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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
Bretaris Genuair AstraZeneca AB Centralised - Yearly update 13 Apr 2018
PritorPlus Bayer AG Centralised - Transfer Marketing Authorisation Holder 13 Apr 2018 EMEA/H/C/414/T/115
Pritor Bayer AG Centralised - Transfer Marketing Authorisation Holder 13 Apr 2018 EMEA/H/C/210/T/124
Travatan Novartis Europharm Limited Centralised - Yearly update 13 Apr 2018
Sialanar Proveca Limited Centralised - Yearly update 13 Apr 2018
Vidaza Celgene Europe Limited Centralised - Yearly update 12 Apr 2018
Lumigan Allergan Pharmaceuticals Ireland Centralised - Yearly update 12 Apr 2018
Ravicti Horizon Pharma Ireland Limited Centralised - Yearly update 12 Apr 2018
Actrapid Novo Nordisk A/S Centralised - Yearly update 12 Apr 2018
Mekinist Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/2643/T/25
Neparvis Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/4343/T/17
Kinzalkomb Bayer AG Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/415/T/105
Signifor Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 12 Apr 2018 EMEA/H/C/2052/T/37
Tadalafil Mylan Generics [UK] Limited Centralised - Yearly update 12 Apr 2018
Sialanar Proveca Limited Centralised - Rectificative 12 Apr 2018
Tarceva Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/618/T/57
Tamiflu Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/402/T/131
Zelboraf Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/2409/T/47
Gazyvaro Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/2799/T/24
Revolade Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/1110/T/47
Fuzeon Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/514/T/50
Herceptin Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/278/T/142
RoActemra Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 6 Apr 2018 EMEA/H/C/955/T/75
Kineret Swedish Orphan Biovitrum AB (publ) Centralised - 2-Monthly update 6 Apr 2018 EMEA/H/C/363/II/56
Bonviva Atnahs Pharma UK Limited Centralised - Transfer Marketing Authorisation Holder 4 Apr 2018 EMEA/H/C/501/T/64
Marixino KRKA, d.d., Novo mesto Centralised - Transfer Marketing Authorisation Holder 4 Apr 2018 EMEA/H/C/2658/T/13
Kinzalmono Bayer AG Centralised - Transfer Marketing Authorisation Holder 4 Apr 2018 EMEA/H/C/211/T/111
Esbriet Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 4 Apr 2018 EMEA/H/C/2154/T/52
Bondronat Atnahs Pharma UK Limited Centralised - Transfer Marketing Authorisation Holder 4 Apr 2018 EMEA/H/C/101/T/79
Lacosamide Accord Accord Healthcare Limited Centralised - 2-Monthly update 4 Apr 2018 EMEA/H/C/4443/IB/1
Tecentriq Roche Registration GmbH Centralised - 2-Monthly update 4 Apr 2018 EMEA/H/C/4143/II/2/G
Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB Centralised - Annual renewal 4 Apr 2018 EMEA/H/C/3963/R/11
Lumark IDB Holland B.V. PSUSA - Modification 4 Apr 2018 EMEA/H/C/2749/PSUSA/10391/201706
Zinbryta Biogen Idec Limited Centralised - Withdrawal 27 Mar 2018
Raplixa Mallinckrodt Pharmaceuticals Ireland Limited Centralised - Withdrawal 27 Mar 2018
Ganfort Allergan Pharmaceuticals Ireland Centralised - Yearly update 27 Mar 2018
Xgeva Amgen Europe B.V. Centralised - 2-Monthly update 27 Mar 2018 EMEA/H/C/2173/II/55
EndolucinBeta ITG Isotope Technologies Garching GmbH PSUSA - Modification 27 Mar 2018 EMEA/H/C/PSUSA/10391/201706
Feraccru Shield TX (UK) Limited Centralised - 2-Monthly update 23 Mar 2018 EMEA/H/C/2733/II/10
Vibativ Theravance Biopharma Ireland Limited Centralised - Withdrawal 23 Mar 2018
Perjeta Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 23 Mar 2018 EMEA/H/C/2547/T/36
Ocrevus Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 23 Mar 2018 EMEA/H/C/4043/T/1
Isentress Merck Sharp & Dohme Limited Centralised - 2-Monthly update 23 Mar 2018 EMEA/H/C/860/II/64
Translarna PTC Therapeutics International Limited Centralised - 2-Monthly update 23 Mar 2018 EMEA/H/C/2720/II/39
KEYTRUDA Merck Sharp & Dohme Limited Centralised - 2-Monthly update 23 Mar 2018 EMEA/H/C/3820/II/37/G
Torisel Pfizer Limited Centralised - 2-Monthly update 23 Mar 2018 EMEA/H/C/799/II/69
Invirase Roche Registration Limited Centralised - Transfer Marketing Authorisation Holder 23 Mar 2018 EMEA/H/C/113/T/124
Lamzede Chiesi Farmaceutici S.p.A. Centralised - Authorisation 23 Mar 2018 EMEA/H/C/3922
Steglujan Merck Sharp & Dohme Limited Centralised - Authorisation 23 Mar 2018 EMEA/H/C/4313
Atripla Bristol-Myers Squibb and Gilead Sciences Limited Centralised - 2-Monthly update 23 Mar 2018 EMEA/H/C/797/II/127/G
Semglee Mylan S.A.S. Centralised - Authorisation 23 Mar 2018 EMEA/H/C/4280
Segluromet Merck Sharp & Dohme Limited Centralised - Authorisation 23 Mar 2018 EMEA/H/C/4314
Opdivo Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 23 Mar 2018 EMEA/H/C/3985/PSUSA/10379/201707
Blincyto Amgen Europe B.V. PSUSA - Modification 23 Mar 2018 EMEA/H/C/3731/PSUSA/10460/201706
Nuwiq Octapharma AB Centralised - Variation 23 Mar 2018 EMEA/H/C/2813/X/20
Pixuvri CTI Life Sciences Ltd Centralised - Annual renewal 23 Mar 2018 EMEA/H/C/2055/R/42
Alofisel TiGenix S.A.U. Centralised - Authorisation 23 Mar 2018 EMEA/H/C/4258
Lokelma AstraZeneca AB Centralised - Authorisation 22 Mar 2018 EMEA/H/C/4029
Aripiprazole Zentiva Zentiva, k.s. Centralised - Yearly update 21 Mar 2018
Faslodex AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 21 Mar 2018 EMEA/H/C/540/T/63
Vibativ Theravance Biopharma Ireland Limited Centralised - Yearly update 21 Mar 2018
Shingrix GlaxoSmithKline Biologicals S.A. Centralised - Authorisation 21 Mar 2018 EMEA/H/C/4336
Steglatro Merck Sharp & Dohme Limited Centralised - Authorisation 21 Mar 2018 EMEA/H/C/4315
PHEBURANE Lucane Pharma Centralised - Renewal 21 Mar 2018 EMEA/H/C/2500/R/17
OCALIVA Intercept Pharma Ltd PSUSA - Modification 21 Mar 2018 EMEA/H/C/4093/PSUSA/10555/201706
Pixuvri CTI Life Sciences Ltd PSUSA - Modification 21 Mar 2018 EMEA/H/C/PSUSA/9261/201705
Invirase Roche Registration Limited Centralised - 2-Monthly update 20 Mar 2018 EMEA/H/C/113/II/122
Xofigo Bayer AG Referral 19 Mar 2018 EMEA/H/C/2653/A-20
IDflu Sanofi Pasteur SA Centralised - Withdrawal 19 Mar 2018
Integrilin Glaxo Group Ltd Centralised - Yearly update 16 Mar 2018
Cetrotide Merck Serono Europe Limited Centralised - Yearly update 16 Mar 2018
Kadcyla Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2018 EMEA/H/C/2389/T/38
Cotellic Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2018 EMEA/H/C/3960/T/11
Mircera Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2018 EMEA/H/C/739/T/66
Mabthera Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2018 EMEA/H/C/165/T/148
Xeloda Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2018 EMEA/H/C/316/T/76
Kinzalkomb Bayer AG Centralised - Yearly update 16 Mar 2018
Avastin Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2018 EMEA/H/C/582/T/100
Aripiprazole Sandoz Sandoz GmbH Centralised - Yearly update 16 Mar 2018
Glyxambi Boehringer Ingelheim International GmbH Centralised - Yearly update 16 Mar 2018
Jentadueto Boehringer Ingelheim International GmbH Centralised - Yearly update 16 Mar 2018
IDflu Sanofi Pasteur SA Centralised - Yearly update 16 Mar 2018
Vaniqa Almirall, S.A. Centralised - Yearly update 16 Mar 2018
Herceptin Roche Registration GmbH Centralised - Yearly update 16 Mar 2018
Silgard Merck Sharp & Dohme Limited Centralised - Yearly update 16 Mar 2018
Zomarist Novartis Europharm Limited Centralised - Yearly update 16 Mar 2018
Alecensa Roche Registration GmbH Corrigendum 15 Mar 2018
Humira AbbVie Deutschland GmbH & Co. KG Centralised - Transfer Marketing Authorisation Holder 15 Mar 2018 EMEA/H/C/481/T/176
NeoRecormon Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 15 Mar 2018 EMEA/H/C/116/T/98
Pegasys Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 15 Mar 2018 EMEA/H/C/395/T/100
Vaxelis MCM Vaccine B.V. Centralised - Yearly update 15 Mar 2018
Erivedge Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 15 Mar 2018 EMEA/H/C/2602/T/37
Alecensa Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 15 Mar 2018 EMEA/H/C/4164/T/13
Latuda Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Corrigendum 12 Mar 2018
Latuda Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Centralised - Transfer Marketing Authorisation Holder 12 Mar 2018 EMEA/H/C/2713/T/19
DuoResp Spiromax Teva Pharma B.V. Centralised - Yearly update 12 Mar 2018
MicardisPlus Boehringer Ingelheim International GmbH Centralised - Yearly update 12 Mar 2018
CellCept Roche Registration Limited Centralised - Transfer Marketing Authorisation Holder 12 Mar 2018 EMEA/H/C/82/T/139
Neuraceq Piramal Imaging Limited Centralised - Transfer Marketing Authorisation Holder 12 Mar 2018 EMEA/H/C/2553/T/22
Oprymea Krka d. d., Novo Mesto Centralised - 2-Monthly update 12 Mar 2018 EMEA/H/C/941/IB/28
Trajenta Boehringer Ingelheim International GmbH Centralised - Yearly update 12 Mar 2018
Zinbryta Biogen Idec Limited Referral 8 Mar 2018 EMEA/H/C/3862/A-20/1462
Tecentriq Roche Registration GmbH Centralised - Transfer Marketing Authorisation Holder 7 Mar 2018 EMEA/H/C/4143/T/6
PritorPlus Bayer AG Centralised - Yearly update 7 Mar 2018
Raplixa Mallinckrodt Pharmaceuticals Ireland Limited Centralised - Yearly update 7 Mar 2018
Lonsurf Les Laboratoires Servier Centralised - Yearly update 7 Mar 2018
Kisplyx Eisai Europe Limited Centralised - Yearly update 7 Mar 2018
Aclasta Novartis Europharm Limited Centralised - Yearly update 7 Mar 2018
Pregabalin Pfizer Pfizer Limited Centralised - Yearly update 7 Mar 2018
Levetiracetam Actavis Actavis Group PTC ehf. Centralised - Yearly update 7 Mar 2018
Revinty Ellipta Glaxo Group Ltd Centralised - 2-Monthly update 7 Mar 2018 EMEA/H/C/2745/WS/1208
Adempas Bayer AG Centralised - 2-Monthly update 7 Mar 2018 EMEA/H/C/2737/II/23
Litak Lipomed GmbH Centralised - 2-Monthly update 7 Mar 2018 EMEA/H/C/504/IB/13
Terrosa Gedeon Richter Plc. Centralised - Yearly update 5 Mar 2018
OLYSIO Janssen-Cilag International NV Centralised - Withdrawal 5 Mar 2018
Hizentra CSL Behring GmbH Centralised - 2-Monthly update 5 Mar 2018 EMEA/H/C/2127/II/87
Relvar Ellipta Glaxo Group Ltd Centralised - 2-Monthly update 5 Mar 2018 EMEA/H/C/2673/WS/1208
Zydelig Gilead Sciences International Limited Centralised - 2-Monthly update 5 Mar 2018 EMEA/H/C/3843/II/38
Viekirax AbbVie Ltd Centralised - 2-Monthly update 5 Mar 2018 EMEA/H/C/3839/II/39
Sirturo Janssen-Cilag International NV Centralised - Annual renewal 5 Mar 2018 EMEA/H/C/2614/R/24
Epivir ViiV Healthcare UK Limited Centralised - 2-Monthly update 5 Mar 2018 EMEA/H/C/107/II/104
Myclausen Passauer Pharma GmbH PSUSA - Modification 5 Mar 2018 EMEA/H/C/1218/PSUSA/10550/201705
CellCept Roche Registration Limited PSUSA - Modification 5 Mar 2018 EMEA/H/C/82/PSUSA/10550/201705
Myfenax Teva B.V. PSUSA - Modification 5 Mar 2018 EMEA/H/C/PSUSA/10550/201705
Mycophenolate mofetil Teva Teva B.V. PSUSA - Modification 5 Mar 2018 EMEA/H/C/882/PSUSA/10550/201705
Adenuric Menarini International Operations Luxembourg S.A. PSUSA - Modification 5 Mar 2018 EMEA/H/C/777/PSUSA/1353/201704
IDELVION CSL Behring GmbH Centralised - Yearly update 1 Mar 2018
Mixtard Novo Nordisk A/S Centralised - Yearly update 1 Mar 2018
Insulatard Novo Nordisk A/S Centralised - Yearly update 1 Mar 2018
GONAL-f Merck Serono Europe Limited Centralised - Yearly update 1 Mar 2018
Protaphane Novo Nordisk A/S Centralised - Yearly update 1 Mar 2018
BiResp Spiromax Teva Pharma B.V. Centralised - Yearly update 1 Mar 2018
Neparvis Novartis Europharm Limited Centralised - Yearly update 1 Mar 2018
Xiliarx Novartis Europharm Limited Centralised - Yearly update 1 Mar 2018
Jalra Novartis Europharm Limited Centralised - Yearly update 1 Mar 2018
Ameluz Biofrontera Bioscience GmbH Centralised - 2-Monthly update 1 Mar 2018 EMEA/H/C/2204/II/27G
Xeplion Janssen-Cilag International NV Centralised - 2-Monthly update 1 Mar 2018 EMEA/H/C/2105/II/35
Galvus Novartis Europharm Limited Centralised - Yearly update 1 Mar 2018
Abasaglar Eli Lilly Nederland B.V. Centralised - Transfer Marketing Authorisation Holder 27 Feb 2018 EMEA/H/C/2835/T/18
Omnitrope Sandoz GmbH PSUSA - Modification 27 Feb 2018 EMEA/H/C/607/PSUSA/2772/201703
Hemlibra Roche Registration Limited Corrigendum 23 Feb 2018
Hemlibra Roche Registration Limited Centralised - Authorisation 23 Feb 2018 EMEA/H/C/4406
Eucreas Novartis Europharm Limited Centralised - Yearly update 22 Feb 2018
Zurampic Grünenthal GmbH Centralised - Yearly update 22 Feb 2018
Dynastat Pfizer Limited Centralised - Yearly update 22 Feb 2018
Trulicity Eli Lilly Nederland B.V. Centralised - 2-Monthly update 22 Feb 2018 EMEA/H/C/2825/II/22
NutropinAq Ipsen Pharma PSUSA - Modification 22 Feb 2018 EMEA/H/C/315/PSUSA/2772/201703
Lyrica Pfizer Limited Centralised - Yearly update 19 Feb 2018
Neulasta Amgen Europe B.V. Centralised - Yearly update 19 Feb 2018
Nucala GlaxoSmithKline Trading Services Limited Centralised - Yearly update 19 Feb 2018
Wilzin Orphan Europe S.A.R.L. Centralised - Yearly update 19 Feb 2018
Anoro Glaxo Group Ltd Centralised - Yearly update 19 Feb 2018
Adcirca Eli Lilly Nederland B.V. Centralised - Yearly update 19 Feb 2018
Senshio Shionogi Limited Centralised - Yearly update 19 Feb 2018
Ongentys Bial - Portela & Cª, SA Centralised - Yearly update 19 Feb 2018
Tenofovir disoproxil Mylan Mylan S.A.S. Centralised - Yearly update 19 Feb 2018
Talmanco Mylan S.A.S. Centralised - Yearly update 19 Feb 2018
Gardasil 9 MSD VACCINS Centralised - Yearly update 19 Feb 2018
Aerivio Spiromax Teva B.V. Centralised - Yearly update 19 Feb 2018
Airexar Spiromax Teva B.V. Centralised - Yearly update 19 Feb 2018
Icandra Novartis Europharm Limited Centralised - Yearly update 19 Feb 2018
Zyprexa Velotab Eli Lilly Nederland B.V. Centralised - Yearly update 19 Feb 2018
PegIntron Merck Sharp & Dohme Limited Centralised - Yearly update 19 Feb 2018
Mycamine Astellas Pharma Europe B.V. Centralised - Renewal 19 Feb 2018 EMEA/H/C/734/R/34
Simulect Novartis Europharm Limited Centralised - Yearly update 19 Feb 2018
CRYSVITA Kyowa Kirin Limited Centralised - Authorisation 19 Feb 2018 EMEA/H/C/4275
Orkambi Vertex Pharmaceuticals (Europe) Limited PSUSA - Modification 19 Feb 2018 EMEA/H/C/PSUSA/10455/201705
Olanzapine Teva Teva B.V. Centralised - Yearly update 19 Feb 2018
ViraferonPeg Merck Sharp & Dohme Limited Centralised - Yearly update 19 Feb 2018
Rebetol Merck Sharp & Dohme Limited Centralised - Yearly update 19 Feb 2018
Vfend Pfizer Limited Centralised - Yearly update 19 Feb 2018
Esmya Gedeon Richter Plc. Referral 16 Feb 2018 EMEA/H/A-20/1460/C/2041/43
Vantavo Merck Sharp & Dohme Limited Centralised - Yearly update 15 Feb 2018
Emselex Merus Labs Luxco II S.à R.L. Centralised - Transfer Marketing Authorisation Holder 15 Feb 2018 EMEA/H/C/554/T/65
Fosavance Merck Sharp & Dohme Limited Centralised - Yearly update 15 Feb 2018
Anagrelide Mylan Mylan S.A.S. Centralised - Authorisation 15 Feb 2018 EMEA/H/C/4585
Cystadane Orphan Europe S.A.R.L. Centralised - Yearly update 9 Feb 2018
Cymbalta Eli Lilly Nederland B.V. Centralised - Yearly update 9 Feb 2018
Ventavis Bayer Pharma AG Centralised - Transfer Marketing Authorisation Holder 9 Feb 2018 EMEA/H/C/474/T/59
Neuraceq Piramal Imaging Limited PSUSA - Modification 9 Feb 2018 EMEA/H/C/2553/PSUSA/10094-201702
Caprelsa Genzyme Europe B.V. Centralised - Annual renewal 9 Feb 2018 EMEA/H/C/2315/R/27
IMBRUVICA Janssen-Cilag International NV PSUSA - Modification 9 Feb 2018 EMEA/H/C/PSUSA/10301/201705
Entyvio Takeda Pharma A/S PSUSA - Modification 9 Feb 2018 EMEA/H/C/2782/PSUSA/10186/201705
Herzuma Celltrion Healthcare Hungary Kft. Centralised - Authorisation 9 Feb 2018 EMEA/H/C/2575
Alkindi Diurnal Limited Centralised - Authorisation 9 Feb 2018 EMEA/H/C/4416
Victrelis Merck Sharp & Dohme Limited Centralised - Yearly update 8 Feb 2018
Exforge Novartis Europharm Limited Centralised - Yearly update 8 Feb 2018
Rezolsta Janssen-Cilag International NV Centralised - Yearly update 8 Feb 2018
Daptomycin Hospira Hospira UK Limited Centralised - 2-Monthly update 8 Feb 2018 EMEA/H/C/4310/IB/5
VELCADE Janssen-Cilag International NV Centralised - Yearly update 8 Feb 2018
Iclusig Incyte Biosciences UK Ltd Centralised - Renewal 8 Feb 2018 EMEA/H/C/2695/R/42
Methylthioninium chloride Proveblue Provepharm S.A.S. PSUSA - Modification 8 Feb 2018 EMEA/H/C/PSUSA/2029/201705
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Krka d. d., Novo Mesto Centralised - Authorisation 8 Feb 2018 EMEA/H/C/4274
Xtandi Astellas Pharma Europe B.V. Centralised - Renewal 8 Feb 2018 EMEA/H/C/2639/R/37
Ozempic Novo Nordisk A/S Centralised - Authorisation 8 Feb 2018 EMEA/H/C/4174
Esbriet Roche Registration GmbH PASS - Modification 8 Feb 2018 EMEA/H/C/2154/PSR/S/11
Bosulif Pfizer Limited Centralised - Annual renewal 8 Feb 2018 EMEA/H/C/2373/R/27
OLYSIO Janssen-Cilag International NV PSUSA - Modification 8 Feb 2018 EMEA/H/C/2777/PSUSA/10255/201705
Voriconazole Accord Accord Healthcare Limited Centralised - Renewal 8 Feb 2018 EMEA/H/C/2669/R/17
Thalidomide Celgene Celgene Europe Limited Centralised - Renewal 8 Feb 2018 EMEA/H/C/823/R/54
Pregabalin Sandoz GmbH Sandoz GmbH Centralised - Yearly update 5 Feb 2018
Pregabalin Sandoz Sandoz GmbH Centralised - Yearly update 5 Feb 2018
PREZISTA Janssen-Cilag International NV Centralised - Yearly update 5 Feb 2018
NULOJIX Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 5 Feb 2018
Truvada Gilead Sciences International Limited Centralised - 2-Monthly update 5 Feb 2018 EMEA/H/C/594/II/135
Pedea Orphan Europe S.A.R.L. Centralised - Yearly update 5 Feb 2018
Vedrop Orphan Europe S.A.R.L. Centralised - Yearly update 5 Feb 2018
Episalvan Amryt AG Centralised - Yearly update 5 Feb 2018
Ebilfumin Actavis Group PTC ehf. Centralised - Yearly update 5 Feb 2018
Rotarix GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 30 Jan 2018
Stelara Janssen-Cilag International NV Centralised - Yearly update 30 Jan 2018
Cresemba Basilea Medical Ltd Centralised - Yearly update 30 Jan 2018
Granpidam Accord Healthcare Limited Centralised - Yearly update 30 Jan 2018
Vectibix Amgen Europe B.V. Centralised - Yearly update 30 Jan 2018
Exforge HCT Novartis Europharm Limited Centralised - Yearly update 30 Jan 2018
Dafiro Novartis Europharm Limited Centralised - Yearly update 30 Jan 2018
Copalia Novartis Europharm Limited Centralised - Yearly update 30 Jan 2018
Fycompa Eisai Europe Limited Centralised - Yearly update 30 Jan 2018
LeukoScan Immunomedics GmbH Centralised - Withdrawal 30 Jan 2018
Dafiro HCT Novartis Europharm Limited Centralised - Yearly update 30 Jan 2018
Hizentra CSL Behring GmbH Centralised - Yearly update 30 Jan 2018
Cialis Eli Lilly Nederland B.V. Centralised - Yearly update 30 Jan 2018
Copalia HCT Novartis Europharm Limited Centralised - Yearly update 30 Jan 2018
Colobreathe Teva B.V. Centralised - Yearly update 30 Jan 2018
Ivemend Merck Sharp & Dohme Limited Centralised - Yearly update 30 Jan 2018
Effentora Teva B.V. Centralised - Yearly update 30 Jan 2018
Nplate Amgen Europe B.V. Centralised - 2-Monthly update 30 Jan 2018 EMEA/H/C/942/II/60/G
Cerdelga Genzyme Europe B.V. Centralised - Yearly update 26 Jan 2018
Mysimba Orexigen Therapeutics Ireland Limited Centralised - 2-Monthly update 26 Jan 2018 EMEA/H/C/3687/II/23
Darunavir Krka Krka d. d., Novo Mesto Centralised - Authorisation 26 Jan 2018 EMEA/H/C/4273
Matever Pharmathen S.A. Centralised - Yearly update 25 Jan 2018
LeukoScan Immunomedics GmbH Centralised - Yearly update 24 Jan 2018
Cervarix GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 24 Jan 2018
DUAVIVE Pfizer Limited Centralised - Yearly update 24 Jan 2018
IBRANCE Pfizer Limited Centralised - 2-Monthly update 24 Jan 2018 EMEA/H/C/3853/II/7
Zoledronic acid Teva Pharma Teva B.V. Centralised - Withdrawal 18 Jan 2018
Omidria Omeros London Limited Centralised - Yearly update 18 Jan 2018
Bortezomib Hospira Hospira UK Limited Centralised - Yearly update 18 Jan 2018
Tenofovir disoproxil Zentiva Zentiva, k.s. Centralised - Yearly update 18 Jan 2018
Leganto UCB Pharma S.A. Centralised - Transfer Marketing Authorisation Holder 18 Jan 2018 EMEA/H/C/2380/T/26
Yervoy Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 18 Jan 2018 EMEA/H/C/2213/II/44
XALKORI Pfizer Limited Centralised - 2-Monthly update 18 Jan 2018 EMEA/H/C/2489/II/50
Taltz Eli Lilly Nederland B.V. Centralised - 2-Monthly update 18 Jan 2018 EMEA/H/C/3943/II/9
Darunavir Krka d.d. Krka d. d., Novo Mesto Centralised - Authorisation 18 Jan 2018 EMEA/H/C/4891
Marixino KRKA, d.d., Novo mesto Centralised - Renewal 18 Jan 2018 EMEA/H/C/2658/R/12
Ciambra Menarini International Operations Luxembourg S.A. Centralised - Yearly update 15 Jan 2018
Prialt Eisai Limited Centralised - Yearly update 15 Jan 2018
Zostavax MSD VACCINS Centralised - Yearly update 15 Jan 2018
Fanaptum Vanda Pharmaceuticals Limited Centralised - Refusal of marketing authorisation 15 Jan 2018 EMEA/H/C/4149
Adasuve Ferrer Internacional S.A. Centralised - Renewal 15 Jan 2018 EMEA/H/C/2400/R/24
Mvasi Amgen Europe B.V. Centralised - Authorisation 15 Jan 2018 EMEA/H/C/4728
Cystadrops Orphan Europe S.A.R.L. Centralised - Yearly update 11 Jan 2018
Libertek AstraZeneca AB Centralised - Withdrawal 11 Jan 2018
Daliresp AstraZeneca AB Centralised - Withdrawal 11 Jan 2018
Levetiracetam Teva Teva B.V. Centralised - Yearly update 11 Jan 2018
Cystagon Orphan Europe S.A.R.L. Centralised - Yearly update 11 Jan 2018
Carbaglu Orphan Europe S.A.R.L. Centralised - Yearly update 11 Jan 2018
Laventair Glaxo Group Ltd Centralised - Yearly update 11 Jan 2018
OLYSIO Janssen-Cilag International NV Centralised - Yearly update 11 Jan 2018
Cinacalcet Mylan Mylan S.A.S. Centralised - Yearly update 11 Jan 2018
Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH Centralised - Withdrawal 11 Jan 2018
Lartruvo Eli Lilly Nederland B.V. PSUSA - Modification 11 Jan 2018 EMEA/H/C/4216/PSUSA/10541/201704
Hexyon Sanofi Pasteur Europe Corrigendum 8 Jan 2018
Comtess Orion Corporation Centralised - Yearly update 8 Jan 2018
Bronchitol Pharmaxis Pharmaceuticals Limited Centralised - Yearly update 8 Jan 2018
Jorveza Dr Falk Pharma GmbH Centralised - Authorisation 8 Jan 2018 EMEA/H/C/4655
HyQvia Baxalta Innovations GmbH Centralised - Renewal 8 Jan 2018 EMEA/H/C/2491/R/37
Memantine LEK Pharmathen S.A. Centralised - Renewal 8 Jan 2018 EMEA/H/C/2630/R/9
Nemdatine Actavis Group PTC ehf. Centralised - Renewal 8 Jan 2018 EMEA/H/C/2680/R/8
Memantine Mylan Generics [UK] Limited Centralised - Renewal 8 Jan 2018 EMEA/H/C/2660/R/10
Tolucombi Krka d. d., Novo Mesto Centralised - Renewal 8 Jan 2018 EMEA/H/C/2549/R/20
Hexyon Sanofi Pasteur Europe Centralised - Renewal 8 Jan 2018 EMEA/H/C/2796/R/72
Hexacima Sanofi Pasteur SA Centralised - Renewal 8 Jan 2018 EMEA/H/C/2702/R/68
Synjardy Boehringer Ingelheim International GmbH PSUSA - Modification 8 Jan 2018 EMEA/H/C/PSUSA/10388/201704
Ixiaro Valneva Austria GmbH PSUSA - Modification 8 Jan 2018 EMEA/H/C/PSUSA/1801/201703
Cimzia UCB Pharma S.A. PSUSA - Modification 8 Jan 2018 EMEA/H/C/1037/PSUSA/624/201703
Stayveer Marklas Nederland B.V. Centralised - Renewal 8 Jan 2018 EMEA/H/C/2644/R/21
Yervoy Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 8 Jan 2018 EMEA/H/C/2213/PSUSA/9200/201703
Orkambi Vertex Pharmaceuticals (Europe) Limited Centralised - Variation 8 Jan 2018 EMEA/H/C/3954/X/20
Votrient Novartis Europharm Limited Centralised - Renewal 8 Jan 2018 EMEA/H/C/1141/R/42
PREVYMIS Merck Sharp & Dohme Limited Centralised - Authorisation 8 Jan 2018 EMEA/H/C/4536
Intrarosa Endoceutics Ltd. Centralised - Authorisation 8 Jan 2018 EMEA/H/C/4138
Onzeald Nektar Therapeutics UK Limited Centralised - Refusal of marketing authorisation 8 Jan 2018 EMEA/H/C/3874
Fasenra AstraZeneca AB Centralised - Authorisation 8 Jan 2018 EMEA/H/C/4433
ADYNOVI Baxalta Innovations GmbH Centralised - Authorisation 8 Jan 2018 EMEA/H/C/4195
Fulvestrant Mylan Mylan S.A.S. Centralised - Authorisation 8 Jan 2018 EMEA/H/C/4649
Jardiance Boehringer Ingelheim International GmbH PSUSA - Modification 8 Jan 2018 EMEA/H/C/PSUSA/10388/201704
Pradaxa Boehringer Ingelheim International GmbH Centralised - Renewal 8 Jan 2018 EMEA/H/C/829/R/105
Ocrevus Roche Registration GmbH Centralised - Authorisation 8 Jan 2018 EMEA/H/C/4043
Zonegran Eisai Limited PSUSA - Modification 8 Jan 2018 EMEA/H/C/PSUSA/3152/201703
Zinbryta Biogen Idec Limited Referral 8 Jan 2018 EMEA/H/C/3862/A-20/1456/C/3862/10
Imatinib Actavis Actavis Group PTC ehf. Centralised - Renewal 8 Jan 2018 EMEA/H/C/2594/R/15
Cometriq Ipsen Pharma Centralised - Annual renewal 8 Jan 2018 EMEA/H/C/2640/R/27
Efient Daiichi Sankyo Europe GmbH Corrigendum 20 Dec 2017
Levetiracetam ratiopharm ratiopharm GmbH Centralised - Yearly update 20 Dec 2017
Levetiracetam SUN Sun Pharmaceutical Industries Europe BV Centralised - Yearly update 20 Dec 2017
Tivicay ViiV Healthcare UK Limited Centralised - Yearly update 20 Dec 2017
Incresync Takeda Pharma A/S Centralised - Yearly update 20 Dec 2017
Fabrazyme Genzyme Europe B.V. Centralised - Yearly update 20 Dec 2017
Duloxetine Lilly Eli Lilly Nederland B.V. Centralised - Yearly update 20 Dec 2017
Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 20 Dec 2017
Xigduo AstraZeneca AB Centralised - 2-Monthly update 20 Dec 2017 EMEA/H/C/2672/WS/1271/G
Efient Daiichi Sankyo Europe GmbH Centralised - Yearly update 20 Dec 2017
Ebymect AstraZeneca AB Centralised - 2-Monthly update 20 Dec 2017 EMEA/H/C/4162/WS/1271G
Gardasil MSD VACCINS Centralised - Yearly update 20 Dec 2017
Qtern AstraZeneca AB Centralised - 2-Monthly update 20 Dec 2017 EMEA/H/C/4057/WS/1271/G
Azilect Teva B.V. Centralised - Yearly update 20 Dec 2017
Ranexa Menarini International Operations Luxembourg S.A. Centralised - Yearly update 20 Dec 2017
Alecensa Roche Registration GmbH Corrigendum 18 Dec 2017
ProQuad MSD VACCINS Centralised - Yearly update 18 Dec 2017
Enbrel Pfizer Limited Centralised - Yearly update 18 Dec 2017
NovoMix Novo Nordisk A/S Centralised - Yearly update 18 Dec 2017
HBVAXPRO MSD VACCINS Centralised - Yearly update 18 Dec 2017
Daklinza Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 18 Dec 2017
Xelevia Merck Sharp & Dohme Limited Centralised - 2-Monthly update 18 Dec 2017 EMEA/H/C/762/WS/1211
Alecensa Roche Registration GmbH Centralised - Authorisation - Switch to non-conditional 18 Dec 2017 EMEA/H/C/4164/II/1
Masipro AB Science Centralised - Refusal of marketing authorisation 18 Dec 2017 EMEA/H/C/4159
Procysbi Chiesi Orphan B.V. Centralised - Yearly update 15 Dec 2017
M-M-RVAXPRO MSD VACCINS Centralised - Yearly update 15 Dec 2017
Ristfor Merck Sharp & Dohme Limited Centralised - 2-Monthly update 15 Dec 2017 EMEA/H/C/1235/WS/1212/G
Velmetia Merck Sharp & Dohme Limited Centralised - 2-Monthly update 15 Dec 2017 EMEA/H/C/862/WS/1212/G
Janumet Merck Sharp & Dohme Limited Centralised - 2-Monthly update 15 Dec 2017 EMEA/H/C/861/WS/1212/G
Efficib Merck Sharp & Dohme Limited Centralised - 2-Monthly update 15 Dec 2017 EMEA/H/C/896/WS/1212/G
Ristaben Merck Sharp & Dohme Limited Centralised - 2-Monthly update 15 Dec 2017 EMEA/H/C/1234/WS/1211/51
Sustiva Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 15 Dec 2017 EMEA/H/C/249/WS/1117/G
Stocrin Merck Sharp & Dohme Limited Centralised - 2-Monthly update 15 Dec 2017 EMEA/H/C/250/WS/1117/G
ADCETRIS Takeda Pharma A/S Centralised - 2-Monthly update 15 Dec 2017 EMEA/H/C/2455/II/48
Eviplera Gilead Sciences International Limited Centralised - 2-Monthly update 15 Dec 2017 EMEA/H/C/2312/WS/1251
Actelsar HCT Actavis Group PTC ehf. Centralised - Renewal 15 Dec 2017 EMEA/H/C/2676/R/15
Rapiscan GE Healthcare AS Centralised - Transfer Marketing Authorisation Holder 11 Dec 2017 EMEA/H/C/1176/T/29
Tarceva Roche Registration GmbH Centralised - 2-Monthly update 11 Dec 2017 EMEA/H/C/618/II/51
Strensiq Alexion Europe SAS Centralised - Yearly update 11 Dec 2017
Zyclara Meda AB Centralised - 2-Monthly update 11 Dec 2017 EMEA/H/C/2387/II/13
Reyataz Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 11 Dec 2017 EMEA/H/C/494/WS/1193
EVOTAZ Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 11 Dec 2017 EMEA/H/C/3904/WS/1193
Holoclar Chiesi Farmaceutici S.p.A. Centralised - Annual renewal 11 Dec 2017 EMEA/H/C/2450/R/15
Odefsey Gilead Sciences International Limited Centralised - 2-Monthly update 11 Dec 2017 EMEA/H/C/4156/WS/1251
Neupro UCB Pharma S.A. PSUSA - Modification 11 Dec 2017 EMEA/H/C/PSUSA/2667/201702
Tesavel Merck Sharp & Dohme Limited Centralised - 2-Monthly update 8 Dec 2017 EMEA/H/C/910/WS/1211/59
Ceplene Noventia Pharma Srl Centralised - Transfer Marketing Authorisation Holder 8 Dec 2017 EMEA/H/C/796/T/33
Esbriet Roche Registration GmbH Centralised - 2-Monthly update 8 Dec 2017 EMEA/H/C/2154/II/43
Genvoya Gilead Sciences International Limited Centralised - 2-Monthly update 8 Dec 2017 EMEA/H/C/4042/II/26
Januvia Merck Sharp & Dohme Limited Centralised - 2-Monthly update 8 Dec 2017 EMEA/H/C/722/WS/1211/59
Humira AbbVie Deutschland GmbH & Co. KG Centralised - Variation 8 Dec 2017 EMEA/H/C/481/X/164
Oncaspar Baxalta Innovations GmbH Centralised - Variation 8 Dec 2017 EMEA/H/C/3789/X/8
GILENYA Novartis Europharm Limited PSUSA - Modification 8 Dec 2017 EMEA/H/C/2202/PSUSA/1393/201702
Mysimba Orexigen Therapeutics Ireland Limited PSUSA - Modification 8 Dec 2017 EMEA/H/C/3687/PSUSA/10366/201703
Lemtrada Genzyme Therapeutics Ltd PSUSA - Modification 8 Dec 2017 EMEA/H/C/3718/PSUSA/10055/201703
Esmya Gedeon Richter Plc. PSUSA - Modification 8 Dec 2017 EMEA/H/C/2041/PSUSA/9325/201702
Selincro H. Lundbeck A/S PSUSA - Modification 8 Dec 2017 EMEA/H/C/2583/PSUSA/10120/201702
Perjeta Roche Registration GmbH Centralised - Renewal 8 Dec 2017 EMEA/H/C/2547/R/31
JETREA ThromboGenics NV Centralised - Renewal 8 Dec 2017 EMEA/H/C/2381/R/33
KEYTRUDA Merck Sharp & Dohme Limited PSUSA - Modification 8 Dec 2017 EMEA/H/C/3820/PSUSA/10403/201703
Leganto UCB Pharma S.A. PSUSA - Modification 8 Dec 2017 EMEA/H/C/PSUSA/2667/201702
Zevalin Spectrum Pharmaceuticals B.V. PSUSA - Modification 8 Dec 2017 EMEA/H/C/PSUSA/1704/201702
Tacforius Teva B.V. Centralised - Authorisation 8 Dec 2017 EMEA/H/C/4435
Truberzi Allergan Pharmaceuticals International Limited PSUSA - Modification 8 Dec 2017 EMEA/H/C/PSUSA/10528/201703
Xiapex Swedish Orphan Biovitrum AB (publ) PSUSA - Modification 8 Dec 2017 EMEA/H/C/2048/PSUSA/871/201702
Moventig Kyowa Kirin Limited PSUSA - Modification 8 Dec 2017 EMEA/H/C/PSUSA/10317/201703
Dexdor Orion Corporation PSUSA - Modification 8 Dec 2017 EMEA/H/C/2268/PSUSA/998/201703
Taltz Eli Lilly Nederland B.V. PSUSA - Modification 8 Dec 2017 EMEA/H/C/3943/PSUSA/10493/201703
Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech XBiotech Germany GmbH Centralised - Refusal of marketing authorisation 8 Dec 2017 EMEA/H/C/4388
Thymanax Servier (Ireland) Industries Limited Centralised - Yearly update 1 Dec 2017
Hetlioz Vanda Pharmaceuticals Limited Centralised - Yearly update 1 Dec 2017
OCALIVA Intercept Pharma Ltd Centralised - Annual renewal 1 Dec 2017 EMEA/H/C/4093/R/2
Jakavi Novartis Europharm Limited PSUSA - Modification 1 Dec 2017 EMEA/H/C/2464/PSUSA/10015/201702
Alecensa Roche Registration GmbH Centralised - Annual renewal 1 Dec 2017 EMEA/H/C/4164/R/7
Zepatier Merck Sharp & Dohme Limited Centralised - Yearly update 30 Nov 2017
Entacapone Orion Orion Corporation Centralised - Yearly update 28 Nov 2017
Prepandrix GlaxoSmithKline Biologicals S.A. Centralised - Renewal 28 Nov 2017 EMEA/H/C/822/R/71
Privigen CSL Behring GmbH Centralised - Renewal 28 Nov 2017 EMEA/H/C/831/R/122
Nuwiq Octapharma AB Referral 24 Nov 2017 EMEA/H/C/2813/A31/15
Advate Baxter AG Referral 24 Nov 2017 EMEA/H/C/520/A31/78
Optimark Guerbet Referral 23 Nov 2017 EMEA/H/A-31/1437/C/745/34
Zejula TESARO U.K. Limited Corrigendum 16 Nov 2017
Taxotere Aventis Pharma S.A. Corrigendum 16 Nov 2017
Levemir Novo Nordisk A/S Centralised - Yearly update 16 Nov 2017
ATryn Laboratoire français du Fractionnement et des Biotechnologies Centralised - Transfer Marketing Authorisation Holder 16 Nov 2017 EMEA/H/C/587/T/31
Levetiracetam Accord Accord Healthcare Limited Centralised - Yearly update 16 Nov 2017
Cubicin Merck Sharp & Dohme Limited Centralised - 2-Monthly update 16 Nov 2017 EMEA/H/C/637/II/61
KOGENATE Bayer Bayer AG Referral 16 Nov 2017 EMEA/H/C/275/A31/185
Helixate NexGen Bayer AG Referral 16 Nov 2017 EMEA/H/C/276/A31/178
Elocta Swedish Orphan Biovitrum AB (publ) Referral 16 Nov 2017 EMEA/H/C/3964/A31/6
Taxotere Aventis Pharma S.A. PSUSA - Modification 16 Nov 2017 EMEA/H/C/73/PSUSA/1152/201611
Docetaxel Winthrop Aventis Pharma S.A. PSUSA - Modification 16 Nov 2017 EMEA/H/C/PSUSA/1152/201611
Adlumiz Helsinn Birex Pharmaceuticals Ltd Centralised - Refusal of marketing authorisation 16 Nov 2017 EMEA/H/C/3847
Zejula TESARO U.K. Limited Centralised - Authorisation 16 Nov 2017 EMEA/H/C/4249
Zydelig Gilead Sciences International Limited PSUSA - Modification 16 Nov 2017 EMEA/H/C/3843/PSUSA/10303-201701
ReFacto AF Pfizer Limited Corrigendum 15 Nov 2017
Imvanex Bavarian Nordic A/S Centralised - Yearly update 15 Nov 2017
Emtricitabine/Tenofovir disoproxil Krka Krka d. d., Novo Mesto Centralised - 2-Monthly update 15 Nov 2017 EMEA/H/C/4215/IB/5G
Saxenda Novo Nordisk A/S Centralised - Yearly update 15 Nov 2017
Aripiprazole Accord Accord Healthcare Limited Centralised - Yearly update 15 Nov 2017
Bortezomib SUN Sun Pharmaceutical Industries Europe BV Centralised - Yearly update 15 Nov 2017
Lemtrada Genzyme Therapeutics Ltd Centralised - 2-Monthly update 15 Nov 2017 EMEA/H/C/3718/II/17
Zytiga Janssen-Cilag International NV Centralised - 2-Monthly update 15 Nov 2017 EMEA/H/C/2321/II/47
Savene Clinigen Healthcare Limited Centralised - 2-Monthly update 15 Nov 2017 EMEA/H/C/682/II/34
EVARREST Omrix Biopharmaceuticals N.V. Centralised - Withdrawal 15 Nov 2017
Viekirax AbbVie Ltd PSUSA - Modification 15 Nov 2017 EMEA/H/C/3839/PSUSA/10367/201701
Ontruzant Samsung Bioepis UK Limited Centralised - Authorisation 15 Nov 2017 EMEA/H/C/4323
Ozurdex Allergan Pharmaceuticals Ireland PSUSA - Modification 15 Nov 2017 EMEA/H/C/1140/PSUSA/985/201701
NovoEight Novo Nordisk A/S Referral 15 Nov 2017 EMEA/H/C/2719/A31/14
ReFacto AF Pfizer Limited Referral 15 Nov 2017 EMEA/H/C/232/A31/134
Voncento CSL Behring GmbH Referral 15 Nov 2017 EMEA/H/C/2493/A31/22
Kyprolis Amgen Europe B.V. PSUSA - Modification 15 Nov 2017 EMEA/H/C/PSUSA/10448/201701
Imatinib Teva B.V. Teva B.V. Centralised - Authorisation 15 Nov 2017 EMEA/H/C/4748
Elebrato Ellipta GlaxoSmithKline Trading Services Limited Centralised - Authorisation 15 Nov 2017 EMEA/H/C/4781
Trelegy Ellipta GlaxoSmithKline Trading Services Limited Centralised - Authorisation 15 Nov 2017 EMEA/H/C/4363
Tasigna Novartis Europharm Limited Centralised - Variation 15 Nov 2017 EMEA/H/C/798/X/88/G
Kovaltry Bayer AG Corrigendum 10 Nov 2017
Iblias Bayer AG Corrigendum 10 Nov 2017
Tandemact Takeda Pharma A/S Centralised - Yearly update 10 Nov 2017
Mepact Takeda France SAS Centralised - Yearly update 10 Nov 2017
Kolbam Retrophin Europe Limited Centralised - Yearly update 10 Nov 2017
Ovitrelle Merck Serono Europe Limited Centralised - Yearly update 10 Nov 2017
Valdoxan Les Laboratoires Servier Centralised - Yearly update 10 Nov 2017
Prevenar Pfizer Limited Centralised - Withdrawal 10 Nov 2017
Revatio Pfizer Limited Centralised - Yearly update 10 Nov 2017
Faslodex AstraZeneca AB Centralised - 2-Monthly update 10 Nov 2017 EMEA/H/C/540/II/59
BYDUREON AstraZeneca AB Centralised - 2-Monthly update 10 Nov 2017 EMEA/H/C/2020/II/45
Emtricitabine /Tenofovir disoproxil Krka d.d. Krka d. d., Novo Mesto Centralised - 2-Monthly update 10 Nov 2017 EMEA/H/C/4686/IB/2/G
Pegasys Roche Registration GmbH Centralised - 2-Monthly update 10 Nov 2017 EMEA/H/C/395/II/91
ellaOne Laboratoire HRA Pharma Centralised - Variation 10 Nov 2017 EMEA/H/C/1027/X/45
Glubrava Takeda Pharma A/S Centralised - Renewal 10 Nov 2017 EMEA/H/C/893/R/54
Cyltezo Boehringer Ingelheim International GmbH Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4319
Ritonavir Mylan Mylan S.A.S. Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4549
Benlysta Glaxo Group Ltd Centralised - Variation 10 Nov 2017 EMEA/H/C/2015/X/46G
Exviera AbbVie Ltd PSUSA - Modification 10 Nov 2017 EMEA/H/C/3837/PSUSA/10363/201701
Selincro H. Lundbeck A/S Centralised - Renewal 10 Nov 2017 EMEA/H/C/2583/R/22
APTIVUS Boehringer Ingelheim International GmbH PSUSA - Modification 10 Nov 2017 EMEA/H/C/PSUSA/2973/201612
Nyxoid Mundipharma Corporation Limited Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4325
Kovaltry Bayer AG Referral 10 Nov 2017 EMEA/H/C/3825/A31/4
Humira AbbVie Deutschland GmbH & Co. KG PSUSA - Modification 10 Nov 2017 EMEA/H/C/481/PSUSA/57/201612
Teysuno Nordic Group B.V. PSUSA - Modification 10 Nov 2017 EMEA/H/C/PSUSA/2875/201701
TOOKAD Steba Biotech S.A Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4182
Zubsolv Mundipharma Corporation Limited Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4407
Iblias Bayer AG Referral 10 Nov 2017 EMEA/H/C/4147/A31/2
VeraSeal Instituto Grifols, S.A. Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4446
Miglustat Gen.Orph Gen.Orph Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4366
Tremfya Janssen-Cilag International NV Centralised - Authorisation 10 Nov 2017 EMEA/H/C/4271
Plegridy Biogen Idec Limited PSUSA - Modification 10 Nov 2017 EMEA/H/C/PSUSA/10275/201701
Exjade Novartis Europharm Limited Centralised - Variation 10 Nov 2017 EMEA/H/C/670/X/54
ADCETRIS Takeda Pharma A/S Centralised - Annual renewal 10 Nov 2017 EMEA/H/C/2455/R/51
NexoBrid MediWound Germany GmbH Centralised - Renewal 10 Nov 2017 EMEA/H/C/2246/R/31
Competact Takeda Pharma A/S Centralised - Yearly update 30 Oct 2017
Epclusa Gilead Sciences International Limited Centralised - Yearly update 30 Oct 2017
Tarceva Roche Registration GmbH Centralised - Yearly update 30 Oct 2017
Multaq Sanofi-Aventis groupe Centralised - Yearly update 30 Oct 2017
Ultibro Breezhaler Novartis Europharm Limited Centralised - Yearly update 30 Oct 2017
Fortacin Recordati Ireland Ltd Centralised - Transfer Marketing Authorisation Holder 30 Oct 2017 EMEA/H/C/2693/T/19
Ibandronic Acid Teva Teva B.V. Centralised - Yearly update 30 Oct 2017
Firdapse BioMarin Europe Ltd. Centralised - Yearly update 30 Oct 2017
Venclyxto AbbVie Ltd Centralised - Annual renewal 30 Oct 2017 EMEA/H/C/4106/R/5
Menveo GSK Vaccines S.r.l. Rectificative Decision 30 Oct 2017
Instanyl Takeda Pharma A/S Centralised - Yearly update 23 Oct 2017
Olanzapine Glenmark Europe Glenmark Pharmaceuticals Europe Limited Centralised - Yearly update 23 Oct 2017
Olanzapine Glenmark Glenmark Pharmaceuticals Europe Limited Centralised - Yearly update 23 Oct 2017
Levetiracetam Actavis Group Actavis Group PTC ehf. Centralised - Yearly update 23 Oct 2017
Giotrif Boehringer Ingelheim International GmbH Centralised - Yearly update 23 Oct 2017
Prevenar 13 Pfizer Limited Centralised - Yearly update 23 Oct 2017
Liprolog Eli Lilly Nederland B.V. Centralised - 2-Monthly update 23 Oct 2017 EMEA/H/C/393/WS/1158/G
Revestive Shire Pharmaceuticals Ireland Limited Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/2345/II/37
Firazyr Shire Orphan Therapies GmbH Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/899/II/34/G
Xarelto Bayer AG Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/944/II/52/G
Yondelis Pharma Mar S.A. Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/773/II/51
Mozobil Genzyme Europe B.V. Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/1030/II/32
Stribild Gilead Sciences International Limited Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/2574/II/79
Humalog Eli Lilly Nederland B.V. Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/88/WS/1158/G
Pradaxa Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/829/II/103
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/3985/II/32
Emend Merck Sharp & Dohme Limited Centralised - 2-Monthly update 19 Oct 2017 EMEA/H/C/527/II/55
Lutathera Advanced Accelerator Applications Corrigendum 26 Sep 2017
Lutathera Advanced Accelerator Applications Corrigendum 26 Sep 2017
Vimpat UCB Pharma S.A. Corrigendum 14 Sep 2017
SonoVue Bracco International B.V. Corrigendum 22 Aug 2017
Tovanor Breezhaler Novartis Europharm Limited Corrigendum 26 Jul 2017
Seebri Breezhaler Novartis Europharm Limited Corrigendum 19 Jul 2017
SomaKit TOC Advanced Accelerator Applications Corrigendum 8 Dec 2016
Venclyxto AbbVie Ltd Corrigendum 5 Dec 2016
Nevanac Novartis Europharm Limited Corrigendum 29 Jul 2016
Emtriva Gilead Sciences International Limited Corrigendum 24 Jun 2016
Tolura Krka d. d., Novo Mesto Corrigendum 4 Sep 2014
Epoetin alfa Hexal Hexal AG Corrigendum 21 Mar 2014
Binocrit Sandoz GmbH Corrigendum 21 Mar 2014
Abseamed Medice Arzneimittel Pütter GmbH & Co KG Corrigendum 21 Mar 2014
Procedures for centrally authorised orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Melatonin (haemorrhage) Therapicon Srl Refusal of orphan designation 16 Apr 2018 EMA/OD/127/17
EU/3/18/2013 Roche Registration Limited Orphan designation 16 Apr 2018 EMA/OD/231/17
EU/3/18/2012 IDEA Innovative Drug European Associates Limited Orphan designation 16 Apr 2018 EMA/OD/244/17
EU/3/18/2011 Ultragenyx Germany GmbH Orphan designation 16 Apr 2018 EMA/OD/026/17
EU/3/18/2010 Novartis Europharm Limited Orphan designation 16 Apr 2018 EMA/OD/249/17
EU/3/18/2009 SOTIO a.s Orphan designation 16 Apr 2018 EMA/OD/246/17
EU/3/18/2008 Stolmár & Partner Patentanwälte PartG mbB Orphan designation 16 Apr 2018 EMA/OD/254/17
EU/3/18/2007 Dr Philippe Moullier Orphan designation 16 Apr 2018 EMA/OD/255/17
Autologous skeletal myoblasts expanded ex vivo Assistance Publique - Hopitaux de Paris (APHP) Refusal of orphan designation 13 Apr 2018 EMA/OD/144/17
EU/3/11/945 Mallinckrodt Pharmaceuticals Ireland Limited Transfer of orphan designation 13 Apr 2018 EMA/OD/105/11/T/03
EU/3/12/1080 AbbVie Deutschland GmbH & Co. KG Transfer of orphan designation 27 Mar 2018 EMA/OD/124/12/T/01
EU/3/13/1177 Astellas Pharma Europe B.V. Transfer of orphan designation 26 Mar 2018 EMA/OD/071/13/T/01
EU/3/12/1092 Astellas Pharma Europe B.V. Transfer of orphan designation 26 Mar 2018 EMA/OD/147/12/T/01
EU/3/10/803 Astellas Pharma Europe B.V. Transfer of orphan designation 26 Mar 2018 EMA/OD/083/10/T/01
EU/3/12/1072 Le4D Limited Transfer of orphan designation 26 Mar 2018 EMA/OD/160/11/T/01
EU/3/17/1876 FGK Representative Service GmbH Transfer of orphan designation 26 Mar 2018 EMA/OD/010/17/T/01
EU/3/04/241 Roche Registration GmbH Transfer of orphan designation 26 Mar 2018 EMEA/OD/052/04/T/03
EU/3/18/2006 Quintiles Ireland Limited Orphan designation 21 Mar 2018 EMA/OD/234/17
EU/3/18/2005 Quintiles Ireland Limited Orphan designation 21 Mar 2018 EMA/OD/222/17
EU/3/18/2004 Quintiles Ireland Limited Orphan designation 21 Mar 2018 EMA/OD/217/17
EU/3/18/2003 Pharmadev Healthcare Ltd Orphan designation 21 Mar 2018 EMA/OD/225/17
EU/3/18/2002 Pharmadev Healthcare Ltd Orphan designation 21 Mar 2018 EMA/OD/224/17
EU/3/18/2001 Soligenix UK Ltd Orphan designation 21 Mar 2018 EMA/OD/242/17
EU/3/18/2000 Amicus Therapeutics UK Ltd Orphan designation 21 Mar 2018 EMA/OD/230/17
EU/3/18/1999 uniQure Biopharma B.V. Orphan designation 21 Mar 2018 EMA/OD/232/17
EU/3/18/1998 Blue-Reg Europe Orphan designation 21 Mar 2018 EMA/OD/206/17
EU/3/18/1997 QRC Consultants Ltd Orphan designation 21 Mar 2018 EMA/OD/226/17
EU/3/18/1996 Therapicon Srl Orphan designation 21 Mar 2018 EMA/OD/227/17
EU/3/18/1995 Loxo Oncology Limited Orphan designation 21 Mar 2018 EMA/OD/213/17
EU/3/18/1994 QRC Consultants Ltd Orphan designation 21 Mar 2018 EMA/OD/172/17
EU/3/18/1993 Quintiles Ireland Limited Orphan designation 21 Mar 2018 EMA/OD/218/17
EU/3/18/1992 argenx BVBA Orphan designation 21 Mar 2018 EMA/OD/245/17
EU/3/18/1991 TurnKey PharmaConsulting Ireland Limited Orphan designation 21 Mar 2018 EMA/OD/235/17
EU/3/18/1990 PharmaBio Consulting Orphan designation 21 Mar 2018 EMA/OD/219/17
EU/3/18/1989 FGK Representative Service GmbH Orphan designation 21 Mar 2018 EMA/OD/208/17
EU/3/17/1882 Richardson Associates Regulatory Affairs Ltd Corrigendum 19 Mar 2018
EU/3/16/1711 Akcea Therapeutics UK Ltd. Transfer of orphan designation 19 Mar 2018 EMA/OD/082/16/T/01
EU/3/17/1861 Roivant Sciences Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/299/16/T/01
EU/3/16/1763 Quintiles Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/150/16/T/01
EU/3/16/1727 Quintiles Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/116/16/T/01
EU/3/16/1714 Quintiles Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/119/16/T/01
EU/3/16/1671 Quintiles Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/023/16/T/01
EU/3/16/1639 Quintiles Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/252/15/T/01
EU/3/15/1595 Quintiles Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/162/15/5T/01
EU/3/14/1363 Quintiles Ireland Limited Transfer of orphan designation 19 Mar 2018 EMA/OD/131/14/T/01
EU/3/11/919 Monopar Therapeutics SARL Transfer of orphan designation 19 Mar 2018 EMA/OD/069/11/T/02
EU/3/17/1947 NeuroVive Pharmaceutical AB Corrigendum 13 Mar 2018
EU/3/17/1903 Inventiva Corrigendum 13 Mar 2018
EU/3/14/1362 Inventiva Corrigendum 13 Mar 2018
EU/3/14/1361 Inventiva Corrigendum 13 Mar 2018
Melatonin (burns) Therapicon Srl Refusal of orphan designation 13 Mar 2018 EMA/OD/039/17
EU/3/16/1789 La Jolla Pharmaceutical II BV Transfer of orphan designation 1 Mar 2018 EMA/OD/144/16/T/02
EU/3/15/1555 La Jolla Pharmaceutical II BV Transfer of orphan designation 1 Mar 2018 EMA/OD/092/15/T/02
EU/3/12/975 Voisin Consulting S.A.R.L. Transfer of orphan designation 1 Mar 2018 EMA/OD/119/11/T/01
EU/3/18/1988 Chiesi Farmaceutici S.p.A. Orphan designation 22 Feb 2018 EMA/OD/203/17
EU/3/18/1987 Richardson Associates Regulatory Affairs Ltd Orphan designation 22 Feb 2018 EMA/OD/185/17
EU/3/18/1986 UCB Biopharma SPRL Orphan designation 22 Feb 2018 EMA/OD/205/17
EU/3/18/1985 Raremoon Consulting Ltd Orphan designation 22 Feb 2018 EMA/OD/221/17
EU/3/18/1984 Omeros London Limited Orphan designation 22 Feb 2018 EMA/OD/200/17
EU/3/18/1983 Medicure Pharma Europe Limited Orphan designation 22 Feb 2018 EMA/OD/201/17
EU/3/18/1982 ATXA Therapeutics Limited Orphan designation 22 Feb 2018 EMA/OD/199/17
EU/3/18/1981 Midatech Pharma Plc Orphan designation 22 Feb 2018 EMA/OD/312/16
EU/3/18/1980 Orion Corporation Orphan designation 22 Feb 2018 EMA/OD/174/17
EU/3/18/1979 Bayer AG Orphan designation 22 Feb 2018 EMA/OD/189/17
EU/3/18/1978 Richardson Associates Regulatory Affairs Ltd Orphan designation 22 Feb 2018 EMA/OD/198/17
EU/3/18/1977 GW Research Ltd Orphan designation 22 Feb 2018 EMA/OD/215/17
EU/3/18/1976 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Orphan designation 22 Feb 2018 EMA/OD/150/17
EU/3/18/1975 Nightstar Therapeutics plc Orphan designation 22 Feb 2018 EMA/OD/220/17
EU/3/18/1974 Takeda Pharma A/S Orphan designation 22 Feb 2018 EMA/OD/193/17
EU/3/18/1973 ProQR Therapeutics IV BV Orphan designation 22 Feb 2018 EMA/OD/197/17
EU/3/18/1972 CATS Consultants GmbH Orphan designation 22 Feb 2018 EMA/OD/202/17
EU/3/15/1559 Genkyotex S.A. Transfer of orphan designation 9 Feb 2018 EMA/OD/105/15/T/01
EU/3/10/802 Genkyotex S.A. Transfer of orphan designation 9 Feb 2018 EMA/OD/079/10/T/02
EU/3/14/1295 Celgene Europe Limited Transfer of orphan designation 9 Feb 2018 EMA/OD/035/14/T/01
EU/3/15/1504 Roche Registration GmbH Transfer of orphan designation 9 Feb 2018 EMA/OD/013/15/T/01
EU/3/14/1325 Roche Registration GmbH Transfer of orphan designation 9 Feb 2018 EMA/OD/092/14/T/01
EU/3/12/1054 Roche Registration GmbH Transfer of orphan designation 9 Feb 2018 EMA/OD/102/12/T/01
EU/3/16/1807 ICON Clinical Research Limited Transfer of orphan designation 1 Feb 2018 EMA/OD/218/16/T/01
EU/3/07/526 ICON Clinical Research Limited Transfer of orphan designation 1 Feb 2018 EMA/OD/099/07/T/03
EU/3/07/478 ICON Clinical Research Limited Transfer of orphan designation 1 Feb 2018 EMA/OD/053/07/T/03
EU/3/13/1174 Oryzon Genomics SA Transfer of orphan designation 1 Feb 2018 EMA/OD/064/13/T/02
EU/3/08/553 Pharma Gateway AB Transfer of orphan designation 1 Feb 2018 EMA/OD/004/08/T/01
EU/3/06/411 Apogenix AG Transfer of orphan designation 25 Jan 2018 EMA/OD/054/06/T/01
EU/3/14/1352 Emergent Countermeasures International Ltd. Transfer of orphan designation 25 Jan 2018 EMA/OD/134/14/T/01
EU/3/09/709 Apogenix AG Transfer of orphan designation 25 Jan 2018 EMA/OD/098/09/T/01
EU/3/17/1971 Edison Orphan Pharma BV Orphan designation 17 Jan 2018 EMA/OD/145/17
EU/3/17/1970 Rare Partners srl Impresa Sociale Orphan designation 17 Jan 2018 EMA/OD/184/17
EU/3/17/1969 University of Cambridge Orphan designation 17 Jan 2018 EMA/OD/182/17
EU/3/17/1968 Regintel Limited Orphan designation 17 Jan 2018 EMA/OD/164/17
EU/3/17/1967 Millendo Therapeutics Ltd Orphan designation 17 Jan 2018 EMA/OD/179/17
EU/3/17/1966 Sirius Regulatory Consulting Limited Orphan designation 17 Jan 2018 EMA/OD/166/17
EU/3/17/1965 Duchenne UK Orphan designation 17 Jan 2018 EMA/OD/154/17
EU/3/17/1964 Incyte Biosciences UK Ltd Orphan designation 17 Jan 2018 EMA/OD/169/17
EU/3/17/1963 Professor Pascale De Lonlay Orphan designation 17 Jan 2018 EMA/OD/177/17
EU/3/17/1962 MWB Consulting Ltd Orphan designation 17 Jan 2018 EMA/OD/155/17
EU/3/17/1961 Astellas Pharma Europe B.V. Orphan designation 17 Jan 2018 EMA/OD/175/17
EU/3/17/1960 Atlas Molecular Pharma S.L. Orphan designation 17 Jan 2018 EMA/OD/186/17
EU/3/17/1959 GW Research Ltd Orphan designation 17 Jan 2018 EMA/OD/165/17
EU/3/17/1958 Voisin Consulting S.A.R.L. Orphan designation 17 Jan 2018 EMA/OD/192/17
EU/3/17/1957 uniQure Biopharma B.V. Orphan designation 17 Jan 2018 EMA/OD/151/17
EU/3/17/1956 Quintiles Ireland Limited Orphan designation 17 Jan 2018 EMA/OD/168/17
EU/3/17/1955 Quintiles Ireland Limited Orphan designation 17 Jan 2018 EMA/OD/167/17
EU/3/14/1272 Voisin Consulting S.A.R.L. Transfer of orphan designation 17 Jan 2018 EMA/OD/201/13/T/01
EU/3/09/681 AOP Orphan Pharmaceuticals AG Transfer of orphan designation 18 Dec 2017 EMA/OD/066/09/T/01
EU/3/13/1139 FGK Representative Service GmbH Transfer of orphan designation 18 Dec 2017 EMA/OD/023/13/T/01
EU/3/16/1681 Calypso Biotech B.V. Transfer of orphan designation 18 Dec 2017 EMA/OD/004/16/T/01
EU/3/17/1954 AbbVie Ltd Orphan designation 12 Dec 2017 EMA/OD/131/17
EU/3/17/1953 Protalix B.V Orphan designation 12 Dec 2017 EMA/OD/138/17
EU/3/17/1952 PhaseRx Ireland, Ltd Orphan designation 12 Dec 2017 EMA/OD/153/17
EU/3/17/1951 Clinical Network Services (UK) Ltd Orphan designation 12 Dec 2017 EMA/OD/157/17
EU/3/17/1950 MeiraGTx UK II Limited Orphan designation 12 Dec 2017 EMA/OD/162/17
EU/3/17/1949 IntraBio Ltd Orphan designation 12 Dec 2017 EMA/OD/158/17
EU/3/17/1948 Premier Research Group Limited Orphan designation 12 Dec 2017 EMA/OD/135/17
EU/3/17/1947 NeuroVive Pharmaceutical AB Orphan designation 12 Dec 2017 EMA/OD/132/17
EU/3/17/1946 FGK Representative Service GmbH Orphan designation 12 Dec 2017 EMA/OD/156/17
EU/3/05/272 Noventia Pharma Srl Transfer of orphan designation 8 Dec 2017 EMEA/OD/094/04/T/03
EU/3/13/1134 Orchard Therapeutics Ltd Transfer of orphan designation 30 Nov 2017 EMA/OD/014/13/T/01
EU/3/09/641 Atlantic Pharmaceuticals (Holdings) Ltd Transfer of orphan designation 30 Nov 2017 EMEA/OD/007/09/T/01
EU/3/12/968 Global Regulatory Limited Transfer of orphan designation 30 Nov 2017 EMA/OD/128/11/T/01
EU/3/12/1025 Aegerion Pharmaceuticals B.V. Transfer of orphan designation 30 Nov 2017 EMA/OD/036/12/T/04
EU/3/12/1024 Aegerion Pharmaceuticals B.V. Transfer of orphan designation 30 Nov 2017 EMA/OD/035/12/T/04
EU/3/12/1023 Aegerion Pharmaceuticals B.V. Transfer of orphan designation 30 Nov 2017 EMA/OD/034/12/T/04
EU/3/12/1022 Aegerion Pharmaceuticals B.V. Transfer of orphan designation 30 Nov 2017 EMA/OD/033/12/T/04
EU/3/15/1606 Loxo Oncology Limited Transfer of orphan designation 30 Nov 2017 EMA/OD/184/15/T/01
EU/3/16/1799 TMC Pharma Services Ltd Transfer of orphan designation 24 Nov 2017 EMA/OD/169/16/T/01
EU/3/16/1806 Abeona Therapeutics Europe SL Transfer of orphan designation 20 Nov 2017 EMA/OD/195/16/T/01
EU/3/14/1337 1st Regulatory Ltd Transfer of orphan designation 16 Nov 2017 EMA/OD/137/14/T/01
EU/3/15/1551 Shire Pharmaceuticals Ireland Limited Transfer of orphan designation 16 Nov 2017 EMA/OD/075/15/T/01
EU/3/14/1339 GW Research Ltd Transfer of orphan designation 16 Nov 2017 EMA/OD/083/14/T/01
EU/3/12/1033 Idorsia Pharmaceuticals Deutschland GmbH Transfer of orphan designation 16 Nov 2017 EMA/OD/042/12/T/01
EU/3/17/1835 Abeona Therapeutics Europe SL Transfer of orphan designation 10 Nov 2017 EMA/OD/283/16/T/01
EU/3/16/1825 Abeona Therapeutics Europe SL Transfer of orphan designation 10 Nov 2017 EMA/OD/226/16/T/01
EU/3/16/1761 Abeona Therapeutics Europe SL Transfer of orphan designation 10 Nov 2017 EMA/OD/164/16/T/01
EU/3/15/1536 Enzyvant Farber Ireland Limited Transfer of orphan designation 10 Nov 2017 EMA/OD/061/15/T/01
EU/3/17/1945 Medical Need Europe AB Orphan designation 8 Nov 2017 EMA/OD/128/17
EU/3/17/1944 Duchenne UK Orphan designation 8 Nov 2017 EMA/OD/133/17
EU/3/17/1943 REGENXBIO EU Limited Orphan designation 8 Nov 2017 EMA/OD/134/17
EU/3/17/1942 Celleron Therapeutics Limited Orphan designation 8 Nov 2017 EMA/OD/121/17
EU/3/17/1941 Soleno Therapeutics UK Ltd Orphan designation 8 Nov 2017 EMA/OD/115/17
EU/3/17/1940 Novo Nordisk A/S Orphan designation 8 Nov 2017 EMA/OD/116/17
EU/3/17/1939 CSL Behring GmbH Orphan designation 8 Nov 2017 EMA/OD/105/17
EU/3/17/1938 ProQR Therapeutics VII BV Orphan designation 8 Nov 2017 EMA/OD/140/17
EU/3/17/1937 Quintiles Ireland Limited Orphan designation 8 Nov 2017 EMA/OD/118/17
EU/3/17/1936 Worldwide Clinical Trials Limited Orphan designation 8 Nov 2017 EMA/OD/119/17
EU/3/17/1935 Edvince AB Orphan designation 8 Nov 2017 EMA/OD/120/17
EU/3/17/1934 Edison Orphan Pharma BV Orphan designation 8 Nov 2017 EMA/OD/136/17
EU/3/17/1933 Quintiles Ireland Limited Orphan designation 8 Nov 2017 EMA/OD/142/17
EU/3/11/919 Monopar Therapeutics SARL Transfer of orphan designation 19 Oct 2017 EMA/OD/069/11/T/01
EU/3/01/028 ElsaLys Biotech SAS Transfer of orphan designation 19 Oct 2017 EMA/OD/038/00/T/01
EU/3/14/1278 Spark Therapeutics Ireland Ltd Transfer of orphan designation 19 Oct 2017 EMA/OD/015/14/T/01
EU/3/16/1786 Diamond BioPharm Limited Transfer of orphan designation 19 Oct 2017 EMA/OD/183/16/T/01
Procedures for centrally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Clevor Orion Corporation Centralised - Authorisation 13 Apr 2018 EMEA/V/C/4417
ProZinc Boehringer Ingelheim Vetmedica GmbH Centralised - Renewal 13 Apr 2018 EMEA/V/C/2634/R/13
Zulvac 8 Ovis Zoetis Belgium S.A. Centralised - Yearly update 11 Apr 2018
Apoquel Zoetis Belgium S.A. Centralised - Yearly update 6 Apr 2018
Stronghold Plus Zoetis Belgium S.A. Centralised - Yearly update 6 Apr 2018
Zulvac 1 Bovis Zoetis Belgium S.A. Centralised - Yearly update 4 Apr 2018
Zulvac 8 Bovis Zoetis Belgium S.A. Centralised - Yearly update 4 Apr 2018
Zulvac 1 Ovis Zoetis Belgium S.A. Centralised - Yearly update 4 Apr 2018
Convenia Zoetis Belgium S.A. Centralised - Yearly update 4 Apr 2018
Stronghold Zoetis Belgium S.A. Centralised - Yearly update 4 Apr 2018
Zulvac 1+8 Ovis Zoetis Belgium S.A. Centralised - Yearly update 27 Mar 2018
Zulvac 1+8 Bovis Zoetis Belgium S.A. Centralised - Yearly update 27 Mar 2018
Versican Plus DHPPi/L4R Zoetis Belgium S.A. Centralised - Yearly update 27 Mar 2018
Versican Plus DHPPi/L4 Zoetis Belgium S.A. Centralised - Yearly update 27 Mar 2018
Versican Plus DHPPi Zoetis Belgium S.A. Centralised - Yearly update 27 Mar 2018
Zulvac SBV Zoetis Belgium S.A. Centralised - Yearly update 27 Mar 2018
Suvaxyn PCV Zoetis Belgium S.A. Centralised - Yearly update 22 Mar 2018
Palladia Zoetis Belgium S.A. Centralised - Yearly update 22 Mar 2018
Suvaxyn CSF Marker Zoetis Belgium S.A. Centralised - Yearly update 22 Mar 2018
Draxxin Zoetis Belgium S.A. Centralised - Yearly update 22 Mar 2018
ERAVAC Laboratorios Hipra, S.A. Centralised - 2-Monthly update 22 Mar 2018 EMEA/V/C/4239/II/3/G
Panacur AquaSol Intervet International B.V. Corrigendum 20 Mar 2018
Panacur AquaSol Intervet International B.V. Centralised - 2-Monthly update 20 Mar 2018 EMEA/V/C/2008/II/15
Oncept IL-2 Merial Centralised - Renewal 20 Mar 2018 EMEA/V/C/2562/R/6
ECOPORC SHIGA IDT Biologika GmbH Centralised - Renewal 20 Mar 2018 EMEA/V/C/2588/R/6
Bravecto Intervet International B.V. Centralised - Yearly update 19 Mar 2018
Metacam Boehringer Ingelheim Vetmedica GmbH Centralised - 2-Monthly update 19 Mar 2018 EMEA/V/C/33/II/127
Porcilis PCV ID Intervet International B.V. Centralised - 2-Monthly update 19 Mar 2018 EMEA/V/C/3942/WS/1277
Porcilis PCV Intervet International B.V. Centralised - Yearly update 20 Feb 2018
Porcilis PCV M Hyo Intervet International B.V. Centralised - Yearly update 20 Feb 2018
Advocate Bayer Animal Health GmbH Centralised - 2-Monthly update 20 Feb 2018 EMEA/V/C/76/II/39/G
Vectormune ND CEVA-Phylaxia Co. Ltd. Centralised - 2-Monthly update 20 Feb 2018 EMEA/V/C/3829/II/7
Suvaxyn Circo Zoetis Belgium S.A. Centralised - Authorisation 7 Feb 2018 EMEA/V/C/4242
Oxybee Dany Bienenwohl GmbH Centralised - Authorisation 1 Feb 2018 EMEA/V/C/4296
Meloxoral Le Vet B.V. Centralised - Yearly update 31 Jan 2018
MiPet Easecto Zoetis Belgium S.A. Centralised - Authorisation 31 Jan 2018 EMEA/V/C/4732
Contacera Zoetis Belgium S.A. Corrigendum 16 Jan 2018
Semintra Boehringer Ingelheim Vetmedica GmbH Centralised - Renewal 16 Jan 2018 EMEA/V/C/2436/R/9
Zactran Merial Centralised - 2-Monthly update 12 Jan 2018 EMEA/V/C/129/II/36
Virbagen Omega VIRBAC S.A. Centralised - Yearly update 12 Jan 2018
Aftovaxpur Doe Merial Centralised - Yearly update 12 Jan 2018
Leucofeligen FeLV/RCP Virbac Centralised - Yearly update 12 Jan 2018
Ypozane VIRBAC S.A. Centralised - Yearly update 9 Jan 2018
Cortavance VIRBAC S.A. Centralised - Yearly update 9 Jan 2018
GALLIPRANT Aratana Therapeutics NV Centralised - Authorisation 9 Jan 2018 EMEA/V/C/4222
Leucogen Virbac Centralised - Yearly update 20 Dec 2017
Easotic VIRBAC S.A. Centralised - Yearly update 20 Dec 2017
Sedadex Le Vet Beheer B.V. Centralised - Yearly update 18 Dec 2017
Spironolactone Ceva Ceva Santé Animale Centralised - Yearly update 6 Dec 2017
Kexxtone Eli Lilly and Company Limited Centralised - Renewal 6 Dec 2017 EMEA/V/C/2235/R/9
Rabitec IDT Biologika GmbH Centralised - Authorisation 1 Dec 2017 EMEA/V/C/4387
Circovac Ceva-Phylaxia Zrt. Centralised - Transfer Marketing Authorisation Holder 21 Nov 2017 EMEA/V/C/114/T/14
Pexion Boehringer Ingelheim Vetmedica GmbH Centralised - Renewal 21 Nov 2017 EMEA/V/C/2543/R/10
Bovilis Blue-8 Intervet International B.V. Centralised - Authorisation 21 Nov 2017 EMEA/V/C/4776
Contacera Zoetis Belgium S.A. Centralised - Renewal 15 Nov 2017 EMEA/V/C/2612/R/9
SevoFlo Zoetis Belgium S.A. Centralised - 2-Monthly update 14 Nov 2017 EMEA/V/C/72/II/20
Nobivac LeuFel Virbac Centralised - Authorisation 6 Nov 2017 EMEA/V/C/4778
Pexion Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 31 Oct 2017
Inflacam Chanelle Pharmaceuticals Manufacturing Limited Centralised - Yearly update 24 Oct 2017
Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 24 Oct 2017
Bovela Boehringer Ingelheim International GmbH Centralised - Yearly update 19 Oct 2017
Simparica Zoetis Belgium S.A. Corrigendum 10 Oct 2017
Simparica Zoetis Belgium S.A. Corrigendum 10 Oct 2017
Innovax-ND-IBD Intervet International B.V. Corrigendum 22 Aug 2017
Cardalis Ceva Santé Animale Corrigendum 8 Jun 2017
Procedures for nationally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Lutetium (177 Lu) chloride PSUSA - Modification 21 Mar 2018 EMEA/H/C/PSUSA/10391/201706
Mycophenolate mofetil, mycophenolic acid PSUSA - Modification 7 Mar 2018 EMEA/H/C/PSUSA/10550/201705
Somatropin PSUSA - Modification 5 Mar 2018 EMEA/H/C/PSUSA/2772/201703
paracetamol, modified and prolonged release Referral 19 Feb 2018 EMEA/H/A-31/1445
Alcover and associated names Referral 18 Dec 2017 EMEA/H/A-29(4)/1451
Docetaxel PSUSA - Modification 24 Nov 2017 EMEA/H/C/PSUSA/1152/201611
Gadolinium Referral 23 Nov 2017 EMEA/H/A-31/1437
pramipexole Rectificative Decision 15 Nov 2017
Human coagulation factor VIII Corrigendum 10 Nov 2017
Human coagulation factor VIII Referral 10 Nov 2017 EMEA/H/A-31/1448
Vancomycin Rectificative Decision 21 Sep 2017
Vancomycin Corrigendum 21 Sep 2017
Vepesid and associated names Corrigendum 26 Jun 2017
Procedures for nationally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
moxidectin - Veterinary medicinal products to be administered orally, topically or subcutaneously to cattle, sheep and horses Corrigendum 25 Sep 2017