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Pharmaceuticals - Community Register

  

Newly adopted Marketing Authorisation Decisions (last six months)

Centralised procedures of medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Clopidogrel BGR Krka, d. d., Novo Mesto Centralised - Transfer Marketing Authorisation Holder 27 Aug 2014 EMEA/H/C/1138/T/20
MACI Aastrom Biosciences DK ApS Centralised - Transfer Marketing Authorisation Holder 26 Aug 2014 EMEA/H/C/2522/T/3
Zalasta Krka, d. d., Novo Mesto Centralised - Variation 26 Aug 2014
Xenical Roche Registration Limited Centralised - Variation 26 Aug 2014
Arixtra Aspen Pharma Trading Limited Centralised - Transfer Marketing Authorisation Holder 26 Aug 2014 EMEA/H/C/403/T/63
Prolia Amgen Europe B.V. Centralised - Variation 26 Aug 2014 EMEA/H/C/1120/II/36, 37, 39
Ozurdex Allergan Pharmaceuticals Ireland Centralised - Variation 26 Aug 2014 EMEA/H/C/1140/II/15
Betaferon Bayer Pharma AG Centralised - Variation 26 Aug 2014 EMEA/H/C/81/II/95
Scintimun CIS bio international Centralised - Renewal 26 Aug 2014 EMEA/H/C/1045/R/5
Nevirapine Teva Teva Pharma B.V. Centralised - Renewal 26 Aug 2014 EMEA/H/C/1119/R/10
Velphoro Vifor Fresenius Medical Care Renal Pharma France Centralised - Authorisation 26 Aug 2014 EMEA/H/C/2705
Eylea Bayer Pharma AG Centralised - Modification 26 Aug 2014 EMEA/H/C/2392/PSUV/11
Baraclude Bristol-Myers Squibb Pharma EEIG Centralised - Variation 22 Aug 2014 EMEA/H/C/623/II/41
Dasselta Krka, d. d., Novo Mesto Centralised - Variation 22 Aug 2014
Clopidogrel HCS HCS bvba Centralised - Variation 22 Aug 2014
Olazax Glenmark Pharmaceuticals s.r.o. Centralised - Renewal 22 Aug 2014 EMEA/H/C/1087/R/14
Victrelis Merck Sharp & Dohme Limited Centralised - Modification 22 Aug 2014 EMEA/H/C/2332/PSUV/28
Imvanex Bavarian Nordic A/S Centralised - Modification 22 Aug 2014 EMEA/H/C/2596/PSUV/7
XALKORI Pfizer Limited Centralised - Annual renewal 22 Aug 2014 EMEA/H/C/2489/R/15
Procoralan Les Laboratoires Servier Centralised - Modification 22 Aug 2014 EMEA/H/C/597/PSUR/31
Corlentor Les Laboratoires Servier Centralised - Modification 22 Aug 2014 EMEA/H/C/598/PSUR/30
Vizamyl GE Healthcare Ltd Centralised - Authorisation 22 Aug 2014 EMEA/H/C/2557
ChondroCelect TiGenix NV Centralised - Renewal 22 Aug 2014 EMEA/H/C/878/R/9
Synagis AbbVie Ltd Centralised - Variation 22 Aug 2014 EMEA/H/C/257/X/95
Daklinza Bristol-Myers Squibb Pharma EEIG Centralised - Authorisation 22 Aug 2014 EMEA/H/C/3768
Isentress Merck Sharp & Dohme Limited Centralised - Variation 22 Aug 2014 EMEA/H/C/860/X/44/G
Elonva Merck Sharp & Dohme Limited Centralised - Renewal 22 Aug 2014 EMEA/H/C/1106/R/18
ADCETRIS Takeda Pharma A/S Centralised - Annual renewal 22 Aug 2014 EMEA/H/C/2455/R/17
Enyglid Krka, d. d., Novo Mesto Centralised - Renewal 22 Aug 2014 EMEA/H/C/1065/R/10
Ristaben Merck Sharp & Dohme Limited Centralised - Variation 19 Aug 2014
Olanzapine Mylan Generics [UK] Limited Centralised - Variation 19 Aug 2014
Rivastigmine 3M Health Care Ltd. 3M Health Care Limited Centralised - Withdrawal 19 Aug 2014
Capecitabine SUN Sun Pharmaceutical Industries Europe BV Centralised - Variation 19 Aug 2014
Retacrit Hospira UK Limited Centralised - Variation 19 Aug 2014 EMEA/H/C/872/IB/55
Olanzapine Glenmark Glenmark Pharmaceuticals Europe Limited Centralised - Renewal 19 Aug 2014 EMEA/H/C/1085/R/19
Olanzapine Glenmark Europe Glenmark Pharmaceuticals Europe Limited Centralised - Renewal 19 Aug 2014 EMEA/H/C/1086/R/18
Fluenz Tetra MedImmune, LLC Centralised - Variation 6 Aug 2014 EMEA/H/C/2617/II/20
Optaflu Novartis Vaccines and Diagnostics GmbH Centralised - Variation 6 Aug 2014 EMEA/H/C/758/II/69
Intanza Sanofi Pasteur MSD, SNC Centralised - Variation 6 Aug 2014 EMEA/H/C/957/II/29
IDflu Sanofi Pasteur SA Centralised - Variation 6 Aug 2014 EMEA/H/C/966/II/26
Sprycel Bristol-Myers Squibb Pharma EEIG Centralised - Variation 6 Aug 2014
APTIVUS Boehringer Ingelheim International GmbH Centralised - Variation 6 Aug 2014 EMEA/H/C/631/II/62/G
Eylea Bayer Pharma AG Centralised - Variation 6 Aug 2014 EMEA/H/C/2392/II/9
Olazax Disperzi Glenmark Pharmaceuticals s.r.o. Centralised - Renewal 6 Aug 2014 EMEA/H/C/1088/R/14
Reasanz Novartis Europharm Limited Centralised - Refusal of marketing authorisation 5 Aug 2014 EMEA/H/C/2817
IOA Merck Sharp & Dohme Limited Centralised - Withdrawal 31 Jul 2014
Doribax Janssen-Cilag International NV Centralised - Withdrawal 31 Jul 2014
Avastin Roche Registration Limited Centralised - Variation 31 Jul 2014 EMEA/H/C/582/II/63
Colobreathe Forest Laboratories UK Ltd Centralised - Variation 31 Jul 2014
Xarelto Bayer Pharma AG Centralised - Variation 31 Jul 2014 EMEA/H/C/944/II/30
Translarna PTC Therapeutics, Limited Centralised - Authorisation 31 Jul 2014 EMEA/H/C/2720
BYDUREON Bristol-Myers Squibb/AstraZeneca EEIG Centralised - Modification 31 Jul 2014 EMEA/H/C/2020/PSUV/18
Xelevia Merck Sharp & Dohme Limited Centralised - Variation 28 Jul 2014
Olanzapine Apotex Apotex Europe B.V. Centralised - Variation 28 Jul 2014
Kalydeco Vertex Pharmaceuticals (U.K.) Limited Centralised - Variation 28 Jul 2014 EMEA/H/C/2494/II/9
Arzerra Glaxo Group Ltd Centralised - Variation 28 Jul 2014 EMEA/H/C/1131/II/27
Byetta AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 28 Jul 2014 EMEA/H/C/698/T/44
Stivarga Bayer Pharma AG Centralised - Variation 28 Jul 2014 EMEA/H/C/2573/II/1
Menveo Novartis Vaccines and Diagnostics S.r.l. Centralised - Variation 28 Jul 2014 EMEA/H/C/1095/II/42
Enbrel Pfizer Limited Centralised - Variation 28 Jul 2014 EMEA/H/C/262/II/167
Eliquis Bristol-Myers Squibb/Pfizer EEIG Centralised - Variation 28 Jul 2014 EMEA/H/C/2148/II/14/G
Pandemrix GlaxoSmithKline Biologicals S.A. Centralised - Variation 28 Jul 2014 EMEA/H/C/832/II/68, 69
Fabrazyme Genzyme Europe B.V. Centralised - Variation 23 Jul 2014
Gazyvaro Roche Registration Limited Centralised - Authorisation 23 Jul 2014 EMEA/H/C/2799
Nuwiq Octapharma AB Centralised - Authorisation 22 Jul 2014 EMEA/H/C/2813
Rapiscan Rapidscan Pharma Solutions EU Ltd. Centralised - Modification 22 Jul 2014 EMEA/H/C/1176/PSUV/14
Tesavel Merck Sharp & Dohme Limited Centralised - Variation 18 Jul 2014
Revasc Canyon Pharmaceuticals Ltd Centralised - Withdrawal 18 Jul 2014
Omnitrope Sandoz GmbH Centralised - Variation 18 Jul 2014
CellCept Roche Registration Limited Centralised - Variation 18 Jul 2014
Glivec Novartis Europharm Limited Centralised - Variation 18 Jul 2014
Savene Clinigen Healthcare Limited Centralised - Transfer Marketing Authorisation Holder 18 Jul 2014 EMEA/H/C/682/T/17
Onglyza Bristol-Myers Squibb/AstraZeneca EEIG Centralised - Renewal 18 Jul 2014 EMEA/H/C/1039/R/23
Ventavis Bayer Pharma AG Centralised - Variation 18 Jul 2014 EMEA/H/C/474/X/43
Zytiga Janssen-Cilag International NV Centralised - Modification 18 Jul 2014 EMEA/H/C/2321/PSUV/19
Tasmar Meda AB Centralised - Renewal 18 Jul 2014 EMEA/H/C/132/R/47
Irbesartan Teva Teva Pharma B.V. Centralised - Renewal 18 Jul 2014 EMEA/H/C/1093/R/19
Simbrinza Alcon Laboratories (UK) Ltd. Centralised - Authorisation 18 Jul 2014 EMEA/H/C/3698
Envarsus Chiesi Farmaceutici S.P.A. Centralised - Authorisation 18 Jul 2014 EMEA/H/C/2655
Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Renewal 18 Jul 2014 EMEA/H/C/1124/R/18
Xagrid Shire Pharmaceutical Contracts Ltd Centralised - Renewal 18 Jul 2014 EMEA/H/C/480/R/60
Votubia Novartis Europharm Limited Centralised - Annual renewal 18 Jul 2014 EMEA/H/C/2311/R/24
SANCUSO ProStrakan Limited Centralised - Modification 18 Jul 2014 EMEA/H/C/2296/PSUV/30
Plegridy Biogen Idec Limited Centralised - Authorisation 18 Jul 2014 EMEA/H/C/2827
Dacogen Janssen-Cilag International NV Centralised - Modification 18 Jul 2014 EMEA/H/C/2221/PSUV/11
Adjupanrix GlaxoSmithKline Biologicals S.A. Centralised - Renewal 18 Jul 2014 EMEA/H/C/1206/R/36
Nimenrix GlaxoSmithKline Biologicals S.A. Centralised - Modification 18 Jul 2014 EMEA/H/C/2226/PSUV/20
Viagra Pfizer Limited Centralised - Variation 14 Jul 2014
Docetaxel Teva Teva Pharma B.V. Centralised - Renewal 14 Jul 2014 EMEA/H/C/1107/R/13
Riluzole Zentiva Aventis Pharma S.A. Centralised - Variation 11 Jul 2014
Rivastigmine HEXAL Hexal AG Centralised - Renewal 11 Jul 2014
Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Centralised - Renewal 11 Jul 2014 EMEA/H/C/1183/R/16
Olanzapine Cipla Cipla (EU) Limited Centralised - Withdrawal 8 Jul 2014
Flebogamma DIF Instituto Grifols, S.A. Centralised - Variation 4 Jul 2014
Optison GE Healthcare AS Centralised - Variation 4 Jul 2014
Efavirenz Teva Teva Pharma B.V. Centralised - Variation 4 Jul 2014
Fuzeon Roche Registration Limited Centralised - Variation 4 Jul 2014
Suboxone RB Pharmaceuticals Limited Corrigendum 4 Jul 2014
Copalia HCT Novartis Europharm Limited Centralised - Renewal 4 Jul 2014 EMEA/H/C/1159/R/38
Dafiro HCT Novartis Europharm Limited Centralised - Renewal 4 Jul 2014 EMEA/H/C/1160
Avastin Roche Registration Limited Centralised - Variation 30 Jun 2014
Perjeta Roche Registration Limited Centralised - Variation 30 Jun 2014
Arzerra Glaxo Group Ltd Centralised - Variation 30 Jun 2014 EMEA/H/C/1131/II/23
Mekinist Glaxo Group Ltd Centralised - Authorisation 30 Jun 2014 EMEA/H/C/2643
Exforge HCT Novartis Europharm Limited Centralised - Renewal 30 Jun 2014 EMEA/H/C/1068/R/37
Topotecan Hospira Hospira UK Limited Centralised - Variation 27 Jun 2014
ZALTRAP Sanofi-Aventis groupe Centralised - Variation 27 Jun 2014
Zoledronic acid Teva Teva Pharma B.V. Centralised - Variation 27 Jun 2014
Orfadin Swedish Orphan Biovitrum International AB Centralised - Variation 27 Jun 2014
Ibandronic Acid Teva Teva Pharma B.V. Centralised - Variation 27 Jun 2014
Amyvid Eli Lilly Nederland B.V. Centralised - Variation 27 Jun 2014
Circadin RAD Neurim Pharmaceuticals EEC Limited Centralised - Variation 27 Jun 2014
HALAVEN Eisai Europe Limited Centralised - Variation 27 Jun 2014 EMEA/H/C/2084/II/11
Xyrem UCB Pharma Ltd. Centralised - Variation 27 Jun 2014 EMEA/H/C/593/II/50
Esbriet InterMune UK Limited Centralised - Variation 27 Jun 2014 EMEA/H/C/2154/II/16
Kineret Swedish Orphan Biovitrum AB (publ) Centralised - Variation 27 Jun 2014 EMEA/H/C/363/IB/49
Foclivia Novartis Vaccines and Diagnostics S.r.l. Centralised - Renewal 27 Jun 2014 EMEA/H/C/1208/R/12
Rasilez Novartis Europharm Limited Centralised - Modification 27 Jun 2014 EMEA/H/C/780/PSUV/90
Cayston Gilead Sciences International Limited Centralised - Modification 27 Jun 2014 EMEA/H/C/996/PSUSA/283
Rasilez HCT Novartis Europharm Limited Centralised - Modification 27 Jun 2014 EMEA/H/C/964/PSUV/60
Rasilamlo Novartis Europharm Limited Centralised - Modification 27 Jun 2014 EMEA/H/C/2073/PSUV/90
Brilique AstraZeneca AB Centralised - Variation 23 Jun 2014
Bosulif Pfizer Limited Centralised - Variation 23 Jun 2014 EMEA/H/C/2373/II/1
Thymanax Servier (Ireland) Industries Limited Centralised - Variation 23 Jun 2014 EMEA/H/C/916/II/19
Diacomit Biocodex Centralised - Variation 23 Jun 2014 EMEA/H/C/664/II/16
Vfend Pfizer Limited Centralised - Variation 23 Jun 2014 EMEA/H/C/387/II/97
Prevenar 13 Pfizer Limited Centralised - Variation 23 Jun 2014 EMEA/H/C/1104/II/98
Zeffix Glaxo Group Ltd Centralised - Renewal 23 Jun 2014 EMEA/H/C/242/R/62
Angiox The Medicines Company UK Ltd Centralised - Renewal 23 Jun 2014 EMEA/H/C/562/R/52
Yondelis Pharma Mar S.A. Centralised - Modification 23 Jun 2014 EMEA/H/C/773/PSUV/38
Ozurdex Allergan Pharmaceuticals Ireland Centralised - Variation 19 Jun 2014
Celvapan Baxter AG Centralised - Variation 19 Jun 2014
Valdoxan Les Laboratoires Servier Centralised - Variation 19 Jun 2014 EMEA/H/C/915/II/21
Topotecan Teva Teva Pharma B.V. Centralised - Renewal 19 Jun 2014 EMEA/H/C/1071/R/7
Ilaris Novartis Europharm Limited Centralised - Renewal 19 Jun 2014 EMEA/H/C/1109/R/31
Javlor Pierre Fabre Médicament Centralised - Modification 19 Jun 2014 EMEA/H/C/983/PSUV/15
Samsca Otsuka Pharmaceutical Europe Ltd. Centralised - Renewal 19 Jun 2014 EMEA/H/C/980/R/16
Osseor Les Laboratoires Servier Centralised - Modification 19 Jun 2014 EMEA/H/C/561/PSUV/37
GILENYA Novartis Europharm Limited Centralised - Modification 19 Jun 2014 EMEA/H/C/2202/PSUV/27
Protelos Les Laboratoires Servier Centralised - Modification 19 Jun 2014 EMEA/H/C/560/PSUV/42
Erivedge Roche Registration Limited Centralised - Annual renewal 19 Jun 2014 EMEA/H/C/2602/R/6
Votubia Novartis Europharm Limited Centralised - Modification 19 Jun 2014 EMEA/H/C/2311/PSUV/22
Simponi Janssen Biologics B.V. Centralised - Renewal 19 Jun 2014 EMEA/H/C/992/R/56
Repaglinide Teva Teva Pharma B.V. Centralised - Renewal 19 Jun 2014 EMEA/H/C/1067/R/8
Tovanor Breezhaler Novartis Europharm Limited Centralised - Modification 19 Jun 2014 EMEA/H/C/2690/PSUV/4
Seebri Breezhaler Novartis Europharm Limited Centralised - Modification 19 Jun 2014 EMEA/H/C/2430/PSUV/4
Enurev Breezhaler Novartis Europharm Limited Centralised - Modification 19 Jun 2014 EMEA/H/C/2691/PSUV/4
Remicade Janssen Biologics B.V. Centralised - Modification 19 Jun 2014 EMEA/H/C/240/PSUV/180
Incivo Janssen-Cilag International NV Centralised - Modification 19 Jun 2014 EMEA/H/C/2313/PSUV/24
Imatinib Actavis Actavis Group PTC ehf. Centralised - Variation 12 Jun 2014 EMEA/H/C/2594/IB/4, EMEA/H/C/2594/X/3
Zutectra Biotest Pharma GmbH Centralised - Variation 6 Jun 2014
Champix Pfizer Limited Centralised - Variation 6 Jun 2014
Telmisartan Teva Pharma Teva Pharma B.V. Centralised - Variation 6 Jun 2014
Silgard Merck Sharp & Dohme Limited Centralised - Variation 6 Jun 2014 EMEA/H/C/732/WS/523
Gardasil Sanofi Pasteur MSD, SNC Centralised - Variation 6 Jun 2014 EMEA/H/C/703/WS/523
Resolor Shire Pharmaceuticals Ireland Limited Centralised - Renewal 6 Jun 2014 EMEA/H/C/1012/R/32
Edarbi Takeda Pharma A/S Centralised - Transfer Marketing Authorisation Holder 6 Jun 2014 EMEA/H/C/2293/T/12
Topotecan Actavis Actavis Group PTC ehf. Centralised - Renewal 6 Jun 2014 EMEA/H/C/1031/R/11
Velmetia Merck Sharp & Dohme Limited Centralised - Variation 3 Jun 2014
Ristfor Merck Sharp & Dohme Limited Centralised - Variation 3 Jun 2014
Efficib Merck Sharp & Dohme Limited Centralised - Variation 3 Jun 2014
Janumet Merck Sharp & Dohme Limited Centralised - Variation 3 Jun 2014
Kepivance Swedish Orphan Biovitrum AB (publ) Centralised - Variation 3 Jun 2014
Prolia Amgen Europe B.V. Centralised - Variation 3 Jun 2014 EMEA/H/C/1120/II/30
Kiovig Baxter AG Centralised - Variation 3 Jun 2014
Macugen PharmaSwiss Ceská republika s.r.o. Centralised - Variation 3 Jun 2014
Nevanac Alcon Laboratories (UK) Ltd. Centralised - Variation 3 Jun 2014
Ibandronic acid Sandoz Sandoz Pharmaceuticals GmbH Centralised - Variation 3 Jun 2014
Adasuve Alexza UK Ltd. Centralised - Variation 3 Jun 2014
Pradaxa Boehringer Ingelheim International GmbH Centralised - Variation 3 Jun 2014 EMEA/H/C/829/II/48
Docetaxel Teva Teva Pharma B.V. Centralised - Variation 3 Jun 2014
Docetaxel Mylan Mylan S.A.S Centralised - Variation 3 Jun 2014
Lysodren Laboratoire HRA Pharma Centralised - Variation 3 Jun 2014
Memantine LEK Pharmathen S.A. Centralised - Variation 3 Jun 2014
Yondelis Pharma Mar S.A. Centralised - Annual reassessment 3 Jun 2014 EMEA/H/C/773/S/37
Clopidogrel Krka d.d. Krka, d. d., Novo Mesto Centralised - Renewal 3 Jun 2014 EMEA/H/C/1137/R/18
Suboxone RB Pharmaceuticals Limited Centralised - Variation 23 May 2014
GILENYA Novartis Europharm Limited Centralised - Variation 23 May 2014 EMEA/H/C/2202/II/21
Nexavar Bayer Pharma AG Centralised - Variation 23 May 2014 EMEA/H/C/690/II/35
Invega Janssen-Cilag International NV Centralised - Variation 23 May 2014 EMEA/H/C/746/II/37
Mabthera Roche Registration Limited Centralised - Variation 23 May 2014 EMEA/H/C/165/II/89
Clopidogrel Acino Acino AG Centralised - Transfer Marketing Authorisation Holder 23 May 2014 EMEA/H/C/1166/T/8
Docetaxel Kabi Fresenius Kabi Oncology Plc. Centralised - Variation 22 May 2014
Iasibon Pharmathen S.A. Centralised - Variation 22 May 2014
Selincro H. Lundbeck A/S Centralised - Variation 22 May 2014
Vaniqa Almirall, S.A. Centralised - Variation 22 May 2014
Grastofil Apotex Europe B.V. Centralised - Variation 22 May 2014 EMEA/H/C/2150/II/3/G
Ipreziv Takeda Pharma A/S Centralised - Transfer Marketing Authorisation Holder 22 May 2014 EMEA/H/C/2517/T/12
Adjupanrix GlaxoSmithKline Biologicals S.A. Centralised - Variation 22 May 2014 EMEA/H/C/1206/II/35
Prepandrix GlaxoSmithKline Biologicals S.A. Centralised - Variation 22 May 2014 EMEA/H/C/822/II/52/G
Busilvex Pierre Fabre Médicament Centralised - Modification 22 May 2014 EMEA/H/C/472/PSUSA/464
Protelos Les Laboratoires Servier Centralised - Renewal 22 May 2014 EMEA/H/C/560/R/41
PegIntron Merck Sharp & Dohme Limited Centralised - Modification 22 May 2014 EMEA/H/C/280/PSUV/117
ViraferonPeg Merck Sharp & Dohme Limited Centralised - Modification 22 May 2014 EMEA/H/C/329/PSUV/110
Sylvant Janssen-Cilag International NV Centralised - Authorisation 22 May 2014 EMEA/H/C/3708
Clopidogrel TAD TAD Pharma GmbH Centralised - Renewal 22 May 2014
Ebilfumin Actavis Group PTC ehf. Centralised - Authorisation 22 May 2014 EMEA/H/C/3717
Osseor Les Laboratoires Servier Centralised - Renewal 22 May 2014 EMEA/H/C/561/R/36
Jardiance Boehringer Ingelheim International GmbH Centralised - Authorisation 22 May 2014 EMEA/H/C/2677
Clopidogrel Mylan Mylan S.A.S Centralised - Renewal 22 May 2014 EMEA/H/C/1134/R/27
Entyvio Takeda Pharma A/S Centralised - Authorisation 22 May 2014 EMEA/H/C/2782
Fampyra Biogen Idec Limited Centralised - Annual renewal 22 May 2014 EMEA/H/C/2097/R/14
Clopidogrel DURA Mylan dura GmbH Centralised - Renewal 22 May 2014 EMEA/H/C/1132/R/17
Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Centralised - Renewal 22 May 2014 EMEA/H/C/1165/R/27
Preotact NPS Pharma Holdings Limited Centralised - Withdrawal 16 May 2014
Docetaxel Accord Accord Healthcare Limited Centralised - Variation 16 May 2014
Clopidogrel Teva Pharma B.V. Teva Pharma B.V. Centralised - Variation 16 May 2014
Relvar Ellipta Glaxo Group Ltd Corrigendum 16 May 2014
Vizarsin Krka, d. d., Novo Mesto Centralised - Renewal 16 May 2014 EMEA/H/C/1076/R/18
Javlor Pierre Fabre Médicament Centralised - Renewal 16 May 2014
Afinitor Novartis Europharm Limited Centralised - Renewal 16 May 2014 EMEA/H/C/1038/R/36
Cimzia UCB Pharma S.A. Centralised - Renewal 16 May 2014 EMEA/H/C/1037/R/40
Clopidogrel Teva Teva Pharma B.V. Centralised - Renewal 16 May 2014 EMEA/H/C/1053/R/29
InductOs Medtronic BioPharma B.V. Centralised - Variation 14 May 2014
Isentress Merck Sharp & Dohme Limited Centralised - Renewal 14 May 2014 EMEA/H/C/860/R/45
Zyllt Krka, d. d., Novo Mesto Centralised - Renewal 14 May 2014 EMEA/H/C/1058/R/16
XALKORI Pfizer Limited Centralised - Modification 14 May 2014 EMEA/H/C/2489/PSUV/12
OLYSIO Janssen-Cilag International NV Centralised - Authorisation 14 May 2014 EMEA/H/C/2777
Pandemic influenza vaccine H5N1 BAXTER Baxter AG Centralised - Renewal 14 May 2014 EMEA/H/C/1200/R/16
Clopidogrel Krka Krka, d. d., Novo Mesto Centralised - Renewal 14 May 2014 EMEA/H/C/1056/R/22
Clopidogrel BGR Krka, d. d., Novo Mesto Centralised - Renewal 8 May 2014 EMEA/H/C/1138/R/13
Clopidogrel Teva Pharma Teva Pharma B.V. Centralised - Renewal 8 May 2014 EMEA/H/C/1133/R/19
Laventair Glaxo Group Ltd Centralised - Authorisation 8 May 2014 EMEA/H/C/3754
Anoro Glaxo Group Ltd Centralised - Authorisation 8 May 2014 EMEA/H/C/2751
Carbaglu Orphan Europe S.A.R.L. Centralised - Variation 7 May 2014
Trobalt Glaxo Group Ltd Centralised - Variation 7 May 2014 EMEA/H/C/1245/II/23
Tresiba Novo Nordisk A/S Centralised - Variation 7 May 2014 EMEA/H/C/2498/II/6
NutropinAq Ipsen Pharma Centralised - Variation 6 May 2014
Rivastigmine 1 A Pharma 1 A Pharma GmbH Centralised - Variation 6 May 2014
Vyndaqel Pfizer Limited Centralised - Variation 6 May 2014
Invirase Roche Registration Limited Centralised - Variation 2 May 2014 EMEA/H/C/113/II/104
Revinty Ellipta Glaxo Group Ltd Centralised - Authorisation 2 May 2014 EMEA/H/C/2745
Orencia Bristol-Myers Squibb Pharma EEIG Corrigendum 28 Apr 2014
Victoza Novo Nordisk A/S Centralised - Variation 28 Apr 2014 EMEA/H/C/1026/II/23, 24
Avamys Glaxo Group Ltd Centralised - Variation 28 Apr 2014
alli Glaxo Group Ltd Centralised - Variation 28 Apr 2014
Orencia Bristol-Myers Squibb Pharma EEIG Centralised - Variation 28 Apr 2014 EMEA/H/C/701/II/77
Exjade Novartis Europharm Limited Centralised - Variation 28 Apr 2014
Tepadina ADIENNE S.r.l. Centralised - Variation 28 Apr 2014
Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Centralised - Variation 28 Apr 2014
Pegasys Roche Registration Limited Centralised - Variation 28 Apr 2014 EMEA/H/C/395/II/73
Vimizim BioMarin Europe Ltd Centralised - Authorisation 28 Apr 2014 EMEA/H/C/2779
Rebetol Merck Sharp & Dohme Limited Centralised - Modification 28 Apr 2014 EMEA/H/C/246/10007/201307
Ribavirin Teva Pharma BV Teva Pharma B.V. Centralised - Modification 28 Apr 2014 EMEA/H/C/1064/PSUSA/10007
Ribavirin Teva Teva Pharma B.V. Centralised - Modification 28 Apr 2014 EMEA/H/C/1018/PSUSA/10007
Incruse Glaxo Group Ltd Centralised - Authorisation 28 Apr 2014 EMEA/H/C/2809
BiResp Spiromax Teva Pharma B.V. Centralised - Authorisation 28 Apr 2014 EMEA/H/C/3890
DuoResp Spiromax Teva Pharma B.V. Centralised - Authorisation 28 Apr 2014 EMEA/H/C/2348
Glybera uniQure biopharma B.V. Centralised - Annual reassessment 28 Apr 2014 EMEA/H/C/2145/S/27
Ribavirin Mylan Generics [UK] Limited Centralised - Modification 28 Apr 2014 EMEA/H/C/1185/PSU/10007
Deltyba Otsuka Novel Products GmbH Centralised - Authorisation 28 Apr 2014 EMEA/H/C/2552
Nimenrix GlaxoSmithKline Biologicals S.A. Centralised - Variation 23 Apr 2014
Integrilin Glaxo Group Ltd Centralised - Variation 23 Apr 2014
Volibris Glaxo Group Ltd Centralised - Variation 23 Apr 2014
Rivastigmine HEXAL Hexal AG Centralised - Variation 23 Apr 2014
Vfend Pfizer Limited Centralised - Variation 23 Apr 2014
Ferriprox Apotex Europe B.V. Centralised - Variation 23 Apr 2014
Ryzodeg Novo Nordisk A/S Centralised - Variation 23 Apr 2014
CANCIDAS Merck Sharp & Dohme Limited Centralised - Variation 23 Apr 2014
Noxafil Merck Sharp & Dohme Limited Centralised - Variation 23 Apr 2014 EMEA/H/C/610/X/28
Elaprase Shire Human Genetic Therapies AB Centralised - Modification 23 Apr 2014 EMEA/H/C/700/PSU/34
Ketek Aventis Pharma S.A. Centralised - Modification 23 Apr 2014 EMEA/H/C/354/PSUV/60
Bretaris Genuair Almirall, S.A. Centralised - Modification 23 Apr 2014 EMEA/H/C/2706/PSUR/8
Eklira Genuair Almirall, S.A. Centralised - Modification 23 Apr 2014 EMEA/H/C/2211/PSUR/8
Instanyl Takeda Pharma A/S Centralised - Renewal 23 Apr 2014 EMEA/H/C/959/R/22
Stocrin Merck Sharp & Dohme Limited Centralised - Renewal 23 Apr 2014 EMEA/H/C/250/R/96
Sustiva Bristol-Myers Squibb Pharma EEIG Centralised - Renewal 23 Apr 2014 EMEA/H/C/249/R/120
Vokanamet Janssen-Cilag International NV Centralised - Authorisation 23 Apr 2014 EMEA/H/C/2656
Onglyza Bristol-Myers Squibb/AstraZeneca EEIG Centralised - Modification 23 Apr 2014 EMEA/H/C/1039/PSU/30
Iressa AstraZeneca AB Centralised - Renewal 23 Apr 2014 EMEA/H/C/1016/1016/R/12
Hemangiol Pierre Fabre Dermatologie Centralised - Authorisation 23 Apr 2014 EMEA/H/C/2621
Ulunar Breezhaler Novartis Europharm Limited Centralised - Authorisation 23 Apr 2014 EMEA/H/C/3875
Pegasys Roche Registration Limited Centralised - Modification 23 Apr 2014 EMEA/H/C/395/PSUV/72
Aloxi Helsinn Birex Pharmaceuticals Ltd Centralised - Modification 23 Apr 2014 EMEA/H/C/563/PSUV/33
Betmiga Astellas Pharma Europe B.V. Centralised - Modification 23 Apr 2014 EMEA/H/C/2388/PSUV/7
Qutenza Astellas Pharma Europe B.V. Centralised - Renewal 23 Apr 2014 EMEA/H/C/909/R/31
Siklos Addmedica Centralised - Modification 23 Apr 2014 EMEA/H/C/689/PSUV/20
Vedrop Orphan Europe S.A.R.L. Centralised - Renewal 23 Apr 2014 EMEA/H/C/920/R/7
RoActemra Roche Registration Limited Centralised - Variation 23 Apr 2014 EMEA/H/C/955/X/30
Protelos Les Laboratoires Servier Referral 15 Apr 2014 EMEA/H/1371/A-20/560/39
Osseor Les Laboratoires Servier Referral 15 Apr 2014 EMEA/H/1371/A-20/561/34
Mozobil Genzyme Europe B.V. Centralised - Renewal 11 Apr 2014 EMEA/H/C/1030/R/19
Grepid Pharmathen S.A. Centralised - Renewal 11 Apr 2014 EMEA/H/C/1059/R/29
Victoza Novo Nordisk A/S Centralised - Renewal 11 Apr 2014 EMEA/H/C/1026/R/25
Viramune Boehringer Ingelheim International GmbH Centralised - Variation 10 Apr 2014
Lonquex UAB "Sicor Biotech" Centralised - Transfer Marketing Authorisation Holder 10 Apr 2014 EMEA/H/C/2556/T/1
Clopidogrel Mylan Mylan S.A.S Centralised - Variation 10 Apr 2014
Abilify Otsuka Pharmaceutical Europe Ltd. Centralised - Variation 10 Apr 2014
Pixuvri CTI Life Sciences Ltd Centralised - Annual renewal 10 Apr 2014 EMEA/H/C/2055/R/14
Pregabalin Pfizer Pfizer Limited Centralised - Authorisation 10 Apr 2014 EMEA/H/C/3880
Exelon Novartis Europharm Limited Centralised - Variation 7 Apr 2014
Granupas Lucane Pharma Centralised - Authorisation 7 Apr 2014 EMEA/H/C/2709
Kolbam FGK Representative Service GmbH Centralised - Authorisation 4 Apr 2014 EMEA/H/C/2081
Neuraceq Piramal Imaging Limited Centralised - Transfer Marketing Authorisation Holder 3 Apr 2014 EMEA/H/C/2553/T/1
Xiapex Swedish Orphan Biovitrum AB (publ) Centralised - Transfer Marketing Authorisation Holder 3 Apr 2014 EMEA/H/C/2048/T/37
Rivastigmine 3M Health Care Ltd. 3M Health Care Limited Centralised - Authorisation 3 Apr 2014 EMEA/H/C/3824
Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Variation 31 Mar 2014
Fluenz Tetra MedImmune, LLC Corrigendum 31 Mar 2014
Altargo Glaxo Group Ltd Centralised - Variation 27 Mar 2014
Gardasil Sanofi Pasteur MSD, SNC Centralised - Variation 27 Mar 2014 EMEA/H/C/703/WS/472
Silgard Merck Sharp & Dohme Limited Centralised - Variation 27 Mar 2014 EMEA/H/C/732/WS/472
Bemfola FINOX Biotech AG Centralised - Authorisation 27 Mar 2014 EMEA/H/C/2615
Adempas Bayer Pharma AG Centralised - Authorisation 27 Mar 2014 EMEA/H/C/2737
Zoledronic acid Teva Generics Teva Generics B.V. Centralised - Authorisation 27 Mar 2014 EMEA/H/C/2805
TachoSil Takeda Austria GmbH Centralised - Variation 21 Mar 2014
Nexium Control Pfizer Consumer Healthcare Limited Centralised - Transfer Marketing Authorisation Holder 21 Mar 2014 EMEA/H/C/2618/T/4
Temozolomide SUN Sun Pharmaceutical Industries Europe BV Centralised - Variation 21 Mar 2014
DuoTrav Alcon Laboratories (UK) Ltd. Centralised - Variation 21 Mar 2014
XALKORI Pfizer Limited Centralised - Variation 21 Mar 2014 EMEA/H/C/2489/II/4
Victrelis Merck Sharp & Dohme Limited Centralised - Variation 21 Mar 2014 EMEA/H/C/2332/II/27
Abseamed Medice Arzneimittel Pütter GmbH & Co KG Centralised - Variation 21 Mar 2014
Epoetin alfa Hexal Hexal AG Centralised - Variation 21 Mar 2014
Binocrit Sandoz GmbH Centralised - Variation 21 Mar 2014
Entacapone Teva Teva Pharma B.V. Centralised - Variation 21 Mar 2014
Elonva Merck Sharp & Dohme Limited Centralised - Variation 21 Mar 2014 EMEA/H/C/1106/II/14
Soliris Alexion Europe SAS Centralised - Variation 21 Mar 2014 EMEA/H/C/791/II/58/G
Clopidogrel Acino Acino AG Centralised - Renewal 21 Mar 2014 EMEA/H/C/1166/R/12
Latuda Takeda Pharma A/S Centralised - Authorisation 21 Mar 2014 EMEA/H/C/2713
Eperzan GlaxoSmithKline Trading Services Limited Centralised - Authorisation 21 Mar 2014 EMEA/H/C/2735
Ceplene Meda AB Centralised - Annual reassessment 21 Mar 2014 EMEA/H/C/796/S/14
Vedrop Orphan Europe S.A.R.L. Centralised - Annual reassessment 21 Mar 2014 EMEA/H/C/920/S/6
Ziagen ViiV Healthcare UK Limited Centralised - Renewal 21 Mar 2014 EMEA/H/C/252/R/71
Dificlir Astellas Pharma Europe B.V. Centralised - Modification 21 Mar 2014 EMEA/H/C/2087/PSU/10
Renvela Genzyme Europe B.V. Centralised - Renewal 21 Mar 2014 EMEA/H/C/993/R/27
Replagal Shire Human Genetic Therapies AB Centralised - Annual reassessment 21 Mar 2014 EMEA/H/C/369/S/80
Mabthera Roche Registration Limited Centralised - Variation 21 Mar 2014 EMEA/H/C/165/X/83
ellaOne Laboratoire HRA Pharma Centralised - Renewal 21 Mar 2014 EMEA/H/C/1027/R/25
Cometriq TMC Pharma Services Ltd. Centralised - Authorisation 21 Mar 2014 EMEA/H/C/2640
Cialis Eli Lilly Nederland B.V. Centralised - Variation 14 Mar 2014
Pandemrix GlaxoSmithKline Biologicals S.A. Centralised - Variation 14 Mar 2014
Zevalin Spectrum Pharmaceuticals B.V. Centralised - Variation 14 Mar 2014
Qutenza Astellas Pharma Europe B.V. Centralised - Variation 12 Mar 2014
Vibativ Clinigen Healthcare Limited Centralised - Variation 12 Mar 2014 EMEA/H/C/1240/II/6
Tyverb Glaxo Group Ltd Centralised - Annual renewal 12 Mar 2014 EMEA/H/C/795/R/30
Osigraft Olympus Biotech International Limited Centralised - Variation 10 Mar 2014
Ruconest Pharming Group N.V. Centralised - Variation 10 Mar 2014
Pedea Orphan Europe S.A.R.L. Centralised - Variation 10 Mar 2014
Forxiga Bristol-Myers Squibb/AstraZeneca EEIG Centralised - Variation 5 Mar 2014
Emadine Alcon Laboratories (UK) Ltd. Centralised - Variation 5 Mar 2014
Azopt Alcon Laboratories (UK) Ltd. Centralised - Variation 5 Mar 2014
Tasmar Meda AB Centralised - Variation 5 Mar 2014
IntronA Merck Sharp & Dohme Limited Centralised - Variation 5 Mar 2014
Sirturo Janssen-Cilag International NV Centralised - Authorisation 5 Mar 2014 EMEA/H/C/2614
Opatanol Alcon Laboratories (UK) Ltd. Centralised - Variation 3 Mar 2014
Sildenafil Actavis Actavis Group PTC ehf. Centralised - Variation 3 Mar 2014
Peyona Chiesi Farmaceutici S.P.A. Centralised - Renewal 3 Mar 2014 EMEA/H/C/1014/R/11
Olanzapine Teva Teva Pharma B.V. Centralised - Variation 28 Feb 2014
Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Variation 28 Feb 2014
Menveo Novartis Vaccines and Diagnostics S.r.l. Centralised - Variation 28 Feb 2014
Rebif Merck Serono Europe Limited Centralised - Variation 28 Feb 2014
Samsca Otsuka Pharmaceutical Europe Ltd. Centralised - Variation 28 Feb 2014 EMEA/H/C/980/II/17
Xolair Novartis Europharm Limited Centralised - Variation 28 Feb 2014 EMEA/H/C/606/II/48
Instanyl Takeda Pharma A/S Centralised - Modification 28 Feb 2014 EMEA/H/C/959/PSUSA/1369
Effentora Teva Pharma B.V. Centralised - Modification 28 Feb 2014 EMEA/H/C/833/PSUSA/1369
PecFent Archimedes Development Ltd Centralised - Modification 28 Feb 2014 EMEA/H/C/1164/PSUSA/1369
Prepandrix GlaxoSmithKline Biologicals S.A. Centralised - Maintain 28 Feb 2014 EMEA/H/C/822/PSUV/49
Ixiaro Valneva Austria GmbH Centralised - Renewal 28 Feb 2014 EMEA/H/C/963/R/55
Pumarix GlaxoSmithKline Biologicals S.A. Centralised - Modification 28 Feb 2014 EMEA/H/C/1212/PSUV/9
Mirapexin Boehringer Ingelheim International GmbH Centralised - Modification 28 Feb 2014 EMEA/H/C/134/PSUSA/2491
Sifrol Boehringer Ingelheim International GmbH Centralised - Modification 28 Feb 2014 EMEA/H/C/133/PSUSA/2491
Adjupanrix GlaxoSmithKline Biologicals S.A. Centralised - Modification 28 Feb 2014 EMEA/H/C/1206/PSUV/32
Temozolomide Hospira Hospira UK Limited Centralised - Variation 28 Feb 2014
Tamiflu Roche Registration Limited Corrigendum 4 Dec 2013
Neulasta Amgen Europe B.V. Corrigendum 15 Nov 2013
Advagraf Astellas Pharma Europe B.V. Corrigendum 18 Feb 2013
Advagraf Astellas Pharma Europe B.V. Corrigendum 18 Feb 2013
Advagraf Astellas Pharma Europe B.V. Corrigendum 18 Feb 2013
Advagraf Astellas Pharma Europe B.V. Corrigendum 18 Feb 2013
Centralised procedures of orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
EU/3/07/485 Theorem Clinical Research GmbH Centralised Orphan - Transfer of orphan designation 12 Aug 2014 EMA/OD/059/07/T/0
EU/3/12/1089 Wilson Therapeutics AB Centralised Orphan - Transfer of orphan designation 30 Jul 2014 EMA/OD/142/12/T/01
EU/3/13/1156 inVentiv Health Germany GmbH Centralised Orphan - Transfer of orphan designation 30 Jul 2014 EMA/OD/045/13/T/01
EU/3/07/446 GlaxoSmithKline Trading Services Limited Centralised Orphan - Transfer of orphan designation 30 Jul 2014 EMA/OD/102/06/T/01
EU/3/05/313 GlaxoSmithKline Trading Services Limited Centralised Orphan - Transfer of orphan designation 30 Jul 2014 EMA/OD/053/05/T/02
EU/3/14/1293 GlaxoSmithKline Trading Services Limited Centralised Orphan - Designation 30 Jul 2014 EMA/OD/021/14
EU/3/14/1292 GlaxoSmithKline Trading Services Limited Centralised Orphan - Designation 30 Jul 2014 EMA/OD/020/14
EU/3/14/1306 Raptor Pharmaceuticals Europe BV Centralised Orphan - Designation 29 Jul 2014 EMA/OD/070/14
EU/3/14/1305 AbbVie Ltd Centralised Orphan - Designation 29 Jul 2014 EMA/OD/065/14
EU/3/14/1304 Alexion Europe SAS Centralised Orphan - Designation 29 Jul 2014 EMA/OD/062/14
EU/3/14/1303 AstraZeneca AB Centralised Orphan - Designation 29 Jul 2014 EMA/OD/059/14
EU/3/14/1302 Maďthé Tauber Centralised Orphan - Designation 29 Jul 2014 EMA/OD/054/14
EU/3/14/1301 Biogen Idec Limited Centralised Orphan - Designation 29 Jul 2014 EMA/OD/051/14
EU/3/14/1300 IDEA Innovative Drug European Associates Limited Centralised Orphan - Designation 29 Jul 2014 EMA/OD/047/14
EU/3/14/1299 Bayer Pharma AG Centralised Orphan - Designation 29 Jul 2014 EMA/OD/044/14
EU/3/14/1298 Alnylam UK Limited Centralised Orphan - Designation 29 Jul 2014 EMA/OD/041/14
EU/3/14/1297 Alnylam UK Limited Centralised Orphan - Designation 29 Jul 2014 EMA/OD/039/14
EU/3/14/1296 Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione Centralised Orphan - Designation 29 Jul 2014 EMA/OD/037/14
EU/3/14/1295 Richardson Associates Regulatory Affairs Ltd Centralised Orphan - Designation 29 Jul 2014 EMA/OD/035/14
EU/3/14/1294 Dr. Ulrich Granzer Centralised Orphan - Designation 29 Jul 2014 EMA/OD/028/14
EU/3/14/1291 Amgen Europe B.V. Centralised Orphan - Designation 29 Jul 2014 EMA/OD/012/14
EU/3/01/059 Clinigen Healthcare Limited Centralised Orphan - Transfer of orphan designation 29 Jul 2014 EMA/OD/021/01/T/03
EU/3/14/1290 NightstaRx Ltd. Centralised Orphan - Designation 4 Jul 2014 EMA/OD/033/14
EU/3/14/1289 A1M Pharma AB Centralised Orphan - Designation 4 Jul 2014 EMA/OD/027/14
EU/3/14/1288 Dr. Falk Pharma GmbH Centralised Orphan - Designation 4 Jul 2014 EMA/OD/026/14
EU/3/14/1287 Dr. Ulrich Granzer Centralised Orphan - Designation 4 Jul 2014 EMA/OD/023/14
EU/3/14/1286 MorphoSys AG Centralised Orphan - Designation 4 Jul 2014 EMA/OD/022/14
EU/3/14/1285 Clinuvel (UK) Limited Centralised Orphan - Designation 4 Jul 2014 EMA/OD/019/14
EU/3/14/1284 Basilea Medical Ltd Centralised Orphan - Designation 4 Jul 2014 EMA/OD/009/14
EU/3/14/1283 Fondazione Telethon Centralised Orphan - Designation 4 Jul 2014 EMA/OD/005/14
EU/3/14/1282 Fondazione Telethon Centralised Orphan - Designation 4 Jul 2014 EMA/OD/004/14
EU/3/14/1281 Vertex Pharmaceuticals (U.K.) Limited Centralised Orphan - Designation 4 Jul 2014 EMA/OD/002/14
EU/3/08/548 Amgen Europe B.V. Centralised Orphan - Transfer of orphan designation 19 Jun 2014 EMA/OD/120/07/T/03
EU/3/10/727 Sanofi-Aventis Recherche & Développement Centralised Orphan - Transfer of orphan designation 19 Jun 2014 EMA/OD/137/09/T/01
EU/3/09/720 Sanofi-Aventis Recherche & Développement Centralised Orphan - Transfer of orphan designation 19 Jun 2014 EMA/OD/127/09/T/01
EU/3/14/1280 Cochamo Systems Ltd Centralised Orphan - Designation 10 Jun 2014 EMA/OD/006/14
EU/3/14/1275 Gene Signal SAS Centralised Orphan - Designation 10 Jun 2014 EMA/OD/008/14
EU/3/14/1279 Clanotech AB Centralised Orphan - Designation 4 Jun 2014 EMA/OD/016/14
EU/3/14/1278 Alan Boyd Consultants Ltd Centralised Orphan - Designation 4 Jun 2014 EMA/OD/015/14
EU/3/14/1277 Imperial Innovations Limited Centralised Orphan - Designation 4 Jun 2014 EMA/OD/013/14
EU/3/14/1276 Basilea Medical Ltd Centralised Orphan - Designation 4 Jun 2014 EMA/OD/010/14
EU/3/14/1274 CLL Pharma Centralised Orphan - Designation 4 Jun 2014 EMA/OD/003/14
EU/3/14/1273 Epitarget AS Centralised Orphan - Designation 4 Jun 2014 EMA/OD/001/14
EU/3/14/1272 Shire Pharmaceuticals Ireland Limited Centralised Orphan - Designation 4 Jun 2014 EMA/OD/201/13
EU/3/14/1271 Nordic Nanovector AS Centralised Orphan - Designation 4 Jun 2014 EMA/OD/200/13
EU/3/14/1270 CellAct Pharma GmbH Centralised Orphan - Designation 4 Jun 2014 EMA/OD/199/13
EU/3/14/1269 ITG Isotope Technologies Garching GmbH Centralised Orphan - Designation 4 Jun 2014 EMA/OD/196/13
EU/3/03/183 Eumedica N.V. Centralised Orphan - Transfer of orphan designation 20 May 2014 EMEA/OD/028/03/T/01
EU/3/12/1013 Inserm-ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Centralised Orphan - Transfer of orphan designation 15 May 2014 EMA/OD/011/12/T/01
EU/3/07/495 Orbona Pharma Ltd Centralised Orphan - Transfer of orphan designation 15 May 2014 EMA/OD/064/07/T/01
EU/3/10/753 Intercept s.r.l. Corrigendum 5 May 2014
EU/3/14/1268 Sanofi-Aventis groupe Centralised Orphan - Designation 29 Apr 2014 EMA/OD/198/13
EU/3/14/1267 Voisin Consulting S.A.R.L. Centralised Orphan - Designation 29 Apr 2014 EMA/OD/194/13
EU/3/14/1266 Novartis Europharm Limited Centralised Orphan - Designation 29 Apr 2014 EMA/OD/187/13
EU/3/14/1265 Oncos Therapeutics Oy Centralised Orphan - Designation 29 Apr 2014 EMA/OD/186/13
EU/3/14/1264 Janssen-Cilag International NV Centralised Orphan - Designation 29 Apr 2014 EMA/OD/185/13
EU/3/14/1263 bluebird bio France Centralised Orphan - Designation 29 Apr 2014 EMA/OD/184/13
EU/3/12/963 Actelion Registration Ltd Centralised Orphan - Transfer of orphan designation 28 Apr 2014 EMA/OD/112/11/T/01
EU/3/09/645 Novartis Europharm Limited Centralised Orphan - Transfer of orphan designation 28 Apr 2014 EMEA/OD/010/09/T/01
EU/3/08/580 Dr Ulrich Bogdahn Centralised Orphan - Transfer of orphan designation 28 Apr 2014 EMEA/OD/042/08/T/01
EU/3/08/532 Dr Ulrich Bogdahn Centralised Orphan - Transfer of orphan designation 28 Apr 2014 EMEA/OD/102/07/T/01
EU/3/12/1020 FGK Representative Service GmbH Centralised Orphan - Transfer of orphan designation 15 Apr 2014 EMA/OD/048/12/T/01
EU/3/12/1024 AstraZeneca AB Centralised Orphan - Transfer of orphan designation 15 Apr 2014 EMA/OD/035/12/T/02
EU/3/14/1262 Dr. Ulrich Granzer Centralised Orphan - Designation 11 Apr 2014 EMA/OD/172/13
EU/3/14/1261 Viridian Pharma Ltd Centralised Orphan - Designation 11 Apr 2014 EMA/OD/161/13
EU/3/08/599 Prosensa Therapeutics B.V. Centralised Orphan - Transfer of orphan designation 11 Apr 2014 EMEA/OD/082/08/T/02
EU/3/12/1025 AstraZeneca AB Centralised Orphan - Transfer of orphan designation 11 Apr 2014 EMA/OD/036/12/T/02
EU/3/12/1022 AstraZeneca AB Centralised Orphan - Transfer of orphan designation 8 Apr 2014 EMA/OD/033/12/T/02
EU/3/12/1023 AstraZeneca AB Centralised Orphan - Transfer of orphan designation 8 Apr 2014 EMA/OD/034/12/T/02
EU/3/14/1259 Insmed Limited Centralised Orphan - Designation 8 Apr 2014 EMA/OD/191/13
EU/3/14/1260 Pharnext SAS Centralised Orphan - Designation 26 Mar 2014 EMA/OD/193/13
EU/3/14/1258 Eudax Srl Centralised Orphan - Designation 26 Mar 2014 EMA/OD/190/13
EU/3/14/1257 Prof. F.J.T.Staal Centralised Orphan - Designation 26 Mar 2014 EMA/OD/188/13
EU/3/14/1256 Fondazione Telethon Centralised Orphan - Designation 26 Mar 2014 EMA/OD/182/13
EU/3/14/1255 Boehringer Ingelheim International GmbH Centralised Orphan - Designation 26 Mar 2014 EMA/OD/181/13
EU/3/14/1254 Alexion Europe SAS Centralised Orphan - Designation 26 Mar 2014 EMA/OD/176/13
EU/3/14/1253 iCell Science AB Centralised Orphan - Designation 26 Mar 2014 EMA/OD/168/13
EU/3/14/1252 Raptor Pharmaceuticals Europe BV Centralised Orphan - Designation 26 Mar 2014 EMA/OD/164/13
EU/3/14/1251 Genzyme Europe B.V. Centralised Orphan - Designation 26 Mar 2014 EMA/OD/148/13
EU/3/14/1250 Isis USA Ltd Centralised Orphan - Designation 26 Mar 2014 EMA/OD/098/13
EU/3/06/391 Novartis Europharm Limited Centralised Orphan - Transfer of orphan designation 12 Mar 2014 EMEA/OD/027/06/T/02
EU/3/06/368 Amicus Therapeutics UK Limited Centralised Orphan - Transfer of orphan designation 12 Mar 2014 EMEA/OD/105/05/T/04
EU/3/14/1249 Isis USA Ltd Centralised Orphan - Designation 19 Feb 2014 EMA/OD/180/13
Centralised procedures of veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Convenia Zoetis Belgium S.A. Centralised - Variation 27 Aug 2014
Stronghold Zoetis Belgium S.A. Centralised - Variation 26 Aug 2014
Naxcel Zoetis Belgium S.A. Centralised - Variation 26 Aug 2014
Zolvix Novartis Healthcare A/S Centralised - Variation 19 Aug 2014
Activyl Tick Plus Intervet International B.V. Centralised - Variation 5 Aug 2014
Versican Plus L4 Zoetis Belgium S.A. Centralised - Authorisation 31 Jul 2014 EMEA/V/C/3680
Palladia Zoetis Belgium S.A. Centralised - Renewal 31 Jul 2014 EMEA/V/C/150/R/7
Versican Plus Pi/L4 Zoetis Belgium S.A. Centralised - Authorisation 31 Jul 2014 EMEA/V/C/3683
Osurnia Novartis Santé Animale S.A.S. Centralised - Authorisation 31 Jul 2014 EMEA/V/C/3753
Poulvac E. coli Zoetis Belgium S.A. Centralised - Variation 28 Jul 2014
ProteqFlu-Te Merial Centralised - Variation 11 Jul 2014 EMEA/V/C/74/II/17
ProteqFlu Merial Centralised - Variation 11 Jul 2014 EMEA/V/C/73/II/14
ERYSENG PARVO Laboratorios Hipra, S.A. Centralised - Authorisation 8 Jul 2014 EMEA/V/C/2762
Draxxin Zoetis Belgium S.A. Centralised - Variation 8 Jul 2014 EMEA/V/C/77/X/26
SevoFlo Abbott Laboratories Ltd Centralised - Variation 8 Jul 2014
Versican Plus DHPPi Zoetis Belgium S.A. Centralised - Authorisation 4 Jul 2014 EMEA/V/C/3679
Versican Plus Pi Zoetis Belgium S.A. Centralised - Authorisation 4 Jul 2014 EMEA/V/C/3681
ERYSENG Laboratorios Hipra, S.A. Centralised - Authorisation 4 Jul 2014 EMEA/V/C/2761
TruScient Zoetis Belgium S.A. Centralised - Variation 30 Jun 2014
Hiprabovis IBR Marker Live Laboratorios Hipra, S.A. Centralised - Variation 27 Jun 2014
Zulvac 8 Ovis Zoetis Belgium S.A. Centralised - Variation 27 Jun 2014
Zulvac 8 Bovis Zoetis Belgium S.A. Centralised - Variation 27 Jun 2014
Econor Novartis Tiergesundheit GmbH Centralised - Transfer Marketing Authorisation Holder 23 Jun 2014 EMEA/V/C/42/T/47
Locatim Biokema Anstalt Centralised - Variation 19 Jun 2014
Previcox Merial Centralised - Variation 19 Jun 2014
Leucogen Virbac Centralised - Renewal 12 Jun 2014 EMEA/V/C/144/R/2
Metacam Boehringer Ingelheim Vetmedica GmbH Centralised - Variation 6 Jun 2014
Cerenia Zoetis Belgium S.A. Centralised - Variation 6 Jun 2014 EMEA/V/C/106/II/22
Melovem Dopharma Research B.V. Centralised - Renewal 6 Jun 2014 EMEA/V/C/152/R/8
Leucofeligen FeLV/RCP Virbac Centralised - Renewal 6 Jun 2014 EMEA/V/C/143/R/3
Suvaxyn PCV Zoetis Belgium S.A. Centralised - Renewal 6 Jun 2014 EMEA/V/C/149/R/16
Vectra Felis CEVA SANTE ANIMALE Centralised - Authorisation 6 Jun 2014 EMEA/V/C/2746
Activyl Intervet International B.V. Centralised - Variation 3 Jun 2014
Circovac Merial Centralised - Variation 16 May 2014
Recocam Cross Vetpharm Group, Ltd Centralised - Variation 7 May 2014
Cardalis CEVA SANTE ANIMALE Centralised - Variation 7 May 2014
Versican Plus DHPPi/L4R Zoetis Belgium S.A. Centralised - Authorisation 7 May 2014 EMEA/V/C/2759
Versican Plus DHPPi/L4 Zoetis Belgium S.A. Centralised - Authorisation 7 May 2014 EMEA/V/C/3678
Flexicam Dechra Veterinary Products A/S Centralised - Withdrawal 6 May 2014
BTVPUR AlSap 2-4 Merial Centralised - Variation 11 Apr 2014 EMEA/V/C/139/S/4
Parvoduk Merial Centralised - Authorisation 11 Apr 2014 EMEA/V/C/2740
Equilis StrepE Intervet International B.V. Centralised - Renewal 10 Apr 2014 EMEA/V/C/78/R/10
Improvac Zoetis Belgium S.A. Centralised - Renewal 10 Apr 2014 EMEA/V/C/136/R/24
Aftovaxpur Doe Merial Centralised - Variation 7 Apr 2014 EMEA/V/C/2292/II/1
Meloxidyl CEVA SANTE ANIMALE Centralised - Variation 31 Mar 2014 EMEA/V/C/115/IB/17
Panacur AquaSol Intervet International B.V. Centralised - Variation 14 Mar 2014 EMEA/V/C/2008/X/3
Bovilis BTV8 Intervet International B.V. Centralised - Variation 14 Mar 2014 EMEA/V/C/148/S/5
RevitaCAM Abbott Laboratories Ltd Centralised - Variation 12 Mar 2014
Equisolon Le Vet B.V. Centralised - Authorisation 12 Mar 2014 EMEA/V/C/2382
Fungitraxx Avimedical B.V. Centralised - Authorisation 12 Mar 2014 EMEA/V/C/2722
BTVPUR AlSap 8 Merial Centralised - Renewal 12 Mar 2014 EMEA/V/C/146/R/10
Loxicom Norbrook Laboratories Ltd Centralised - Renewal 12 Mar 2014 EMEA/V/C/141/R/18
Community referrals for human medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Nerventra Teva Pharma GmbH Centralised - Refusal of marketing authorisation 19 Aug 2014 EMEA/H/C/2546
Estradiol Referral 19 Aug 2014 EMEA/H/R/A-31/1336
Dexamed and associated names Referral 6 Aug 2014 EMEA/A-29/1375
Seroquel/Seroquel XR and associated names AstraZeneca UK Limited Referral 6 Aug 2014 EMEA/H/A-30/1362
Domperidone Art 31 Corrigendum 5 Aug 2014
Neocepri Endocyte Europe B.V. Centralised - Refusal of marketing authorisation 5 Aug 2014 EMEA/H/C/2773
Folcepri Endocyte Europe B.V. Centralised - Refusal of marketing authorisation 5 Aug 2014 EMEA/H/C/2570
Vynfinit Endocyte Europe B.V. Centralised - Refusal of marketing authorisation 5 Aug 2014 EMEA/H/C/2571
Masiviera AB Science S.A. Centralised - Refusal of marketing authorisation 23 Jul 2014 EMEA/H/C/2659
Domperidone Art 31 Referral 14 Jul 2014 EMEA/H/A-31/1365
Caustinerf arsenical, Yranicid arsenical and other associated names for topical use Referral 11 Jul 2014
Masican AB Science S.A. Centralised - Refusal of marketing authorisation 4 Jul 2014 EMEA/H/C/2670
Crestor and associated names AstraZeneca UK Limited Referral 30 Jun 2014 EMEA/H/A-29-PAE/1378
Zolpidem Referral 23 Jun 2014 EMEA/H/A-31/1377
Ribavirin Centralised - Modification 28 Apr 2014 EMEA/H/C/PSUSA/10007/201307
methysergide Referral 28 Apr 2014 EMEA/H/A-31/1335
5-aminolevulinic acid Biofrontera Bioscience GmbH Centralised - Modification 3 Apr 2014 EMEA/H/C/PSUSA/10006/201306
5-Chloro-N2-[2-isopropoxy-5-methyl-4-(4-piperidinyl)phenyl]-N4-[2-(isopropylsulfonyl)phenyl]-2,4-pyrimidinediamine Novartis Europharm Limited Centralised Orphan - Refusal of orphan designation 28 Mar 2014 EMA/OD/113/13
Rocephin and associated names Roche group of companies and associated companies Referral 21 Mar 2014 EMEA/H/A-30/1302
Winfuran Toray International U.K. Limited Centralised - Refusal of marketing authorisation 21 Mar 2014 EMEA/H/C/2683
Valebo Referral 10 Mar 2014 EMEA/H/A-29/1364
Tibocina and associated names ArIsto Pharma GmbH Referral 5 Mar 2014 EMEA/H/A-29/1390
Tibolona Aristo ArIsto Pharma GmbH Referral 5 Mar 2014 EMEA/H/A-29/1389
Flupirtine Teva GmbH Corrigendum 28 Feb 2014
Fentanyl Centralised - Modification 28 Feb 2014 EMEA/H/C/PSUSA/1369
Nanotop Referral 28 Feb 2014 EMEA/H/A-29/1386
Community referrals for veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Enrofloxacin Corrigendum 22 Jul 2014
Fiprex CAT 52.5 mg spot-on solution for cats, Fiprex S 75 mg spot-on solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for dogs, Fiprex XL 412.5 mg spot-on solution for dogs Vet-Agro Trading Sp. z o.o. Referral 14 Jul 2014 EMEA/V/A/99
Linco-Spectin 100 and its associated names Referral 11 Jul 2014 EMEA/V/A/88/Art.34
Barium selenate Referral 28 Mar 2014 EMEA/V/A/77
Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle Referral 21 Mar 2014 EMEA/V/A/98
Enrofloxacin Referral 28 Feb 2014 EMEA/V/A/89