo S.ar.l. Desloratadine Rue Heienhaff 5 Alvotadin 2.5 mg szájban 2,5 mg diszpergálódó tabletta Orodispersible Oral use tablet L-1736 Senningerberg Luxembourg Hungary Alvogen IPCo S.ar.l. Rue Heienhaff 5 Desloratadine Alvotadin 5 mg szájban diszpergálódó tabletta 5 mg Orodispersible Oral use tablet L-1736 Senningerberg Luxembourg GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 44/133 Member State Marketing Authorisation (in EEA) Holder Hungary Generics (UK) Ltd Esomeprazole Station Close, Potters Bar magnesium INN Hertfordshire, EN6 1TL Invented name Esomeprazol Mylan 20 mg Strength 20 mg gyomornedv-ellenálló Pharmaceutical Route of Form administration Gastro - resistant Oral use capsule, hard kemény kapszula United Kingdom Hungary Generics (UK) Ltd Esomeprazole Station Close, Potters Bar magnesium Hertfordshire, EN6 1TL Esomeprazol Mylan 40 mg 40 mg gyomornedv-ellenálló Gastro - resistant Oral use capsule, hard kemény kapszula United Kingdom Hungary Glenmark Pharmaceuticals Trimetazidine Apstar 35 mg retard s.r.o. dihydrochloride tabletta Desloratadine Inaller 5 mg filmtabletta 35 mg Prolonged - Oral use release tablet Hvězdova 1716/2b 14078 Praha 4 Czech Republic Hungary Goodwill Pharma Kft. 5 mg H-6724 Szeged Film - coated Oral use tablet Cserzy Mihály u. 32. Hungary Hungary Goodwill Pharma Kft. Desloratadine H-6724 Szeged Inaller 0.5 mg/ml 0,5 mg/ml Oral solution Oral use 35 mg Prolonged - Oral use belsőleges oldat Cserzy Mihály u. 32. Hungary Hungary Mylan SAS 117 allée des Parcs Trimetazidine Trimetazidine Mylan 35 mg retard tabletta release tablet 69792 Saint-Priest Cedex France GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 45/133 Member State Marketing Authorisation (in EEA) Holder Hungary Sandoz Hungária Kft. Trimetazidine Trimetazidine Sandoz 35 H-1114 Budapest dihydrochloride mg retard tabletta Desloratadine Desloratadin Teva 2.5 mg INN Invented name Strength 35 mg Pharmaceutical Route of Form administration Prolonged - Oral use release tablet Bartók Béla út 43-47. Hungary Hungary Teva Gyógyszergyár Zrt. H-4042 Debrecen szájban diszpergálódó Pallagi út 13. tabletta 2,5 mg Orodispersible Oral use tablet Hungary Hungary Teva Gyógyszergyár Zrt. Desloratadine Desloratadin Teva 5 mg H-4042 Debrecen szájban diszpergálódó Pallagi út 13. tabletta 5 mg Orodispersible Oral use tablet Hungary Iceland ratiopharm GmbH Desloratadine Desloratadine ratiopharm 5 mg Graf-Arco-Strasse 3 Orodispersible Oral use tablet D-89079 Ulm Germany Ireland Accord Healthcare Limited Ropinirole Ropinirole 0.25 mg Film- Sage House, 319 Pinner Road hydrochloride coated Tablets Accord Healthcare Limited Ropinirole Ropinirole 0.5 mg Film- Sage House, 319 Pinner Road hydrochloride coated Tablets 0,25 mg Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom Ireland 0,5 mg Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 46/133 Member State Marketing Authorisation (in EEA) Holder Ireland Accord Healthcare Limited Ropinirole Ropinirole 1 mg Film- Sage House, 319 Pinner Road hydrochloride coated Tablets Accord Healthcare Limited Ropinirole Ropinirole 2 mg Film- Sage House, 319 Pinner Road hydrochloride coated Tablets Accord Healthcare Limited Ropinirole Ropinirole 5 mg Film- Sage House, 319 Pinner Road hydrochloride coated Tablets Alendronic acid Alendronic Acid Once INN Invented name Strength 1 mg Pharmaceutical Route of Form administration Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom Ireland 2 mg Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom Ireland 5 mg Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom Ireland Accord Healthcare Limited Sage House, 319 Pinner Road 70 mg Tablet Oral use Oral use Weekly 70 mg Tablets North Harrow HA1 4HF Middlesex United Kingdom Ireland Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/Hydrochlorothiaz 160 Film - coated Planckstrasse 13 orothiazide ide Fair-Med 160 mg/12.5 mg/12,5 tablet mg film-coated tablets. mg DE-22765 Hamburg Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 47/133 Member State Marketing Authorisation (in EEA) Holder Ireland Fair-Med Healthcare GmbH Valsartan/hydrochl Planckstrasse 13 orothiazide INN DE-22765 Hamburg Invented name Strength Pharmaceutical Route of Form administration Oral use Valsartan/Hydrochlorothiaz 320 Film - coated tablet ide Fair-Med 320 mg/12.5 mg/12,5 mg film-coated tablets mg Valsartan/Hydrochlorothiaz 320 mg/25 Film - coated ide Fair-Med 320 mg/25 mg tablet 120 mg Film - coated Germany Ireland Fair-Med Healthcare GmbH Valsartan/hydrochl Planckstrasse 13 orothiazide DE-22765 Hamburg Oral use mg film-coated tablets Germany Ireland Fannin (UK) Ltd Fexofenadine Fexofenadine 120 mg film- 42-46 Booth Drive hydrochloride coated tablets Fannin (UK) Ltd Fexofenadine Fexofenadine 180 mg film- 42-46 Booth Drive hydrochloride coated tablets Donepezil Aripil Orotab 5mg Oral use tablet Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom Ireland 180 mg Film - coated Oral use tablet Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom Ireland McDermott Laboratories Ltd t/a Gerard Laboratories Orodispersible Tablet 5 mg Orodispersible Oral use tablet 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 48/133 Member State Marketing Authorisation (in EEA) Holder Ireland McDermott Laboratories Ltd INN Donepezil t/a Gerard Laboratories Invented name Aripil Orotab 10mg Strength 10 mg Orodispersible Tablet Pharmaceutical Route of Form administration Orodispersible Oral use tablet 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Ireland McDermott Laboratories Ltd Esomeprazole Esomeprazole Mylan 20 mg t/a Gerard Laboratories Gastro-resistant Capsules, 35/36 Baldoyle Industrial hard 20 mg Gastro - resistant Oral use capsule Estate Grange Road Dublin 13 Ireland Ireland McDermott Laboratories Ltd Esomeprazole Esomeprazole Mylan 40 mg t/a Gerard Laboratories Gastro-resistant Capsules, 35/36 Baldoyle Industrial hard 40 mg Gastro - resistant Oral use capsule Estate Grange Road Dublin 13 Ireland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 49/133 Member State Marketing Authorisation (in EEA) Holder Ireland McDermott Laboratories Ltd INN Candesartan t/a Gerard Laboratories Invented name Candesartan Mylan 4mg Pharmaceutical Route of Form administration 4 mg Tablet Oral use 8 mg Tablet Oral use 16 mg Tablet Oral use Strength Tablets 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Ireland McDermott Laboratories Ltd Candesartan t/a Gerard Laboratories Candesartan Mylan 8 mg Tablets 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Ireland McDermott Laboratories Ltd t/a Gerard Laboratories Candesartan Candesartan Mylan 16 mg Tablets 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 50/133 Member State Marketing Authorisation (in EEA) Holder Ireland McDermott Laboratories Ltd INN Candesartan t/a Gerard Laboratories Invented name Candesartan Mylan 32 mg Pharmaceutical Route of Form administration 32 mg Tablet Oral use 250 mg Film - coated Oral use Strength Tablets 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Ireland Morningside Healthcare Phenoxymethyl Phenoxymethylpenicillin Limited penicillin 250mg Film-coated Tablets Amlodipine besilate Amlodipine Niche 5mg tablet 115 Narborough Road Leicester, LE3 0PA United Kingdom Ireland Niche Generics Limited 1 The Cam Centre 5 mg Tablet Oral use 10 mg Tablet Oral use 150 mg Film - coated Oral use tablets Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom Ireland Niche Generics Limited Amlodipine besilate 1 The Cam Centre Amlodipine Niche 10mg Tablets Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom Ireland Niche Generics Limited 1 The Cam Centre Irbesartan Irbesartan Niche 150mg film coated tablets tablet Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 51/133 Member State Marketing Authorisation (in EEA) Holder Ireland Niche Generics Limited INN Irbesartan 1 The Cam Centre Invented name Irbesartan Niche 300mg Strength 300 mg film coated tablets Pharmaceutical Route of Form administration Film - coated Oral use tablet Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom Ireland Wockhardt UK Limited Clopidogrel Clopidogrel 75mg film- Ash Road North hydrochloride coated tablets Metoclopramide METOCLOPRAMIDE 75 mg Film - coated Oral use tablet Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom Italy Accord Healthcare Italia S.r.l. Largo Esterle, 4 10 mg Tablet Oral use ACCORD 20052 Monza Italy Italy Accord Healthcare Limited Alendronic acid ALENDRONATO AHCL 10 mg Tablet Oral use Alendronic acid ALENDRONATO AHCL 70 mg Tablet Oral use Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex United Kingdom Italy Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 52/133 Member State Marketing Authorisation (in EEA) Holder Italy Doc Generici SRL INN Desloratadine Via Turati, 40 Invented name DESLORATADINA DOC Strength 5 mg GENERICI Pharmaceutical Route of Form administration Film - coated Oral use tablet 20121 Milano Italy Italy Doc Generici SRL Desloratadine Via Turati, 40 DESLORATADINA DOC 2,5 mg GENERICI Orodispersible Oral use tablet 20121 Milano Italy Italy Doc Generici SRL Desloratadine Via Turati, 40 DESLORATADINA DOC 5 mg GENERICI Orodispersible Oral use tablet 20121 Milano Italy Italy Farmaceutici Caber S.P.A. Valsartan VALSOTEN 40 mg Viale Citta' D'Europa, 681 Film - coated Oral use tablet 00144 Rome Italy Italy Farmaceutici Caber S.P.A. Valsartan VALSOTEN 80 mg Viale Citta' D'Europa, 681 Film - coated Oral use tablet 00144 Rome Italy Italy Farmaceutici Caber S.P.A. Valsartan VALSOTEN Viale Citta' D'Europa, 681 160 mg Film - coated Oral use tablet 00144 Rome Italy GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 53/133 Member State Marketing Authorisation (in EEA) Holder Italy Farmaceutici Caber S.P.A. INN Valsartan Invented name VALSOTEN Strength 320 mg Viale Citta' D'Europa, 681 Pharmaceutical Route of Form administration Film - coated Oral use tablet 00144 Rome Italy Italy Mylan S.P.A. Esomeprazole Via Vittor Pisani, 20 magnesium ESOMEPRAZOLO MYLAN 20 mg Gastro - resistant Oral use capsule, hard 20124 Milan Italy Italy Mylan S.P.A. Esomeprazole Via Vittor Pisani, 20 magnesium ESOMEPRAZOLO MYLAN 40 mg Gastro - resistant Oral use capsule, hard 20124 Milan Italy Italy Mylan S.P.A. Rizatriptan RIAZATRIPTAN MYLAN Via Vittor Pisani, 20 benzoate GENERICS Mylan S.P.A. Rizatriptan RIAZATRIPTAN MYLAN Via Vittor Pisani, 20 benzoate GENERICS Mylan S.P.A. Donepezil DONEPEZIL MYLAN Via Vittor Pisani, 20 hydrochloride GENERICS ITALIA 5 mg Orodispersible Oral use tablet 20124 Milan Italy Italy 10 mg Orodispersible Oral use tablet 20124 Milan Italy Italy 5 mg Orodispersible Oral use tablet 20124 Milan Italy GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 54/133 Member State Marketing Authorisation (in EEA) Holder Italy Mylan S.P.A. Donepezil DONEPEZIL MYLAN Via Vittor Pisani, 20 hydrochloride GENERICS ITALIA Repaglinide REPAGLINIDE MYLAN 0,5 mg Tablet Oral use Repaglinide REPAGLINIDE MYLAN 1 mg Tablet Oral use Repaglinide REPAGLINIDE MYLAN 2 mg Tablet Oral use Alendronic acid Alendronato Pensa 70 mg Tablet Oral use 70 mg Tablet Oral use INN Invented name Strength 10 mg Pharmaceutical Route of Form administration Orodispersible Oral use tablet 20124 Milan Italy Italy Mylan S.P.A. Via Vittor Pisani, 20 20124 Milan Italy Italy Mylan S.P.A. Via Vittor Pisani, 20 20124 Milan Italy Italy Mylan S.P.A. Via Vittor Pisani, 20 20124 Milan Italy Italy Pensa Pharma S.P.A. Via Rossellini Ippolito, 12 70 mg compresse 20124 Milan Italy Italy Ranbaxy Italia S.P.A. Piazza Filippo Meda, 4, 3 Alendronic acid ALENDRONATO RANBAXY ITALIA 20121 - Milano Italy GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 55/133 Member State Marketing Authorisation (in EEA) Holder Italy Tecnigen S.R.L. INN Leflunomide Invented name LEFLUNOMIDE TECNIGEN Strength 20 mg Via Galileo Galilei 40 Pharmaceutical Route of Form administration Film - coated Oral use tablet 20092 Cinisello Balsamo, Milan Italy Italy Tecnigen S.R.L. Leflunomide LEFLUNOMIDE TECNIGEN 10 mg Via Galileo Galilei 40 Film - coated Oral use tablet 20092 Cinisello Balsamo, Milan Italy Latvia Sandoz Pharmaceuticals d.d. Trimetazidine Verovskova 57 dihydrochloride Zidmetin 35 mg Modified - release Oral use tablet Ljubljana SI-1000 Slovenia Lithuania Accord Healthcare Limited Alendronic acid Alendronic acid Accord 70 mg Tablet Oral use Ropinirole Ropinirole Lambada 0,5 mg Film - coated Oral use Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex United Kingdom Lithuania Lambda Therapeutic Limited Sage House tablet 319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 56/133 Member State Marketing Authorisation (in EEA) Holder Lithuania Lambda Therapeutic Limited INN Ropinirole Invented name Ropinirole Lambada Strength 1 mg Sage House Pharmaceutical Route of Form administration Film - coated Oral use tablet 319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Lithuania Lambda Therapeutic Limited Ropinirole Ropinirole Lambada 2 mg Sage House Film - coated Oral use tablet 319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Lithuania Lambda Therapeutic Limited Ropinirole Ropinirole Lambada 5 mg Sage House Film - coated Oral use tablet 319 Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom Lithuania Torrent Pharma GmbH Irbesartan Irbesartanas Torrent 75 mg Südwestpark 50 Film - coated Oral use tablet 90449 Nürnberg Germany Lithuania Torrent Pharma GmbH Irbesartan Irbesartanas Torrent Südwestpark 50 150 mg Film - coated Oral use tablet 90449 Nürnberg Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 57/133 Member State Marketing Authorisation (in EEA) Holder Lithuania Torrent Pharma GmbH INN Irbesartan Invented name Irbesartanas Torrent Strength 300 mg Südwestpark 50 Pharmaceutical Route of Form administration Film - coated Oral use tablet 90449 Nürnberg Germany Lithuania Torrent Pharma GmbH Irbesartan/hydroch Irbesartanas/Hidrochlorotia 150 Film - coated Südwestpark 50 lorothiazide zidas Torrent mg/12,5 tablet 90449 Nürnberg Oral use mg Germany Lithuania Torrent Pharma GmbH Irbesartan/hydroch Irbesartanas/Hidrochlorotia 300 Film - coated Südwestpark 50 lorothiazide zidas Torrent mg/12,5 tablet 90449 Nürnberg Oral use mg Germany Lithuania Torrent Pharma GmbH Irbesartan/hydroch Irbesartanas/Hidrochlorotia 300 mg/25 Film - coated Südwestpark 50 lorothiazide zidas Torrent mg tablet Oral use Repaglinide Repaglinide Mylan Pharma 0,5 mg Tablet Oral use 1 mg Tablet Oral use 90449 Nürnberg Germany Luxembourg Mylan bvba/sprl Terhulpsesteenweg 6A 0,5 mg tabletten 1560 Hoeilaart Belgium Luxembourg Mylan bvba/sprl Terhulpsesteenweg 6A Repaglinide Repaglinide Mylan Pharma 1 mg tabletten 1560 Hoeilaart Belgium GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 58/133 Member State Marketing Authorisation (in EEA) Holder Luxembourg Mylan bvba/sprl INN Repaglinide Terhulpsesteenweg 6A Invented name Repaglinide Mylan Pharma Pharmaceutical Route of Form administration 2 mg Tablet Oral use 20 mg Gastro - resistant Oral use Strength 2 mg tabletten 1560 Hoeilaart Belgium Luxembourg Mylan bvba/sprl Esomeprazole Esomeprazole Mylan Terhulpsesteenweg 6A capsule, hard 1560 Hoeilaart Belgium Luxembourg Mylan bvba/sprl Esomeprazole Esomeprazole Mylan 40 mg Terhulpsesteenweg 6A Gastro - resistant Oral use capsule, hard 1560 Hoeilaart Belgium Malta Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/hydrochlorthiazid 160 Film - coated Planckstrasse 13 orothiazide "Fair-Med" Coated tablets mg/12,5 tablet DE-22765 Hamburg Oral use mg Germany Malta Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/hydrochlorthiazid 320 Film - coated Planckstrasse 13 orothiazide "Fair-Med" Coated tablets mg/12,5 tablet DE-22765 Hamburg Oral use mg Germany Malta Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/hydrochlorthiazid 320 mg/25 Film - coated Planckstrasse 13 orothiazide "Fair-Med" Coated tablets mg tablet Oral use DE-22765 Hamburg Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 59/133 Member State Marketing Authorisation (in EEA) Holder Malta Fair-Med Healthcare GmbH INN Ciprofloxacin Planckstrasse 13 Invented name Ciprofloxacin Fair-Med Strength 250 mg Coated Tablets Pharmaceutical Route of Form administration Film - coated Oral use tablet DE-22765 Hamburg Germany Malta Fair-Med Healthcare GmbH Ciprofloxacin Planckstrasse 13 Ciprofloxacin Fair-Med 500 mg Coated Tablets Film - coated Oral use tablet DE-22765 Hamburg Germany Malta Fair-Med Healthcare GmbH irbesartan Planckstrasse 13 Irbesartan Fairmed 75mg 75 mg Film-coated Tablets Film - coated Oral use tablet DE-22765 Hamburg Germany Malta Fair-Med Healthcare GmbH irbesartan Planckstrasse 13 Irbesartan Fairmed 150mg 150 mg Film-coated Tablets Film - coated Oral use tablet DE-22765 Hamburg Germany Malta Fair-Med Healthcare GmbH irbesartan Planckstrasse 13 Irbesartan Fairmed 300mg 300 mg Film-coated Tablets Film - coated Oral use tablet DE-22765 Hamburg Germany Malta Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan/Hydrochlorothia 150 Film - coated Planckstrasse 13 lorothiazide tablet zide Fairmed mg/12,5 DE-22765 Hamburg 150mg/12.5mg film-coated mg Germany tablets GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Oral use Page 60/133 Member State Marketing Authorisation (in EEA) Holder Malta Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan/Hydrochlorothia Planckstrasse 13 lorothiazide INN DE-22765 Hamburg Germany Malta Pharmaceutical Route of Form administration 300 Film - coated Oral use zide Fairmed mg/12,5 tablet 300mg/12.5mg film-coated mg Invented name Strength tablets Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan/Hydrochlorothia 300 mg/25 Film - coated Planckstrasse 13 lorothiazide zide Fairmed 300mg/25mg mg tablet 37,5 mg Prolonged - DE-22765 Hamburg Oral use film-coated tablets Germany Malta Fair-Med Healthcare GmbH Venlafaxine Venlafaxine Fair-Med Planckstrasse 13 release capsule, DE-22765 Hamburg hard Oral use Germany Malta Fair-Med Healthcare GmbH Venlafaxine Venlafaxine Fair-Med 75 mg Prolonged - Planckstrasse 13 release capsule, DE-22765 Hamburg hard Oral use Germany Malta Fair-Med Healthcare GmbH Venlafaxine Venlafaxine Fair-Med 150 mg Prolonged - Planckstrasse 13 release capsule, DE-22765 Hamburg hard Oral use Germany Malta Wockhardt UK Limited Ash Road North Clopidogrel Clopidogrel 75mg Filmcoated Tablets 75 mg Film - coated Oral use tablet Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 61/133 Member State Marketing Authorisation (in EEA) Holder Malta Wockhardt UK Limited INN Clopidogrel Ash Road North Invented name Clopidogrel 75mg Coated Strength 75 mg Tablets Pharmaceutical Route of Form administration Film - coated Oral use tablet Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom Norway Bluefish Pharmaceuticals AB Fluconazole Fluconazol Bluefish 50 mg Capsule, hard Oral use Fluconazole Fluconazol Bluefish 150 mg Capsule, hard Oral use Fluconazole Fluconazol Bluefish 200 mg Capsule, hard Oral use Esomeprazole Esomeprazol Mylan 20 mg Gastro - resistant Oral use Torsgatan 11 SE-11123 Stockholm Sweden Norway Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden Norway Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden Norway Mylan AB PO Box 230 33 capsule, hard SE-104 35 Stockholm Sweden Norway Mylan AB Esomeprazole Esomeprazol Mylan PO Box 230 33 40 mg Gastro - resistant Oral use capsule, hard SE-104 35 Stockholm Sweden GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 62/133 Member State Marketing Authorisation (in EEA) Holder Norway Mylan AB INN Eletriptan Invented name Eletriptan Mylan Strength 20 mg PO Box 230 33 Pharmaceutical Route of Form administration Film - coated Oral use tablet SE-104 35 Stockholm Sweden Norway Mylan AB Eletriptan Eletriptan Mylan 40 mg PO Box 230 33 Film - coated Oral use tablet SE-104 35 Stockholm Sweden Norway Mylan AB Candesartan PO Box 230 33 cilexetil Kandrozid 4 mg tablet Oral use Kandrozid 8 mg tablet Oral use Kandrozid 16 mg tablet Oral use Kandrozid 32 mg tablet Oral use SE-104 35 Stockholm Sweden Norway Mylan AB Candesartan PO Box 230 33 cilexetil SE-104 35 Stockholm Sweden Norway Mylan AB Candesartan PO Box 230 33 cilexetil SE-104 35 Stockholm Sweden Norway Mylan AB Candesartan PO Box 230 33 cilexetil SE-104 35 Stockholm Sweden GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 63/133 Member State Marketing Authorisation (in EEA) Holder Norway Mylan AB Candesartan PO Box 230 33 cilexetil INN Invented name Strength Pharmaceutical Route of Form administration Mylcande 8 mg tablet Oral use Mylcande 16 mg tablet Oral use Mylcande 32 mg tablet Oral use RIZATRIPTAN MYLAN 10 10 mg Orodispersible Oral use SE-104 35 Stockholm Sweden Norway Mylan AB Candesartan PO Box 230 33 cilexetil SE-104 35 Stockholm Sweden Norway Mylan AB Candesartan PO Box 230 33 cilexetil SE-104 35 Stockholm Sweden Norway Mylan AB Rizatriptan PO Box 230 33 mg, orodispersible tablet tablet SE-104 35 Stockholm Sweden Norway Sandoz A/S Quetiapin fumarate Quetiapin Sandoz 50 mg Edvard Thomsens Vei 14 Prolonged - Oral use release tablet DK 2300 København S Denmark Norway ratiopharm GmbH Desloratadine Desloratadin Ratiopharm Graf-Arco-Strasse 3 2,5 mg Orodispersible Oral use tablet D-89079 Ulm Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 64/133 Member State Marketing Authorisation (in EEA) Holder Norway ratiopharm GmbH INN Desloratadine Invented name Desloratadin Ratiopharm Strength 5 mg Graf-Arco-Strasse 3 Pharmaceutical Route of Form administration Orodispersible Oral use tablet D-89079 Ulm Germany Poland Abbott Laboratories Poland Escitalopram Savandra 5 mg Sp. z o.o. Film - coated Oral use tablet ul. Postępu 21B 02-676 Warszawa Poland Poland Abbott Laboratories Poland Escitalopram Savandra 10 mg Sp. z o.o. Film - coated Oral use tablet ul. Postępu 21B 02-676 Warszawa Poland Poland Abbott Laboratories Poland Escitalopram Savandra 15 mg Sp. z o.o. Film - coated Oral use tablet ul. Postępu 21B 02-676 Warszawa Poland Poland Abbott Laboratories Poland Escitalopram Savandra Sp. z o.o. 20 mg Film - coated Oral use tablet ul. Postępu 21B 02-676 Warszawa Poland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 65/133 Member State Marketing Authorisation (in EEA) Holder Poland Actavis Group PTC ehf. INN Metformin Invented name Metformin SR Actavis Strength 500 mg Reykjavikurvegi 76-78 Pharmaceutical Route of Form administration Film - coated Oral use tablet 220 Hafnarfjördur Iceland Poland Actavis Group PTC ehf. Metformin Metformin SR Actavis 750 mg Reykjavikurvegi 76-78 Film - coated Oral use tablet 220 Hafnarfjördur Iceland Poland Actavis Group PTC ehf. Metformin Metformin SR Actavis 1000 mg Reykjavikurvegi 76-78 Film - coated Oral use tablet 220 Hafnarfjördur Iceland Poland Adamed Sp. z o.o. Desloratadine Desada 5 mg Pieńków 149 Orodispersible Oral use tablet 05-152 Czosnów k. Warszawy Poland Poland Adamed Sp. z o.o. Desloratadine Hitaxa Fast 2,5 mg Pieńków 149 Orodispersible Oral use tablet 05-152 Czosnów k. Warszawy Poland Poland Adamed Sp. z o.o. Desloratadine Hitaxa Pieńków 149 2,5 mg Orodispersible Oral use tablet 05-152 Czosnów k. Warszawy Poland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 66/133 Member State Marketing Authorisation (in EEA) Holder Poland Adamed Sp. z o.o. INN Desloratadine Invented name Hitaxa Strength 5 mg Pieńków 149 Pharmaceutical Route of Form administration Orodispersible Oral use tablet 05-152 Czosnów k. Warszawy Poland Poland Aflofarm Farmacja Polska Sp. Desloratadine Teslor 5 mg z o.o. Film - coated Oral use tablet ul. Partyzancka 133/151 95-200 Pabianice Poland Poland Aflofarm Farmacja Polska Sp. Desloratadine Teslor fast 5 mg z o.o. Orodispersible Oral use tablet ul. Partyzancka 133/151 95-200 Pabianice Poland Poland Aflofarm Farmacja Polska Sp. Desloratadine Teslor fast junior 2,5 mg z o.o. Orodispersible Oral use tablet ul. Partyzancka 133/151 95-200 Pabianice Poland Poland Apotex Europe B.V. Trimetazidine ApoTrimet PR 35 mg Darwinweg 20 Prolonged - Oral use release tablet NL 2333 CR Leiden Netherlands Poland Bio-Profil Polska Sp. z o.o. Desloratadine Desloratadine Peseri Trakt Lubelski 135 5 mg Film - coated Oral use tablet 04-790 Warszawa Poland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 67/133 Member State Marketing Authorisation (in EEA) Holder Poland Fair-Med Healthcare GmbH Valsartan/hydrochl Planckstrasse 13 orothiazide INN Invented name Valsartan HCT Fair-Med DE-22765 Hamburg Pharmaceutical Route of Form administration 320 Film - coated Oral use mg/12,5 tablet Strength mg Germany Poland Fair-Med Healthcare GmbH Valsartan/hydrochl Planckstrasse 13 orothiazide Valsartan HCT Fair-Med 320 mg/25 Film - coated mg tablet 250 mg Film - coated Oral use DE-22765 Hamburg Germany Poland Fair-Med Healthcare GmbH Ciprofloxacin Ciprofloxacin Fair-Med Planckstrasse 13 Oral use tablet DE-22765 Hamburg Germany Poland Fair-Med Healthcare GmbH Ciprofloxacin Ciprofloxacin Fair-Med 500 mg Planckstrasse 13 Film - coated Oral use tablet DE-22765 Hamburg Germany Poland Fair-Med Healthcare GmbH Irbesartan Irbesartan Fair-Med 75 mg Planckstrasse 13 Film - coated Oral use tablet DE-22765 Hamburg Germany Poland Fair-Med Healthcare GmbH Irbesartan Irbesartan Fair-Med Planckstrasse 13 150 mg Film - coated Oral use tablet DE-22765 Hamburg Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 68/133 Member State Marketing Authorisation (in EEA) Holder Poland Fair-Med Healthcare GmbH INN Irbesartan Invented name Irbesartan Fair-Med Strength 300 mg Planckstrasse 13 Pharmaceutical Route of Form administration Film - coated Oral use tablet DE-22765 Hamburg Germany Poland Fair-Med Healthcare GmbH Irbesartan/hydroch Planckstrasse 13 lorothiazide Irbesartan HCT Fair-Med DE-22765 Hamburg 150 Film - coated mg/12,5 tablet Oral use mg Germany Poland Fair-Med Healthcare GmbH Irbesartan/hydroch Planckstrasse 13 lorothiazide Irbesartan HCT Fair-Med DE-22765 Hamburg 300 Film - coated mg/12,5 tablet Oral use mg Germany Poland Fair-Med Healthcare GmbH Irbesartan/hydroch Planckstrasse 13 lorothiazide Irbesartan HCT Fair-Med 300 mg/25 Film - coated mg tablet Oral use DE-22765 Hamburg Germany Poland Fair-Med Healthcare GmbH Valsartan/hydrochl Planckstrasse 13 orothiazide Valsartan HCT Fair-Med DE-22765 Hamburg 160 Film - coated mg/12,5 tablet Oral use mg Germany Poland Fair-Med Healthcare GmbH Venlafaxine VENLAFAXINE FAIR-MED 37,5 mg Prolonged - Planckstrasse 13 release capsule, DE-22765 Hamburg hard Oral use Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 69/133 Member State Marketing Authorisation (in EEA) Holder Poland Fair-Med Healthcare GmbH INN Venlafaxine Invented name VENLAFAXINE FAIR-MED Strength 75 mg Pharmaceutical Route of Form administration Prolonged - Oral use Planckstrasse 13 release capsule, DE-22765 Hamburg hard Germany Poland Fair-Med Healthcare GmbH Venlafaxine VENLAFAXINE FAIR-MED 150 mg Prolonged - Planckstrasse 13 release capsule, DE-22765 Hamburg hard Oral use Germany Poland Generics (UK) Ltd Candesartan Station Close, Potters Bar cilexetil Kangen 8 mg Tablet Oral use Kangen 16 mg Tablet Oral use Desloratadyna 5 mg Film - coated Oral use Hertfordshire, EN6 1TL United Kingdom Poland Generics (UK) Ltd Candesartan Station Close, Potters Bar cilexetil Hertfordshire, EN6 1TL United Kingdom Poland Ibermedgen, S.A. Desloratadine Ronda de Valdecarrizo IBERMEDGEN tablet 28760 Tres Cantos, Madrid Spain Poland Labormed-Pharma, SA Desloratadine Desloratadine Labormed Theodor Pallady, 44B 2,5 mg Orodispersible Oral use tablet 032266 Bucharest Romania GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 70/133 Member State Marketing Authorisation (in EEA) Holder Poland Labormed-Pharma, SA INN Desloratadine Invented name Desloratadine Labormed Strength 5 mg Theodor Pallady, 44B Pharmaceutical Route of Form administration Orodispersible Oral use tablet 032266 Bucharest Romania Poland Medicplast Polska Sp. z o.o Desloratadine Desalergo 5 mg ul. Wólczyńska 232 Film - coated Oral use tablet 01-919 Warszawa Poland Poland Medicplast Polska Sp. z o.o Desloratadine Desalergo 2,5 mg ul. Wólczyńska 232 Orodispersible Oral use tablet 01-919 Warszawa Poland Poland Medicplast Polska Sp. z o.o Desloratadine Desalergo 5 mg ul. Wólczyńska 232 Orodispersible Oral use tablet 01-919 Warszawa Poland Poland Orion Corporation Valsartan Valsartan Orion 40 mg Orion Pharma Film - coated Oral use tablet PO BOX 65 02101 Espoo Finland Poland Orion Corporation Valsartan Valsartan Orion Orion Pharma 80 mg Film - coated Oral use tablet PO BOX 65 02101 Espoo Finland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 71/133 Member State Marketing Authorisation (in EEA) Holder Poland Orion Corporation INN Valsartan Invented name Valsartan Orion Strength 160 mg Orion Pharma Pharmaceutical Route of Form administration Film - coated Oral use tablet PO BOX 65 02101 Espoo Finland Poland Orion Corporation Valsartan Valsartan Orion 320 mg Orion Pharma Film - coated Oral use tablet PO BOX 65 02101 Espoo Finland Poland Peseri Trading Limited Desloratadine Desloratadine Peseri 2,5 mg 20 Queen Frederica Street Orodispersible Oral use tablet El-Greco House, office 301 1066 Nicosia Cyprus Poland Peseri Trading Limited Desloratadine Desloratadine Peseri 5 mg 20 Queen Frederica Street Orodispersible Oral use tablet El-Greco House, office 301 1066 Nicosia Cyprus Poland Ranbaxy (Poland) Sp. z o.o. Alendronic acid Alendran 70 70 mg Tablet Oral use Kubickiego 11 02-954 Warszawa Poland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 72/133 Member State Marketing Authorisation (in EEA) Holder Poland Sandoz GmbH INN Trimetazidine Invented name Dimesar Strength 35 mg Biochemiestrasse 10 Pharmaceutical Route of Form administration Prolonged - Oral use release tablet A-6250 Kundl Austria Poland S-Lab Sp. z o.o. Desloratadine Suprodeslon 5 mg ul. Kiełczowska 2 Film - coated Oral use tablet 55-095 Mirków Poland Poland S-Lab Sp. z o.o. Desloratadine Suprodeslon 2,5 mg ul. Kiełczowska 2 Orodispersible Oral use tablet 55-095 Mirków Poland Poland S-Lab Sp. z o.o. Desloratadine Suprodeslon 5 mg ul. Kiełczowska 2 Orodispersible Oral use tablet 55-095 Mirków Poland Poland SymPhar Sp. z o.o. Desloratadine Symdes 5 mg ul. Włoska 1 Film - coated Oral use tablet 00-777 Warszawa Poland Poland Tactica Pharmaceuticals sp. z Desloratadine Goldesin o.o. 5 mg Film - coated Oral use tablet ul. Bankowa 4 44-100 Gliwice Poland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 73/133 Member State Marketing Authorisation (in EEA) Holder Poland US Pharmacia Sp. z o.o. INN Desloratadine Invented name Aleric Deslo Strength 5 mg ul.Ziębicka 40 Pharmaceutical Route of Form administration Film - coated Oral use tablet 50-507 Wrocław Poland Poland US Pharmacia Sp. z o.o. Desloratadine Aleric Deslo 2,5 mg ul.Ziębicka 40 Orodispersible Oral use tablet 50-507 Wrocław Poland Poland US Pharmacia Sp. z o.o. Desloratadine Aleric Deslo Active 5 mg ul.Ziębicka 40 Orodispersible Oral use tablet 50-507 Wrocław Poland Poland Wockhardt UK Limited Clopidogrel Clopidogrel Wockhardt 75 mg Ash Road North Film - coated Oral use tablet Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom Portugal Accord Healthcare Limited Alendronic acid Ácido alendrónico Accord 70 mg tablet Oral use Cefpodoxime Cefpodoxima Alkaloid 200 mg Tablet Oral use Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex United Kingdom Portugal Alkaloid - INT d.o.o. Šlandrova 4 1231 Ljubljana - Črnuče Slovenia GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 74/133 Member State Marketing Authorisation (in EEA) Holder Portugal Brown & Burk UK, Ltd. Tramadol/paraceta Tramadol + Paracetamol 5, Marryat Close mol Trimetazidine INN Pharmaceutical Route of Form administration 37,5 Film - coated Oral use Brown mg/325 mg tablet Trimetazidina Brown 35 mg Modified - release Invented name Strength Hounslow TW4 5DQ Middlesex United Kingdom Portugal Brown & Burk UK, Ltd. 5, Marryat Close Oral use tablet Hounslow TW4 5DQ Middlesex United Kingdom Portugal Brown & Burk UK, Ltd. Escitalopram Escitalopram Brown 10 mg 5, Marryat Close Film - coated Oral use tablet Hounslow TW4 5DQ Middlesex United Kingdom Portugal Brown & Burk UK, Ltd. Escitalopram Escitalopram Brown 15 mg 5, Marryat Close Film - coated Oral use tablet Hounslow TW4 5DQ Middlesex United Kingdom Portugal Brown & Burk UK, Ltd. Escitalopram Escitalopram Brown 5, Marryat Close 5 mg Film - coated Oral use tablet Hounslow TW4 5DQ Middlesex United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 75/133 Member State Marketing Authorisation (in EEA) Holder Portugal Brown & Burk UK, Ltd. INN Escitalopram Invented name Escitalopram Brown Strength 20 mg 5, Marryat Close Pharmaceutical Route of Form administration Film - coated Oral use tablet Hounslow TW4 5DQ Middlesex United Kingdom Portugal Brown & Burk UK, Ltd. Ebastine Ebastina Brown 10 mg 5, Marryat Close Film - coated Oral use tablet Hounslow TW4 5DQ Middlesex United Kingdom Portugal Brown & Burk UK, Ltd. Ebastine Ebastina Brown 20 mg 5, Marryat Close Film - coated Oral use tablet Hounslow TW4 5DQ Middlesex United Kingdom Portugal Daquimed - Comércio de Quetiapine Quetiapina Daquimed Produtos Farmacêuticos, S.A. 25 mg Film - coated Oral use tablet Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres Portugal GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 76/133 Member State Marketing Authorisation (in EEA) Holder Portugal Daquimed - Comércio de INN Quetiapine Invented name Quetiapina Daquimed Strength 100 mg Produtos Farmacêuticos, S.A. Pharmaceutical Route of Form administration Film - coated Oral use tablet Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres Portugal Portugal Daquimed - Comércio de Quetiapine Quetiapina Daquimed 150 mg Produtos Farmacêuticos, S.A. Film - coated Oral use tablet Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres Portugal Portugal Daquimed - Comércio de Quetiapine Quetiapina Daquimed Produtos Farmacêuticos, S.A. 200 mg Film - coated Oral use tablet Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres Portugal GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 77/133 Member State Marketing Authorisation (in EEA) Holder Portugal Daquimed - Comércio de INN Quetiapine Invented name Quetiapina Daquimed Strength 300 mg Produtos Farmacêuticos, S.A. Pharmaceutical Route of Form administration Film - coated Oral use tablet Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres Portugal Portugal Generis Farmacêutica, S. A. Levodopa/carbidop Levodopa + Carbidopa + 50 mg/12,5 Film - coated Rua João de Deus, 19 a/entacapone Entacapona Generis mg/200 mg tablet Generis Farmacêutica, S. A. Levodopa/carbidop Levodopa + Carbidopa + 75 Film - coated Rua João de Deus, 19 a/entacapone Entacapona Generis mg/18,75 tablet Oral use 2700-487 Amadora Portugal Portugal 2700-487 Amadora Oral use mg/200 mg Portugal Portugal Generis Farmacêutica, S. A. Levodopa/carbidop Levodopa + Carbidopa + 100 mg/25 Film - coated Rua João de Deus, 19 a/entacapone Entacapona Generis mg/200 mg tablet Generis Farmacêutica, S. A. Levodopa/carbidop Levodopa + Carbidopa + 125 Film - coated Rua João de Deus, 19 a/entacapone Entacapona Generis mg/31,250 tablet Oral use 2700-487 Amadora Portugal Portugal 2700-487 Amadora Oral use mg/200 mg Portugal GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 78/133 Member State Marketing Authorisation (in EEA) Holder Portugal Generis Farmacêutica, S. A. Levodopa/carbidop Levodopa + Carbidopa + Rua João de Deus, 19 a/entacapone Entacapona Generis INN Invented name 2700-487 Amadora Pharmaceutical Route of Form administration 150 Film - coated Oral use mg/37,5 tablet Strength mg/200 mg Portugal Portugal Generis Farmacêutica, S. A. Levodopa/carbidop Levodopa + Carbidopa + 175 Film - coated Rua João de Deus, 19 a/entacapone Entacapona Generis mg/43,75 tablet 2700-487 Amadora Oral use mg/200 mg Portugal Portugal Generis Farmacêutica, S. A. Levodopa/carbidop Levodopa + Carbidopa + 200 mg/50 Film - coated Rua João de Deus, 19 a/entacapone Entacapona Generis mg/200 mg tablet Entacapone Entacapona Generis 200 mg Film - coated Oral use 2700-487 Amadora Portugal Portugal Generis Farmacêutica, S. A. Rua João de Deus, 19 Oral use tablet 2700-487 Amadora Portugal Portugal Labesfal, Genéricos, S.A. Desloratadine Desloratadina Labesfal OD 2,5 mg Av. Dr. Afonso Costa, nº 1370 Orodispersible Oral use tablet 3465-051 Campo de Besteiros Portugal Portugal Labesfal, Genéricos, S.A. Desloratadine Desloratadina Labesfal OD Av. Dr. Afonso Costa, nº 1370 5 mg Orodispersible Oral use tablet 3465-051 Campo de Besteiros Portugal GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 79/133 Member State Marketing Authorisation (in EEA) Holder Portugal Labesfal, Genéricos, S.A. INN Invented name Strength Pharmaceutical Route of Form administration Alendronic acid Ácido alendrónico Labesfal 70 mg tablet Oral use Donepezil Donepezilo Anova 5 mg Orodispersible Oral use Av. Dr. Afonso Costa, nº 1370 3465-051 Campo de Besteiros Portugal Portugal Laboratórios Anova - Produtos Farmacêuticos, Lda. tablet Rua Doutor António Loureiro Borges Edíficio Arquiparque 1, R/C Esqº 1499-016 Algés Portugal Portugal Laboratórios Anova - Produtos Donepezil Donepezilo Anova Farmacêuticos, Lda. 10 mg Orodispersible Oral use tablet Rua Doutor António Loureiro Borges Edíficio Arquiparque 1, R/C Esqº 1499-016 Algés Portugal GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 80/133 Member State Marketing Authorisation (in EEA) Holder Portugal Laboratórios Anova - Produtos INN Esomeprazole Invented name Esomeprazol Anova Strength 20 mg Farmacêuticos, Lda. Pharmaceutical Route of Form administration Gastro - resistant Oral use capsule, hard Rua Doutor António Loureiro Borges Edíficio Arquiparque 1, R/C Esqº 1499-016 Algés Portugal Portugal Laboratórios Anova - Produtos Esomeprazole Esomeprazol Anova 40 mg Farmacêuticos, Lda. Gastro - resistant Oral use capsule, hard Rua Doutor António Loureiro Borges Edíficio Arquiparque 1, R/C Esqº 1499-016 Algés Portugal Portugal Laboratórios Azevedos - Venlafaxine Venlafaxina Azevedos 37,5 mg Prolonged - Indústria Farmacêutica, S.A. release capsule, Edifícios Azevedos - Estrada hard Oral use Nacional 117-2, Alfragide 2614-504 Amadora Portugal GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 81/133 Member State Marketing Authorisation (in EEA) Holder Portugal Laboratórios Azevedos - INN Venlafaxine Invented name Venlafaxina Azevedos Strength 75 mg Pharmaceutical Route of Form administration 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 150 mg Prolonged - Indústria Farmacêutica, S.A. release capsule, Edifícios Azevedos - Estrada hard Oral use Nacional 117-2, Alfragide 2614-504 Amadora Portugal Portugal Laboratórios Basi - Indústria Fluconazole Fluconazol Basi 50 mg Capsule Oral use Fluconazole Fluconazol Basi 150 mg Capsule Oral use Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal Portugal Laboratórios Basi - Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 82/133 Member State Marketing Authorisation (in EEA) Holder Portugal Laboratórios Basi - Indústria INN Invented name Strength Pharmaceutical Route of Form administration Fluconazole Fluconazol Basi 200 mg Capsule Oral use Desloratadine Desloratadina Labormed 5 mg Orodispersible Oral use Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal Portugal Labormed-Pharma, SA Theodor Pallady, 44B tablet 032266 Bucharest Romania Portugal Labormed-Pharma, SA Desloratadine Desloratadina Labormed 2,5 mg Theodor Pallady, 44B Orodispersible Oral use tablet 032266 Bucharest Romania Portugal Lupin (Europe) Limited Cefpodoxime Cefpodoxima Lupin 200 mg Victoria Court, Bexton Road Film - coated Oral use tablet Knutsford, Cheshire WA16 0PF United Kingdom Portugal Mylan, Lda. Esomeprazole Esomeprazol Mylan Parque Expo, Edifício Atlantis, 20 mg Gastro - resistant Oral use capsule, hard Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 83/133 Member State Marketing Authorisation (in EEA) Holder Portugal Mylan, Lda. INN Esomeprazole Invented name Esomeprazol Mylan Strength 40 mg Parque Expo, Edifício Atlantis, Pharmaceutical Route of Form administration Gastro - resistant Oral use capsule, hard Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal Mylan, Lda. Atorvastatin Atorvastatina Anova 10 mg Parque Expo, Edifício Atlantis, Film - coated Oral use tablet Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal Mylan, Lda. Atorvastatin Atorvastatina Anova 20 mg Parque Expo, Edifício Atlantis, Film - coated Oral use tablet Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal Mylan, Lda. Atorvastatin Atorvastatina Anova Parque Expo, Edifício Atlantis, 40 mg Film - coated Oral use tablet Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 84/133 Member State Marketing Authorisation (in EEA) Holder Portugal Mylan, Lda. INN Atorvastatin Invented name Atorvastatina Anova Strength 80 mg Parque Expo, Edifício Atlantis, Pharmaceutical Route of Form administration Film - coated Oral use tablet Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal Mylan, Lda. Donepezil Donepezilo Mylan 5 mg Parque Expo, Edifício Atlantis, Orodispersible Oral use tablet Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal Mylan, Lda. Donepezil Donepezilo Mylan 10 mg Parque Expo, Edifício Atlantis, Orodispersible Oral use tablet Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal Mylan, Lda. Trimetazidine Trimetazidina Mylan Parque Expo, Edifício Atlantis, 35 mg Modified - release Oral use tablet Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 85/133 Member State Marketing Authorisation (in EEA) Holder Portugal Mylan, Lda. INN Invented name Strength Pharmaceutical Route of Form administration Candesartan Candesartan Mylan 4 mg Tablet Oral use Candesartan Candesartan Mylan 8 mg Tablet Oral use Candesartan Candesartan Mylan 16 mg Tablet Oral use Candesartan Candesartan Mylan 32 mg Tablet Oral use Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal Mylan, Lda. Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal Mylan, Lda. Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal Portugal Mylan, Lda. Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa Portugal GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 86/133 Member State Marketing Authorisation (in EEA) Holder Portugal Pentafarma - Sociedade INN Leflunomide Invented name Leflunomida Pentafarma Strength 10 mg Técnico-Medicinal, S.A. Pharmaceutical Route of Form administration Film - coated Oral use tablet Rua da Tapada Grande, nº2 Abrunheira 2710-089 Sintra Portugal Portugal Pentafarma - Sociedade Leflunomide Leflunomida Pentafarma 20 mg Técnico-Medicinal, S.A. Film - coated Oral use tablet Rua da Tapada Grande, nº2 Abrunheira 2710-089 Sintra Portugal Portugal Peseri Trading Limited Desloratadine Desloratadina Peseri 5 mg 20 Queen Frederica Street Film - coated Oral use tablet El-Greco House, office 301 1066 Nicosia Cyprus Portugal Peseri Trading Limited Desloratadine Desloratadina Peseri 5 mg 20 Queen Frederica Street Orodispersible Oral use tablet El-Greco House, office 301 1066 Nicosia Cyprus Portugal Peseri Trading Limited Desloratadine Desloratadina Peseri 0,5 mg/ml Oral solution Oral use 20 Queen Frederica Street El-Greco House, office 301 1066 Nicosia Cyprus GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 87/133 Member State Marketing Authorisation (in EEA) Holder Portugal Peseri Trading Limited INN Desloratadine Invented name Desloratadina Peseri Strength 2,5 mg 20 Queen Frederica Street Pharmaceutical Route of Form administration Orodispersible Oral use tablet El-Greco House, office 301 1066 Nicosia Cyprus Portugal Pharmakern Portugal - Trimetazidine Trimetazidina Pharmakern 35 mg Produtos Farmacêuticos, Modified - release Oral use 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 Indústria de Produtos Orodispersible Oral use tablet Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal Portugal Ratiopharm - Comércio e Desloratadine Desloratadina Ratiopharm Indústria de Produtos 5 mg Orodispersible Oral use tablet Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 88/133 Member State Marketing Authorisation (in EEA) Holder Portugal Sandoz Farmaceutica Lda. INN Trimetazidine Invented name Trimetazidina Itraxel Strength 35 mg Avenida Professor Doutor Pharmaceutical Route of Form administration Prolonged - Oral use release tablet Cavaco Silva, n. 10E Taguspark 2740-255 Porto Salvo Portugal Portugal Teva Pharma - Produtos Desloratadine Desloratadina Teva 2,5 mg Farmacêuticos,Lda. Orodispersible Oral use tablet Edificio Tejo, Rua Quinta do Pinheiro, 16 - 6º 2790-143 Carnaxide Portugal Portugal Teva Pharma - Produtos Desloratadine Desloratadina Teva 5 mg Farmacêuticos,Lda. Orodispersible Oral use tablet Edificio Tejo, Rua Quinta do Pinheiro, 16 - 6º 2790-143 Carnaxide Portugal Romania Abbott Products SAS Escitalopram 42 rue Rouget de Lisle SAVANDRA 5 mg 5 mg comprimate filmate Film - coated Oral use tablet 92150 Suresnes France Romania Abbott Products SAS 42 rue Rouget de Lisle Escitalopram SAVANDRA 10 mg comprimate filmate 10 mg Film - coated Oral use tablet 92150 Suresnes France GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 89/133 Member State Marketing Authorisation (in EEA) Holder Romania Abbott Products SAS INN Escitalopram 42 rue Rouget de Lisle Invented name SAVANDRA 15 mg Strength 15 mg comprimate filmate Pharmaceutical Route of Form administration Film - coated Oral use tablet 92150 Suresnes France Romania Abbott Products SAS Escitalopram 42 rue Rouget de Lisle SAVANDRA 20 mg 20 mg comprimate filmate Film - coated Oral use tablet 92150 Suresnes France Romania Alkaloid - INT d.o.o. Cefpodoxime Šlandrova 4 Forexo 200 mg 200 mg Tablet Oral use 5 mg Film - coated Oral use comprimate filmate 1231 Ljubljana - Črnuče Slovenia Romania Alvogen IPCo S.ar.l. Desloratadine Rue Heienhaff 5 Desloratadina Alvogen 5 mg comprimate filmate tablet L-1736 Senningerberg Luxembourg Romania Alvogen IPCo S.ar.l. Voriconazole Rue Heienhaff 5 Conaverifin 50 mg 50 mg comprimate filmate Film - coated Oral use tablet L-1736 Senningerberg Luxembourg Romania Alvogen IPCo S.ar.l. Rue Heienhaff 5 Voriconazole Conaverifin 200 mg comprimate filmate 200 mg Film - coated Oral use tablet L-1736 Senningerberg Luxembourg GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 90/133 Member State Marketing Authorisation (in EEA) Holder Romania Dr. Reddy’s Laboratories INN Levetiracetam Invented name Levetiracetam Dr. Reddy’s, Romania SRL 250 mg, comprimate 71st-73rd Nicolae Caramfil, filmate Pharmaceutical Route of Form administration 250 mg Tablet Oral use 500 mg Tablet Oral use 750 mg Tablet Oral use 1000 mg Tablet Oral use 40 mg Tablet Oral use Strength Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania Dr. Reddy’s Laboratories Levetiracetam Levetiracetam Dr. Reddy’s, Romania SRL 500mg, comprimate 71st-73rd Nicolae Caramfil, filmate Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania Dr. Reddy’s Laboratories Levetiracetam Levetiracetam Dr. Reddy’s, Romania SRL 750 mg, comprimate 71st-73rd Nicolae Caramfil, filmate Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania Dr. Reddy’s Laboratories Levetiracetam Levetiracetam Dr. Reddy’s, Romania SRL 1000 mg, comprimate 71st-73rd Nicolae Caramfil, filmate Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania Dr. Reddy’s Laboratories Romania SRL Telmisartan Telmisartan Dr. Reddy's 40 mg comprimate 71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 91/133 Member State Marketing Authorisation (in EEA) Holder Romania Dr. Reddy’s Laboratories INN Telmisartan Romania SRL Invented name Telmisartan Dr. Reddy's 80 Pharmaceutical Route of Form administration 80 mg Tablet Oral use Tablet Oral use Tablet Oral use Tablet Oral use Gastro - resistant Oral use Strength mg comprimate 71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania Dr. Reddy’s Laboratories Telmisartan/ Telmisartan HCT Dr. 40 mg/12,5 Romania SRL hydrochlorothiazide Reddy’s 40 mg/12,5 mg mg 71st-73rd Nicolae Caramfil, comprimate Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania Dr. Reddy’s Laboratories Telmisartan/ Telmisartan HCT Dr. 80 mg/12,5 Romania SRL hydrochlorothiazide Reddy’s 80 mg/12,5 mg mg 71st-73rd Nicolae Caramfil, comprimate Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania Dr. Reddy’s Laboratories Telmisartan/ Telmisartan HCT Dr. 80 mg/25 Romania SRL hydrochlorothiazide Reddy’s 80 mg/25 mg mg 71st-73rd Nicolae Caramfil, comprimate Floor 5, Space 10, Sector 1, Bucuresti, Romania Romania Generics (UK) Ltd Esomeprazole Esomeprazol Mylan 20 mg Station Close, Potters Bar magnesium capsule gastrorezistente 20 mg capsule, hard Hertfordshire, EN6 1TL United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 92/133 Member State Marketing Authorisation (in EEA) Holder Romania Generics (UK) Ltd Esomeprazole Esomeprazol Mylan 40 mg Station Close, Potters Bar magnesium capsule gastrorezistente Generics (UK) Ltd Donepezil Donepezil Mylan 5 mg Station Close, Potters Bar hydrochloride comprimate INN Invented name Strength 40 mg Pharmaceutical Route of Form administration Gastro - resistant Oral use capsule, hard Hertfordshire, EN6 1TL United Kingdom Romania Hertfordshire, EN6 1TL 5 mg Orodispersible Oral use tablet orodispersabile United Kingdom Romania Generics (UK) Ltd Donepezil Donepezil Mylan 10 mg Station Close, Potters Bar hydrochloride comprimate Hertfordshire, EN6 1TL 10 mg Orodispersible Oral use tablet orodispersabile United Kingdom Romania Generics (UK) Ltd Repaglinide Station Close, Potters Bar Repaglinida Generics 0.5 0,5 mg Tablet Oral use 1 mg Tablet Oral use 2 mg Tablet Oral use mg comprimate Hertfordshire, EN6 1TL United Kingdom Romania Generics (UK) Ltd Repaglinide Station Close, Potters Bar Repaglinida Genericsl 1 mg comprimate Hertfordshire, EN6 1TL United Kingdom Romania Generics (UK) Ltd Station Close, Potters Bar Repaglinide Repaglinida Generics 2 mg comprimate Hertfordshire, EN6 1TL United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 93/133 Member State Marketing Authorisation (in EEA) Holder Romania Generics (UK) Ltd Candesartan Candesartan Mylan 4 mg Station Close, Potters Bar cilexetil comprimate Generics (UK) Ltd Candesartan Candesartan Mylan 8 mg Station Close, Potters Bar cilexetil comprimate Generics (UK) Ltd Candesartan Candesartan Mylan 16 mg Station Close, Potters Bar cilexetil comprimate Generics (UK) Ltd Rizatriptan Rizatriptan Mylan 5 mg Station Close, Potters Bar benzoate comprimate INN Invented name Pharmaceutical Route of Form administration 4 mg Tablet Oral use 8 mg Tablet Oral use 16 mg Tablet Oral use 5 mg Orodispersible Oral use Strength Hertfordshire, EN6 1TL United Kingdom Romania Hertfordshire, EN6 1TL United Kingdom Romania Hertfordshire, EN6 1TL United Kingdom Romania Hertfordshire, EN6 1TL tablet orrodispersabile United Kingdom Romania Generics (UK) Ltd Rizatriptan Rizatriptan Mylan 10 mg Station Close, Potters Bar benzoate comprimate Hertfordshire, EN6 1TL 10 mg Orodispersible Oral use tablet orrodispersabile United Kingdom Romania Glenmark Pharmaceuticals Trimetazidine Apstar 35mg s.r.o. Comprimate cu Hvězdova 1716/2b eliberare 14078 Praha 4 prelungită 35 mg Modified - release Oral use tablet Czech Republic GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 94/133 Member State Marketing Authorisation (in EEA) Holder Romania Ibermedgen, S.A. INN Desloratadine Ronda de Valdecarrizo Invented name Desloratadina Ibermedgen Strength 5 mg 5 mg comprimate filmate Pharmaceutical Route of Form administration Film - coated Oral use tablet 28760 Tres Cantos, Madrid Spain Romania Labormed Pharma SA Desloratadine Desloratadine Labormed Bd. Theodor Pallady nr. 44 B 2.5 mg comprimate 032266, sector 3, Bucureşti orodispersabile 2,5 mg Orodispersible Oral use tablet România Romania Labormed Pharma SA Desloratadine Desloratadine Labormed 5 Bd. Theodor Pallady nr. 44 B mg comprimate 032266, sector 3, Bucureşti orodispersabile 5 mg Orodispersible Oral use tablet România Romania Mylan SAS Trimetazidine Trimetazidina Mylan 35 mg 117 allée des Parcs comprimate filmate cu 69792 Saint-Priest Cedex eliberare prelungita 35 mg Prolonged - Oral use release tablet France Romania Sandoz Pharma Services SRL Quetiapine Eufrenin V 50 mg Calea Floreasca Street fumarate comprimate cu eliberare No 169A, district 2 50 mg Prolonged - Oral use release tablet prelungită Bucharest Romania Romania Sandoz Pharma Services SRL Trimetazidine Trimeluzine Limited 35 mg Calea Floreasca Street comprimate filmate cu No 169A, district 2 eliberare modificata 35 mg Modified - release Oral use tablet Bucharest Romania GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 95/133 Member State Marketing Authorisation (in EEA) Holder Romania STADA Hemofarm S.R.L. INN Entacapone Calea Torontalului km 6 - Invented name ENTTANIDA 200 Strength 200 mg comprimate filmate Pharmaceutical Route of Form administration Film - coated Oral use tablet PITT 300633 Timişoara Romania Romania Teva Pharmaceuticals S.R.L. Desloratadine Desloratadina Teva 5 mg Str. Domniţa Ruxandra nr. comprimate 12, parter, sector 2, orodispersabile 5 mg Orodispersible Oral use tablet Bucureşti, România Romania Torrent Pharma SRL Irbesartan Irbesartan Torrent 75 mg Str. Stirbei Voda nr. 36 comprimate et. 2, biroul A, sector 1 filmate 75 mg Film - coated Oral use tablet Bucharest Romania Romania Torrent Pharma SRL Irbesartan Irbesartan Torrent 150 mg Str. Stirbei Voda nr. 36 comprimate et. 2, biroul A, sector 1 filmate 150 mg Film - coated Oral use tablet Bucharest Romania Romania Torrent Pharma SRL Irbesartan Irbesartan Torrent 300 mg Str. Stirbei Voda nr. 36 comprimate et. 2, biroul A, sector 1 filmate 300 mg Film - coated Oral use tablet Bucharest Romania GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 96/133 Member State Marketing Authorisation (in EEA) Holder Romania Torrent Pharma SRL Irbesartan/hydroch Irbesartan Torrent Str. Stirbei Voda nr. 36 lorothiazide INN Invented name Pharmaceutical Route of Form administration 150 Film - coated Oral use tablet Strength Hidrochlorotiazida mg/12,5 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 Str. Stirbei Voda nr. 36 lorothiazide Hidrochlorotiazida mg/12,5 tablet et. 2, biroul A, sector 1 300/12,5mg comprimate mg Bucharest filmate Oral use Romania Romania Torrent Pharma SRL Irbesartan/hydroch Irbesartan Torrent 300 mg/25 Film - coated Str. Stirbei Voda nr. 36 lorothiazide Hidrochlorotiazida mg tablet 200 mg Film - coated et. 2, biroul A, sector 1 300/25 mg comprimate Bucharest filmate Oral use Romania Slovak Republic Alkaloid - INT d.o.o. Cefpodoxime Šlandrova 4 FOREXO 200 mg filmom obalené tablety Oral use tablet 1231 Ljubljana - Črnuče Slovenia Slovak Republic Alvogen IPCo S.àr.l. Desloratadine 412F Route d'Esch Dezloratadin Alvogen 5 mg 5 mg filmom obalené tablety Film - coated Oral use tablet L - 2086 Luxembourg Slovak Republic Genericon s.r.o., Desloratadine GESLORA 5 mg Anny Letenské 1108/15, 5 mg Film - coated Oral use tablet 120 00 Praha 2 - Vinohrady Czech Republic GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 97/133 Member State Marketing Authorisation (in EEA) Holder Slovak Republic Generics (UK) Ltd Donepezil Donepezil Mylan 5 mg Station Close, Potters Bar hydrochloride orodispergovateľné tablety Generics (UK) Ltd Donepezil Donepezil Mylan 10 mg Station Close, Potters Bar hydrochloride orodispergovateľné tablety Generics (UK) Ltd Rizatriptan Rizatriptan Mylan 10 mg Station Close, Potters Bar benzoate INN Invented name Strength 5 mg Pharmaceutical Route of Form administration Orodispersible Oral use tablet Hertfordshire, EN6 1TL United Kingdom Slovak Republic 10 mg Orodispersible Oral use tablet Hertfordshire, EN6 1TL United Kingdom Slovak Republic 10 mg Orodispersible Oral use tablet Hertfordshire, EN6 1TL United Kingdom Slovak Republic Glenmark Pharmaceuticals Trimetazidine s.r.o. Apstar 35 mg tablety s 35 mg predĺženým uvoľňovaním Modified - release Oral use tablet Hvězdova 1716/2b 14078 Praha 4 Czech Republic Slovak Republic Mylan SAS Trimetazidine Trimetazidin Mylan 35 mg 35 mg 117 allée des Parcs Modified - release Oral use tablet 69792 Saint-Priest Cedex France Slovak Republic SVUS Pharma a.s. Smetanovo nábřeží 1238/20a Desloratadine LOTERA 5 mg filmom obalené tablety 5 mg Film - coated Oral use tablet 500 02 Hradec Králové Czech Republic GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 98/133 Member State Marketing Authorisation (in EEA) Holder Slovak Republic Teva Pharmaceuticals INN Desloratadine Slovakia s.r.o. Invented name Dezloratadin Teva OROTAB Strength 2,5 mg 2,5 mg Pharmaceutical Route of Form administration Orodispersible Oral use tablet Teslova 26 821 02 Bratislava Slovak Republic Slovak Republic Teva Pharmaceuticals Desloratadine Slovakia s.r.o. Dezloratadin Teva OROTAB 5 mg 5 mg Orodispersible Oral use tablet Teslova 26 821 02 Bratislava Slovak Republic Slovenia Alkaloid - INT d.o.o. Cefpodoxime Šlandrova 4 Trexodo 200 mg filmsko 200 mg obložene tablete Film - coated Oral use tablet 1231 Ljubljana - Črnuče Slovenia Slovenia Generics (UK) Ltd Esomeprazole Esomeprazol Mylan 20 mg Station Close, Potters Bar magnesium trde gastrorezistentne Hertfordshire, EN6 1TL 20 mg Gastro - resistant Oral use capsule, hard kapsule United Kingdom Slovenia Generics (UK) Ltd Esomeprazole Esomeprazol Mylan 40 mg Station Close, Potters Bar magnesium trde gastrorezistentne Hertfordshire, EN6 1TL 40 mg Gastro - resistant Oral use capsule, hard kapsule United Kingdom Slovenia Generics (UK) Ltd Donepezil Donepezil Mylan 5 mg Station Close, Potters Bar hydrochloride orodisperzibilne tablete 5 mg Orodispersible Oral use tablet Hertfordshire, EN6 1TL United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 99/133 Member State Marketing Authorisation (in EEA) Holder Slovenia Generics (UK) Ltd Donepezil Donepezil Mylan 10 mg Station Close, Potters Bar hydrochloride orodisperzibilne tablete Lek farmacevtska družba d.d. Trimetazidine Trimeluzine 35 mg tablete Verovškova 57 hydrochloride s podaljšanim sproščanjem Metoclopramide METOCLOPRAMIDA INN Invented name Strength 10 mg Pharmaceutical Route of Form administration Orodispersible Oral use tablet Hertfordshire, EN6 1TL United Kingdom Slovenia 35 mg Prolonged - Oral use release tablet 1526 Ljubljana Slovenia Spain Accord Healthcare, S.L.U. Moll de Barcelona s/n. World ACCORD 10 mg Trade Center. Edifici Est 6ª COMPRIMIDOS EFG 10 mg Tablet Oral use Film - coated Oral use planta, 8039 Barcelona Spain Spain Spain Apotex Europe B.V. Desloratadine DESLORATADINA APOTEX Darwinweg 20 5 mg COMPRIMIDOS NL 2333 CR Leiden RECUBIERTOS CON Netherlands PELICULA EFG Brown & Burk UK, Ltd. Ebastine EBASTINA BROWN 10 mg 5, Marryat Close COMPRIMIDOS Hounslow BUCODISPERSABLES EFG 5 mg tablet 10 mg Orodispersible Oral use tablet TW4 5DQ Middlesex United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 100/133 Member State Marketing Authorisation (in EEA) Holder Spain Farmalider, S.A. Valsartan/hydrochl VALSARTAN/HIDROCLORO Aragoneses 15 orothiazide INN Invented name Pharmaceutical Route of Form administration 160 Film - coated Oral use tablet Strength TIAZIDA CODRAMOL 160 mg/12,5 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 Aragoneses 15 orothiazide TIAZIDA CODRAMOL mg tablet 28108 Madrid 160/25 mg COMPRIMIDOS Spain RECUBIERTOS CON Oral use PELICULA EFG Spain Farmalider, S.A. Valsartan/hydrochl VALSARTAN/HIDROCLORO 320 Film - coated Aragoneses 15 orothiazide TIAZIDA CODRAMOL mg/12,5 tablet 28108 Madrid 320/12.5 mg mg Spain COMPRIMIDOS Oral use RECUBIERTOS CON PELICULA EFG Spain Farmalider, S.A. Valsartan/hydrochl VALSARTAN/HIDROCLORO 320 mg/25 Film - coated Aragoneses 15 orothiazide TIAZIDA CODRAMOL mg tablet 28108 Madrid 320/25 mg COMPRIMIDOS Spain RECUBIERTOS CON Oral use PELICULA EFG GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 101/133 Member State Marketing Authorisation (in EEA) Holder Spain Farmalider, S.A. Valsartan/hydrochl VALSARTAN/HIDROCLORO Aragoneses 15 orothiazide TIAZIDA CODRAMOL INN Invented name 28108 Madrid 80/12.5 mg COMPRIMIDOS Spain RECUBIERTOS CON Pharmaceutical Route of Form administration 80 mg/12,5 Film - coated Oral use mg tablet 5 mg Film - coated Strength PELICULA EFG Spain Laboratorios Combix, S.L.U. Desloratadine DESLORATADINA COMBIX C/ Badajoz 2, Edificio 2 5 mg COMPRIMIDOS Pozuelo de Alarcon RECUBIERTOS CON Madrid 28223 PELÍCULA EFG Oral use tablet Spain Spain Laboratorios Combix, S.L.U. Desloratadine DESLORATADINA FLAS C/ Badajoz 2, Edificio 2 COMBIX 5 mg Pozuelo de Alarcon COMPRIMIDOS Madrid 28223 BUCODISPERSABLES EFG 5 mg Film - coated Oral use tablet Spain Spain Laboratorios Combix, S.L.U. Escitalopram ESCITALOPRAM COMBIX C/ Badajoz 2, Edificio 2 10 mg COMPRIMIDOS Pozuelo de Alarcon RECUBIERTOS CON Madrid 28223 PELICULA EFG 10 mg Film - coated Oral use tablet Spain Spain Laboratorios Combix, S.L.U. Escitalopram ESCITALOPRAM COMBIX C/ Badajoz 2, Edificio 2 15 mg COMPRIMIDOS Pozuelo de Alarcon RECUBIERTOS CON Madrid 28223 PELICULA EFG 15 mg Film - coated Oral use tablet Spain GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 102/133 Member State Marketing Authorisation (in EEA) Holder Spain Laboratorios Combix, S.L.U. INN Escitalopram Invented name ESCITALOPRAM COMBIX C/ Badajoz 2, Edificio 2 20 mg COMPRIMIDOS Pozuelo de Alarcon RECUBIERTOS CON Madrid 28223 PELICULA EFG Strength 20 mg Pharmaceutical Route of Form administration Film - coated Oral use tablet Spain Spain Laboratorios Combix, S.L.U. Escitalopram ESCITALOPRAM COMBIX 5 C/ Badajoz 2, Edificio 2 mg COMPRIMIDOS Pozuelo de Alarcon RECUBIERTOS CON Madrid 28223 PELICULA EFG 5 mg Film - coated Oral use tablet Spain Spain Laboratorios Ranbaxy, S. L U. Alendronic acid ACIDO ALENDRONICO Paseig de Gracia 9 SEMANAL RANBAXY 70 mg 7a Pl COMPRIMIDOS EFG 70 mg Tablet Oral use 10 mg Orodispersible Oral use Barcelona 08007 Spain Spain Mylan Pharmaceuticals, S.L. Donepezil Plom 2-4, 5º Planta PHARMACEUTICALS 10 mg 8038 Barcelona COMPRIMIDOS Spain Spain Spain DONEPEZILO FLAS MYLAN Mylan Pharmaceuticals, S.L. BUCODISPERSABLES EFG Donepezil DONEPEZILO FLAS MYLAN Plom 2-4, 5º Planta PHARMACEUTICALS 5 mg 8038 Barcelona COMPRIMIDOS Spain BUCODISPERSABLES EFG Mylan Pharmaceuticals, S.L. tablet Esomeprazole ESOMEPRAZOL MYLAN 20 Plom 2-4, 5º Planta mg CAPSULAS 8038 Barcelona GASTRORRESISTENTES Spain EFG GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 5 mg Orodispersible Oral use tablet 20 mg Gastro - resistant Oral use capsule Page 103/133 Member State Marketing Authorisation (in EEA) Holder Spain Mylan Pharmaceuticals, S.L. INN Esomeprazole ESOMEPRAZOL MYLAN 40 Plom 2-4, 5º Planta mg CAPSULAS 8038 Barcelona GASTRORRESISTENTES Spain Spain Invented name Mylan Pharmaceuticals, S.L. Strength 40 mg Pharmaceutical Route of Form administration Gastro - resistant Oral use capsule EFG Repaglinide Plom 2-4, 5º Planta REPAGLINIDA MYLAN 0,5 0,5 mg Tablet Oral use 1 mg Tablet Oral use 2 mg Tablet Oral use 10 mg Orodispersible Oral use mg COMPRIMIDOS EFG 8038 Barcelona Spain Spain Mylan Pharmaceuticals, S.L. Repaglinide Plom 2-4, 5º Planta REPAGLINIDA MYLAN 1 mg COMPRIMIDOS EFG 8038 Barcelona Spain Spain Mylan Pharmaceuticals, S.L. Repaglinide Plom 2-4, 5º Planta REPAGLINIDA MYLAN 2 mg COMPRIMIDOS EFG 8038 Barcelona Spain Spain Mylan Pharmaceuticals, S.L. Rizatriptan RIZATRIPTAN MAX MYLAN Plom 2-4, 5º Planta 10 mg COMPRIMIDOS 8038 Barcelona BUCODISPERSABLES EFG tablet Spain Spain PENSA PHARMA, S.A.U Alendronic acid ACIDO ALENDRONICO Jorge Comín (médico SEMANAL PENSA 70 mg pediatra) COMPRIMIDOS EFG 70 mg Tablet Oral use 3 - bajos 46015– Valencia (Valencia) Spain GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 104/133 Member State Marketing Authorisation (in EEA) Holder Spain Pharmagenus, S.A., INN Desloratadine Invented name DESLORATADINA Avda. Camí Real, 51-57, PHARMAGENUS 2,5 mg 08184 Palau-solita i COMPRIMIDOS Plegamans (Barcelona) BUCODISPERSABLES EFG Strength 2,5 mg Pharmaceutical Route of Form administration Orodispersible Oral use tablet Spain Spain Pharmagenus, S.A., Desloratadine DESLORATADINA Avda. Camí Real, 51-57, PHARMAGENUS 5 mg 08184 Palau-solita i COMPRIMIDOS Plegamans (Barcelona) BUCODISPERSABLES EFG 5 mg Orodispersible Oral use tablet Spain Spain Teva Pharma S.L.U. Desloratadine DESLORATADINA TEVA 5 C/ Anabel Segura, 11 mg COMPRIMIDOS Edificio Albatros B, 1ª planta BUCODISPERSABLES EFG 5 mg Orodispersible Oral use tablet Madrid 28108 Spain Spain Welding GmbH & Co. KG Irbesartan IRBESARTAN/HIDROCLOR 150 Film - coated Esplanade 39 OTIAZIDA WELDING 150 mg/12,5 tablet D-20354 Hamburg mg/12.5 mg mg Germany COMPRIMIDOS Oral use RECUBIERTOS CON PELICULA EFG Spain Welding GmbH & Co. KG Irbesartan IRBESARTAN/HIDROCLOR 300 Film - coated Esplanade 39 OTIAZIDA WELDING 300 mg/12,5 tablet D-20354 Hamburg mg/12.5 mg mg Germany COMPRIMIDOS Oral use RECUBIERTOS CON PELICULA EFG GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 105/133 Member State Marketing Authorisation (in EEA) Holder Spain Welding GmbH & Co. KG INN Irbesartan Invented name Strength Pharmaceutical Route of Form administration Oral use IRBESARTAN/HIDROCLOR 300 mg/25 Film - coated Esplanade 39 OTIAZIDA WELDING 300 mg tablet D-20354 Hamburg mg/25 mg COMPRIMIDOS Germany RECUBIERTOS CON 70 mg Tablet Oral use Clindamycin Alternova 150 mg Capsule, hard Oral use Fluconazole Fluconazol Bluefish 50 mg Capsule, hard Oral use Fluconazole Fluconazol Bluefish 150 mg Capsule, hard Oral use Fluconazole Fluconazol Bluefish 200 mg Capsule, hard Oral use PELICULA EFG Sweden Accord Healthcare Limited Alendronic acid Sage House, 319 Pinner Road Alendronat Accord Veckotablett North Harrow HA1 4HF Middlesex United Kingdom Sweden Alternova A/S Clindamycin Lodshusvej 11 hydrochloride DK-4230 Skælskør Denmark Sweden Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden Sweden Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden Sweden Bluefish Pharmaceuticals AB Torsgatan 11 SE-11123 Stockholm Sweden GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 106/133 Member State Marketing Authorisation (in EEA) Holder Sweden Generics (UK) Ltd Donepezil Station Close, Potters Bar hydrochloride INN Invented name Donezil Strength 5 mg Pharmaceutical Route of Form administration Orodispersible Oral use tablet Hertfordshire, EN6 1TL United Kingdom Sweden Generics (UK) Ltd Donepezil Station Close, Potters Bar hydrochloride Donezil 10 mg Orodispersible Oral use tablet Hertfordshire, EN6 1TL United Kingdom Sweden Mylan AB Donepezil Donepezil Mylan 5 mg PO Box 230 33 Orodispersible Oral use tablet SE-104 35 Stockholm Sweden Sweden Mylan AB Donepezil Donepezil Mylan 10 mg PO Box 230 33 Orodispersible Oral use tablet SE-104 35 Stockholm Sweden Sweden Mylan AB Rizatriptan Rizatriptan Mylan 10 mg PO Box 230 33 Orodispersible Oral use tablet 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 GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 107/133 Member State Marketing Authorisation (in EEA) Holder Sweden Mylan AB INN Invented name Strength Pharmaceutical Route of Form administration Repaglinide Repaglinid Mylan 1 mg Tablet Oral use Repaglinide Repaglinid Mylan 2 mg Tablet Oral use Esomeprazole Esomeprazol Mylan 20 mg Gastro - resistant Oral use PO Box 230 33 SE-104 35 Stockholm Sweden Sweden Mylan AB PO Box 230 33 SE-104 35 Stockholm Sweden Sweden Mylan AB PO Box 230 33 capsule, hard SE-104 35 Stockholm Sweden Sweden Mylan AB Esomeprazole Esomeprazol Mylan 40 mg PO Box 230 33 Gastro - resistant Oral use capsule, hard SE-104 35 Stockholm Sweden Sweden Mylan AB Eletriptan Eletriptan Mylan 20 mg PO Box 230 33 Film - coated Oral use tablet SE-104 35 Stockholm Sweden Sweden Mylan AB Eletriptan Eletriptan Mylan PO Box 230 33 40 mg Film - coated Oral use tablet SE-104 35 Stockholm Sweden GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 108/133 Member State Marketing Authorisation (in EEA) Holder Sweden Orion Corporation INN Valsartan Invented name Valsartan Orion Strength 40 mg Orion Pharma Pharmaceutical Route of Form administration Film - coated Oral use tablet PO BOX 65 02101 Espoo Finland Sweden Orion Corporation Valsartan Valsartan Orion 80 mg Orion Pharma Film - coated Oral use tablet PO BOX 65 02101 Espoo Finland Sweden Orion Corporation Valsartan Valsartan Orion 160 mg Orion Pharma Film - coated Oral use tablet PO BOX 65 02101 Espoo Finland Sweden Orion Corporation Valsartan Valsartan Orion 320 mg Orion Pharma Film - coated Oral use tablet PO BOX 65 02101 Espoo Finland Sweden Ranbaxy UK Ltd. Alendronic acid Alendronat Ranbaxy Building 4, Chiswick Park Veckotablett 70 mg 566 Chiswick High Road tabletter 70 mg Tablet Oral use London, W4 5YE Untied Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 109/133 Member State Marketing Authorisation (in EEA) Holder Sweden Stada Arzneimittel AG INN Entacapone Invented name Entakapon STADA Strength 200 mg Stadastrasse 2-18 Pharmaceutical Route of Form administration Film - coated Oral use tablet DE-61118 Bad Vilbel Germany The Accord Healthcare Limited Netherlands Sage House, 319 Pinner Road Ropinirole Ropinirol Accord 5 mg, 5 mg filmomhulde tabletten Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom The Accord Healthcare Limited Netherlands Sage House, 319 Pinner Road Ropinirole Ropinirol Accord 0,25 mg 0,25 mg filmomhulde tabletten Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom The Accord Healthcare Limited Netherlands Sage House, 319 Pinner Road Ropinirole Ropinirol Accord 0,5 mg 0,5 mg filmomhulde tabletten Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom The Accord Healthcare Limited Netherlands Sage House, 319 Pinner Road Ropinirole Ropinirol Accord 1 mg filmomhulde tabletten 1 mg Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 110/133 Member State Marketing Authorisation (in EEA) Holder The Accord Healthcare Limited Netherlands Sage House, 319 Pinner Road INN Ropinirole Invented name Ropinirol Accord 2 mg Strength 2 mg filmomhulde tabletten Pharmaceutical Route of Form administration Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom The Accord Healthcare Limited Netherlands Sage House, 319 Pinner Road Alendronic acid Alendroninezuur Accord 10 mg Tablet Oral use 70 mg Tablet Oral use 10 mg Tablet Oral use 37,5 mg Prolonged - Oral use 10mg Tabletten North Harrow HA1 4HF Middlesex United Kingdom The Accord Healthcare Limited Netherlands Sage House, 319 Pinner Road Alendronic acid Alendroninezuur Accord 70mg Tabletten North Harrow HA1 4HF Middlesex United Kingdom The Accord Healthcare Limited Metoclopramide Metoclopramidemonohydro Netherlands Sage House, 319 Pinner Road hydrochloride chloride Accord 10 mg, North Harrow HA1 4HF Tabletten Middlesex United Kingdom The Alembic Pharmaceuticals Netherlands Europe Limited Alembic 37,5 mg, capsule release capsule, Palazzo Pietro Stiges, 103, met verlengde afgifte, hard hard Venlafaxine Venlafaxine HCl Retard Strait Street VLT 1436 Valletta Malta GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 111/133 Member State Marketing Authorisation (in EEA) Holder The Alembic Pharmaceuticals Netherlands Europe Limited Alembic 75 mg, capsule release capsule, Palazzo Pietro Stiges, 103, met verlengde afgifte, hard hard INN Venlafaxine Invented name Venlafaxine HCl Retard Strength 75 mg Pharmaceutical Route of Form administration Prolonged - Oral use Strait Street VLT 1436 Valletta Malta The Alembic Pharmaceuticals Netherlands Europe Limited Venlafaxine Venlafaxine HCl Retard Alembic 150 mg, capsule 150 mg Prolonged release capsule, Palazzo Pietro Stiges, 103, met verlengde afgifte, hard hard Oral use Strait Street VLT 1436 Valletta Malta The Brown & Burk UK, Ltd. Ebastine Ebastine BB 10 mg Netherlands 5, Marryat Close orodispergeerbare Hounslow tabletten 10 mg Orodispersible Oral use tablet TW4 5DQ Middlesex United Kingdom The Centrafarm B.V. Netherlands Nieuwe Donk 3 Entacapone Entacapone CF 200 mg, 200 mg filmomhulde tablet Film - coated Oral use tablet 4879 AC Etten Leur The Netherlands The Fair-Med Healthcare GmbH Netherlands Planckstrasse 13 Ciprofloxacin Ciprofloxacine Fair-Med 250 mg, filmomhulde DE-22765 Hamburg tabletten 250 mg Film - coated Oral use tablet Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 112/133 Member State Marketing Authorisation (in EEA) Holder The Fair-Med Healthcare GmbH Netherlands Planckstrasse 13 500 mg, filmomhulde DE-22765 Hamburg tabletten INN Ciprofloxacin Invented name Ciprofloxacine Fair-Med Strength 500 mg Pharmaceutical Route of Form administration Film - coated Oral use tablet Germany The Fair-Med Healthcare GmbH Ciprofloxacin Ciprofloxacine Fair-Med Netherlands Planckstrasse 13 750 mg, filmomhulde DE-22765 Hamburg tabletten 750 mg Film - coated Oral use tablet Germany The Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/HCTZ Fair-Med 160 Film - coated Netherlands Planckstrasse 13 orothiazide 160 mg/12,5 mg, mg/12,5 tablet filmomhulde tabletten mg DE-22765 Hamburg Oral use Germany The Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/HCTZ Fair-Med 320 Film - coated Netherlands Planckstrasse 13 orothiazide 320 mg/12,5 mg, mg/12,5 tablet filmomhulde tabletten mg DE-22765 Hamburg Oral use Germany The Fair-Med Healthcare GmbH Valsartan/hydrochl Valsartan/HCTZ Fair-Med 320 mg/25 Film - coated Netherlands Planckstrasse 13 orothiazide 320 mg/25 mg, mg tablet 37,5 mg Prolonged - DE-22765 Hamburg Oral use filmomhulde tabletten Germany The Fair-Med Healthcare GmbH Venlafaxine Venlafaxine Fair-Med 37,5 Netherlands Planckstrasse 13 mg capsules met verlengde release capsule, DE-22765 Hamburg afgifte, hard hard Oral use Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 113/133 Member State Marketing Authorisation (in EEA) Holder The Fair-Med Healthcare GmbH Netherlands Planckstrasse 13 mg capsules met verlengde release capsule, DE-22765 Hamburg afgifte, hard hard INN Venlafaxine Invented name Venlafaxine Fair-Med 75 Strength 75 mg Pharmaceutical Route of Form administration Prolonged - Oral use Germany The Fair-Med Healthcare GmbH Venlafaxine Venlafaxine Fair-Med 150 150 mg Prolonged - Netherlands Planckstrasse 13 mg capsules met verlengde release capsule, DE-22765 Hamburg afgifte, hard hard Oral use Germany The Mylan B.V. Esomeprazole Esomeprazol Mylan 20 mg, Netherlands Dieselweg 25 maagsapresistente 3752 LB Bunschoten capsules, hard 20 mg Gastro - resistant Oral use capsule, hard The Netherlands The Mylan B.V. Netherlands Dieselweg 25 Esomeprazole Esomeprazol Mylan 40 mg, maagsapresistente 3752 LB Bunschoten capsules, hard 40 mg Gastro - resistant Oral use capsule, hard The Netherlands The Mylan B.V. Netherlands Dieselweg 25 Rizatriptan Rizatriptan SmeltTab Mylan 5 mg, orodispergeerbare 3752 LB Bunschoten tabletten 5 mg Orodispersible Oral use tablet The Netherlands The Mylan B.V. Rizatriptan Rizatriptan SmeltTab Mylan Netherlands Dieselweg 25 10 mg, orodispergeerbare 3752 LB Bunschoten tabletten 10 mg Orodispersible Oral use tablet The Netherlands GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 114/133 Member State Marketing Authorisation (in EEA) Holder The Ranbaxy UK Ltd. Netherlands Building 4, Chiswick Park INN Alendronic acid Invented name Alendroninezuur 70 Pharmaceutical Route of Form administration 70 mg Tablet Oral use 0,5 mg Tablet Oral use 2 mg Tablet Oral use 10 mg Tablet Oral use 2,5 mg Orodispersible Oral use Strength Ranbaxy, tabletten 70 mg 566 Chiswick High Road London, W4 5YE Untied Kingdom The Sandoz B.V. Netherlands Veluwezoom 22 Clonazepam Clonazepam Sandoz 0,5 mg, tabletten 1327 AH Almere The Netherlands The Sandoz B.V. Netherlands Veluwezoom 22 Clonazepam Clonazepam Sandoz 2 mg, tabletten 1327 AH Almere The Netherlands The Sandoz B.V. Netherlands Veluwezoom 22 Clobazam Clobazam Sandoz 10 mg, tabletten 1327 AH Almere The Netherlands The Teva Nederland B.V. Desloratadine Netherlands Swensweg 5 2,5 mg Teva, 2031 GA Haarlem orodispergeerbare The Netherlands Desloratadine Smelttablet tablet tabletten The Teva Nederland B.V. Desloratadine Desloratadine Smelttablet Netherlands Swensweg 5 5 mg Teva, 2031 GA Haarlem orodispergeerbare The Netherlands tabletten GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 5 mg Orodispersible Oral use tablet Page 115/133 Member State Marketing Authorisation (in EEA) Holder The TioFarma b.v. Netherlands Benjamin Franklinstraat 5-10 INN Clonazepam Invented name Clonazepam TioFarma 0,5 Pharmaceutical Route of Form administration 0,5 mg Tablet Oral use 2 mg Tablet Oral use 10 mg Tablet Oral use 20 mg Tablet Oral use 75 mg Film - coated Oral use Strength mg tabletten, tabletten 3261 LW Oud-Beyerland The Netherlands The TioFarma b.v. Netherlands Benjamin Franklinstraat 5-10 Clonazepam Clonazepam TioFarma 2 mg tabletten, tabletten 3261 LW Oud-Beyerland The Netherlands The TioFarma b.v. Netherlands Benjamin Franklinstraat 5-10 Clobazam Clobazam TioFarma 10 mg, tabletten 3261 LW Oud-Beyerland The Netherlands The TioFarma b.v. Netherlands Benjamin Franklinstraat 5-10 Clobazam Clobazam TioFarma 20 mg, tabletten 3261 LW Oud-Beyerland The Netherlands The Torrent Pharma GmbH Netherlands Südwestpark 50 irbesartan Irbesartan Torrent 75 mg filmomhulde tabletten tablet 90449 Nürnberg Germany The Torrent Pharma GmbH Netherlands Südwestpark 50 irbesartan Irbesartan Torrent 150 mg filmomhulde tabletten 150 mg Film - coated Oral use tablet 90449 Nürnberg Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 116/133 Member State Marketing Authorisation (in EEA) Holder The Torrent Pharma GmbH Netherlands Südwestpark 50 INN irbesartan Invented name Irbesartan Torrent 300 mg Strength 300 mg filmomhulde tabletten Pharmaceutical Route of Form administration Film - coated Oral use tablet 90449 Nürnberg Germany The Torrent Pharma GmbH Irbesartan/hydroch Irbesartan 150 Film - coated Netherlands Südwestpark 50 lorothiazide Hydrochloorthiazide mg/12,5 tablet Torrent 150 mg/12,5 mg mg 90449 Nürnberg Germany filmomhulde tabletten The Torrent Pharma GmbH Irbesartan/hydroch Irbesartan 300 Film - coated Netherlands Südwestpark 50 lorothiazide tablet Hydrochloorthiazide mg/12,5 90449 Nürnberg Torrent 300 mg/12,5 mg mg Germany filmomhulde tabletten The Torrent Pharma GmbH Irbesartan/hydroch Irbesartan 300 mg/25 Film - coated Netherlands Südwestpark 50 lorothiazide Hydrochloorthiazide mg tablet 150 mg Film - coated 90449 Nürnberg Torrent 300 mg/25 mg Germany filmomhulde tabletten The Unichem Laboratories Ltd. Netherlands Studio 8B Ard Gaoithe Oral use irbesartan Irbesartan Unichem 150 mg filmomhulde tabletten Oral use Oral use Oral use tablet Commercial Centre, Business Park Cashel Road Clonmel, Co Tipperary Ireland GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 117/133 Member State Marketing Authorisation (in EEA) Holder The Unichem Laboratories Ltd. Netherlands Studio 8B Ard Gaoithe INN irbesartan Invented name Irbesartan Unichem 300 Strength 300 mg mg filmomhulde tabletten Pharmaceutical Route of Form administration Film - coated Oral use tablet Commercial Centre, Business Park Cashel Road Clonmel, Co Tipperary Ireland United Accord Healthcare Limited Kingdom Sage House, 319 Pinner Road Ropinirole Ropinirole 0.25mg film- 0,25 mg coated tablets Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom United Accord Healthcare Limited Kingdom Sage House, 319 Pinner Road Ropinirole Ropinirole 0.5mg film- 0,5 mg coated tablets Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom United Accord Healthcare Limited Kingdom Sage House, 319 Pinner Road Ropinirole Ropinirole 1mg film-coated 1 mg tablets Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom United Accord Healthcare Limited Kingdom Sage House, 319 Pinner Road Ropinirole Ropinirole 2mg film-coated tablets 2 mg Film - coated Oral use tablet North Harrow HA1 4HF Middlesex United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 118/133 Member State Marketing Authorisation (in EEA) Holder United Accord Healthcare Limited Kingdom Sage House, 319 Pinner Road INN Alendronic acid Invented name alendronic acid 10mg Pharmaceutical Route of Form administration 10 mg Tablet Oral use 70 mg Tablet Oral use 10 mg Tablet Oral use 5 mg Film - coated Oral use Strength Tablets North Harrow HA1 4HF Middlesex United Kingdom United Accord Healthcare Limited Kingdom Sage House, 319 Pinner Road Alendronic acid alendronic acid 70mg Once Daily Tablets North Harrow HA1 4HF Middlesex United Kingdom United Accord Healthcare Limited Metoclopramide metoclopramide Kingdom Sage House, 319 Pinner Road hydrochloride hydrochloride 10mg tablets Ropinirole Ropinirole 5mg film-coated North Harrow HA1 4HF Middlesex United Kingdom United Accord Healthcare Limited Kingdom Sage House, 319 Pinner Road tablets tablet North Harrow HA1 4HF Middlesex United Kingdom United Aptil Pharma Limited Kingdom 9th Floor, CP House Fluconazole Fluconazole 50mg capsules 50 mg Capsule, hard Oral use 97-107 Uxbridge Road London W5 5TL United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 119/133 Member State Marketing Authorisation (in EEA) Holder United Aptil Pharma Limited Kingdom 9th Floor, CP House INN Fluconazole Pharmaceutical Route of Form administration 150 mg Capsule, hard Oral use 200 mg Capsule, hard Oral use 2 mg Tablet Oral use Tyvera 50mg Tablets 50 mg Tablet Oral use Tyvera 100mg Tablets 100 mg Tablet Oral use Invented name Fluconazole 150mg Strength capsules 97-107 Uxbridge Road London W5 5TL United Kingdom United Aptil Pharma Limited Kingdom 9th Floor, CP House Fluconazole Fluconazole 200mg capsules 97-107 Uxbridge Road London W5 5TL United Kingdom United Auden McKenzie Limited Kingdom McKenzie House Dexamethasone Dexamethasone 2mg Tablets Bury Street, Ruislip Middlesex HA4 7TL United Kingdom United Auden McKenzie Limited Thiamine Kingdom McKenzie House hydrochloride Bury Street, Ruislip Middlesex HA4 7TL United Kingdom United Auden McKenzie Limited Thiamine Kingdom McKenzie House hydrochloride Bury Street, Ruislip Middlesex HA4 7TL United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 120/133 Member State Marketing Authorisation (in EEA) Holder United Auden McKenzie Limited Kingdom McKenzie House INN Clonazepam Invented name Clonazepam 500mcg Pharmaceutical Route of Form administration 0,5 mg Tablet Oral use Strength Tablet Bury Street, Ruislip Middlesex HA4 7TL United Kingdom United Auden McKenzie Limited Kingdom McKenzie House Clonazepam Clonazepam 2mg Tablet 2 mg Tablet Oral use Clonazepam Clonazepam 10mg Tablet 10 mg Tablet Oral use 250 mg Film - coated Oral use Bury Street, Ruislip Middlesex HA4 7TL United Kingdom United Auden McKenzie Limited Kingdom McKenzie House Bury Street, Ruislip Middlesex HA4 7TL United Kingdom United Brown & Burk UK, Ltd. Phenoxymethyl Phenoxymethylpenicillin 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- Kingdom 5, Marryat Close oxalate coated tablets 5 mg Film - coated Oral use tablet Hounslow TW4 5DQ Middlesex United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 121/133 Member State Marketing Authorisation (in EEA) Holder United Brown & Burk UK, Ltd. Escitalopram Escitalopram 10mg Film- Kingdom 5, Marryat Close oxalate coated tablets INN Invented name Strength 10 mg Pharmaceutical Route of Form administration Film - coated Oral use tablet Hounslow TW4 5DQ Middlesex United Kingdom United Brown & Burk UK, Ltd. Escitalopram Escitalopram 15mg Film- Kingdom 5, Marryat Close oxalate coated tablets 15 mg Film - coated Oral use tablet Hounslow TW4 5DQ Middlesex United Kingdom United Brown & Burk UK, Ltd. Escitalopram Escitalopram 20mg Film- Kingdom 5, Marryat Close oxalate coated tablets 20 mg Film - coated Oral use tablet Hounslow TW4 5DQ Middlesex United Kingdom United Brown & Burk UK, Ltd. Tramadol Aceon 100mg Prolonged- Kingdom 5, Marryat Close hydrochloride release tablets 100 mg Prolonged - Oral use release tablet Hounslow TW4 5DQ Middlesex United Kingdom United Brown & Burk UK, Ltd. Tramadol Aceon 150mg Prolonged- Kingdom 5, Marryat Close hydrochloride release tablets 150 mg Prolonged - Oral use release tablet Hounslow TW4 5DQ Middlesex United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 122/133 Member State Marketing Authorisation (in EEA) Holder United Brown & Burk UK, Ltd. Tramadol Aceon 200mg Prolonged- Kingdom 5, Marryat Close hydrochloride release tablets Valsartan Valsartan 40mg Capsules 40 mg Capsule Oral use Valsartan Valsartan 80mg Capsules 80 mg Capsule Oral use Valsartan Valsartan 160mg Capsules 160 mg Capsule Oral use Valsartan Valsartan 320mg Capsules 320 mg Capsule Oral use INN Invented name Strength 200 mg Pharmaceutical Route of Form administration Prolonged - Oral use release tablet Hounslow TW4 5DQ Middlesex United Kingdom United Dr Reddy's Laboratories (UK) Kingdom Limited 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Kingdom Limited 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Kingdom Limited 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Kingdom Limited 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 123/133 Member State Marketing Authorisation (in EEA) Holder United Dr Reddy's Laboratories (UK) Kingdom Limited INN Levetiracetam Invented name Levetiracetam 250mg film- Strength 250 mg coated tablets Pharmaceutical Route of Form administration Film - coated Oral use tablet 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Kingdom Limited Levetiracetam Levetiracetam 500mg film- 500 mg coated tablets Film - coated Oral use tablet 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Kingdom Limited Levetiracetam Levetiracetam 750mg film- 750 mg coated tablets Film - coated Oral use tablet 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Kingdom Limited Levetiracetam Levetiracetam 1000mg 1000 mg film-coated tablets Film - coated Oral use tablet 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Kingdom Limited Pioglitazone Pioglitazone 15mg Tablets 15 mg Tablet Oral use 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 124/133 Member State Marketing Authorisation (in EEA) Holder United Dr Reddy's Laboratories (UK) Kingdom Limited INN Invented name Strength Pharmaceutical Route of Form administration Pioglitazone Pioglitazone 30mg Tablets 30 mg Tablet Oral use Pioglitazone Pioglitazone 45mg Tablets 45 mg Tablet Oral use Dipyridamole Attia 200mg Modified 200 mg Modified - release Oral use 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Kingdom Limited 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Kingdom Limited Release Capsules capsule, hard 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Kingdom Limited Telmisartan Telmisartan 20mg Tablets 20 mg Tablet Oral use Telmisartan Telmisartan 40mg Tablets 40 mg Tablet Oral use 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Kingdom Limited 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 125/133 Member State Marketing Authorisation (in EEA) Holder United Dr Reddy's Laboratories (UK) Kingdom Limited INN Invented name Strength Pharmaceutical Route of Form administration Telmisartan Telmisartan 80mg Tablets 80 mg Tablet Oral use Tablet Oral use Tablet Oral use Tablet Oral use Film - coated Oral use 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Telmisartan/ Telmisartan/Hydrochlorothi 40 mg/12,5 Kingdom Limited hydrochlorothiazide azide 40mg/12.5mg mg 6 Riverview Road, Beverley Tablets East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Telmisartan/ Telmisartan/Hydrochlorothi 80 mg/12,5 Kingdom Limited hydrochlorothiazide azide 80mg/12.5mg mg 6 Riverview Road, Beverley Tablets East Yorkshire HU17 0LD United Kingdom United Dr Reddy's Laboratories (UK) Telmisartan/ Telmisartan/Hydrochlorothi 80 mg/25 Kingdom Limited hydrochlorothiazide azide 80mg/25mg Tablets mg irbesartan Irbesartan 75mg Film- 75 mg 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom United Fair-Med Healthcare GmbH Kingdom Planckstrasse 13 coated Tablets tablet DE-22765 Hamburg Germany GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 126/133 Member State Marketing Authorisation (in EEA) Holder United Fair-Med Healthcare GmbH Kingdom Planckstrasse 13 INN irbesartan Invented name Irbesartan 150mg Film- Strength 150 mg coated Tablets Pharmaceutical Route of Form administration Film - coated Oral use tablet DE-22765 Hamburg Germany United Fair-Med Healthcare GmbH Kingdom Planckstrasse 13 irbesartan Irbesartan 300mg Film- 300 mg coated Tablets Film - coated Oral use tablet DE-22765 Hamburg Germany United Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan/Hydrochlorothia 150 Film - coated Kingdom Planckstrasse 13 lorothiazide zide 150mg/12.5mg film- mg/12,5 tablet coated tablets mg DE-22765 Hamburg Oral use Germany United Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan/Hydrochlorothia 300 Film - coated Kingdom Planckstrasse 13 lorothiazide zide 300mg/12.5mg film- mg/12,5 tablet coated tablets mg DE-22765 Hamburg Oral use Germany United Fair-Med Healthcare GmbH Irbesartan/hydroch Irbesartan/Hydrochlorothia 300 mg/25 Film - coated Kingdom Planckstrasse 13 lorothiazide zide 300mg/25mg film- mg tablet 150 mg Capsule, hard DE-22765 Hamburg Oral use coated tablets Germany United Fannin (UK) Ltd Kingdom 42-46 Booth Drive Fluconazole Fluconazole 150mg capsule Oral use Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 127/133 Member State Marketing Authorisation (in EEA) Holder United Fannin (UK) Ltd Kingdom 42-46 Booth Drive INN Fexofenadine Invented name Fexofenadine 120mg film- Strength 120 mg coated tablets Pharmaceutical Route of Form administration Film - coated Oral use tablet Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom United Fannin (UK) Ltd Kingdom 42-46 Booth Drive Fexofenadine Fexofenadine 180mg film- 180 mg coated tablets Film - coated Oral use tablet Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom United FDC Pharma Kingdom Unit 6, Fulcrum 1, Solent Way Amlodipine Amlodipine 5mg Tablets 5 mg Tablet Oral use Amlodipine Amlodipine 10mg Tablets 10 mg Tablet Oral use Repaglinide Repaglinide Mylan 0.5mg 0,5 mg Tablet Oral use Whiteley, Fareham Hampshire PO15 7FE United Kingdom United FDC Pharma Kingdom Unit 6, Fulcrum 1, Solent Way Whiteley, Fareham Hampshire PO15 7FE United Kingdom United Generics (UK) Ltd Kingdom Station Close, Potters Bar Tablets Hertfordshire, EN6 1TL United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 128/133 Member State Marketing Authorisation (in EEA) Holder United Generics (UK) Ltd Kingdom Station Close, Potters Bar INN Repaglinide Invented name Repaglinide Mylan 1mg Pharmaceutical Route of Form administration 1 mg Tablet Oral use 2 mg Tablet Oral use 5 mg Orodispersible Oral use Strength Tablets Hertfordshire, EN6 1TL United Kingdom United Generics (UK) Ltd Kingdom Station Close, Potters Bar Repaglinide Repaglinide Mylan 2mg Tablets Hertfordshire, EN6 1TL United Kingdom United Generics (UK) Ltd Donepezil Donepezil Hydrochloride Kingdom Station Close, Potters Bar hydrochloride 5mg Orodispersible Tables tablet Hertfordshire, EN6 1TL United Kingdom United Generics (UK) Ltd Donepezil Donepezil Hydrochloride Kingdom Station Close, Potters Bar hydrochloride 10mg Orodispersible Hertfordshire, EN6 1TL 10 mg Orodispersible Oral use tablet Tables United Kingdom United Generics (UK) Ltd Rizatriptan Rizatriptan 10mg Kingdom Station Close, Potters Bar benzoate Orodispersible Tablet Generics (UK) Ltd Esomeprazole Esomeprazole 20mg Station Close, Potters Bar magnesium 10 mg Orodispersible Oral use tablet Hertfordshire, EN6 1TL United Kingdom United Kingdom Hertfordshire, EN6 1TL Gastro-resistant Capsules, 20 mg Gastro - resistant Oral use capsule hard United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 129/133 Member State Marketing Authorisation (in EEA) Holder United Generics (UK) Ltd Esomeprazole Kingdom Station Close, Potters Bar magnesium INN Hertfordshire, EN6 1TL Invented name Esomeprazole 40mg Strength 40 mg Gastro-resistant Capsules, Pharmaceutical Route of Form administration Gastro - resistant Oral use capsule hard United Kingdom United Generics (UK) Ltd Levodopa/carbidop Kingdom Station Close, Potters Bar a/entacapone Hertfordshire, EN6 1TL Levodopa/Carbidopa/Entac 150 Film - coated tablet apone film-coated tablets mg/37,5 150/37.5/200mg mg/200 mg Pantoprazole 20mg Gastro- 20 mg Oral use United Kingdom United Lupin (Europe) Limited Kingdom Victoria Court, Bexton Road Pantoprazole Resistant tablets Gastro - resistant Oral use tablet Knutsford, Cheshire WA16 0PF United Kingdom United Lupin (Europe) Limited Kingdom Victoria Court, Bexton Road Pantoprazole Pantoprazole 40mg Gastro- 40 mg Resistant tablets Gastro - resistant Oral use tablet Knutsford, Cheshire WA16 0PF United Kingdom United Morningside Healthcare Phenoxymethyl Phenoxymethylpenicillin Kingdom Limited penicillin 250mg Film-coated Tablets 250 mg Film - coated Oral use tablet 115 Narborough Road Leicester, LE3 0PA United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 130/133 Member State Marketing Authorisation (in EEA) Holder United Morningside Healthcare Metformin Bolamyn/Metabet SR Kingdom Limited hydrochloride 1000mg Prolonged Release INN 115 Narborough Road Invented name Strength 1000 mg Pharmaceutical Route of Form administration Prolonged - Oral use release tablet Tablets Leicester, LE3 0PA United Kingdom United Niche Generics Limited Kingdom 1 The Cam Centre irbesartan Irbesartan Niche 150mg 150 mg film-coated tablets Film - coated Oral use tablet Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom United Niche Generics Limited Kingdom 1 The Cam Centre irbesartan Irbesartan Niche 150mg 150 mg film-coated tablets Film - coated Oral use tablet Wilbury Way, Hitchin Hertfordshire SG4 0TW United Kingdom United Ranbaxy UK Ltd. Kingdom Building 4, Chiswick Park Alendronic acid Alendronic Acid 70mg 70 mg Tablet Oral use Oral use Tablets 566 Chiswick High Road London, W4 5YE Untied Kingdom United Torrent Pharma GmbH Irbesartan/hydroch Irbesartan 150 Film - coated Kingdom Südwestpark 50 lorothiazide Hydrochlorothiazide mg/12,5 tablet 90449 Nürnberg 150mg/12.5mg Film- mg Germany coated tablets GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 131/133 Member State Marketing Authorisation (in EEA) Holder United Torrent Pharma GmbH Irbesartan/hydroch Irbesartan Kingdom Südwestpark 50 lorothiazide INN 90449 Nürnberg Germany Pharmaceutical Route of Form administration 300 Film - coated Oral use Hydrochlorothiazide mg/12,5 tablet 300mg/12.5mg Film- mg Invented name Strength coated tablets United Torrent Pharma GmbH Irbesartan/hydroch Irbesartan 300 mg/25 Film - coated Kingdom Südwestpark 50 lorothiazide Hydrochlorothiazide mg tablet 75 mg Film - coated 90449 Nürnberg 300mg/25mg Film-coated Germany United Torrent Pharma GmbH Kingdom Südwestpark 50 Oral use tablets irbesartan Irbesartan 75mg Filmcoated tablets Oral use tablet 90449 Nürnberg Germany United Torrent Pharma GmbH Kingdom Südwestpark 50 irbesartan Irbesartan 150mg Film- 150 mg coated tablets Film - coated Oral use tablet 90449 Nürnberg Germany United Torrent Pharma GmbH Kingdom Südwestpark 50 irbesartan Irbesartan 300mg Film- 300 mg coated tablets Film - coated Oral use tablet 90449 Nürnberg Germany United Waymade PLC Venlafaxine Venlasov XL 75mg Modified Kingdom Sovereign House hydrochloride Release Capsules Miles Grat Road, Basildon 75 mg Prolonged - Oral use release capsule, hard Essex SS14 3FR United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 132/133 Member State Marketing Authorisation (in EEA) Holder United Waymade PLC Venlafaxine Venlasov XL 150mg Kingdom Sovereign House hydrochloride Modified Release Capsules INN Invented name Strength 150 mg Pharmaceutical Route of Form administration Prolonged - Oral use release capsule, Miles Grat Road, Basildon hard Essex SS14 3FR United Kingdom United Wockhardt UK Limited Kingdom Ash Road North Clopidogrel Clopidogrel 75mg Film- 75 mg coated Tablets Film - coated Oral use tablet Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom United YJBPort Limited Kingdom 74 Briarwood Drive Hydrocortisone Hydrocortisone 10mg 10 mg Tablet Oral use 20 mg Tablet Oral use Tablets Northwood Hills Middlesex HA6 1PL United Kingdom United YJBPort Limited Kingdom 74 Briarwood Drive Hydrocortisone Hydrocortisone 20mg Tablets Northwood Hills Middlesex HA6 1PL United Kingdom GVK Bio - Products for which the marketing authorisations are recommended for suspension – Rev. 1 EMA/52196/2015 Page 133/133
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