List of nationally authorised medicinal products
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1 13 May 2016 EMA/351661/2016 Procedure Management and Committees Support Active substance: bisoprolol Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is provided the source is acknowledged.
2 Bisoprolol AUROBINDO 5 mg, comprimé pelliculé sécable UK/H/1684/ AUROBINDO PHARMA FRANCE SARL FR Hybrid (Article 10(3) of Bisoprolol AUROBINDO 5 mg, comprimé pelliculé sécable UK/H/1684/ AUROBINDO PHARMA FRANCE SARL FR Hybrid (Article 10(3) of Bisoprolol AUROBINDO 5 mg, comprimé pelliculé sécable UK/H/1684/ AUROBINDO PHARMA FRANCE SARL FR Hybrid (Article 10(3) of Concor COR 1,25 mg filmom obložene tablete SE/H/0184/001 HR-H MERCK D.O.O HR Concor COR 1,25 mg filmom obložene tablete SE/H/0184/001 HR-H MERCK D.O.O HR EMA/351661/2016 Page 2/46
3 Concor COR 1,25 mg filmom obložene tablete SE/H/0184/001 HR-H MERCK D.O.O HR Concor COR 1,25 mg filmom obložene tablete SE/H/0184/001 HR-H MERCK D.O.O HR Concor COR 2,5 mg filmom obložene tablete SE/H/0184/002 HR-H MERCK D.O.O HR Concor COR 2,5 mg filmom obložene tablete SE/H/0184/002 HR-H MERCK D.O.O HR Concor COR 2,5 mg filmom obložene tablete SE/H/0184/002 HR-H MERCK D.O.O HR Concor COR 2,5 mg filmom obložene tablete SE/H/0184/002 HR-H MERCK D.O.O HR EMA/351661/2016 Page 3/46
4 Concor COR 2,5 mg filmom obložene tablete SE/H/0184/002 HR-H MERCK D.O.O HR Concor COR 2,5 mg filmom obložene tablete SE/H/0184/002 HR-H MERCK D.O.O HR Concor COR 2,5 mg filmom obložene tablete SE/H/0184/002 HR-H MERCK D.O.O HR Concor COR 2,5 mg filmom obložene tablete SE/H/0184/002 HR-H MERCK D.O.O HR Emconcor 10 mg Filmtabletten not available BE MERCK N.V.-S.A. BE Concor 10 mg filmcoated tablets not available MERCK A.E. CY EMA/351661/2016 Page 4/46
5 Bisoprolol Merck 3.75 mg film-coated tablets SE/H/0187/ MERCK KGAA SE Bisoprolol Merck 5 mg film-coated tablets SE/H/0187/ MERCK KGAA SE Cardicor 2.5 mg film-coated tablets SE/H/0185/ MERCK KGAA SE EMCONCOR 5 mg επικαλυμμένα με λεπτό υμένιο δισκία SE/H/0187/ / MERCK A.E. GR EMCONCOR 2,5 mg επικαλυμμένα με λεπτό υμένιο δισκία SE/H/0187/ / MERCK A.E. GR Emconcor Minor 2,5 mg comprimés pelliculés SE/H/0184/002 BE MERCK N.V.-S.A. BE EMA/351661/2016 Page 5/46
6 Конкор КОР 2.5 mg филмирани таблетки not available MERCK KGAA BG Конкор КОР 5 mg филмирани таблетки not available MERCK KGAA BG Конкор 10 mg филмирани таблетки not available II-7679/ MERCK KGAA BG Конкор 5 mg филмирани таблетки not available II-7678/ MERCK KGAA BG Concor 5 mg filmcoated tablets not available MERCK A.E. CY Concor COR 10 mg potahované tablety not available 77/028/01-C MERCK KGAA CZ EMA/351661/2016 Page 6/46
7 Concor COR 2,5 mg potahované tablety not available 77/026/01-C MERCK KGAA CZ Concor COR 5 mg potahované tablety not available 77/027/01-C MERCK KGAA CZ Concor 10, potahované tablety not available 41/304/89-B/C MERCK KGAA CZ Concor 5, potahované tablety not available 41/304/89-A/C MERCK KGAA CZ Concor 10 mg Filmtabletten not available GMBH DE Emconcor Cor 2,5 mg comprimidos recubiertos con película SE/H/0184/ MERCK KGAA ES EMA/351661/2016 Page 7/46
8 Emconcor Cor 5 mg comprimidos recubiertos con película SE/H/0184/ MERCK KGAA ES Emconcor 10 mg comprimidos recubiertos con película not available MERCK, S.L. ES Emconcor 5 mg comprimidos recubiertos con película not available MERCK, S.L. ES Emconcor CHF 1,25 mg tabletti, kalvopäällysteinen SE/H/0184/ MERCK OY FI EMCONCOR CHF 10 mg tabletti, kalvopäällysteinen SE/H/0184/ MERCK OY FI Emconcor CHF 2,5 mg tabletti, kalvopäällysteinen SE/H/0184/ MERCK OY FI EMA/351661/2016 Page 8/46
9 Emconcor CHF 3,75 mg tabletti, kalvopäällysteinen SE/H/0184/ MERCK OY FI Emconcor CHF 5 mg tabletti, kalvopäällysteinen SE/H/0184/ MERCK OY FI Emconcor CHF 7,5 mg tabletti, kalvopäällysteinen SE/H/0184/ MERCK OY FI Emconcor 10 mg tabletti, kalvopäällysteinen not available MERCK KGAA FI Emconcor 5 mg tabletti, kalvopäällysteinen not available MERCK KGAA FI Congescor 1.25 mg film-coated tablets not available PL 11648/0035 LTD. UK EMA/351661/2016 Page 9/46
10 Cardicor 1.25 mg film-coated tablets SE/H/0184/001 PL 11648/0071 LTD. UK Cardicor 10 mg filmcoated tablets SE/H/0184/006 PL 11648/0076 LTD. UK Congescor 2.5 mg film-coated tablets not available PL 11648/0036 LTD. UK Cardicor 2.5 mg film-coated tablets SE/H/0184/002 PL 11648/0072 LTD. UK Cardicor 3.75 mg film-coated tablets SE/H/0184/003 PL 11648/0073 LTD. UK Cardicor 5 mg filmcoated tablets SE/H/0184/004 PL 11648/0074 LTD. UK EMA/351661/2016 Page 10/46
11 Emcor 10 mg film coated tablets not available PL 11648/0070 LTD. UK Emcor LS 5 mg filmcoated tablets not available PL 11648/0069 LTD. UK CONCOR 10 mg επικαλυμμένα με λεπτό υμένιο δισκία not available 78137/ MERCK A.E. GR CONCOR 5 mg επικαλυμμένα με λεπτό υμένιο δισκία not available 36771/ MERCK A.E. GR Concor COR 1.25 mg filmtabletta not available OGYI-T-8324/01 MERCK KFT. HU Concor COR 1,25 mg filmtabletta not available OGYI-T-8324/02 MERCK KFT. HU EMA/351661/2016 Page 11/46
12 Concor COR 10 mg filmtabletta not available OGYI-T-8324/12 MERCK KFT. HU Concor COR 10 mg filmtabletta not available OGYI-T-8324/11 MERCK KFT. HU Concor COR 2,5 mg filmtabletta not available OGYI-T-8324/04 MERCK KFT. HU Concor COR 2,5 mg filmtabletta not available OGYI-T-8324/03 MERCK KFT. HU Concor 10 mg filmtabletta not available OGYI-T-4015/06 MERCK KFT. HU Concor 10 mg filmtabletta not available OGYI-T-4015/05 MERCK KFT. HU EMA/351661/2016 Page 12/46
13 Concor 10 mg filmtabletta not available OGYI-T-4015/04 MERCK KFT. HU Concor 5 mg filmtabletta not available OGYI-T-4015/03 MERCK KFT. HU Concor 5 mg filmtabletta not available OGYI-T-4015/02 MERCK KFT. HU Concor 5 mg filmtabletta not available OGYI-T-4015/01 MERCK KFT. HU Cardicor 1.25 mg film-coated tablets SE/H/0184/001 PA 654/7/1 LTD. IE Cardicor 10 mg filmcoated tablets SE/H/0184/006 PA 654/7/6 LTD. IE EMA/351661/2016 Page 13/46
14 Cardicor 2.5 mg film-coated tablets SE/H/0184/002 PA 654/7/2 LTD. IE Cardicor 3.75 mg film-coated tablets SE/H/0184/003 PA 654/7/3 LTD. IE Cardicor 5 mg filmcoated tablets SE/H/0184/004 PA 654/7/4 LTD. IE Cardicor 7.5 mg film-coated tablets SE/H/0184/005 PA 654/7/5 LTD. IE Emcor 10 mg filmcoated tablets not available PA 654/12/2 LTD. IE Emcor 5 mg filmcoated tablets not available PA 654/12/1 LTD. IE EMA/351661/2016 Page 14/46
15 Concor COR 2,5 mg apvalkotās tabletes not available MERCK KGAA LV Concor COR 5 mg apvalkotās tabletes not available MERCK KGAA LV Concor 10 mg apvalkotās tabletes not available MERCK KGAA LV Concor 5 mg apvalkotās tabletes not available MERCK KGAA LV EMCORDECO 2,5, filmomhulde tabletten 2,5 mg SE/H/0184/002 RVG MERCK B.V. NL EMCORDECO 7,5, filmomhulde tabletten 7,5 mg SE/H/0184/005 RVG MERCK B.V. NL EMA/351661/2016 Page 15/46
16 Emcor 5, filmomhulde tabletten 5 mg not available RVG MERCK B.V. NL Emconcor CHF 1,25 mg tablett, filmdrasjert SE/H/0184/ MERCK KGAA NO Emconcor CHF 10 mg tablett, filmdrasjert SE/H/0184/ MERCK KGAA NO Emconcor CHF 2.5 mg tablett, filmdrasjert SE/H/0184/ MERCK KGAA NO Emconcor CHF 3.75 mg tablett, filmdrasjert SE/H/0184/ MERCK KGAA NO Emconcor CHF 5 mg tablett, filmdrasjert SE/H/0184/ MERCK KGAA NO EMA/351661/2016 Page 16/46
17 Emconcor 5 mg filmcoated tablets not available MERCK KGAA NO Concor Cor 1,25, 1,25 mg, tabletki powlekane not available 8589 MERCK KGAA PL Concor Cor 10, 10 mg, tabletki powlekane not available 8594 MERCK KGAA PL Concor Cor 2,5, 2,5 mg, tabletki powlekane not available 8590 MERCK KGAA PL Concor Cor 3,75, 3,75 mg, tabletki powlekane not available 8591 MERCK KGAA PL Concor Cor 5, 5 mg, tabletki powlekane not available 8592 MERCK KGAA PL EMA/351661/2016 Page 17/46
18 Concor Cor 7,5, 7,5 mg, tabletki powlekane not available 8593 MERCK KGAA PL Bisopromerck 10; 10 mg tabletki powlekane not available 4895 MERCK KGAA PL Generic (Article 10(1) Concor, 10 mg tabletki powlekane not available R/3735 MERCK KGAA PL Bisopromerck 5; 5 mg tabletki powlekane not available 4894 MERCK KGAA PL Generic (Article 10(1) Concor, 5 mg tabletki powlekane not available R/3734 MERCK KGAA PL Concor IC 2,5 mg comprimidos revestidos por película SE/H/0184/ MERCK, S.A. PT EMA/351661/2016 Page 18/46
19 Concor 10 mg comprimido revestido not available MERCK, S.A. PT Concor 10 mg comprimido revestido not available MERCK, S.A. PT Concor 5 mg comprimido revestido not available MERCK, S.A. PT Concor 5 mg comprimido revestido not available MERCK, S.A. PT CONCOR COR 10 mg comprimate filmate not available 6096/2014/03 MERCK KGAA RO CONCOR COR 10 mg comprimate filmate not available 6096/2014/04 MERCK KGAA RO EMA/351661/2016 Page 19/46
20 CONCOR COR 10 mg comprimate filmate not available 6096/2014/01 MERCK KGAA RO CONCOR COR 10 mg comprimate filmate not available 6096/2014/02 MERCK KGAA RO CONCOR COR 2,5 mg comprimate filmate not available 6094/2014/03 MERCK KGAA RO CONCOR COR 2,5 mg comprimate filmate not available 6094/2014/02 MERCK KGAA RO CONCOR COR 2,5 mg comprimate filmate not available 6094/2014/01 MERCK KGAA RO CONCOR COR 2,5 mg comprimate filmate not available 6094/2014/04 MERCK KGAA RO EMA/351661/2016 Page 20/46
21 CONCOR COR 5 mg comprimate filmate not available 6095/2014/01 MERCK KGAA RO CONCOR COR 5 mg comprimate filmate not available 6095/2014/04 MERCK KGAA RO CONCOR COR 5 mg comprimate filmate not available 6095/2014/03 MERCK KGAA RO CONCOR COR 5 mg comprimate filmate not available 6095/2014/02 MERCK KGAA RO Concor 10 mg comprimate filmate not available 6252/2014/01 MERCK KGAA RO Concor 5 mg comprimate filmate not available 6251/2014/01 MERCK KGAA RO EMA/351661/2016 Page 21/46
22 CARDENSIEL 1,25 mg, comprimé pelliculé SE/H/0184/ MERCK SANTÉ S.A.S. FR CARDENSIEL 10 mg, comprimé pelliculé sécable SE/H/0184/ MERCK SANTÉ S.A.S. FR CARDENSIEL 2,5 mg, comprimé pelliculé sécable SE/H/0184/ MERCK SANTÉ S.A.S. FR CARDENSIEL 3,75 mg, comprimé pelliculé sécable SE/H/0184/ MERCK SANTÉ S.A.S. FR CARDENSIEL 5 mg, comprimé pelliculé sécable SE/H/0184/ MERCK SANTÉ S.A.S. FR CARDENSIEL 7,5 mg, comprimé pelliculé sécable SE/H/0184/ MERCK SANTÉ S.A.S. FR EMA/351661/2016 Page 22/46
23 Bisoprolol Merck 1.25 mg film-coated tablets SE/H/0187/ MERCK KGAA SE Libracor 1.25 mg film-coated tablets SE/H/0186/ MERCK KGAA SE Emconcor CHF 1,25 mg filmdragerade tabletter SE/H/0184/ MERCK KGAA SE Cardicor 1.25 mg film-coated tablets SE/H/0185/ MERCK KGAA SE Emconcor CHF 10 mg filmdragerade tabletter SE/H/0184/ MERCK KGAA SE Bisoprolol Merck 10 mg film-coated tablets SE/H/0187/ MERCK KGAA SE EMA/351661/2016 Page 23/46
24 Libracor 10 mg filmcoated tablets SE/H/0186/ MERCK KGAA SE Cardicor 10 mg filmcoated tablets SE/H/0185/ MERCK KGAA SE Emconcor CHF 2,5 mg filmdragerade tabletter SE/H/0184/ MERCK KGAA SE Bisoprolol Merck 2.5 mg film-coated tablets SE/H/0187/ MERCK KGAA SE Cardicor 5 mg filmcoated tablets SE/H/0185/ MERCK KGAA SE Libracor 2.5 mg filmcoated tablets SE/H/0186/ MERCK KGAA SE EMA/351661/2016 Page 24/46
25 Cardicor 3.75 mg film-coated tablets SE/H/0185/ MERCK KGAA SE Emconcor CHF 3,75 mg filmdragerade tabletter SE/H/0184/ MERCK KGAA SE Libracor 3.75 mg film-coated tablets SE/H/0186/ MERCK KGAA SE Emconcor CHF 5 mg filmdragerade tabletter SE/H/0184/ MERCK KGAA SE Libracor 5 mg filmcoated tablets SE/H/0186/ MERCK KGAA SE Libracor 7.5 mg filmcoated tablets SE/H/0186/ MERCK KGAA SE EMA/351661/2016 Page 25/46
26 Emconcor CHF 7,5 mg filmdragerade tabletter SE/H/0184/ MERCK KGAA SE Cardicor 7.5 mg film-coated tablets SE/H/0185/ MERCK KGAA SE Bisoprolol Merck 7.5 mg film-coated tablets SE/H/0187/ MERCK KGAA SE Emconcor 5 mg filmdragerade tabletter not available MERCK KGAA SE Concor COR 10 mg not available 41/0012/02-S MERCK KGAA SK Concor COR 5 mg not available 41/0011/02-S MERCK KGAA SK EMA/351661/2016 Page 26/46
27 Concor 10 not available 41/0304/89-S MERCK KGAA SK Bisomerck 10 not available 41/0055/03-S MERCK KGAA SK Concor 5 not available 41/0304/89-S MERCK KGAA SK Bisomerck 5 not available 41/0054/03-S MERCK KGAA SK Concor COR 2,5 mg not available 41/0010/02-S MERCK KGAA SK Concor COR 1,25 mg filmsko obložene tablete not available 5363-I-555/12 MERCK D.O.O. SI EMA/351661/2016 Page 27/46
28 Concor COR 10 mg filmsko obložene tablete not available 5363-I-1803/13 MERCK D.O.O. SI Concor COR 2,5 mg filmsko obložene tablete not available 5363-I-26/13 MERCK D.O.O. SI Concor COR 5 mg filmsko obložene tablete not available 5363-I-558/12 MERCK D.O.O. SI Concor COR 7,5 mg filmsko obložene tablete not available 5363-I-1185/12 MERCK D.O.O. SI Concor 10 mg filmsko obložene tablete not available 5363-I-554/12 MERCK D.O.O. SI Concor 5 mg filmsko obložene tablete not available 5363-I-27/13 MERCK D.O.O. SI EMA/351661/2016 Page 28/46
29 CONGESCOR 1,25 mg, compresse filmrivestite SE/H/0186/ /M DAIICHI SANKYO ITALIA S.P.A IT Informed consent (Article 10c of CONGESCOR 2,5 mg, compresse filmrivestite SE/H/0186/ /M DAIICHI SANKYO ITALIA S.P.A IT Informed consent (Article 10c of CONGESCOR 3,75 mg, compresse filmrivestite SE/H/0186/ /M DAIICHI SANKYO ITALIA S.P.A IT Informed consent (Article 10c of CONGESCOR 5 mg, compresse filmrivestite SE/H/0186/ /M DAIICHI SANKYO ITALIA S.P.A IT Informed consent (Article 10c of EMA/351661/2016 Page 29/46
30 CONGESCOR 7,5 mg, compresse filmrivestite SE/H/0186/ /M DAIICHI SANKYO ITALIA S.P.A IT Informed consent (Article 10c of CONGESCOR 10 mg, compresse filmrivestite SE/H/0186/ /M DAIICHI SANKYO ITALIA S.P.A IT Informed consent (Article 10c of Concor Cor 1,25 mg Filmtabletten SE/H/0184/ MERCK GESELLSCHAFT MBH AT Concor Cor 10 mg Filmtabletten SE/H/0184/ MERCK GESELLSCHAFT MBH AT Concor Cor 2,5 mg Filmtabletten SE/H/0184/ MERCK GESELLSCHAFT MBH AT EMA/351661/2016 Page 30/46
31 Concor Cor 3,75 mg Filmtabletten SE/H/0184/ MERCK GESELLSCHAFT MBH AT Concor Cor 5 mg Filmtabletten SE/H/0184/ MERCK GESELLSCHAFT MBH AT Concor Cor 7,5 mg Filmtabletten SE/H/0184/ MERCK GESELLSCHAFT MBH AT Concor 10 mg - Filmtabletten not available MERCK GESELLSCHAFT MBH AT Concor 5 mg - Filmtabletten not available MERCK GESELLSCHAFT MBH AT Concor COR 1,25 mg Filmtabletten SE/H/0184/ GMBH DE EMA/351661/2016 Page 31/46
32 Concor COR 10 mg Filmtabletten SE/H/0184/ GMBH DE Concor COR 2,5 mg Filmtabletten SE/H/0184/ GMBH DE Concor COR 3,75 mg Filmtabletten SE/H/0184/ GMBH DE Concor COR 5 mg Filmtabletten SE/H/0184/ GMBH DE Concor COR 7,5 mg Filmtabletten SE/H/0184/ GMBH DE Concor 5 mg Filmtabletten not available GMBH DE EMA/351661/2016 Page 32/46
33 Cardicor 2,5 mg compresse rivestite con film SE/H/0185/ /M RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. IT Cardicor 3,75 mg compresse rivestite con film SE/H/0185/ /M RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. IT Cardicor 5 mg compresse rivestite con film SE/H/0185/ RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. IT Cardicor 7,5 mg compresse rivestite con film SE/H/0185/ RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. IT Emconcor Mitis 5 mg filmomhulde tabletten not available BE MERCK N.V.-S.A. BE EMA/351661/2016 Page 33/46
34 Sequacor 1,25 mg compresse rivestite con film SE/H/184/ /M BRACCO SPA IT Sequacor 2,5 mg compresse rivestite con film SE/H/184/ /M BRACCO SPA IT Sequacor 3.75 mg compresse rivestite con film SE/H/184/ /M BRACCO SPA IT Sequacor 5 mg compresse rivestite con film SE/H/184/ /M BRACCO SPA IT Sequacor 7,5 mg compresse rivestite con film SE/H/184/ /M BRACCO SPA IT Sequacor 10 mg compresse rivestite con film SE/H/184/ /M BRACCO SPA IT EMA/351661/2016 Page 34/46
35 Isoten 5 mg filmomhulde tabletten SE/H/185/04 BE S.A. MEDA PHARMA N.V. BE Isoten 10 mg filmomhulde tabletten SE/H/185/06 BE S.A. MEDA PHARMA N.V. BE CARDIOCOR 1,25 mg, comprimé pelliculé SE/H/185/ MEDA PHARMA SAS FR CARDIOCOR 2,5 mg, comprimé pelliculé sécable SE/H/185/ MEDA PHARMA SAS FR CARDIOCOR 5 mg, comprimé pelliculé sécable SE/H/185/ MEDA PHARMA SAS FR EMA/351661/2016 Page 35/46
36 BISOPROLOL BIOGARAN 10 mg, comprimé pelliculé sécable not available BIOGARAN FR Bisoprolol Apotex 5 mg filmomhulde tabletten not available BE APOTEX NV BE Informed consent (Article 10c of Bisoprolol Apotex 10 mg filmomhulde tabletten not available BE APOTEX NV BE Bisoprolol 'Arcana' 5 mg - Filmtabletten Arcana Arzneimittel GmbH AT Bisoprolol 'Arcana' 10 mg - Filmtabletten Arcana Arzneimittel GmbH AT CONCOR 10mg compresse Bracco SpA IT EMA/351661/2016 Page 36/46
37 Bisoprolol AUROBINDO 5 mg, comprimé pelliculé sécable UK/H/1684/ AUROBINDO PHARMA FRANCE SARL FR Hybrid (Article 10(3) of Bisoprolol AUROBINDO 5 mg, comprimé pelliculé sécable UK/H/1684/ AUROBINDO PHARMA FRANCE SARL FR Hybrid (Article 10(3) of Bisoprolol AUROBINDO 5 mg, comprimé pelliculé sécable UK/H/1684/ AUROBINDO PHARMA FRANCE SARL FR Hybrid (Article 10(3) of Bisoprolol AUROBINDO 5 mg, comprimé pelliculé sécable UK/H/1684/ AUROBINDO PHARMA FRANCE SARL FR Hybrid (Article 10(3) of Bisoprolol AUROBINDO 5 mg, comprimé pelliculé sécable UK/H/1684/ AUROBINDO PHARMA FRANCE SARL FR Hybrid (Article 10(3) of EMA/351661/2016 Page 37/46
38 Bisoprolol AUROBINDO 5 mg, comprimé pelliculé sécable UK/H/1684/ AUROBINDO PHARMA FRANCE SARL FR Hybrid (Article 10(3) of Concor COR SE/H/0184/ GMBH LU Isoten 2,5 mg SE/H/0185/002 BE Meda PHARMA, Belgium BE Cardicor 1,25 mg compresse rivestite con film SE/H/0185/ /M RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. IT Bisprololfumaraat Deco Mylan 2,5 mg SE/H/0185/002 RVG Mylan B.V. Netherlands NL EMA/351661/2016 Page 38/46
39 Bisprololfumaraat Deco Mylan 10 mg SE/H/0185/006 RVG Mylan B.V. Netherlands NL Bisoce, 1,25 mg SE/H/0186/ , , Mylan, France FR Bisoce, 2,5 mg SE/H/0186/ Mylan, France FR Bisoce, 3,75 mg SE/H/0186/ , , Mylan, France FR Bisoce, 5mg SE/H/0186/ , Mylan, France FR Bisoce, 7,5 mg SE/H/0186/ , Mylan, France FR EMA/351661/2016 Page 39/46
40 Bisoce, 10mg SE/H/0186/ , Mylan, France FR Emconcor 2,5mg SE/H/0187/ CG Papaloisou CY Emconcor 5 mg SE/H/0187/ CG Papaloisou CY BISOPROLOL BGR 1,25 mg comprimé pelliculé sécable SE/H/187/ , BIOGARAN FR Informed consent (Article 10c of BISOPROLOL BGR 2,5 mg comprimé pelliculé sécable SE/H/0187/ , BIOGARAN FR Informed consent (Article 10c of EMA/351661/2016 Page 40/46
41 BISOPROLOL BGR 1,25 mg comprimé pelliculé SE/H/187/04 NL BIOGARAN FR Informed consent (Article 10c of BISOPROLOL BGR 7,5 mg comprimé pelliculé sécable SE/H/187/ , BIOGARAN FR Informed consent (Article 10c of BISOPROLOL BGR 10 mg comprimé pelliculé sécable SE/H/187/05 NL BIOGARAN FR Informed consent (Article 10c of DETENSIEL MERCK SANTÉ S.A.S. FR EMA/351661/2016 Page 41/46
42 Bisoprolol Mylan NL Mylan, France FR Bisoprolol Zentiva 10 mg , , , Sanofi-Aventis, France FR Concor COR 1,25 mg filmtabletta not available OGYI-T-8324/14 MERCK KFT. HU Concor COR 2,5 mg filmtabletta not available OGYI-T-8324/13 MERCK KFT. HU Concor COR 10 mg filmtabletta not available OGYI-T-8324/16 MERCK KFT. HU Concor 10 mg filmtabletta not available OGYI-T-4015/09 MERCK KFT. HU EMA/351661/2016 Page 42/46
43 Concor 10 mg filmtabletta not available OGYI-T-4015/10 MERCK KFT. HU Emcolol 5mg PA 577/38/1 LTD. IE Emcolol 10 mg PA 577/38/2 LTD. IE Bisoprolol 5mg RVG Mylan B.V. Netherlands NL Bisoprolol 10 mg RVG Mylan B.V. Netherlands NL Concor 5 mg not available 1/11/86 MERCK, S.A. PT EMA/351661/2016 Page 43/46
44 Concor 10 mg not available 1/11/86 MERCK, S.A. PT Bisoprololo Zentiva IT/H/0173/001/MRP Zentiva Italia SRL IT Hybrid (Article 10(3) of EMA/351661/2016 Page 44/46
45 Cardicor 7.5mg Filmcoated Tablets SE/H/0184/001/IA/048 PL 11648/0075 LTD. UK Cardicor 10 mg filmcoated tablets SE/H/0185/ /M RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. IT Bisoprolol Sandoz 5 mg , , , , , , , , , , , , , , , , , , , , SANDOZ N.V. LU Hybrid (Article 10(3) of EMA/351661/2016 Page 45/46
46 Bisoprolol Sandoz 10 mg , , , , , , , , , , , , , , , , , , , , , SANDOZ N.V. LU Hybrid (Article 10(3) of EMA/351661/2016 Page 46/46
Please note that this draft Annex I may be updated to reflect further information on concerned products/mahs
2 May 2016 EMA/314147/2016 Corr. 7 Procedure Management and Committees Support Annex I List of the names, pharmaceutical s, strengths of the medicinal products, routes of, marketing authorisat s in the
Name. Priligy 30 mg Filmtabletten. Priligy 60 mg Filmtabletten. Priligy 30 mg filmomhulde tablet. Priligy 60 mg filmomhulde tablet
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 1 Austria Janssen-Cilag Pharma
List of nationally authorised medicinal products
9 July 2015 EMA/483660/2015 Procedure Management and Committees Support Active substance: diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated), haemophilus type b conjugate
Products for which the marketing authorisations are recommended for suspension by the CHMP on 21 May 2015
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