List of nationally authorised medicinal products
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1 30 November 2017 EMA/787721/2017 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance(s): carvedilol 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 authorised provided the source is acknowledged.
2 Cardiol 12,5 mg tabletti not available ROCHE OY FI Cardiol 25 mg tabletti not available ROCHE OY FI Cardiol 12,5 mg tabletter not available ROCHE OY FI Cardiol 25 mg tabletter not available ROCHE OY FI Carvedilol - 1 A Pharma 12,5 mg DE/H/1986/ A PHARMA GMBH DE Tabletten Carvedilol - 1 A Pharma 50 mg DE/H/1986/ A PHARMA GMBH DE Tabletten Carvedilol 12.5 mg Tablets - PL 40378/0138 TORRENT PHARMA LTD. UK Carvedilol 12.5mg Tablets not available PL 11311/0482 TILLOMED LABORATORIES LTD UK Carvedilol 25 mg Tablets - PL 40378/0139 TORRENT PHARMA LTD. UK Carvedilol 25mg Tablets not available PL 11311/0483 TILLOMED LABORATORIES LTD UK Carvedilol mg film-coated /H/0588/001 MA807/05901 AUROBINDO PHARMA (MALTA) MT tablets Carvedilol mg Tablets - PL 40378/0136 TORRENT PHARMA LTD. UK Carvedilol 3.125mg Tablets not available PL 11311/0480 TILLOMED LABORATORIES LTD UK Carvedilol 6.25 mg Tablets - PL 40378/0137 TORRENT PHARMA LTD. UK Carvedilol 6.25mg Tablets not available PL 11311/0481 TILLOMED LABORATORIES LTD UK Carvedilol Aurobindo 12,5 mg, not available RVG AUROBINDO PHARMA B.V. NL filmomhulde tabletten Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/02 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/03 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/04 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/05 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/06 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/07 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/08 AUROBINDO PHARMA (MALTA) RO EMA/787721/2017 Page 2/8
3 Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/09 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/10 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/11 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/12 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/13 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/14 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/15 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/16 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/17 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/18 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/19 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/20 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/21 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/22 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/23 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/24 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/25 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/26 AUROBINDO PHARMA (MALTA) RO EMA/787721/2017 Page 3/8
4 Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/27 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/28 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/29 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/30 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg /H/0588/ /2012/01 AUROBINDO PHARMA (MALTA) RO Carvedilol Aurobindo 3,125 mg, not available RVG AUROBINDO PHARMA B.V. NL filmomhulde tabletten Carvedilol Hexal 12,5 mg Tabletten DE/H/1985/ HEXAL AG DE Carvedilol HEXAL 3,125 mg tabletit FI/H/0182/ HEXAL A/S FI Carvedilol Hexal 3,125 mg tablett DE/H/1985/ HEXAL A/S SE Carvedilol HEXAL 50 mg tabletit FI/H/0182/ HEXAL A/S FI Carvedilol Hexal 50 mg Tabletten DE/H/1985/ HEXAL AG DE CARVEDILOL SANDOZ 3,125 MG DE/H/1985/001 RVG SANDOZ B.V. NL TABLETTEN Carvedilol Sandoz 50 mg DE/H/1985/ /03/04/0006 HEXAL AG LU comprimés Carvedilol Sandoz 50 mg tabletten DE/H/1985/005 BE SANDOZ N.V. BE Carvedilol Sandoz 50 mg tabletten DE/H/1985/005 BE SANDOZ N.V. BE Carvedilol Sandoz 50 mg Tabletten not available HEXAL AG DE CARVEDILOL SANDOZ 50 MG DE/H/1985/005 RVG SANDOZ B.V. NL TABLETTEN Carvedilol Teva 12,5 mg, tabletten not available RVG TEVA NEDERLAND B.V. NL Carvedilol TEVA 25 mg comprime not available NL30497 TEVA SANTÉ FR secable Carvedilol Teva 25 mg, tabletten not available RVG TEVA NEDERLAND B.V. NL Carvedilol Teva 3,125 mg, tabletten not available RVG TEVA NEDERLAND B.V. NL Carvedilol Teva 6,25 mg, tabletten not available RVG TEVA NEDERLAND B.V. NL Carvipress 12,5 mg compresse not available VISUFARMA SPA IT EMA/787721/2017 Page 4/8
5 Carvipress 12,5 mg compresse not available VISUFARMA SPA IT Carvipress 25 mg compresse not available VISUFARMA SPA IT Carvipress 25 mg compresse not available VISUFARMA SPA IT Carvipress 3,125 mg compresse not available VISUFARMA SPA IT Carvipress 50 mg compresse not available VISUFARMA SPA IT Carvipress 6,25 mg compresse not available VISUFARMA SPA IT Carvipress 6,25 mg compresse not available VISUFARMA SPA IT Carvipress 6,25 mg compresse not available VISUFARMA SPA IT Coropres 25 mg comprimidos not available ROCHE FARMA, S.A. ES Coropres 6,25 mg comprimidos not available ROCHE FARMA, S.A. ES Dilatrend 12,5 mg - Tabletten not available ROCHE AUSTRIA GMBH AT Dilatrend 12,5 mg compresse not available ROCHE S.P.A. IT Dilatrend 12,5 mg compresse not available ROCHE S.P.A. IT Dilatrend 12,5 mg comprimate not available 7688/2015/01 ROCHE ROMANIA SRL RO Dilatrend 12,5 mg tablete not available UP/I /13-02/429 ROCHE D.O.O. HR Dilatrend 12,5 mg tablete not available 5363-I-1818/09 ROCHE FARMACEVTSKA DRUŽBA SI D.O.O. Dilatrend 12,5 mg tabletta not available OGYI-T-4965/02 ROCHE (MAGYARORSZÁG) KFT HU Dilatrend 25 mg - Tabletten not available ROCHE AUSTRIA GMBH AT Dilatrend 25 mg compresse not available ROCHE S.P.A. IT Dilatrend 25 mg compresse not available ROCHE S.P.A. IT Dilatrend 25 mg comprimate not available 7689/2015/01 ROCHE ROMANIA SRL RO Dilatrend 25 mg tablete not available UP/I /13-02/430 ROCHE D.O.O. HR Dilatrend 25 mg tablete not available 5363-I-1819/09 ROCHE FARMACEVTSKA DRUŽBA SI D.O.O. Dilatrend 25 mg tabletes not available ROCHE LATVIJA SIA LV Dilatrend 25 mg tablety not available 77/0083/13-S ROCHE SLOVENSKO S.R.O. SK DILATREND 25 tablety not available 77/1015/92-S/C ROCHE S. R. O. CZ Dilatrend 6,25 mg - Tabletten not available ROCHE AUSTRIA GMBH AT Dilatrend 6,25 mg compresse not available ROCHE S.P.A. IT Dilatrend 6,25 mg compresse not available ROCHE S.P.A. IT Dilatrend 6,25 mg compresse not available ROCHE S.P.A. IT Dilatrend 6,25 mg comprimate not available 7687/2015/01 ROCHE ROMANIA SRL RO Dilatrend 6,25 mg tablete not available UP/I /13-02/428 ROCHE D.O.O. HR EMA/787721/2017 Page 5/8
6 Dilatrend 6,25 mg tablete not available 5363-I-1817/09 ROCHE FARMACEVTSKA DRUŽBA SI D.O.O. Dilatrend 6,25 mg tabletes not available ROCHE LATVIJA SIA LV Dilatrend 6,25 mg tabletta not available OGYI-T-4965/03 ROCHE (MAGYARORSZÁG) KFT HU DILATREND 6,25 tablety not available 77/1289/97-C ROCHE S. R. O. CZ Dilatrend, 12,5 mg, tabletki not available R/7162 ROCHE POLSKA SP.O.O. PL Dilatrend, 25 mg, tabletki not available R/7176 ROCHE POLSKA SP.O.O. PL Dilatrend, 6,25 mg, tabletki not available R/7161 ROCHE POLSKA SP.O.O. PL Dilatrend 12,5 mg, Tabletten not available CHEPLAPHARM ARZNEIMITTEL DE GMBH Dilatrend 12,5 mg, Tabletten not available CHEPLAPHARM ARZNEIMITTEL DE GMBH Dilatrend 12,5 mg/ταβ, δισκία not available 74113/10/ ROCHE (HELLAS) SA GR Dilatrend 25 mg, Tabletten not available CHEPLAPHARM ARZNEIMITTEL DE GMBH Dilatrend 25 mg/ταβ, δισκία not available 74112/10/ ROCHE (HELLAS) SA GR Dilatrend 6,25 mg, Tabletten not available CHEPLAPHARM ARZNEIMITTEL DE GMBH Dilatrend 6,25/ΤΑΒ mg, δισκία not available 74110/10/ ROCHE (HELLAS) SA GR Dilbloc 25 mg comprimidos not available ROCHE FARMACÊUTICA Dilbloc 25 mg Comprimidos not available ROCHE FARMACÊUTICA Dilbloc 25 mg Comprimidos not available ROCHE FARMACÊUTICA Dilbloc IC 6,25 mg comprimidos not available ROCHE FARMACÊUTICA Dilbloc IC 6,25 mg Comprimidos not available ROCHE FARMACÊUTICA Dimitone 25 mg comprimés not available BE N.V. ROCHE S.A. BE Dimitone 25 mg comprimés not available N.V. ROCHE S.A. LU Dimitone 25 mg tabletten not available BE N.V. ROCHE S.A. BE Dimitone 25 mg Tabletten not available BE N.V. ROCHE S.A. BE Dimitone 25 mg Tabletten not available N.V. ROCHE S.A. LU EMA/787721/2017 Page 6/8
7 Eucardic 12.5 mg Tablets not available PA 50/142/2 ROCHE PRODUCTS LTD IE Eucardic 25 mg Tablets not available PA 50/142/3 ROCHE PRODUCTS LTD IE Eucardic mg Tablets not available PA 50/142/4 ROCHE PRODUCTS LTD IE Eucardic 6.25 mg Tablets not available PA 50/142/1 ROCHE PRODUCTS LTD IE Kredex 12,5 mg comprimés not available BE N.V. ROCHE S.A. BE Kredex 12,5 mg comprimés not available N.V. ROCHE S.A. LU Kredex 12,5 mg tabletten not available BE N.V. ROCHE S.A. BE Kredex 12,5 mg Tabletten not available BE N.V. ROCHE S.A. BE Kredex 12,5 mg Tabletten not available N.V. ROCHE S.A. LU Kredex 12,5 mg tabletter not available ROCHE AB SE KREDEX 12,5 mg, comprimé not available ROCHE FR KREDEX 12,5 mg, comprimé not available ROCHE FR KREDEX 12,5 mg, comprimé not available ROCHE FR Kredex 25 mg comprimés not available BE N.V. ROCHE S.A. BE Kredex 25 mg comprimés not available N.V. ROCHE S.A. LU Kredex 25 mg tabletten not available BE N.V. ROCHE S.A. BE Kredex 25 mg Tabletten not available BE N.V. ROCHE S.A. BE Kredex 25 mg Tabletten not available N.V. ROCHE S.A. LU Kredex 25 mg tabletter not available ROCHE AB SE KREDEX 25 mg, comprimé not available ROCHE FR KREDEX 25 mg, comprimé not available ROCHE FR KREDEX 25 mg, comprimé not available ROCHE FR KREDEX 25 mg, comprimé not available ROCHE FR Kredex 6,25 mg comprimés not available BE N.V. ROCHE S.A. BE Kredex 6,25 mg comprimés not available N.V. ROCHE S.A. LU Kredex 6,25 mg tabletten not available BE N.V. ROCHE S.A. BE Kredex 6,25 mg Tabletten not available BE N.V. ROCHE S.A. BE Kredex 6,25 mg Tabletten not available N.V. ROCHE S.A. LU not available ROCHE FR not available ROCHE FR EMA/787721/2017 Page 7/8
8 not available ROCHE FR not available ROCHE FR not available ROCHE FR not available ROCHE FR Дилатренд 12,5 mg таблетки not available ІІ-3429 TCHAIKAPHARMA HIGH QUALITY BG MEDICINES, INC. Дилатренд 25 mg таблетки not available ІІ-3431 TCHAIKAPHARMA HIGH QUALITY BG MEDICINES, INC. Дилатренд 6,25 mg таблетки not available ІІ-3428 TCHAIKAPHARMA HIGH QUALITY MEDICINES, INC. BG EMA/787721/2017 Page 8/8
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