List of nationally authorised medicinal products
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1 14 September 2016 EMA/270645/2015 Human Medicines Evaluation Division Active substance: hydromorphone 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 National Number Hidromorfona Aristo DE/H/3761/001 $ DE/H/3761/002 $ DE/H/3761/003 $ DE/H/3761/ $ $ $ Aristo Pharma Iberia, S.L. Spain Hydal DE/H/1540/001 $ $ $ $ Mundipharma Gesellschaft M.B.H. Hydromorphon Aristo AT/H/0494/001 $ AT/H/0494/002 $ AT/H/0494/003 $ $ $ $ Aristo Pharma Gmbh AT/H/0494/004 Hydromorphon Aristo AT/H/0494/001 $ AT/H/0494/002 $ AT/H/0494/003 $ $ $ $ Aristo Pharma Gmbh AT/H/0494/004 Hydromorphon Aristo Long DE/H/3761/001/DC $ DE/H/3761/002/DC $ DE/H/3761/003/DC $ $ $ $ Aristo Pharma Gmbh (Art 57) DE/H/3761/004/DC Hydromorphon Awd DE/H/2246/001 $ DE/H/2246/002 $ DE/H/2246/ $ $ Teva Gmbh Hydromorphon Develco DE/H/3737/001/DC Develco Pharma Gmbh Hydromorphon Develco DE/H/3737/002/DC Develco Pharma Gmbh EMA/703492/2016 Page 2/16
3 National Number Hydromorphon Develco DE/H/3737/003/DC Develco Pharma Gmbh Hydromorphon Develco DE/H/3737/004/DC Develco Pharma Gmbh Hydromorphon HCl- Hormosan DE/H/2246/001 $ DE/H/2246/002 $ DE/H/2246/003 $ $ $ $ Hormosan Pharma Gmbh DE/H/2246/004 Hydromorphon Hexal DE/H/2248/001 $ DE/H/2248/002 $ DE/H/2248/003 $ $ $ $ Hexal Pharma Gmbh DE/H/2248/004 Hydromorphon Hexal Retard DE/H/2431/001 $ DE/H/2431/002 $ DE/H/2431/003 $ DE/H/2431/004 $ $ $ $ $ Hexal Ag DE/H/2431/005 Hydromorphon Neuraxpharm DE/H/3762/001/DC $ DE/H/3762/002/DC $ DE/H/3762/003/DC $ $ $ $ Aristo Pharma GmbH DE/H/3762/004/DC Hydromorphon Ratiopharm DE/H/2245/001 $ DE/H/2245/002 $ DE/H/2245/003 $ $ $ $ Ratiopharm Gmbh DE/H/2245/004 EMA/703492/2016 Page 3/16
4 National Number Hydromorphon Ratiopharm DE/H/2245/001 $ DE/H/2245/ $ Ratiopharm Arzneimittel Vertriebs-Gmbh Hydromorphon Ratiopharm DE/H/2245/003 $ DE/H/2245/ $ Ratiopharm Arzneimittel Vertriebs-Gmbh Hydromorphon Hexal Retard DE/H/2248/001 $ DE/H/2248/002 $ DE/H/2248/003 $ DE/H/2248/ $ $ $ Hexal Ag Hydromorphon Winthrop DE/H/2247/001 $ DE/H/2247/002 $ DE/H/2247/003 $ DE/H/2247/ $ $ $ Winthrop Arzneimittel Gmbh Hydromorphon-Awd DE-H $ $ Teva Gmbh Hydromorphon-Hcl 1 A Pharma $ $ $ A Pharma Gmbh Hydromorphone-HCL- Acino $ $ $ $ Acino Ag Hydromorphon-Hcl Ratiopharm $ $ Ratiopharm Gmbh Hydromorphon-Hcl Ratiopharm $ Ratiopharm Gmbh EMA/703492/2016 Page 4/16
5 National Number Hydromorphone Hcl Ratiopharm $ $ $ $ Ratiopharm Gmbh Hydromorphone Hcl Ratiopharm DE-H $ $ $ Ratiopharm Arzneimittel Vertriebs-Gmbh Hydromorphone Hcl Ratiopharm DE-H $ $ $ Ratiopharm Gmbh Hydromorphone Hydrochloride PA 361/18/1 $ PA 361/18/2 Martindale Pharmaceuticals Ltd Ireland Jurnista Janssen-Cilag Ag Liechtenstein EMA/703492/2016 Page 5/16
6 National Number Jurnista DK/H/0869/001 $ DK/H/0869/002 $ DK/H/0869/003 $ DK/H/0869/004 $ DK/H/0869/ $ $ $ $ $ $ $ /M $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ Janssen-Cilag Spa Italy EMA/703492/2016 Page 6/16
7 National Number Jurnista DK/H/0869/001 $ DK/H/0869/002 $ $ $ $ $ Janssen-Cilag Spa Italy DK/H/0869/003 $ DK/H/0869/004 $ $ $ $ $ DK/H/0869/ $ $ Jurnista DK/H/0869/001 $ DK/H/0869/002 $ DK/H/0869/003 $ $ $ $ $ Janssen-Cilag A/S Denmark DK/H/0869/004 $ DK/H/0869/005 Jurnista DK/H/0869/001 $ DK/H/0869/002 $ $ $ $ $ Janssen-Cilag Gmbh DK/H/0869/003 $ DK/H/0869/004 $ DK/H/0869/005 EMA/703492/2016 Page 7/16
8 National Number Jurnista DK/H/0869/001 $ DK/H/0869/002 $ DK/H/0869/003 $ DK/H/0869/004 $ DK/H/0869/005 OGYI-T-20162/01 $ OGYI-T /02 $ OGYI-T-20162/03 $ OGYI-T-20162/04 $ OGYI-T /05 $ OGYI-T-20162/06 $ OGYI-T-20162/07 $ OGYI-T /08 $ OGYI-T-20162/09 $ OGYI-T-20162/10 $ OGYI-T /11 $ OGYI-T-20162/12 $ OGYI-T-20162/13 $ OGYI-T /14 $ OGYI-T-20162/15 $ OGYI-T-20162/16 $ OGYI-T /17 $ OGYI-T-20162/18 $ OGYI-T-20162/19 $ OGYI-T /20 $ OGYI-T-20162/21 $ OGYI-T-20162/22 $ OGYI-T /23 $ OGYI-T-20162/24 $ OGYI-T-20162/25 $ OGYI-T /26 $ OGYI-T-20162/27 $ OGYI-T-20162/28 $ OGYI-T /29 $ OGYI-T-20162/30 $ OGYI-T-20162/31 $ OGYI-T /32 $ OGYI-T-20162/33 $ OGYI-T-20162/34 $ OGYI-T /35 $ OGYI-T-20162/36 $ OGYI-T-20162/37 $ OGYI-T /38 $ OGYI-T-20162/39 $ OGYI-T-20162/40 $ OGYI-T /41 $ OGYI-T-20162/42 $ OGYI-T-20162/43 $ OGYI-T- Janssen-Cilag Kft. Hungary 20162/44 $ OGYI-T-20162/45 $ EMA/703492/2016 Page 8/16 OGYI-T-20162/46 $ OGYI-T /47 $ OGYI-T-20162/48 $ OGYI-T-20162/49 $ OGYI-T /50 $ OGYI-T-20162/51 $
9 National Number Jurnista DK/H/0869/001 $ DK/H/0869/002 $ DK/H/0869/003 $ DK/H/0869/004 $ $ $ $ $ $ $ $ $ $ $ $ $ Janssen-Cilag Farmacêutica, Lda. Portugal DK/H/0869/005 $ $ $ DK/H/0869/005 Jurnista DK/H/0869/001 $ DK/H/0869/002 $ DK/H/0869/003 $ 65/187/06-C $ 65/188/06-C $ 65/189/06-C $ 65/723/07-C Janssen-Cilag S.R.O Czech Republic DK/H/0869/005 Jurnista DK/H/0869/001 $ DK/H/0869/002 $ DK/H/0869/003 $ DK/H/0869/ $ $ $ Janssen-Cilag S.A. Spain Palladon $ $ $ Norpharma A/S Denmark Palladon $ Norpharma A/S Denmark Palladon $ $ Norpharma A/S Denmark Palladone DE/H/1540/001 $ BE $ BE $ BE $ BE Mundipharma Comm Va Belgium Palladone Immediate Release BE $ BE Mundipharma Comm Va Belgium EMA/703492/2016 Page 9/16
10 National Number Palladon DE/H/1540/001 $ $ $ $ Norpharma A/S Denmark Palladon DE/H/1540/001 $ IS/1/08/079/01 $ IS/1/08/079/02 $ IS/1/08/079/03 $ IS/1/08/079/04 Norpharma A/S Iceland Palladon IS/1/00/056/01 $ IS/1/00/056/02 Norpharma A/S Iceland Palladon (IS) $ (IS) $ (IS) $ (IS) Norpharma A/S Iceland Palladone Slow Release BE $ BE $ BE $ BE Mundipharma Comm Va Belgium Palladon $ $ $ $ $ Mundipharma Oy Finland Palladon DE/H/1540/001 $ $ $ $ Mundipharma Oy Finland Sophidone L.P $ $ $ Mundipharma France EMA/703492/2016 Page 10/16
11 National Number Sophidone L.P $ $ Sophidone L.P. NL $ NL $ NL $ NL Sophidone L.P $ $ $ $ $ $ $ $ Palladon Injekt $ $ Mundipharma Mundipharma SAS Mundipharma Sas Mundipharma Gmbh France France France Palladone 5363-I-1202/09 $ 5363-I-1204/09 $ 5363-I-1206/09 $ 5363-I- 1207/09 $ 5363-I-1208/09 $ I-1210/09 $ 5363-I-1211/09 $ 5363-I-1212/09 $ 5363-I-1214/09 $ 5363-I-1215/09 $ 5363-I- 1216/09 $ 5363-I-1218/09 $ I-1220/09 Medis, D.O.O. Slovenia Palladone PL16950/0163 $ PL16950/0164 $ PL16950/0165 Napp Pharmaceuticals Ltd United Kingdom Palladone PL16950/0166 Napp Pharmaceuticals Ltd United Kingdom EMA/703492/2016 Page 11/16
12 National Number Palladone SR PL16950/0051 $ PL16950/0052 $ PL16950/0053 $ PL16950/0054 $ PL169/0055 Napp Pharmaceuticals Ltd United Kingdom Palladone PL16950/0049 $ PL16950/0050 Napp Pharmaceuticals Ltd United Kingdom Palladon Injekt DE/H/1540/001 $ $ $ $ Mundipharma Gmbh Palladon retard $ $ $ Mundipharma Gmbh Palladon IE/H/0131/005/MR $ IE/H/0131/006/MR $ Mundipharma Gmbh Palladone IE/H/0131/005 $ IE/H/0131/006 PA 1688/007/001 $ PA 1688/007/002 Mundipharma Pharmaceuticals Limited Ireland Palladone Sr IE/H/0131/001 $ IE/H/0131/002 $ IE/H/0131/003 $ PA 1688/007/007 $ PA 1688/007/008 $ PA 1688/007/009 $ PA 1688/007/010 $ PA Mundipharma Pharmaceuticals Limited Ireland IE/H/0131/ /007/011 Palladone DE/H/1540/001 $ 1495/ $ 1495/ $ 1495/ $ Mundipharma Comm Va Luxembourg 1495/ EMA/703492/2016 Page 12/16
13 National Number Palladone Immediate Release 1495/ $ 1495/ Mundipharma Comm Va Luxembourg Palladone Slow Release 1495/ $ 1495/ $ 1495/ $ 1495/ Mundipharma Comm Va Luxembourg Palladon Injectie RVG $ RVG $ RVG $ RVG Mundipharma Pharmaceuticals Bv Netherlands Palladon-Ir RVG $ RVG Mundipharma Pharmaceuticals Bv Netherlands Palladon-Sr Capsules RVG $ RVG $ RVG $ RVG $ RVG Mundipharma Pharmaceuticals Bv Netherlands Palladon DE/H/1540/001 $ $ $ $ Mundipharma As. Norway Palladon IE/H/0131/001 $ IE/H/0131/002 $ IE/H/0131/003 $ IE/H/0131/ $ $ $ Mundipharma As. Norway Palladon IE/H/0131/005 $ IE/H/0131/ $ Mundipharma As. Norway Palladone-Sr 65/0248/03-S $ 65/0249/03-S $ 65/0250/03-S $ 65/0251/03-S Mundipharma Ges.M.B.H Slovakia EMA/703492/2016 Page 13/16
14 National Number Rexaphon $ $ $ $ Acino Ag Palladone DE/H/1540/001 $ $ $ $ Mundipharma Pharmaceuticals Sl Spain Palladone Continus $ $ $ Mundipharma Pharmaceuticals Sl Spain Palladon DE/H/1540/001 $ $ $ $ Mundipharma Ab Sweden HYDROMORPHON-HCI- ACTAVIS 4 MG HARTKAPSELN, RETARDIERT HYDROMORPHON-HCI- ACTAVIS 8 MG HARTKAPSELN, RETARDIERT DE/H/2432/ ACTAVIS GROUP PTC EHF. DE/H/2432/ ACTAVIS GROUP PTC EHF. EMA/703492/2016 Page 14/16
15 National Number DE/H/2432/ ACTAVIS GROUP PTC EHF. DE/H/2432/ ACTAVIS GROUP PTC EHF. Palladon $ $ $ $ $ Mundipharma Ab Sweden STADA 24 MG RETARDTABLETTEN DE/H/2326/ STADAPHARM GMBH HYDROMORPHON STADA 8 MG RETARDTABLETTEN HYDROMORPHON STADA 16 MG RETARDTABLETTEN DE/H/2326/ STADA ARZNEIMITTEL GMBH DE/H/2326/ STADA ARZNEIMITTEL GMBH HYDROMORPHON-HCI- ACTAVIS 16 MG HARTKAPSELN, RETARDIERT HYDROMORPHON-HCI- ACTAVIS 24 MG HARTKAPSELN, RETARDIERT HYDROMORPHON- HYDROMORPHON- STADA 16 MG RETARDTABLETTEN DE/H/2326/ STADAPHARM GMBH HYDROMORPHON STADA 4 MG RETARDTABLETTEN DE/H/2326/ STADA ARZNEIMITTEL GMBH EMA/703492/2016 Page 15/16
16 National Number HYDROMORPHON STADA 24 MG RETARDTABLETTEN DE/H/2326/ STADA ARZNEIMITTEL GMBH HYDROMORPHON- STADA 8 MG RETARDTABLETTEN HYDROMORPHON- STADA 4 MG RETARDTABLETTEN HYDROMORPHON-AL 24 MG RETARDTABLETTEN HYDROMORPHON-AL 8 MG RETARDTABLETTEN HYDROMORPHON-AL 16 MG RETARDTABLETTEN HYDROMORPHON-AL 4 MG RETARDTABLETTEN DE/H/2326/ STADAPHARM GMBH DE/H/2326/ STADAPHARM GMBH DE/H/2327/ ALIUD PHARMA GMBH DE/H/2327/ ALIUD PHARMA GMBH DE/H/2327/ ALIUD PHARMA GMBH DE/H/2327/ ALIUD PHARMA GMBH Hydromorphon Develco Develco Pharma Gmbh Luxembourg Hydromorphon Develco Develco Pharma Gmbh Luxembourg Hydromorphon Develco Develco Pharma Gmbh Luxembourg Hydromorphon Develco Develco Pharma Gmbh Luxembourg EMA/703492/2016 Page 16/16
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