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Pharmaceuticals - Community Register

  

Newly adopted Marketing Authorisation Decisions (last six months)

Procedures for centrally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Abseamed Medice Arzneimittel Pütter GmbH & Co KG Centralised - Yearly update 18 Sep 2017
Gazyvaro Roche Registration Limited Centralised - Variation 18 Sep 2017 EMEA/H/C/002799/II/0016
RoActemra Roche Registration Limited Centralised - 2-Monthly update 18 Sep 2017 EMEA/H/C/000955/II/0066
Zebinix Bial - Portela & Cª, SA Centralised - 2-Monthly update 18 Sep 2017 EMEA/H/C/000988/IB/0063/G
Retacrit Hospira UK Limited Centralised - Yearly update 18 Sep 2017
Ibandronic acid Accord Accord Healthcare Limited Centralised - Renewal 18 Sep 2017 EMEA/H/C/2638/R/13
Opdivo Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/10379/201701
Blincyto Amgen Europe B.V. PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/10460/201612
Xgeva Amgen Europe B.V. Centralised - Variation 18 Sep 2017 EMEA/H/C/2173/X/48/G
Oslif Breezhaler Novartis Europharm Limited PSUSA - Modification 18 Sep 2017 EMEA/H/C/1210/
Signifor Novartis Europharm Limited Centralised - Variation 18 Sep 2017 EMEA/H/C/2052/X/30/G
Lacosamide Accord Accord Healthcare Limited Centralised - Authorisation 18 Sep 2017 EMEA/H/C/4443
Ninlaro Takeda Pharma A/S Centralised - Annual renewal 18 Sep 2017 EMEA/H/C/003844/R/03
Lyxumia Sanofi-Aventis groupe Centralised - Renewal 18 Sep 2017 EMEA/H/C/2445/R/23
Betmiga Astellas Pharma Europe B.V. Centralised - Renewal 18 Sep 2017 EMEA/H/C/2388/R/26
Rydapt Novartis Europharm Limited Centralised - Authorisation 18 Sep 2017 EMEA/H/C/4095/00
Lumark IDB Holland B.V. PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/00010391/201612
Bavencio Merck Serono Europe Limited Centralised - Authorisation 18 Sep 2017 EMEA/H/C/4338
Entecavir Mylan Mylan S.A.S. Centralised - Authorisation 18 Sep 2017 EMEA/H/C/004377/0000
Xermelo Ipsen Pharma Centralised - Authorisation 18 Sep 2017 EMEA/H/C/3937
Revlimid Celgene Europe Limited PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/1838/201612
Lynparza AstraZeneca AB PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/10322/201612
RotaTeq MSD VACCINS PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/2666/201611
Angiox The Medicines Company UK Ltd Centralised - Yearly update 14 Sep 2017
Eurartesim Alfasigma S.p.A. Centralised - Transfer Marketing Authorisation Holder 14 Sep 2017 EMEA/H/C/1199/T/29
Wakix Bioprojet Pharma Centralised - Yearly update 14 Sep 2017
Ebixa H. Lundbeck A/S Centralised - Yearly update 14 Sep 2017
Olazax Disperzi Glenmark Pharmaceuticals s.r.o. Centralised - Yearly update 14 Sep 2017
Ifirmasta Krka, d. d., Novo Mesto Centralised - Yearly update 14 Sep 2017
Vimpat UCB Pharma S.A. Centralised - 2-Monthly update 14 Sep 2017 EMEA/H/C/000863/II/0065/G
Olanzapine Apotex Apotex Europe B.V. Centralised - Yearly update 14 Sep 2017
Trevicta Janssen-Cilag International NV Centralised - Yearly update 14 Sep 2017
Glidipion Actavis Group PTC ehf. Centralised - Yearly update 14 Sep 2017
Sovaldi Gilead Sciences International Limited Centralised - 2-Monthly update 14 Sep 2017 EMEA/H/C/002798/II/0036
Ventavis Bayer Pharma AG Centralised - Yearly update 11 Sep 2017
Votrient Novartis Europharm Limited Centralised - Yearly update 11 Sep 2017
Simponi Janssen Biologics B.V. Centralised - Yearly update 11 Sep 2017
Jinarc Otsuka Pharmaceutical Europe Ltd. Centralised - Yearly update 11 Sep 2017
Protelos Les Laboratoires Servier Centralised - Yearly update 11 Sep 2017
Osseor Les Laboratoires Servier Centralised - Yearly update 11 Sep 2017
Zerit Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 11 Sep 2017
Tesavel Merck Sharp & Dohme Limited Centralised - Yearly update 11 Sep 2017
Xelevia Merck Sharp & Dohme Limited Centralised - Yearly update 11 Sep 2017
Zyprexa Eli Lilly Nederland B.V. Centralised - Yearly update 11 Sep 2017
Tysabri Biogen Idec Limited Centralised - Yearly update 11 Sep 2017
Methylthioninium chloride Proveblue Provepharm S.A.S. Centralised - Yearly update 11 Sep 2017
Infanrix hexa GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 11 Sep 2017
Epoetin alfa Hexal Hexal AG Centralised - Yearly update 7 Sep 2017
Binocrit Sandoz GmbH Centralised - Yearly update 7 Sep 2017
Taltz Eli Lilly Nederland B.V. Centralised - Yearly update 7 Sep 2017
Fexeric Keryx Biopharma UK Ltd. Centralised - Yearly update 7 Sep 2017
Intanza Sanofi Pasteur Europe Centralised - Variation 7 Sep 2017 EMEA/H/C/000957/II/54
Olazax Glenmark Pharmaceuticals s.r.o. Centralised - Yearly update 5 Sep 2017
Thorinane Techdow Pharma Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 5 Sep 2017 EMEA/H/C/003795/T/03
Humira AbbVie Ltd Centralised - 2-Monthly update 5 Sep 2017 EMEA/H/C/481/II/163
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. Centralised - Authorisation 5 Sep 2017 EMEA/H/C/4240
Cuprior gmp-orphan SA Centralised - Authorisation 5 Sep 2017 EMEA/H/C/4005
Zinbryta Biogen Idec Limited Rectificative Decision 29 Aug 2017
Rasilez HCT Noden Pharma DAC Centralised - Transfer Marketing Authorisation Holder 28 Aug 2017 EMEA/H/C/000964/T/0082
Irbesartan HCT Zentiva Sanofi-Aventis groupe PSUSA - Modification 28 Aug 2017 EMEA/H/C/783/PSUSA/00001653/201609
Mimpara Amgen Europe B.V. Centralised - Variation 28 Aug 2017 EMEA/H/C/000570/X/0055/G
Ecalta Pfizer Limited Centralised - Renewal 28 Aug 2017 EMEA/H/C/000788/R/0033
Forxiga AstraZeneca AB Centralised - Renewal 28 Aug 2017 EMEA/H/C/002322/R/0035
Constella Allergan Pharmaceuticals International Limited Centralised - Renewal 28 Aug 2017 EMEA/H/C/2490/R/0032
Aranesp Amgen Europe B.V. Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/332/II/141
Fluenz Tetra AstraZeneca AB Centralised - Variation 24 Aug 2017 EMEA/H/C/2617/II/72
Invega Janssen-Cilag International NV Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/746/II/56/G
Norvir AbbVie Ltd Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/127/II/147
Kaletra AbbVie Ltd Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/368/WS/1178
BYDUREON AstraZeneca AB Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/2020/II/41
Dacogen Janssen-Cilag International NV Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/2221/II/31
KEYTRUDA Merck Sharp & Dohme Limited Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/003820/II/23/G
EDURANT Janssen-Cilag International NV Centralised - 2-Monthly update 24 Aug 2017 EMEA/H/C/2264/II/24
Karvezide Sanofi-Aventis groupe PSUSA - Modification 24 Aug 2017 EMEA/H/C/PSUSA/1653/201609
Imraldi Samsung Bioepis UK Limited Centralised - Authorisation 24 Aug 2017 EMEA/H/C/4279
Skilarence Almirall, S.A. Rectificative Decision 24 Aug 2017
Orkambi Vertex Pharmaceuticals (Europe) Limited PSUSA - Modification 24 Aug 2017 EMEA/H/C/PSUSA/10455/201611
Zoledronic acid Hospira Hospira UK Limited Centralised - Renewal 24 Aug 2017 EMEA/H/C/2365/R/26
Ruconest Pharming Group N.V. PSUSA - Modification 24 Aug 2017 EMEA/H/C/PSUSA/873/201610
IMBRUVICA Janssen-Cilag International NV PSUSA - Modification 24 Aug 2017 EMEA/H/C/PSUSA/10301/201611
Nitisinone MendeliKABS MendeliKABS Europe Limited Centralised - Authorisation 24 Aug 2017 EMEA/H/C/4281/00
Fotivda EUSA Pharma (UK) Limited Centralised - Authorisation 24 Aug 2017 EMEA/H/C/4131/00
SonoVue Bracco International B.V. Corrigendum 22 Aug 2017
MAVENCLAD Merck Serono Europe Limited Corrigendum 22 Aug 2017
MAVENCLAD Merck Serono Europe Limited Corrigendum 22 Aug 2017
Rasilez Noden Pharma DAC Centralised - Transfer Marketing Authorisation Holder 22 Aug 2017 EMEA/H/C/780/T/114
Xarelto Bayer AG Centralised - 2-Monthly update 22 Aug 2017 EMEA/H/C/944/II/50
CoAprovel Sanofi Clir SNC PSUSA - Modification 22 Aug 2017 EMEA/H/C/222//PSUSA/1653/201609
SonoVue Bracco International B.V. Centralised - Variation 22 Aug 2017 EMEA/H/C/303/X/34
Ketoconazole HRA Laboratoire HRA Pharma PSUSA - Modification 22 Aug 2017 EMEA/H/C/EMEA/H/C/3906/10316/201611
MAVENCLAD Merck Serono Europe Limited Centralised - Authorisation 22 Aug 2017 EMEA/H/C/4230
Kisqali Novartis Europharm Limited Centralised - Authorisation 22 Aug 2017 EMEA/H/C/004213/0000
Xofigo Bayer AG PSUSA - Modification 14 Aug 2017 EMEA/H/C/2653/PSUSA/10132/201611
Soliris Alexion Europe SAS Centralised - 2-Monthly update 14 Aug 2017 EMEA/H/C/791/II/90
Mekinist Novartis Europharm Limited PSUSA - Modification 14 Aug 2017 EMEA/H/C/PSUSA/10262/201611
Vargatef Boehringer Ingelheim International GmbH PSUSA - Modification 14 Aug 2017 EMEA/H/C/PSUSA/00010318/201611
Exjade Novartis Europharm Limited PSUSA - Modification 14 Aug 2017 EMEA/H/C/PSUSA/939/201610
Nordimet Nordic Group B.V. Centralised - Yearly update 7 Aug 2017
Stivarga Bayer AG Centralised - Transfer Marketing Authorisation Holder 7 Aug 2017 EMEA/H/C/2573/T/23
Colobreathe Teva B.V. Centralised - Transfer Marketing Authorisation Holder 7 Aug 2017 EMEA/H/C/1225/T/28
Abilify Otsuka Pharmaceutical Europe Ltd. Centralised - Yearly update 3 Aug 2017
Apidra Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 3 Aug 2017
Zyllt Krka, d. d., Novo Mesto Centralised - 2-Monthly update 2 Aug 2017 EMEA/H/C/1058/IB/29/G
Stivarga Bayer AG Centralised - 2-Monthly update 2 Aug 2017 EMEA/H/C/2573/II/20
Bridion Merck Sharp & Dohme Limited Centralised - Yearly update 26 Jul 2017
Aripiprazole Mylan Pharma Mylan S.A.S Centralised - Yearly update 26 Jul 2017
Velphoro Vifor Fresenius Medical Care Renal Pharma France Centralised - Yearly update 26 Jul 2017
Oprymea Krka, d. d., Novo Mesto Centralised - Yearly update 26 Jul 2017
Yellox PharmaSwiss Ceská republika s.r.o. Centralised - Yearly update 26 Jul 2017
Maviret AbbVie Ltd Centralised - Authorisation 26 Jul 2017 EMEA/H/C/004430/0000
Vosevi Gilead Sciences International Limited Centralised - Authorisation 26 Jul 2017 EMEA/H/C/4350
Votubia Novartis Europharm Limited Centralised - 2-Monthly update 26 Jul 2017 EMEA/H/C/2311/II/44
Kaletra AbbVie Ltd Centralised - 2-Monthly update 26 Jul 2017 EMEA/H/C/368/II/161/G
Tovanor Breezhaler Novartis Europharm Limited Centralised - Renewal 26 Jul 2017 EMEA/H/C/2690/R/22
Zykadia Novartis Europharm Limited Centralised - Authorisation - Switch to non-conditional 26 Jul 2017 EMEA/H/C/3819/II/10
Olanzapine Mylan Generics [UK] Limited Centralised - Yearly update 25 Jul 2017
Granupas Lucane Pharma Centralised - Yearly update 25 Jul 2017
Victoza Novo Nordisk A/S Centralised - 2-Monthly update 25 Jul 2017 EMEA/H/C/1026/II/42
Rivastigmine 1 A Pharma 1 A Pharma GmbH Centralised - Yearly update 25 Jul 2017
Faslodex AstraZeneca UK Limited Centralised - 2-Monthly update 25 Jul 2017 EMEA/H/C/540/II/57
Voncento CSL Behring GmbH Centralised - 2-Monthly update 25 Jul 2017 EMEA/H/C/2493/II/17/G
Orencia Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 25 Jul 2017 EMEA/H/C/000701/II/0105
Harvoni Gilead Sciences International Limited Centralised - 2-Monthly update 19 Jul 2017 EMEA/H/C/3850/II/39
Clopidogrel Krka Krka, d. d., Novo Mesto Centralised - 2-Monthly update 19 Jul 2017 EMEA/H/C/1056/IB/29/G
Qtern AstraZeneca AB Centralised - 2-Monthly update 19 Jul 2017 EMEA/H/C/4057/IB/07
Grepid Pharmathen S.A. Centralised - 2-Monthly update 19 Jul 2017 EMEA/H/C/1059/IB/40/G
Repso Teva B.V. Centralised - Withdrawal 19 Jul 2017
Zavesca Actelion Registration Ltd Centralised - Yearly update 19 Jul 2017
Zavicefta Pfizer Ireland Pharmaceuticals Centralised - Transfer Marketing Authorisation Holder 19 Jul 2017 EMEA/H/C/4027/T/06
Enzepi Allergan Pharmaceuticals International Limited Centralised - Withdrawal 19 Jul 2017
Tracleer Actelion Registration Ltd Centralised - Yearly update 19 Jul 2017
Clopidogrel TAD TAD Pharma GmbH Centralised - 2-Monthly update 19 Jul 2017 EMEA/H/C/1136/IB/28/G
Raxone Santhera Pharmaceuticals (Deutschland) GmbH Centralised - Yearly update 19 Jul 2017
Clopidogrel BGR Laboratoires BIOGARAN Centralised - 2-Monthly update 19 Jul 2017 EMEA/H/C/1138/IB/31/G
Cuprymina SPARKLE S.r.l. Centralised - Renewal 19 Jul 2017 EMEA/H/C/2136/R/14
Synjardy Boehringer Ingelheim International GmbH PSUSA - Modification 19 Jul 2017 EMEA/H/C/PSUSA/00010388/201610
Ofev Boehringer Ingelheim International GmbH PSUSA - Modification 19 Jul 2017 EMEA/H/C/PSUSA/00010319/201610
Revolade Novartis Europharm Limited PSUSA - Modification 19 Jul 2017 EMEA/H/C/PSUSA/00001205/201609
Forxiga AstraZeneca AB PSUSA - Modification 19 Jul 2017 EMEA/H/C/PSUSA/00010029/201610
Seebri Breezhaler Novartis Europharm Limited Centralised - Renewal 19 Jul 2017 EMEA/H/C/2430/R/20
Insulin lispro Sanofi Sanofi-Aventis groupe Centralised - Authorisation 19 Jul 2017 EMEA/H/C/4303
Veltassa Vifor Fresenius Medical Care Renal Pharma France Centralised - Authorisation 19 Jul 2017 EMEA/H/C/4180/00
Jardiance Boehringer Ingelheim International GmbH PSUSA - Modification 19 Jul 2017 EMEA/H/C/PSUSA/10388/201610
Rivastigmine Sandoz Sandoz GmbH Centralised - Yearly update 17 Jul 2017
Dinutuximab beta Apeiron EUSA Pharma (UK) Limited Centralised - Transfer Marketing Authorisation Holder 17 Jul 2017 EMEA/H/C/3918/T/01
Opsumit Actelion Registration Ltd Centralised - Yearly update 17 Jul 2017
Zinforo Pfizer Ireland Pharmaceuticals Centralised - Transfer Marketing Authorisation Holder 17 Jul 2017 EMEA/H/C/2252/T/34
Thorinane Techdow Pharma Netherlands B.V. Centralised - 2-Monthly update 17 Jul 2017 EMEA/H/C/003795/IB/02
Inhixa Techdow Europe AB Centralised - 2-Monthly update 17 Jul 2017 EMEA/H/C/004264/IB/14/G
Trimbow Chiesi Farmaceutici S.p.A. Centralised - Authorisation 17 Jul 2017 EMEA/H/C/4257
Kyntheum Leo Pharma A/S Centralised - Authorisation 17 Jul 2017 EMEA/H/C/3959
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. Centralised - Authorisation 17 Jul 2017 Caroline Blanc
Zinbryta Biogen Idec Limited Referral 14 Jul 2017 EMEA/H/A-20/1456/C/3862/10
Zevalin Spectrum Pharmaceuticals B.V. Rectificative Decision 13 Jul 2017
Praxbind Boehringer Ingelheim International GmbH Centralised - Yearly update 13 Jul 2017
Zoledronic acid Accord Accord Healthcare Limited Centralised - Yearly update 13 Jul 2017
Xultophy Novo Nordisk A/S PSUSA - Modification 13 Jul 2017 EMEA/H/C/PSUSA/00010272/201609
Rituzena Celltrion Healthcare Hungary Kft. Centralised - Authorisation 13 Jul 2017 EMEA/H/C/004724/1206
Reagila Gedeon Richter Plc. Centralised - Authorisation 13 Jul 2017 EMEA/H/C/002770/1209
Lixiana Daiichi Sankyo Europe GmbH PSUSA - Modification 13 Jul 2017 EMEA/H/C/2629/PSUSA/10387/201610
Memantine Merz Merz Pharmaceuticals GmbH Centralised - Renewal 13 Jul 2017 EMEA/H/C/2711/R/12
Zalmoxis MolMed S.p.A. Centralised - Annual renewal 13 Jul 2017 EMEA/H/C/2801/R/03
Enurev Breezhaler Novartis Europharm Limited Centralised - Renewal 13 Jul 2017 EMEA/H/C/2691/R/20
Isentress Merck Sharp & Dohme Limited Centralised - Variation 13 Jul 2017 EMEA/H/C/860/X/59
Xaluprine Nova Laboratories Limited PSUSA - Modification 13 Jul 2017
Kuvan BioMarin International Limited Centralised - Variation 13 Jul 2017 EMEA/H/C/943/X/47
Blitzima Celltrion Healthcare Hungary Kft. Centralised - Authorisation 13 Jul 2017 EMEA/H/C/4723
Torisel Pfizer Limited Centralised - Renewal 13 Jul 2017 EMEA/H/C/000799/R/0065
Ritemvia Celltrion Healthcare Hungary Kft. Centralised - Authorisation 13 Jul 2017 EMEA/H/C/4725
Latuda Sunovion Pharmaceuticals Europe Ltd PSUSA - Modification 13 Jul 2017 EMEA/H/C/PSUSA/00010114/201610
Eylea Bayer AG Centralised - Renewal 13 Jul 2017 EMEA/H/C/2392/R/33
Picato LEO Laboratories Ltd. Centralised - Renewal 13 Jul 2017 EMEA/H/C/2275/R/23
Incruse Glaxo Group Ltd PSUSA - Modification 13 Jul 2017 EMEA/H/C/PSUSA/10263/201610
Edistride AstraZeneca AB PSUSA - Modification 13 Jul 2017 EMEA/H/C/PSUSA/10029/201610
Memantine Accord Accord Healthcare Limited Centralised - Yearly update 10 Jul 2017
Xeloda Roche Registration Limited Centralised - Yearly update 10 Jul 2017
Spherox CO.DON AG Centralised - Authorisation 10 Jul 2017 EMEA/H/C/002736/0000
Myozyme Genzyme Europe B.V. PSUSA - Modification 10 Jul 2017 EMEA/H/C/PSUSA/86/201609
Nexavar Bayer AG Centralised - Transfer Marketing Authorisation Holder 6 Jul 2017 EMEA/H/C/690/T/42
Toviaz Pfizer Limited Centralised - Yearly update 6 Jul 2017
Kivexa ViiV Healthcare UK Limited Centralised - Yearly update 6 Jul 2017
Imlygic Amgen Europe B.V. Centralised - Yearly update 6 Jul 2017
OXERVATE Dompé farmaceutici S.p.A. Centralised - Authorisation 6 Jul 2017 EMEA/H/C/4209
Clopidogrel Krka d.d. Krka, d. d., Novo Mesto Centralised - 2-Monthly update 6 Jul 2017 EMEA/H/C/1137/IB/24/G
Celsentri ViiV Healthcare UK Limited Centralised - Variation 6 Jul 2017 EMEA/H/C/811/X/46/G
Xyrem UCB Pharma Ltd Centralised - Yearly update 29 Jun 2017
IKERVIS Santen Oy Centralised - Yearly update 29 Jun 2017
Vizamyl GE Healthcare Ltd Centralised - Yearly update 29 Jun 2017
Ibandronic acid Sandoz Sandoz GmbH Centralised - Yearly update 29 Jun 2017
Clopidogrel HCS HCS bvba Centralised - 2-Monthly update 29 Jun 2017 EMEA/H/C/2255/IB/22
Clopidogrel ratiopharm Teva B.V. Centralised - 2-Monthly update 29 Jun 2017 EMEA/H/C/4006/IB/07
Uptravi Actelion Registration Ltd Centralised - 2-Monthly update 29 Jun 2017 EMEA/H/C/3774/II/07
alli Glaxo Group Ltd Centralised - Renewal 29 Jun 2017 EMEA/H/C/854/R/54
Besponsa Pfizer Limited Centralised - Authorisation 29 Jun 2017 EMEA/H/C/4119
Mirapexin Boehringer Ingelheim International GmbH Rectificative Decision 29 Jun 2017
Sifrol Boehringer Ingelheim International GmbH Rectificative Decision 29 Jun 2017
Grastofil Apotex Europe B.V. Centralised - Yearly update 26 Jun 2017
Voriconazole Accord Accord Healthcare Limited Centralised - Yearly update 26 Jun 2017
Noxafil Merck Sharp & Dohme Limited Centralised - Yearly update 26 Jun 2017
Triumeq ViiV Healthcare UK Limited Centralised - Yearly update 26 Jun 2017
Macugen PharmaSwiss Ceská republika s.r.o. Centralised - Yearly update 26 Jun 2017
Onglyza AstraZeneca AB Centralised - 2-Monthly update 26 Jun 2017 EMEA/H/C/1039/WS/1078
Pregabalin Accord Accord Healthcare Limited Centralised - 2-Monthly update 26 Jun 2017 EMEA/H/C/4024/IB/05
Renvela Genzyme Europe B.V. Centralised - 2-Monthly update 26 Jun 2017 EMEA/H/C/993/WS/965
Komboglyze AstraZeneca AB Centralised - 2-Monthly update 26 Jun 2017 EMEA/H/C/2059/WS/1078
Evra Janssen-Cilag International NV Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/410/II/41
Rapamune Pfizer Limited Centralised - Yearly update 23 Jun 2017
Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 23 Jun 2017 EMEA/H/C/3963/T/05
Clopidogrel Teva Teva B.V. Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/1053/IB/42/G
Zykadia Novartis Europharm Limited Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/3819/II/12
Zontivity Merck Sharp & Dohme Limited Centralised - Withdrawal 23 Jun 2017
Emselex Merus Labs Luxco S.à R.L. Centralised - Yearly update 23 Jun 2017
Sevelamer carbonate Zentiva Genzyme Europe B.V. Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/3971/WS/965
Izba Novartis Europharm Limited Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/002738/II/0005
KEYTRUDA Merck Sharp & Dohme Limited Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/003820/II/0025
Revestive Shire Pharmaceuticals Ireland Limited Centralised - Renewal 23 Jun 2017 EMEA/H/C/2345/R/38, EMEA/H/C/2345/X/29
Farydak Novartis Europharm Limited PSUSA - Modification 23 Jun 2017 EMEA/H/C/PSUSA/00010409/201608
Sebivo Novartis Europharm Limited PSUSA - Modification 23 Jun 2017 EMEA/H/C/PSUSA/00002880/201608
ALPROLIX Swedish Orphan Biovitrum AB (publ) PSUSA - Modification 23 Jun 2017 EMEA/H/C/PSUSA/00010499/201609
Mysimba Orexigen Therapeutics Ireland Limited PSUSA - Modification 23 Jun 2017 EMEA/H/C/3687/PSUSA/10366/201609
Xarelto Bayer AG PSUSA - Modification 23 Jun 2017 EMEA/H/C/944/PSUSA/2653/201609
Prolia Amgen Europe B.V. PSUSA - Modification 23 Jun 2017 EMEA/H/C/1120/PSUSA/954/201609
Skilarence Almirall, S.A. Centralised - Authorisation 23 Jun 2017 EMEA/H/C/2157
Ucedane Lucane Pharma Centralised - Authorisation 23 Jun 2017 EMEA/H/C/4019
Kevzara Sanofi-Aventis groupe Centralised - Authorisation 23 Jun 2017 EMEA/H/C/004254/0000
Erelzi Sandoz GmbH Centralised - Authorisation 23 Jun 2017 EMEA/H/C/004192/0000
Flixabi Samsung Bioepis UK Limited Centralised - Yearly update 23 Jun 2017
Tadalafil Mylan Generics [UK] Limited Referral 23 Jun 2017 EMEA/H/A31/1450/C/3787/05
Sivextro Merck Sharp & Dohme Limited Centralised - Yearly update 16 Jun 2017
Trizivir ViiV Healthcare UK Limited Centralised - Yearly update 16 Jun 2017
Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Centralised - 2-Monthly update 16 Jun 2017 EMEA/H/C/1165/IB/33/G
Cubicin Merck Sharp & Dohme Limited PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/00000931/201609
Xgeva Amgen Europe B.V. PSUSA - Modification 16 Jun 2017 EMEA/H/C/2173/PSUSA/9119/201609
Intuniv Shire Pharmaceuticals Ireland Limited PSUSA - Modification 16 Jun 2017 EMEA/H/C/3759/PSUSA/10413/201609
Sirturo Janssen-Cilag International NV PSUSA - Modification 16 Jun 2017
Atriance Novartis Europharm Limited Centralised - Renewal 16 Jun 2017 EMEA/H/C/752/R/37
Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Renewal 16 Jun 2017 EMEA/H/C/2568/R/17
KEYTRUDA Merck Sharp & Dohme Limited PSUSA - Modification 16 Jun 2017 EMEA/H/C/3820/PSUSA/00010403/201609
Yondelis Pharma Mar S.A. PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/3001/201609
Trulicity Eli Lilly Nederland B.V. PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/10311/201609
Zoledronic acid Hospira Hospira UK Limited PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/3149/201608
Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/3149/201608
INCRELEX Ipsen Pharma Centralised - Renewal 16 Jun 2017 EMEA/H/C/704/R/42
Translarna PTC Therapeutics International Limited Centralised - Annual renewal 16 Jun 2017 EMEA/H/C/2720/R/32
Xagrid Shire Pharmaceutical Contracts Ltd PSUSA - Modification 16 Jun 2017 EMEA/H/C/480/PSUSA/208/201609
Eporatio ratiopharm GmbH Centralised - Yearly update 15 Jun 2017
Clopidogrel Mylan Mylan S.A.S Centralised - 2-Monthly update 15 Jun 2017 EMEA/H/C/1134/IB/35/G
Clopidogrel Teva Pharma Teva B.V. Centralised - Withdrawal 15 Jun 2017
Riximyo Sandoz GmbH Centralised - Authorisation 15 Jun 2017 EMEA/H/C/004729/0000
Febuxostat Mylan Mylan S.A.S. Centralised - Authorisation 15 Jun 2017 EMEA/H/C/4374
Rixathon Sandoz GmbH Centralised - Authorisation 15 Jun 2017 EMEA/H/C/3903
Zometa Novartis Europharm Limited PSUSA - Modification 15 Jun 2017 EMEA/H/C/336/PSUSA/3149/201608
AUBAGIO Sanofi-Aventis groupe PSUSA - Modification 15 Jun 2017 EMEA/H/C/PSUSA/00010135/201609
Nexium Control Pfizer Consumer Healthcare Limited Centralised - Variation 15 Jun 2017 EMEA/H/C/2618/X/16
Biopoin Teva GmbH Centralised - Yearly update 12 Jun 2017
Stivarga Bayer AG PSUSA - Modification 12 Jun 2017 EMEA/H/C/PSUSA/00010133/201609
Irbesartan Teva Teva B.V. Centralised - Yearly update 12 Jun 2017
ellaOne Laboratoire HRA Pharma Centralised - Yearly update 8 Jun 2017
Nplate Amgen Europe B.V. Centralised - Yearly update 2 Jun 2017
Cerezyme Genzyme Europe B.V. Centralised - Yearly update 2 Jun 2017
Caspofungin Accord Accord Healthcare Limited Centralised - Yearly update 2 Jun 2017
Somavert Pfizer Limited Centralised - Yearly update 2 Jun 2017
PecFent Archimedes Development Ltd Centralised - Yearly update 2 Jun 2017
Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/004050/II/0001
Removab Neovii Biotech GmbH Centralised - Withdrawal 2 Jun 2017
Pregabalin Mylan Pharma Generics [UK] Limited Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/003962/IB/0004/G
Pregabalin Mylan Generics [UK] Limited Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/004078/IB/0004/G
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/3985/II/19
Norvir AbbVie Ltd Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/127/WS/1077/143/G
Avastin Roche Registration Limited Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/582/II/92
INCRELEX Ipsen Pharma Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/704/II/40
Elmiron bene-Arzneimittel GmbH Centralised - Authorisation 2 Jun 2017 EMEA/H/C/4246/00
Refixia Novo Nordisk A/S Centralised - Authorisation 2 Jun 2017 EMEA/H/C/4178
Clopidogrel Apotex Apotex Europe B.V. Centralised - 2-Monthly update 31 May 2017 EMEA/H/C/1189/IB/27/G
Lopinavir/Ritonavir Mylan Mylan S.A.S Centralised - Yearly update 31 May 2017
Chenodeoxycholic acid Leadiant Leadiant GmbH Centralised - Transfer Marketing Authorisation Holder 31 May 2017 EMEA/H/C/004061/T/01
Yervoy Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 31 May 2017
Elocta Swedish Orphan Biovitrum AB (publ) Centralised - Yearly update 31 May 2017
Odomzo Sun Pharmaceutical Industries Europe BV Centralised - Transfer Marketing Authorisation Holder 31 May 2017 EMEA/H/C/002839/T/0012
Azopt Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 31 May 2017 EMEA/H/C/000267/T/0066
Sycrest Organon N.V. Centralised - Yearly update 31 May 2017
InductOs Medtronic BioPharma B.V. Centralised - 2-Monthly update 31 May 2017 EMEA/H/C/408/IB/85
Benepali Samsung Bioepis UK Limited Centralised - Variation 31 May 2017 EMEA/H/C/004007/X/0016
Brineura BioMarin International Limited Centralised - Authorisation 30 May 2017 EMEA/H/C/4065
Spinraza Biogen Idec Limited Centralised - Authorisation 30 May 2017 EMEA/H/C/4312/00
Busilvex Pierre Fabre Médicament Corrigendum 24 May 2017
Memantine LEK Pharmathen S.A. Centralised - Yearly update 24 May 2017
Fasturtec Sanofi-Aventis groupe Centralised - Yearly update 24 May 2017
Epivir ViiV Healthcare UK Limited Centralised - Yearly update 24 May 2017
Imnovid Celgene Europe Limited Centralised - Yearly update 24 May 2017
Ecalta Pfizer Limited Centralised - Yearly update 24 May 2017
Harvoni Gilead Sciences International Limited Centralised - 2-Monthly update 24 May 2017 EMEA/H/C/3850/II/35
Tasigna Novartis Europharm Limited Centralised - 2-Monthly update 24 May 2017 EMEA/H/C/798/II/84/G
Kaletra AbbVie Ltd Centralised - 2-Monthly update 24 May 2017 EMEA/H/C/368/WS/1077/163/G
Neoclarityn Merck Sharp & Dohme Limited PSUSA - Modification 24 May 2017 EMEA/H/C/PSUSA/962/201607
Azomyr Merck Sharp & Dohme Limited PSUSA - Modification 24 May 2017 EMEA/H/C/310/PSUSA/962/201607
Aerius Merck Sharp & Dohme Limited PSUSA - Modification 24 May 2017 EMEA/H/C/313/PSUSA/962/201607
Desloratadine Teva Teva B.V. PSUSA - Modification 24 May 2017 EMEA/H/C/2419/PSUSA/962/201607
Busilvex Pierre Fabre Médicament PSUSA - Modification 24 May 2017 EMEA/H/C/472/PSUSA/00000464/201607
NovoThirteen Novo Nordisk A/S Centralised - Renewal 24 May 2017 EMEA/H/C/002284/R/0020
Trumenba Pfizer Limited Centralised - Authorisation 24 May 2017 EMEA/H/C/004051/0000
Cotellic Roche Registration Limited PSUSA - Modification 24 May 2017 EMEA/H/C/PSUSA/10450/201608
Mirvaso Galderma International PSUSA - Modification 24 May 2017 EMEA/H/C/PSUSA/00010093/201608
Tafinlar Novartis Europharm Limited PSUSA - Modification 24 May 2017 EMEA/H/C/PSUSA/00010084/201608
Ferriprox Apotex Europe B.V. PSUSA - Modification 24 May 2017 EMEA/H/C/PSUSA/00000940/201608
Zoledronic acid Mylan Mylan S.A.S Centralised - Renewal 24 May 2017 EMEA/H/C/002482/R/0013
Respreeza CSL Behring GmbH Centralised - Yearly update 22 May 2017
Faslodex AstraZeneca UK Limited Centralised - Yearly update 22 May 2017
Clopidogrel BGR Laboratoires BIOGARAN Centralised - Yearly update 22 May 2017
IntronA Merck Sharp & Dohme Limited Centralised - Yearly update 22 May 2017
Tasigna Novartis Europharm Limited Centralised - Yearly update 22 May 2017
Zeffix Glaxo Group Ltd Centralised - Yearly update 22 May 2017
Temozolomide Accord Accord Healthcare Limited Centralised - Yearly update 22 May 2017
PHEBURANE Lucane Pharma Centralised - Yearly update 22 May 2017
Sildenafil Actavis Actavis Group PTC ehf. Centralised - Yearly update 22 May 2017
Fampyra Biogen Idec Limited Centralised - Authorisation - Switch to non-conditional 22 May 2017 EMEA/H/C/2097/II/36/G
Axumin Blue Earth Diagnostics Ltd Centralised - Authorisation 22 May 2017 EMEA/H/C/004197/0000
Rasilez Noden Pharma DAC Centralised - Renewal 22 May 2017 EMEA/H/C/780/R/112
Aerinaze Merck Sharp & Dohme Limited PSUSA - Modification 22 May 2017 EMEA/H/C/PSUSA/00000963/201607
Zoledronic acid Teva Pharma Teva B.V. Centralised - Renewal 22 May 2017 EMEA/H/C/2437/R/14
Zoledronic acid Teva Teva B.V. Centralised - Renewal 22 May 2017 EMEA/H/C/2439/R/18
Inlyta Pfizer Limited Centralised - Renewal 22 May 2017 EMEA/H/C/2406/R/21
Dacogen Janssen-Cilag International NV Centralised - Renewal 22 May 2017 EMEA/H/C/2221/R/30
Ivabradine Accord Accord Healthcare Limited Centralised - Authorisation 22 May 2017 EMEA/H/C/4241
Ratiograstim ratiopharm GmbH Centralised - Yearly update 18 May 2017
Zalasta Krka, d. d., Novo Mesto Centralised - Yearly update 18 May 2017
Taxotere Aventis Pharma S.A. Centralised - Yearly update 18 May 2017
Fampyra Biogen Idec Limited Centralised - Annual renewal 18 May 2017 EMEA/H/C/2097/R/37
Desloratadine ratiopharm ratiopharm GmbH PSUSA - Modification 18 May 2017 EMEA/H/C/2404/PSUSA/962/201607
Desloratadine Actavis Actavis Group PTC ehf. PSUSA - Modification 18 May 2017 EMEA/H/C/2435/PSUSA/962/201607
Zelboraf Roche Registration Limited PSUSA - Modification 18 May 2017 EMEA/H/C/2409/PSUSA/9329/201608
Brilique AstraZeneca AB Centralised - Variation 18 May 2017 EMEA/H/C/1241/X/34
Nevanac Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 16 May 2017 EMEA/H/C/818/T/35
Emadine Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 16 May 2017 EMEA/H/C/223/T/44
Azarga Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 16 May 2017 EMEA/H/C/960/T/37
DuoTrav Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 16 May 2017 EMEA/H/C/665/T/49
Mabthera Roche Registration Limited Centralised - Yearly update 16 May 2017
Tygacil Pfizer Limited Centralised - Yearly update 16 May 2017
Marixino Consilient Health Ltd Centralised - Yearly update 16 May 2017
Lysodren Laboratoire HRA Pharma Centralised - Yearly update 16 May 2017
Obizur Baxalta Innovations GmbH Centralised - Yearly update 16 May 2017
Feraccru Shield TX (UK) Limited Centralised - Yearly update 16 May 2017
Akynzeo Helsinn Birex Pharmaceuticals Ltd Centralised - Yearly update 8 May 2017
Glivec Novartis Europharm Limited Centralised - Yearly update 8 May 2017
Ivabradine Anpharm ANPHARM Przedsiebiorstwo Farmaceutyczne S.A. Centralised - Yearly update 8 May 2017
Simbrinza Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 8 May 2017 EMEA/H/C/3698/T/09
Xarelto Bayer AG Centralised - Transfer Marketing Authorisation Holder 8 May 2017 EMEA/H/C/944/T/54
Rasagiline Mylan Mylan S.A.S Centralised - Yearly update 8 May 2017
Dinutuximab beta Apeiron EUSA Pharma (UK) Limited Centralised - Authorisation 8 May 2017 EMEA/H/C/3918
Pergoveris Merck Serono Europe Limited Centralised - Renewal 8 May 2017 EMEA/H/C/000714/R/0050, EMEA/H/C/000714/X/0047
Qutenza Grünenthal GmbH Centralised - Transfer Marketing Authorisation Holder 4 May 2017 EMEA/H/C/909/T/43
Imatinib Accord Accord Healthcare Limited Centralised - 2-Monthly update 4 May 2017 EMEA/H/C/2681/IB/15
Ebymect AstraZeneca AB Referral 4 May 2017 EMEA/H/C/4162/A-20/013
Adempas Bayer AG Centralised - Transfer Marketing Authorisation Holder 2 May 2017 EMEA/H/C/2737/T/22
Prolia Amgen Europe B.V. Centralised - Yearly update 2 May 2017
Xenical CHEPLAPHARM Arzneimittel GmbH Centralised - Transfer Marketing Authorisation Holder 2 May 2017 EMEA/H/C/154/T/76
KEYTRUDA Merck Sharp & Dohme Limited Centralised - 2-Monthly update 2 May 2017 EMEA/H/C/003820/II/14
Emtricitabine/Tenofovir disoproxil Krka Krka, d. d., Novo Mesto Centralised - 2-Monthly update 2 May 2017 EMEA/H/C/4215/IB/02
Glustin Takeda Pharma A/S Centralised - Yearly update 28 Apr 2017
Actos Takeda Pharma A/S Centralised - Yearly update 28 Apr 2017
Cimzia UCB Pharma S.A. Centralised - Yearly update 28 Apr 2017
Vizarsin Krka, d. d., Novo Mesto Centralised - Yearly update 28 Apr 2017
Temozolomide Teva Teva B.V. Centralised - Yearly update 28 Apr 2017
SOMAC Control Takeda GmbH, (HRB 701016) Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/1098/WS/1041
Xeplion Janssen-Cilag International NV Centralised - Yearly update 28 Apr 2017
Prandin Novo Nordisk A/S Centralised - Yearly update 28 Apr 2017
Fertavid Merck Sharp & Dohme Limited Centralised - Yearly update 28 Apr 2017
PANTOZOL Control Takeda GmbH, (HRB 701016) Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/1013/WS/1041
Vokanamet Janssen-Cilag International NV Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/2656/II/23
Trobalt Glaxo Group Ltd Centralised - Yearly update 28 Apr 2017
Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 28 Apr 2017
Cholestagel Genzyme Europe B.V. Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/512/IB/37
NovoNorm Novo Nordisk A/S Centralised - Yearly update 28 Apr 2017
Ixiaro Valneva Austria GmbH Centralised - Yearly update 28 Apr 2017
Puregon Merck Sharp & Dohme Limited Centralised - Yearly update 28 Apr 2017
Repaglinide Teva Teva B.V. Centralised - Yearly update 28 Apr 2017
Tresiba Novo Nordisk A/S Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/2498/II/24/G
CONTROLOC Control Takeda GmbH, (HRB 701016) Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/1097/WS/1041
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/3985/II/17
Invokana Janssen-Cilag International NV Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/2649/II/26
PANTOLOC Control Takeda GmbH, (HRB 701016) Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/1100/WS/1041
Cinqaero Teva Pharmaceuticals Limited Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/003912/II/05/G
Zebinix Bial - Portela & Cª, SA Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/000988/II/0053
Kalydeco Vertex Pharmaceuticals (Europe) Limited Centralised - Renewal 28 Apr 2017 EMEA/H/C/2494/R/52
Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Renewal 28 Apr 2017 EMEA/H/C/2359/R/18
Darzalex Janssen-Cilag International NV Centralised - Authorisation - Switch to non-conditional 28 Apr 2017 EMEA/H/C/004077/II/02
Emtricitabine /Tenofovir disoproxil Krka d.d. KRKA, d.d. Centralised - Authorisation 28 Apr 2017 EMEA/H/C/004686/0000
Opatanol Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 24 Apr 2017 EMEA/H/C/407/T/34
Imatinib Actavis Actavis Group PTC ehf. Centralised - Yearly update 24 Apr 2017
CANCIDAS Merck Sharp & Dohme Limited Centralised - Yearly update 24 Apr 2017
Docetaxel Winthrop Aventis Pharma S.A. Centralised - Yearly update 24 Apr 2017
DUTREBIS Merck Sharp & Dohme Limited Centralised - Withdrawal 24 Apr 2017
TAGRISSO AstraZeneca AB Centralised - Authorisation - Switch to non-conditional 24 Apr 2017 EMEA/H/C/4124/II/09/G
Siklos Addmedica SAS Centralised - Renewal 24 Apr 2017 EMEA/H/C/689/R/30
Natpar Shire Pharmaceuticals Ireland Limited Centralised - Authorisation 24 Apr 2017 EMEA/H/C/3861/00
Flebogamma DIF Instituto Grifols, S.A. Centralised - Renewal 24 Apr 2017 EMEA/H/C/781/R/48
Darzalex Janssen-Cilag International NV Centralised - Annual renewal 24 Apr 2017 EMEA/H/C/004077/R/0003
Esbriet Roche Registration Limited Centralised - Variation 24 Apr 2017 EMEA/H/C/002154/X/0035/G
Jakavi Novartis Europharm Limited Centralised - Renewal 24 Apr 2017 EMEA/H/C/2464/R/32
Zinforo Pfizer Ireland Pharmaceuticals Centralised - Renewal 24 Apr 2017 EMEA/H/C/2252/R-31
Pemetrexed Hospira UK Limited Hospira UK Limited Centralised - Authorisation 24 Apr 2017 EMEA/H/C/4488
Travatan Novartis Europharm Limited Corrigendum 20 Apr 2017
Izba Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 20 Apr 2017 EMEA/H/C/2738/T/07
Travatan Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 20 Apr 2017 EMEA/H/C/390/T/56
Lonquex UAB "Sicor Biotech" Centralised - Yearly update 20 Apr 2017
Mycophenolate mofetil Teva Teva B.V. Centralised - Yearly update 20 Apr 2017
Tamiflu Roche Registration Limited Centralised - Yearly update 20 Apr 2017
Cetrotide Merck Serono Europe Limited Centralised - Yearly update 20 Apr 2017
Briviact UCB Pharma S.A. PSUSA - Modification 20 Apr 2017 EMEA/H/C/3898/PSUSA/10447/201607
EVOTAZ Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 20 Apr 2017 EMEA/H/C/3904/PSUSA/10404/201607
Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB Centralised - Annual renewal 20 Apr 2017 EMEA/H/C/3963/R/03
Vokanamet Janssen-Cilag International NV Referral 20 Apr 2017 EMEA/H/A-20/1442/C/2656-0014
Varuby TESARO UK LIMITED Centralised - Authorisation 20 Apr 2017 EMEA/H/C/4196
Eklira Genuair AstraZeneca AB Centralised - Renewal 20 Apr 2017 EMEA/H/C/2211/R/31
Bretaris Genuair AstraZeneca AB Centralised - Renewal 20 Apr 2017 EMEA/H/C/2706/R/31
Forxiga AstraZeneca AB Referral 20 Apr 2017 EMEA/H/A-20/1442/C/2322/0029
Synjardy Boehringer Ingelheim International GmbH Referral 20 Apr 2017 EMEA/H/A-20/1442/C/3770/0022
Jardiance Boehringer Ingelheim International GmbH Referral 20 Apr 2017 EMEA/H/A-20/1442/C/2677/23
Edistride AstraZeneca AB Referral 20 Apr 2017 EMEA/H/A-20/1442/C/4161/10
Glybera uniQure biopharma B.V. Centralised - Annual reassessment 20 Apr 2017 EMEA/H/C/2145/S/57
Picato LEO Laboratories Ltd. PSUSA - Modification 20 Apr 2017 EMEA/H/C/PSUSA/00010035/201607
Xigduo AstraZeneca AB Referral 20 Apr 2017 EMEA/H/A-20/1442/C/2672/24
Roteas Daiichi Sankyo Europe GmbH Centralised - Authorisation 20 Apr 2017 EMEA/H/C/004339/0000
Invokana Janssen-Cilag International NV Referral 20 Apr 2017 EMEA/H/A-20/1442/C/2649/18
Rotarix GlaxoSmithKline Biologicals S.A. PSUSA - Modification 20 Apr 2017 EMEA/H/C/PSUSA/2665/201607
Myfenax Teva B.V. Centralised - Yearly update 12 Apr 2017
Tecfidera Biogen Idec Limited Centralised - Yearly update 12 Apr 2017
Eylea Bayer AG Centralised - Transfer Marketing Authorisation Holder 12 Apr 2017 EMEA/H/C/2392/T/36
Ovaleap Teva B.V. Centralised - Yearly update 12 Apr 2017
Abasaglar Eli Lilly Regional Operations GmbH. Centralised - Yearly update 11 Apr 2017
Kovaltry Bayer AG Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/003825T/09
Envarsus Chiesi Farmaceutici S.p.A. Centralised - Yearly update 11 Apr 2017
Iblias Bayer AG Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/4147/T/06
Helixate NexGen Bayer AG Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/276/T/0189
KOGENATE Bayer Bayer AG Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/275/T/0197
Optimark Guerbet Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/000745/T/0037
Constella Allergan Pharmaceuticals International Limited Centralised - Yearly update 11 Apr 2017
Hexacima Sanofi Pasteur SA Centralised - Yearly update 11 Apr 2017
Onglyza AstraZeneca AB Centralised - Yearly update 11 Apr 2017
Orgalutran Merck Sharp & Dohme Limited Centralised - Yearly update 11 Apr 2017
Sylvant Janssen-Cilag International NV Centralised - Yearly update 11 Apr 2017
Chenodeoxycholic acid Leadiant Leadiant GmbH Centralised - Authorisation 10 Apr 2017 EMEA/H/C/004061/0000
Levetiracetam Hospira Hospira UK Limited Centralised - Yearly update 6 Apr 2017
Evra Janssen-Cilag International NV Centralised - Yearly update 6 Apr 2017
Zalviso Grünenthal GmbH Centralised - Yearly update 6 Apr 2017
Vivanza Bayer AG Centralised - Transfer Marketing Authorisation Holder 6 Apr 2017 EMEA/H/C/488/T/55
Fycompa Eisai Europe Limited Centralised - Renewal 6 Apr 2017 EMEA/H/C/2434/R/35
Procoralan Les Laboratoires Servier Centralised - Yearly update 3 Apr 2017
Corlentor Les Laboratoires Servier Centralised - Yearly update 3 Apr 2017
Xofigo Bayer AG Centralised - Transfer Marketing Authorisation Holder 3 Apr 2017 EMEA/H/C/2653/T/24
Vepacel Nanotherapeutics UK Limited Centralised - Transfer Marketing Authorisation Holder 3 Apr 2017 EMEA/H/C/2089/T/17
DuoPlavin Sanofi Clir SNC Centralised - 2-Monthly update 3 Apr 2017 EMEA/H/C/1143/WS/1091
Clopidogrel Zentiva Sanofi-Aventis groupe Centralised - 2-Monthly update 3 Apr 2017 EMEA/H/C/975/WS/1091
JEVTANA Sanofi-Aventis groupe Centralised - 2-Monthly update 3 Apr 2017 EMEA/H/C/2018/II/34
Imprida Novartis Europharm Limited Centralised - Withdrawal 3 Apr 2017
Levitra Bayer AG Centralised - Transfer Marketing Authorisation Holder 29 Mar 2017 EMEA/H/C/475/T/59
Descovy Gilead Sciences International Limited Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/4094/WS/1010
Iressa AstraZeneca AB Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/1016/II/26
EVARREST Omrix Biopharmaceuticals N.V. Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/2515/II/27/G
Clopidogrel/Acetylsalicylic acid Zentiva Sanofi-Aventis groupe Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/1144/WS/1091
Tafinlar Novartis Europharm Limited Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/2604/WS/0996
Plavix Sanofi Clir SNC Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/174/WS/1091
Jylamvo Therakind Ltd Centralised - Authorisation 29 Mar 2017 EMEA/H/C/3756
Docetaxel Kabi Fresenius Kabi Oncology Plc. Corrigendum 23 Feb 2017
Zarzio Sandoz GmbH Corrigendum 30 Jun 2016
Filgrastim Hexal Hexal AG Corrigendum 30 Jun 2016
Binocrit Sandoz GmbH Corrigendum 31 Mar 2016
Abseamed Medice Arzneimittel Pütter GmbH & Co KG Corrigendum 30 Mar 2016
Telmisartan Actavis Actavis Group PTC ehf. Corrigendum 4 Sep 2014
Dafiro HCT Novartis Europharm Limited Corrigendum 4 Sep 2014
Dafiro Novartis Europharm Limited Corrigendum 4 Sep 2014
Copalia HCT Novartis Europharm Limited Corrigendum 4 Sep 2014
Copalia Novartis Europharm Limited Corrigendum 4 Sep 2014
Exforge HCT Novartis Europharm Limited Corrigendum 4 Sep 2014
Exforge Novartis Europharm Limited Corrigendum 4 Sep 2014
MicardisPlus Boehringer Ingelheim International GmbH Corrigendum 4 Sep 2014
Micardis Boehringer Ingelheim International GmbH Corrigendum 4 Sep 2014
Dexdor Orion Corporation Corrigendum 16 Sep 2011
Daxas AstraZeneca AB Corrigendum 5 Jul 2010
Procedures for centrally authorised orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
EU/3/16/1660 GlaxoSmithKline Trading Services Limited Transfer of orphan designation 5 Sep 2017 EMA/OD/024/16/T/01
EU/3/03/182 Idorsia Pharmaceuticals Deutschland GmbH Transfer of orphan designation 5 Sep 2017 EMEA/OD/057/03/T/02
EU/3/12/1062 EUSA Pharma (UK) Limited Transfer of orphan designation 5 Sep 2017 EMA/OD/112/12/T/01
EU/3/16/1740 Allergan Pharmaceuticals International Limited Transfer of orphan designation 5 Sep 2017 EMA/OD/158/16/T/01
EU/3/14/1269 ITM Solucin GmbH Transfer of orphan designation 28 Aug 2017 EMA/OD/196/13/T/01
EU/3/07/518 Bayer AG Transfer of orphan designation 28 Aug 2017 EMEA/OD/088/07/T/02
EU/3/06/364 Bayer AG Transfer of orphan designation 28 Aug 2017 EMEA/OD/109/05/T/02
EU/3/15/1567 TMC Pharma Services Ltd Transfer of orphan designation 23 Aug 2017 EMA/OD/064/15/T/01
EU/3/15/1563 TMC Pharma Services Ltd Transfer of orphan designation 23 Aug 2017 EMA/OD/112/15/T/01
EU/3/17/1913 Neupharma S.r.l. Orphan designation 23 Aug 2017 EMA/OD/085/17
EU/3/17/1912 VIVUS B.V. Orphan designation 23 Aug 2017 EMA/OD/099/17
EU/3/17/1911 Ability Pharmaceuticals SL Orphan designation 23 Aug 2017 EMA/OD/078/17
EU/3/17/1910 Best Regulatory Consulting Ltd Orphan designation 23 Aug 2017 EMA/OD/047/17
EU/3/17/1909 Vaximm GmbH Orphan designation 23 Aug 2017 EMA/OD/069/17
EU/3/17/1908 Dorian Regulatory Affairs BV Orphan designation 23 Aug 2017 EMA/OD/086/17
EU/3/17/1907 Trimunocor Ltd Orphan designation 23 Aug 2017 EMA/OD/049/17
EU/3/17/1906 Voisin Consulting S.A.R.L. Orphan designation 23 Aug 2017 EMA/OD/093/17
EU/3/17/1905 Archivel Farma S.L. Orphan designation 23 Aug 2017 EMA/OD/098/17
EU/3/17/1904 Axelar AB Orphan designation 23 Aug 2017 EMA/OD/068/17
EU/3/17/1903 Inventiva Orphan designation 23 Aug 2017 EMA/OD/043/17
EU/3/17/1902 Eisai Europe Limited Orphan designation 23 Aug 2017 EMA/OD/052/17
EU/3/17/1901 Mayne Pharma UK Limited Orphan designation 23 Aug 2017 EMA/OD/056/17
EU/3/17/1900 Apogenix AG Orphan designation 23 Aug 2017 EMA/OD/050/17
EU/3/17/1899 ProQR Therapeutics IV BV Orphan designation 23 Aug 2017 EMA/OD/094/17
EU/3/17/1898 Vivet Therapeutics SAS Orphan designation 23 Aug 2017 EMA/OD/084/17
EU/3/07/469 Bayer AG Transfer of orphan designation 17 Aug 2017 EMEA/OD/092/06/T/02
EU/3/14/1299 Bayer AG Transfer of orphan designation 17 Aug 2017 EMA/OD/044/14/T/01
EU/3/13/1200 Bayer AG Transfer of orphan designation 17 Aug 2017 EMA/OD/093/13/T/01
EU/3/13/1199 Bayer AG Transfer of orphan designation 17 Aug 2017 EMA/OD/092/13/T/01
EU/3/12/1073 Bayer AG Transfer of orphan designation 17 Aug 2017 EMA/OD/063/12/T/01
EU/3/10/847 Bayer AG Transfer of orphan designation 17 Aug 2017 EMA/OD/128/10/T/01
EU/3/04/210 Breath Therapeutics GmbH Transfer of orphan designation 3 Aug 2017 EMA/OD/022/04/T/01
EU/3/04/209 Breath Therapeutics GmbH Transfer of orphan designation 3 Aug 2017 EMA/OD/012/04/T/01
EU/3/15/1522 Biogen Idec Limited Transfer of orphan designation 3 Aug 2017 EMA/OD/044/15/T/01
EU/3/14/1280 Orchard Therapeutics Ltd Transfer of orphan designation 3 Aug 2017 EMA/OD/006/14
EU/3/16/1686 Mereo Biopharma 3 Limited Transfer of orphan designation 3 Aug 2017 EMA/OD/052/16
EU/3/17/1897 PhaRA bvba Orphan designation 17 Jul 2017 EMA/OD/038/17
EU/3/17/1896 Raremoon Consulting Ltd Orphan designation 17 Jul 2017 EMA/OD/025/17
EU/3/17/1895 orphanix GmbH Orphan designation 17 Jul 2017 EMA/OD/051/17
EU/3/17/1894 The Medical & Regulatory Partnership Limited Orphan designation 17 Jul 2017 EMA/OD/030/17
EU/3/17/1893 SFL Regulatory Affairs Consulting Ltd Orphan designation 17 Jul 2017 EMA/OD/048/17
EU/3/17/1892 RDD Pharma Limited Orphan designation 17 Jul 2017 EMA/OD/325/16
EU/3/17/1891 Allena Pharmaceuticals Ireland Limited Orphan designation 17 Jul 2017 EMA/OD/058/17
EU/3/17/1890 Celgene Europe Limited Orphan designation 17 Jul 2017 EMA/OD/045/17
EU/3/17/1889 PhaRA bvba Orphan designation 17 Jul 2017 EMA/OD/037/17
EU/3/16/1789 Cogas Pharma Limited Transfer of orphan designation 10 Jul 2017 EMA/OD/144/16/T/01
EU/3/14/1249 Akcea Therapeutics UK Ltd. Transfer of orphan designation 6 Jul 2017 EMA/OD/180/13/T/01
EU/3/15/1494 Voisin Consulting S.A.R.L. Transfer of orphan designation 6 Jul 2017 EMA/OD/005/15/T/01
EU/3/15/1555 Cogas Pharma Limited Transfer of orphan designation 6 Jul 2017 EMA/OD/092/15/T/01
EU/3/17/1888 Advicenne Pharma SA Orphan designation 20 Jun 2017 EMA/OD/016/17
EU/3/17/1887 Zealand Pharma A/S Orphan designation 20 Jun 2017 EMA/OD/002/17
EU/3/17/1886 Vale Pharmaceuticals Limited Orphan designation 20 Jun 2017 EMA/OD/007/17
EU/3/17/1885 Avivia Beheer BV Orphan designation 20 Jun 2017 EMA/OD/304/16
EU/3/17/1884 Voisin Consulting S.A.R.L. Orphan designation 20 Jun 2017 EMA/OD/018/17
EU/3/17/1883 NeuroScios GmbH Orphan designation 20 Jun 2017 EMA/OD/034/17
EU/3/17/1882 Richardson Associates Regulatory Affairs Ltd Orphan designation 20 Jun 2017 EMA/OD/013/17
EU/3/17/1881 Ulrich Muehlner Orphan designation 20 Jun 2017 EMA/OD/008/17
EU/3/17/1880 ChemoCentryx Limited Orphan designation 20 Jun 2017 EMA/OD/028/17
EU/3/17/1879 Envigo Pharma Consulting Ltd Orphan designation 20 Jun 2017 EMA/OD/031/17
EU/3/14/1307 orphanix GmbH Transfer of orphan designation 8 Jun 2017 EMA/OD/018/14/T/01
EU/3/14/1243 Enzyvant Farber Ireland Limited Transfer of orphan designation 8 Jun 2017 EMA/OD/167/13/T/02
EU/3/14/1406 Leadiant GmbH Transfer of orphan designation 8 Jun 2017 EMA/OD/196/14/T/02
EU/3/07/462 Baxalta Innovations GmbH Transfer of orphan designation 8 Jun 2017 EMA/OD/028/07/T/01
EU/3/04/210 Breath Therapeutics GmbH Amendment of orphan designation 24 May 2017 EMEA/OD/022/04
EU/3/17/1878 IntraBio Ltd Orphan designation 22 May 2017 EMA/OD/316/16
EU/3/17/1877 GB Pharma Srl Orphan designation 22 May 2017 EMA/OD/006/17
EU/3/17/1876 TMC Pharma Services Ltd Orphan designation 22 May 2017 EMA/OD/010/17
EU/3/17/1875 NeoImmuneTech, INC., Spólka Akcyjna, Oddzial w Polsce Orphan designation 22 May 2017 EMA/OD/321/16
EU/3/17/1874 Coté Orphan Consulting UK Limited Orphan designation 22 May 2017 EMA/OD/019/17
EU/3/17/1873 Best Regulatory Consulting Ltd Orphan designation 22 May 2017 EMA/OD/004/17
EU/3/17/1872 Miragen Therapeutics Europe Ltd Orphan designation 22 May 2017 EMA/OD/011/17
EU/3/17/1871 Voisin Consulting S.A.R.L. Orphan designation 22 May 2017 EMA/OD/319/16
EU/3/16/1822 HV-Polysaccharides GmbH & Co. KG Transfer of orphan designation 22 May 2017 EMA/OD/130/16/T/01
EU/3/16/1716 Pfizer Limited Transfer of orphan designation 22 May 2017 EMA/OD/096/16/T/01
EU/3/16/1674 Bellicum Pharma Limited Transfer of orphan designation 8 May 2017 EMA/OD/020/16/T/01
EU/3/16/1666 Bellicum Pharma Limited Transfer of orphan designation 8 May 2017 EMA/OD/017/16/T/01
EU/3/16/1663 NextraResearch S.r.l. Transfer of orphan designation 8 May 2017 EMA/OD/003/16/T/01
EU/3/17/1865 Mithra Pharmaceuticals S.A. Orphan designation 28 Apr 2017 EMA/OD/309/16
EU/3/17/1870 Vall d'Hebron Institute of Research Corrigendum 20 Apr 2017
20% I.V. fat emulsion consisting of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection Alan Boyd Consultants Ltd Refusal of orphan designation 20 Apr 2017 EMA/OD/062/16
EU/3/17/1870 Vall d'Hebron Institute of Research Orphan designation 20 Apr 2017 EMA//OD/317/16
EU/3/17/1869 Hôpital Foch Orphan designation 20 Apr 2017 EMA/OD/286/16
EU/3/17/1868 Sentinel Oncology Limited Orphan designation 20 Apr 2017 EMA/OD/293/16
EU/3/17/1867 PhaseRx Ireland, Ltd Orphan designation 20 Apr 2017 EMA/OD/326/16
EU/3/17/1866 Hôpital Foch Orphan designation 20 Apr 2017 EMA/OD/287/16
EU/3/17/1864 NBMI Science Limited Orphan designation 20 Apr 2017 EMA/OD/329/16
EU/3/17/1863 bluebird bio France Orphan designation 20 Apr 2017 EMA/OD/270/16
EU/3/17/1862 Igenomix, S.L. Orphan designation 20 Apr 2017 EMA/OD/313/16
EU/3/17/1861 Biological Consulting Europe Ltd Orphan designation 20 Apr 2017 EMA/OD/299/16
EU/3/16/1783 Cogas Pharma Limited Transfer of orphan designation 11 Apr 2017 EMA/OD/138/16/T/01
EU/3/14/1281 Vertex Pharmaceuticals (Europe) Limited Transfer of orphan designation 11 Apr 2017 EMA/OD/002/14/T/01
EU/3/14/1240 Istituto Europeo per la Ricerca sulla Fibrosi Cistica - ONLUS Transfer of orphan designation 6 Apr 2017 EMA/OD/159/13/T/02
EU/3/11/857 Alnylam UK Limited Amendment of orphan designation 6 Apr 2017 EMA/OD/142/10
EU/3/15/1579 Kite Pharma EU B.V. Corrigendum 3 Apr 2017
EU/3/15/1572 Kite Pharma EU B.V. Corrigendum 3 Apr 2017
EU/3/15/1571 Kite Pharma EU B.V. Corrigendum 3 Apr 2017
EU/3/15/1553 Kite Pharma EU B.V. Corrigendum 3 Apr 2017
EU/3/15/1552 Kite Pharma EU B.V. Corrigendum 3 Apr 2017
EU/3/14/1393 Kite Pharma EU B.V. Corrigendum 3 Apr 2017
EU/3/15/1579 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/135/15/T/01
EU/3/15/1572 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/108/15/T/01
EU/3/15/1571 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/107/15/T/01
EU/3/15/1553 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/078/15/T/01
EU/3/15/1552 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/077/15/T/01
EU/3/14/1393 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/171/14/T/01
EU/3/15/1488 Celgene Europe Limited Transfer of orphan designation 3 Apr 2017 EMA/OD/314/14/T/01
EU/3/16/1790 Dr Ulrich Granzer Corrigendum 18 Nov 2016
Procedures for centrally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Equilis Te Intervet International B.V. Centralised - Yearly update 14 Sep 2017
Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Centralised - Yearly update 14 Sep 2017
Nobivac Myxo-RHD Intervet International B.V. Centralised - Yearly update 14 Sep 2017
LETIFEND Laboratorios LETI, S.L.unipersonal Centralised - Yearly update 14 Sep 2017
SevoFlo Zoetis Belgium S.A. Centralised - Yearly update 7 Sep 2017
Suvaxyn PRRS MLV Zoetis Belgium S.A. Centralised - Authorisation 24 Aug 2017 EMEA/V/C/4276
Innovax-ND-IBD Intervet International B.V. Centralised - Authorisation 22 Aug 2017
Exzolt Intervet International B.V. Centralised - Authorisation 18 Aug 2017 EMEA/V/C/004344/0000
VEPURED Laboratorios Hipra, S.A. Centralised - Authorisation 17 Aug 2017 EMEA/V/C/4364
Canigen L4 Intervet International B.V. Centralised - Yearly update 10 Aug 2017
BLUEVAC BTV8 CZ Veterinaria, S.A. Centralised - Yearly update 3 Aug 2017
EQUIOXX CEVA SANTE ANIMALE Corrigendum 3 Aug 2017
Loxicom Norbrook Laboratories Ltd Centralised - Yearly update 28 Jul 2017
Vaxxitek HVT + IBD Merial Centralised - Yearly update 28 Jul 2017
Aivlosin ECO Animal Health Ltd Centralised - Yearly update 19 Jul 2017
Nobilis IB Primo QX Intervet International B.V. Centralised - Yearly update 14 Jul 2017
Zolvix Elanco Europe Ltd. Centralised - Yearly update 14 Jul 2017
Onsior Elanco Europe Ltd. Centralised - Yearly update 10 Jul 2017
EQUIOXX CEVA SANTE ANIMALE Centralised - Transfer Marketing Authorisation Holder 29 Jun 2017 EMEA/V/C/142/T/19
CLYNAV Elanco Europe Ltd. Centralised - Authorisation 27 Jun 2017 EMEA/V/C/2390
Prevomax Le Vet Beheer B.V. Centralised - Authorisation 19 Jun 2017 EMEA/V/C/4331
Circovac Ceva-Phylaxia Zrt. Centralised - Transfer Marketing Authorisation Holder 13 Jun 2017 EMEA/V/C/114/T/14
Clomicalm Elanco Europe Ltd. Centralised - Yearly update 13 Jun 2017
BROADLINE Merial Centralised - 2-Monthly update 13 Jun 2017 EMEA/V/C/2700/II/13
Veraflox Bayer Animal Health GmbH Centralised - Yearly update 13 Jun 2017
Cardalis CEVA SANTE ANIMALE Corrigendum 8 Jun 2017
Cardalis CEVA SANTE ANIMALE Centralised - Renewal 8 Jun 2017 EMEA/V/C/2524/R/09
Econor Elanco Europe Ltd. Centralised - Yearly update 7 Jun 2017
Advocate Bayer Animal Health GmbH Centralised - Yearly update 6 Jun 2017
Profender Bayer Animal Health GmbH Centralised - Yearly update 24 May 2017
Activyl Tick Plus Intervet International B.V. Centralised - 2-Monthly update 24 May 2017 EMEA/V/C/2234/II/08
Ingelvac PCV FLEX Boehringer Ingelheim Vetmedica GmbH Centralised - Authorisation 24 May 2017 EMA/CVMP/132446/2017
Suvaxyn Circo + MH RTU Zoetis Belgium S.A. Centralised - 2-Monthly update 17 May 2017 EMEA/V/C/3924/II/04/G
Suprelorin VIRBAC S.A. Centralised - Renewal 17 May 2017 EMEA/V/C/109/R/16
RESPIPORC FLUpan H1N1 IDT Biologika GmbH Centralised - Authorisation 17 May 2017 EMEA/V/C/3993
NEXGARD SPECTRA Merial Centralised - 2-Monthly update 15 May 2017 EMEA/V/C/3842/II/08
Novem Boehringer Ingelheim Vetmedica GmbH Centralised - Variation 15 May 2017 EMEA/V/C/000086/X/0018
Zeleris Ceva Santé Animale Centralised - Authorisation 15 May 2017 EMEA/V/C/69358
Zactran Merial Centralised - Variation 15 May 2017 EMEA/V/C/129/X/34
Poulvac E. coli Zoetis Belgium S.A. Centralised - Renewal 15 May 2017 EMEA/V/C/2007/R/12
Activyl Intervet International B.V. Centralised - Yearly update 5 May 2017
Kexxtone Eli Lilly and Company Limited Centralised - Yearly update 5 May 2017
Versican Plus Pi/L4R Zoetis Belgium S.A. Centralised - Yearly update 5 May 2017
Quadrisol VETCOOL B.V. Centralised - Transfer Marketing Authorisation Holder 25 Apr 2017 EMEA/V/C/32/T/37
Cerenia Zoetis Belgium S.A. Centralised - Yearly update 25 Apr 2017
Zulvac BTV Ovis Zoetis Belgium S.A. Centralised - Authorisation 25 Apr 2017 EMEA/V/C/4185
Credelio Elanco Europe Ltd. Centralised - Authorisation 25 Apr 2017 EMEA/V/C/004247/0000
CYTOPOINT Zoetis Belgium S.A. Centralised - Authorisation 25 Apr 2017 EMEA/V/C/3939
FORTEKOR PLUS Elanco Europe Ltd. Centralised - Yearly update 12 Apr 2017
Procox Bayer Animal Health GmbH Centralised - Yearly update 11 Apr 2017
Dexdomitor Orion Corporation Centralised - Yearly update 29 Mar 2017
Porcilis ColiClos Intervet International B.V. Centralised - Renewal 29 Mar 2017 EMEA/V/C/002011/R/0006
Stronghold Plus Zoetis Belgium S.A. Corrigendum 9 Feb 2017
NEXGARD SPECTRA Merial Corrigendum 15 Jan 2015
Vectra Felis CEVA SANTE ANIMALE Corrigendum 6 Jun 2014
Procedures for nationally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Vancomycin Referral 21 Sep 2017 EMEA/H/A-31/1440
Interferon alfa 2-b PSUSA - Modification 18 Sep 2017 EMEA/H/C/PSUSA/00001758/201609
Symbioflor 2 and associated names containing Escherichia coli bacteria (cells and autolysate) Referral 28 Aug 2017 EMEA/H/A-31/1441
hydrochlorothiazide / irbesartan WILCARE PHARMA LIMITED PSUSA - Modification 24 Aug 2017 EMEA/H/C/PSUSA/1653/201609
Paracetamol / ibuprofen 500 mg / 150 mg Film-coated tablets (Paracomb) Referral 7 Aug 2017 EMEA/H/A-29(4)/1447
busulfan PSUSA - Modification 26 Jul 2017 EMEA/H/C/PSUSA/00000464/201607
Cardioxane Art 13 Referral 19 Jul 2017 EMEA/H/A-13/1453
pramipexole Rectificative Decision 17 Jul 2017
Mercaptopurine PSUSA - Modification 13 Jul 2017
RAS-acting agents - Renin-angiotensin system Corrigendum 29 Jun 2017
Vepesid and associated names Referral 26 Jun 2017 EMEA/H/A-30/1425
Etopophos and associated names Referral 26 Jun 2017 EMEA/H/A-30/1417
Micro therapeutic Research Labs Referral 23 Jun 2017 EMEA/H/A-31/1450
anagrelide PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/208/201609
Zoledronic acid (indicated for cancer and fractures) PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/3149/201608
Haldol and associated names Corrigendum 12 Jun 2017
desloratadine PSUSA - Modification 24 May 2017 EMEA/H/C/PSUSA/962/201607
Saroten and associated names Referral 8 May 2017 EMEA/H/A-30/1430
Haldol Decanoate and associated names Referral 28 Apr 2017 EMEA/H/A-30/1405
Haldol and associated names Referral 28 Apr 2017 EMEA/H/R/A-30/1393
Procedures for nationally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Denagard 45% and associated names Elanco Deutschland GmbH Referral 14 Jul 2017 EMEA/V/A/114
veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp. Referral 10 Jul 2017 EMEA/V/A/121
Zinc oxide - Veterinary medicinal products containing zinc oxide to be administered orally to food producing species Referral 26 Jun 2017 EMEA/V/A/118
Veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for use in target species cattle Zoetis France Referral 20 Jun 2017 EMEA/V/A/119