List of nationally authorised medicinal products
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1 14 January 2016 EMA/51946/2016 Procedure Management and Committees Support Active substance: ranitidine Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 National Alquén Smithkline Beecham Farma, S.A. Spain Ardoral Laboratorios Cinfa, S.A. Spain Azantac NL12566 Laboratoire Glaxosmithkline France Azantac NL13488 Laboratoire Glaxosmithkline France Azantac NL14236 Laboratoire Glaxosmithkline France Azantac NL16208 $ NL17391 Laboratoire Glaxosmithkline France Azantac NL22422 Laboratoire Glaxosmithkline France Gastridina $ $ Medibial - Produtos Médicos E Farmacêuticos, S.A. Portugal $ Raniben $ Fabbrica Italiana Ritrovati Medicinali Ed Affini Italy F.I.R.M.A. - S.P.A. Ranibloc $ Istituto Biochimico Nazionale Savio S.R.L Italy Ranicalm PL 17907/0247 Bristol Laboratories Ltd (Berkhamsted) Ranidil $ A. Menarini - Industrie Farmaceutiche Riunite - S.R.L. Italy Ranidil $ A. Menarini - Industrie Farmaceutiche Riunite - S.R.L. Italy Ranidil A. Menarini - Industrie Farmaceutiche Riunite - S.R.L. Italy Ranidil A. Menarini - Industrie Farmaceutiche Riunite - S.R.L. Italy Ranidil $ A. Menarini - Industrie Farmaceutiche Riunite - S.R.L. Italy Raniplex $ $ Abbott Products Sas (Suresnes) France $ $ $ $ Raniplex $ $ Abbott Products Sas (Suresnes) France $ $ $ $ $ Ranital 09/0007/87-S Sandoz Pharmaceuticals D.D. Slovakia Ranital 09/0007/87-S Sandoz Pharmaceuticals D.D. Slovakia Ranital 09/0048/88-S Sandoz Pharmaceuticals D.D. Slovakia EMA/51946/2016 Page 2/8
3 Ranitidin-Teva National OGYI-T-5671/01 $ OGYI- T-5671/02 $ OGYI-T- 5671/03 $ OGYI-T- 5671/04 TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY Ranitidine Biogaran NL16207 Laboratoires Saint-Germain France Ranitidine Biogaran NL17397 Laboratoires Saint-Germain France Portugal Ranitidine Film-Coated PL 21880/0022 $ PL Medreich Plc Tablets 21880/0133 Ranitidine Film-Coated PL 21880/0023 Medreich Plc Tablets Ranitidine Film-Coated PL 21880/0024 Medreich Plc Tablets Ranitidine PL $ PL Fourrts (Uk) Pharmacare Limited Ranzac PL Fourrts (Uk) Pharmacare Limited Ranitidine Sandoz B.V. UK/H/0235/001 $ PL 15627/0005 $ PL Sandoz B.V. UK/H/0235/ /0006 Ranitidine Tablets PL 21880/0091 $ PL Medreich Plc 21880/0092 Ranitil PL 11311/0138 $ PL Tillomed Laboratories Ltd 11311/0139 Tanidina Ferrer Internacional, S.A. Spain Ulceran OGYI-T-3680/01 $ OGYI- T-3680/02 $ OGYI-T- 3680/03 TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY Ulcex $ Laboratori Guidotti S.P.A. Italy Ulsal Gebro Pharma Gmbh Austria Ulsal Gebro Pharma Gmbh Austria Ulsal Gebro Pharma Gmbh Austria Ulsal Gebro Pharma Gmbh Austria Ulsal Gebro Pharma Gmbh Austria Zantac $ Glaxosmithkline S.P.A. Italy Hungary EMA/51946/2016 Page 3/8
4 National Zantac Glaxosmithkline S.P.A. Italy Zantac Glaxosmithkline S.P.A. Italy Zantac $ Glaxosmithkline S.P.A. Italy Zantac $ Glaxosmithkline Ab Sweden Zantac Glaxosmithkline Pharma Gmbh. Austria Zantac Glaxosmithkline Pharma Gmbh. Austria Zantac Glaxosmithkline Pharma Gmbh. Austria Zantac Glaxosmithkline Pharma Gmbh. Austria Zantac Glaxosmithkline Ab Sweden Zantac Laboratoire Glaxosmithkline Finland Zantac Laboratoire Glaxosmithkline Finland Zantac $ Glaxosmithkline Pharma A/S Denmark Zantac Glaxosmithkline Ab Sweden Zantac Laboratoire Glaxosmithkline Finland Zantac Laboratoire Glaxosmithkline Finland Zantac Glaxosmithkline Ab Sweden Zantac Glaxosmithkline Pharma A/S Denmark Zantac 13410/ Glaxosmithkline Aebe Greece Zantac $ Glaxosmithkline Pharma A/S Denmark Zantac Glaxosmithkline Export Ltd Estonia Zantac Glaxo Group Limited Cyprus Zantac Glaxo Group Limited Cyprus Zantac Glaxosmithkline Aebe Greece Zantac 18762/ Glaxosmithkline Aebe Greece Zantac Glaxo Group Limited Cyprus Zantac Glaxosmithkline Pharmaceuticals Sa Luxembourg EMA/51946/2016 Page 4/8
5 National Zantac Glaxosmithkline Pharmaceuticals Sa Luxembourg Zantac Glaxosmithkline Pharmaceuticals Sa Luxembourg Zantac Glaxosmithkline Pharmaceuticals Sa Luxembourg Zantac Glaxosmithkline Pharmaceuticals Sa Luxembourg Zantac Glaxosmithkline Pharmaceuticals Sa Luxembourg Zantac Glaxo Group Limited Cyprus Zantac Glaxosmithkline Export Ltd Estonia Zantac Glaxosmithkline Export Ltd Estonia Zantac 39320/ Glaxosmithkline Aebe Greece Zantac 448/2007/01 $ Glaxo Wellcome Uk Limited Romania 448/2007/02 Zantac Glaxosmithkline - Produtos Farmaceuticos, Limitada Portugal Zantac $ Glaxosmithkline S.A. Spain Zantac Glaxosmithkline S.A. Spain Zantac 6897 $ 7031 Glaxosmithkline As Norway Zantac 7030 Glaxosmithkline As Norway Zantac 7518 Glaxosmithkline As Norway Zantac 7771 Glaxosmithkline As Norway Zantac (IS) Glaxosmithkline Ehf. Iceland Zantac $ $ Glaxosmithkline - Produtos Farmaceuticos, Limitada Portugal Zantac Glaxosmithkline - Produtos Farmaceuticos, Limitada Portugal Zantac 8708 Glaxo Operations Uk Ltd Finland Zantac 8708 $ 9141 Glaxo Operations Uk Ltd Finland Zantac 9141 Glaxo Operations Uk Ltd Finland Zantac Glaxosmithkline As Norway Zantac 9885 Glaxo Operations Uk Ltd Finland EMA/51946/2016 Page 5/8
6 National Zantac 9885 Glaxo Operations Uk Ltd Finland Zantac Glaxosmithkline As Norway Zantac BE Glaxosmithkline Pharmaceuticals Sa Belgium Zantac BE Glaxosmithkline Pharmaceuticals Sa Belgium Zantac BE Glaxosmithkline Pharmaceuticals Sa Belgium Zantac BE Glaxosmithkline Pharmaceuticals Sa Belgium Zantac BE Glaxosmithkline Pharmaceuticals Sa Belgium Zantac BE Glaxosmithkline Pharmaceuticals Sa Belgium Zantac BE Glaxosmithkline Pharmaceuticals Sa Belgium Zantac BE Glaxosmithkline Pharmaceuticals Sa Belgium Zantac BE Glaxosmithkline Pharmaceuticals Sa Belgium Zantac IS/1/13/002/01 Glaxosmithkline Ehf. Iceland Zantac MA 167/01301 Glaxo Wellcome Uk Limited Malta Zantac MA 167/01303 Glaxo Wellcome Uk Limited Malta Zantac MA192/01101 Glaxosmithkline (Ireland) Limited Malta Zantac OGYI-T-1534/01 Glaxosmithkline Kft. Hungary Zantac OGYI-T-1534/02 Glaxosmithkline Kft. Hungary Zantac OGYI-T-1534/03 Glaxosmithkline Kft. Hungary Zantac PA 1077/13/1 Glaxosmithkline (Ireland) Limited Ireland Zantac PA 1077/13/2 Glaxosmithkline (Ireland) Limited Ireland Zantac PA 1077/13/3 Glaxosmithkline (Ireland) Limited Ireland Zantac PA 1077/13/4 Glaxosmithkline (Ireland) Limited Ireland Zantac PA 1077/13/5 Glaxosmithkline (Ireland) Limited Ireland Zantac PL 10949/0042 Glaxo Wellcome Uk Limited Zantac PL 10949/0043 Glaxo Wellcome Uk Limited Zantac PL 10949/0108 Glaxo Wellcome Uk Limited EMA/51946/2016 Page 6/8
7 National Zantac PL 10949/0109 Glaxo Wellcome Uk Limited Zantac PL 10949/0137 Glaxo Wellcome Uk Limited Zantac PL 10949/0138 Glaxo Wellcome Uk Limited Zantac R/2839 Glaxosmithkline Export Ltd Poland Zantac R/2840 Glaxosmithkline Export Ltd Poland Zantac RVG Glaxosmithkline B.V. Netherlands Zantac RVG Glaxosmithkline B.V. Netherlands Zantac RVG Glaxosmithkline B.V. Netherlands Zantac RVG Glaxosmithkline B.V. Netherlands Zantic Glaxosmithkline Gmbh & Co. Kg Germany Ranitidine 75mg Tablets PL 16028/0122 $ PL Galpharm Healthcare Limited 16028/0123 RANUBER 150 mg MEDA Pharma SAU Spain COMPRIMIDOS RANUBER 300 mg MEDA Pharma SAU Spain COMPRIMIDOS Zantac 75, tabletten 75 NL/H/0112/001 RVG Omega Pharma Nederland B.V. Netherlands mg Zantac 75 Bruis, NL/H/0112/002 RVG Omega Pharma Nederland B.V. Netherlands bruistabletten 75 mg Zantac MA192/01101 Glaxosmithkline (Ireland) Limited Malta Zantac Tablets 150mg MA167/01301 Glaxo Wellcome Uk Limited Malta Zantac syrup MA167/01303 Glaxo Wellcome Uk Limited Malta Zantac Solution for MA192/01101 Glaxo SmithKline Ireland Limited Malta Injection or infusion 25mg/ml Zantac MA 1005/00201 Chefaro Ireland Limited Malta Zantac PL 02855/0082 Omega Pharma Ltd Zantac PL 02855/0082 Omega Pharma Ltd EMA/51946/2016 Page 7/8
8 Ranitidine Alice oral solution 30mg/ml Kirkland Signature Indigestion Relief 75mg Tablets National CZ/H/0491/001 09/261/14-C Alice Loren Co. Ltd Czech Republic PL 16028/0122 Galpharm Healthcare Limited EMA/51946/2016 Page 8/8
List of nationally authorised medicinal products
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