Please note that this draft Annex I may be updated to reflect further information on concerned products/mahs
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1 2 May 2016 EMA/314147/2016 Corr. 7 Procedure Management and Committees Support Annex I List of the names, pharmaceutical s, strengths of the medicinal products, routes of, marketing authorisat s in the member states for which clinical and bioanalytical parts of the bioequivalence studies were pered at the Semler Research Center (SRC) Private Limited located at SRC Private Limited, 75A, 15th Cross, 1st Phase, JP Nagar, Bangalore , Karnataka, India (also known as JP Nagar site) and Semler Research Center (SRC) Private Limited PA Arcade, No 21, 22, 23, Kodigehali Main Road, Sahakaranagar Post, Bangalore , Karnataka, India (also known as Sakar Nagar Clinical site) Article 31 of Directive 2001/83/EC Procedure number: EMEA/H/A-31/1443 Please note that this draft Annex I may be updated to reflect further inat on concerned products/mahs 30 Churchill Place Canary Wharf London E14 5EU Telephone +44 (0) Facsimile +44 (0) Send a quest via our website An agency of the European Un European Medicines Agency, Reproduct is authorised provided the source is acknowledged.
2 Belgium Teva Teva Pharma Belgium NV Belgium Teva Teva Pharma Belgium NV Belgium Malaprotec NV Belgium Malaprotec NV Belgium Saquinavir NV Saquinavir Mesylate 500 mg Film-coated Croatia Denmark Tramadol/Paracetamol PharmaS 37,5 mg/325 mg filmom obložene e Orifarm PharmaS d.o.o. Tramadol/Paracetamol 37.5 mg/325 mg Film-coated Orifarm Generics A/S Denmark ratiopharm ratiopharm GmBH Denmark Horisto A/S Denmark Horisto A/S Denmark Eletriptan Mylan Mylan AB Eletriptan Hydrobromide 40 mg Film-coated EMA/314147/2016 Page 2/11
3 Finland ratiopharm ratiopharm GmbH Finland Rumbabor A/S Finland Rumbabor A/S Finland Eletriptan Mylan Mylan AB Eletriptan Hydrobromide 40 mg Film-coated Amoxicilline Authou Medipha Sante Amoxicilline 1 g Orodispersible ENFANTS Teva ENFANTS Teva Sante Teva Teva Sante EBACHOI Venipharm Ebastine 10 mg Orodispersible EBARREN Venipharm Ebastine 10 mg Film-coated EMA/314147/2016 Page 3/11
4 EBASTINE BIOGARAN Biogaran Ebastine 10 mg Film-coated EBASTINE BIOGARAN Biogaran Ebastine 10 mg Orodispersible EBASTINE MYLAN Mylan SAS Ebastine 10 mg Orodispersible EBASTINE MYLAN Mylan SAS Ebastine 10 mg Film-coated EBASTINE ZENTIVA Sanofi Aventis Ebastine 10 mg Film-coated EBASTINE ZENTIVA Sanofi Aventis Ebastine 10 mg Orodispersible EBONDE Venipharm Ebastine 10 mg Film-coated EBONTAN Venipharm Ebastine 10 mg Orodispersible EBOUDA Venipharm Ebastine 10 mg Film-coated Eletriptan Mylan Mylan SAS Eletriptan Hydrobromide 20 mg Film-coated Eletriptan Mylan Mylan SAS Eletriptan Hydrobromide 40 mg Film-coated EMA/314147/2016 Page 4/11
5 Tramadol/Paracétamol Nialex Tramadol/Paracétamol Zydus Medipha Sante Tramadol/Paracetamol 37.5 mg/325 mg Film-coated Zydus Tramadol/Paracetamol 37.5 mg/325 mg Film-coated Saquinavir HEXAL 500 mg Filmten Hexal Aktiengesellschaft Saquinavir Mesylate 500 mg Film-coated Atovaquon/Proguanilhydroch lorid-ratiopharm 62,5 mg/25 mg Filmten ratiopharm GmbH Atovaquon/Proguanilhydroch ratiopharm GmbH lorid-ratiopharm 250 mg/100 mg Filmten Atovaquon/Proguanilhydroch 1A Pharma GmbH lorid - 1 A Pharma 250 mg/100 mg Filmten Atovaquon/Proguanilhydroch 1A Pharma GmbH lorid - 1 A Pharma 62,5 mg/25 mg Filmten Malacomp HEXAL Hexal Aktiengesellschaft Malacomp HEXAL junior Hexal Aktiengesellschaft Pregabalin-Hormosan 25 mg Hartkapseln Eprosartan Aristo 600 mg Filmten Hormosan Pharma Gesellschaft mit beschränkter Haftung Pregabalin 25 mg Capsule, hard Aristo Pharma GmbH Eprosartan Mesylate 600 mg Film-coated EMA/314147/2016 Page 5/11
6 Celecoxib Glenmark 200 mg Hartkapseln Glenmark Arzneimittel GmbH Celecoxib 200 mg Capsule, hard Celecoxib Glenmark 100 mg Hartkapseln Glenmark Arzneimittel GmbH Celecoxib 100 mg Capsule, hard Iceland Celecoxib LYFIS Lyfis ehf. Celecoxib 100 mg Capsule, hard Iceland Celecoxib LYFIS Lyfis ehf. Celecoxib 200 mg Capsule, hard Italy ATOVAQUONE E PROGUANILE SANDOZ S.p.A. Italy ATOVAQUONE E PROGUANILE SANDOZ S.p.A. Italy SAQUINAVIR SANDOZ S.p.A. Saquinavir Mesylate 500 mg Film-coated Italy ELETRIPTAN MYLAN Mylan S.p.A. Eletriptan Hydrobromide 20 mg Film-coated Italy ELETRIPTAN MYLAN Mylan S.p.A. Eletriptan Hydrobromide 40 mg Film-coated Luxembourg Malaprotec S.A. Luxembourg Malaprotec S.A. EMA/314147/2016 Page 6/11
7 Luxembourg Luxembourg Atovaquon/Proguanilhydroch lorid-ratiopharm 62,5 mg/25 mg Filmten Atovaquon/Proguanilhydroch lorid-ratiopharm 250 mg/100 mg Filmten ratiopharm GmbH ratiopharm GmbH Malta Reprapog 1A Pharma GmbH Malta Reprapog 1A Pharma GmbH Norway Eletriptan Mylan Mylan AB Eletriptan hydrobromide 40 mg Film-coated Norway Eletriptan Mylan Mylan AB Eletriptan Hydrobromide 20 mg Film-coated Norway Orifarm Orifarm Generics A/S Poland Saquinavir GmbH Saquinavir Mesylate 500 mg Film-coated Portugal Eprosartan Hetero Hetero Europe, S.L. Eprosartan Mesylate 600 mg Film-coated Portugal Saquinavir Farmoz Farmoz - Sociedade Saquinavir Mesylate 500 mg Film-coated Técnico Medicinal, S.A. Portugal Pregabalina Lupin Lupin (Europe) Ltd Pregabalin 25 mg Capsule, hard EMA/314147/2016 Page 7/11
8 Spain Spain Spain Spain Spain Atovacuona/Hidrocloruro de Proguanil Teva 250 mg/100 mg comprimidos recubiertos con película EFG Atovacuona/Hidrocloruro de Proguanil 250 mg/100 mg comprimidos recubiertos con película EFG Eprosartan Pensa 600 mg comprimidos recubiertos con película EFG Celecoxib VIR 200 mg cápsulas duras EFG Abacavir/Lamivudina Mylan 600 mg/300 mg comprimidos recubiertos con película EFG Teva Pharma, S.L.U. Farmaceutica, S.A. Pensa Pharma, S.A.U. Industria Química Y Farmacéutica VIR, S.A. Mylan Pharmaceuticals, S.L. Sweden Horisto A/S Eprosartan Mesylate 600 mg Film-coated Celecoxib 200 mg Capsule, hard Abacavir/Lamivudine 600 mg/300 mg Film-coated Sweden Horisto A/S Sweden Eletriptan Mylan Mylan AB Eletriptan Hydrobromide 20 mg Film-coated Sweden Eletriptan Mylan Mylan AB Eletriptan Hydrobromide 40 mg Film-coated Sweden Orifarm Orifarm Generics A/S EMA/314147/2016 Page 8/11
9 Sweden Celecoxib Medical Valley Medical Valley Invest AB Sweden Celecoxib Medical Valley Medical Valley Invest AB Celecoxib 100 mg Capsule, hard Celecoxib 200 mg Capsule, hard Teva Teva Nederland B.V. Teva Teva Nederland B.V. B.V. B.V. B.V. B.V. Saquinavir B.V. Saquinavir Mesylate 500 mg Film-coated Saquinavir B.V. Saquinavir Mesylate 500 mg Film-coated Celecoxib Hetero Hetero Europe, S.L. Celecoxib 100 mg Capsule, hard EMA/314147/2016 Page 9/11
10 Celecoxib Hetero Hetero Europe, S.L. Celecoxib 200 mg Capsule, hard MAFAMOZ 250MG/100MG FILM-COATED TABLETS Teva UK Limited 250 mg/100 mg Tablet MAFAMOZ 62.5MG/25 MG FILM-COATED TABLETS Teva UK Limited 62.5 mg/25 mg Tablet REPRAPOG 62.5 MG/25 MG FILM-COATED TABLETS Limited REPRAPOG 250 MG/100 MG FILM-COATED TABLETS Limited AMOXICILLIN SUGAR FREE 3G POWDER FOR ORAL SUSPENSION SACHETS EPROSARTAN 300 MG FILM- COATED TABLETS Brown & Burk UK Limited Amoxicilline mg Powder for oral suspens Hetero Europe, S.L. Eprosartan Mesylate 300 mg Film-coated EPROSARTAN 400 MG FILM- COATED TABLETS Hetero Europe, S.L. Eprosartan Mesylate 400 mg Film-coated EPROSARTAN 600 MG FILM- COATED TABLETS Hetero Europe, S.L. Eprosartan Mesylate 600 mg Film-coated CELECOXIB CAPSULES, HARD 100MG Bristol Laboratories Limited Celecoxib 100 mg Capsule, hard CELECOXIB CAPSULES, HARD 200MG Bristol Laboratories Limited Celecoxib 200 mg Capsule, hard EMA/314147/2016 Page 10/11
11 Pregabalin Lupin 25mg hard capsules Lupin (Europe) Ltd Pregabalin 25 mg Capsule, hard EMA/314147/2016 Page 11/11
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