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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
Daklinza Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 10 Dec 2018
Oncaspar Les Laboratoires Servier Centralised - Transfer Marketing Authorisation Holder 10 Dec 2018 EMEA/H/C/3789/T/21
Tenofovir disoproxil Zentiva Zentiva, k.s. Centralised - Yearly update 7 Dec 2018
Xermelo Ipsen Pharma Centralised - Yearly update 7 Dec 2018
Ziagen ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 7 Dec 2018 EMEA/H/C/252/T/104
Rubraca Clovis Oncology Ireland Limited Centralised - Transfer Marketing Authorisation Holder 7 Dec 2018 EMEA/H/C/4272/T/5
Elocta Swedish Orphan Biovitrum AB (publ) Centralised - Variation 7 Dec 2018 EMEA/H/C/3964/X/21
Ivabradine JensonR JensonR+ Limited Centralised - Withdrawal 6 Dec 2018
Darunavir Mylan Mylan S.A.S. Centralised - 2-Monthly update 6 Dec 2018 EMEA/H/C/4068/IB/7/G
Exondys AVI BioPharma International Ltd Centralised - Refusal of marketing authorisation 6 Dec 2018 EMEA/H/C/4355
Pregabalin Zentiva k.s Zentiva, k.s. Centralised - Yearly update 28 Nov 2018
AMGEVITA Amgen Europe B.V. Centralised - 2-Monthly update 28 Nov 2018 EMEA/H/C/4212/IB/12/G
Spinraza Biogen Netherlands B.V. Centralised - 2-Monthly update 28 Nov 2018 EMEA/H/C/4312/IB/9
Keppra UCB Pharma S.A. Centralised - Yearly update 28 Nov 2018
Pioglitazone Teva Pharma Teva B.V. Centralised - Yearly update 28 Nov 2018
Pioglitazone Teva Teva B.V. Centralised - Yearly update 28 Nov 2018
Pregabalin Mylan Pharma Mylan S.A.S. Rectificative Decision 28 Nov 2018
Anoro Ellipta Glaxo Group Ltd Centralised - Yearly update 26 Nov 2018
Darunavir Krka d.d. Krka d. d., Novo mesto Centralised - 2-Monthly update 26 Nov 2018 EMEA/H/C/4891/IB/2/G
Leflunomide ratiopharm ratiopharm GmbH Centralised - Yearly update 26 Nov 2018
Zeffix GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/H/C/242/T/73
alli GlaxoSmithKline Dungarvan Limited Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/H/C/854/T/59
PHEBURANE Eurocept International BV Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/H/C/2500/T/20
Orkambi Vertex Pharmaceuticals (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/H/C/3954/T/39
Kalydeco Vertex Pharmaceuticals (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/H/C/2494/T/71
Docetaxel Zentiva Zentiva k.s. Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/H/C/808/T/56
Wakix Bioprojet Pharma Centralised - Yearly update 22 Nov 2018
Zinforo Pfizer Ireland Pharmaceuticals Centralised - Yearly update 22 Nov 2018
Kentera Teva B.V. Centralised - Transfer Marketing Authorisation Holder 22 Nov 2018 EMEA/H/C/532/T/49
Soliris Alexion Europe SAS Centralised - Yearly update 22 Nov 2018
Kyprolis Amgen Europe B.V. Centralised - Yearly update 22 Nov 2018
Nyxoid Mundipharma Corporation (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 22 Nov 2018 EMEA/H/C/4325/T/4
TAKHZYRO Shire Pharmaceuticals Ireland Limited Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4806
Docetaxel Zentiva Zentiva k.s. Centralised - Yearly update 22 Nov 2018
Kalydeco Vertex Pharmaceuticals (Ireland) Limited Centralised - 2-Monthly update 22 Nov 2018 EMEA/H/C/2494/II/69
Synflorix GlaxoSmithKline Biologicals S.A. Centralised - Renewal 22 Nov 2018 EMEA/H/C/973/R/128
Levetiracetam Hospira Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 22 Nov 2018 EMEA/H/C/2783/T/19
Ixiaro Valneva Austria GmbH Centralised - Renewal 22 Nov 2018 EMEA/H/C/963/R/91
Jivi Bayer AG Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4054
Inlyta Pfizer Europe MA EEIG PSUSA - Modification 22 Nov 2018 EMEA/H/C/2406/PSUSA/10022/201801
Bexsero GlaxoSmithKline Vaccines S.r.l. PSUSA - Modification 22 Nov 2018 EMEA/H/C/2333/PSUSA/10043/201801
Erivedge Roche Registration GmbH PSUSA - Modification 22 Nov 2018 EMEA/H/C/PSUSA/10140/201801
Poteligeo Kyowa Kirin Holdings B.V. Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4232
Alunbrig Takeda Pharma A/S Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4248/
GILENYA Novartis Europharm Limited Centralised - Variation 22 Nov 2018 EMEA/H/C/2202/X/44
Viekirax AbbVie Deutschland GmbH & Co. KG PSUSA - Modification 22 Nov 2018 EMEA/H/C/3839/PSUSA/10367/201801
Ziextenzo Sandoz GmbH Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4802
Pifeltro Merck Sharp & Dohme B.V. Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4747
Delstrigo Merck Sharp & Dohme B.V. Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4746
Luxturna Spark Therapeutics Ireland Ltd Centralised - Authorisation 22 Nov 2018 EMEA/H/C/4451
Atripla Bristol-Myers Squibb and Gilead Sciences Limited Centralised - 2-Monthly update 22 Nov 2018 EMEA/H/C/797/II/130
Mirvaso Galderma International Centralised - Renewal 22 Nov 2018 EMEA/H/C/2642/R/21
Ranexa Menarini International Operations Luxembourg S.A. PSUSA - Modification 22 Nov 2018 EMEA/H/C/805/PSUSA/2611/201801
Efient Daiichi Sankyo Europe GmbH PSUSA - Modification 22 Nov 2018 EMEA/H/C/PSUSA/2499/201802
Rapiscan GE Healthcare AS Centralised - Yearly update 20 Nov 2018
Brineura BioMarin International Limited Centralised - Yearly update 20 Nov 2018
NovoSeven Novo Nordisk A/S Centralised - 2-Monthly update 20 Nov 2018 EMEA/H/C/74/II/104
Emtricitabine/Tenofovir disoproxil Krka Krka d. d., Novo mesto Centralised - 2-Monthly update 20 Nov 2018 EMEA/H/C/4215/IB/10G
Rezolsta Janssen-Cilag International NV Centralised - 2-Monthly update 20 Nov 2018 EMEA/H/C/2819/WS1474/27/G
PREZISTA Janssen-Cilag International NV Centralised - 2-Monthly update 20 Nov 2018 EMEA/H/C/707/WS/1474
Symtuza Janssen-Cilag International NV Centralised - 2-Monthly update 20 Nov 2018 EMEA/H/C/4391/WS/1474
Incruse Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 20 Nov 2018 EMEA/H/C/2809/T/22
Venclyxto AbbVie Deutschland GmbH & Co. KG Centralised - Authorisation - Switch to non-conditional 20 Nov 2018 EMEA/H/C/4106/II/11
Levetiracetam Hospira Pfizer Europe MA EEIG Centralised - Renewal 20 Nov 2018 EMEA/H/C/2783/R/18
Brintellix H. Lundbeck A/S Centralised - Renewal 20 Nov 2018 EMEA/H/C/2717/R/19
Ozurdex Allergan Pharmaceuticals Ireland PSUSA - Modification 20 Nov 2018 EMEA/H/C/1140/PSUSA/985/201801
Orfadin Swedish Orphan Biovitrum International AB PSUSA - Modification 20 Nov 2018 EMEA/H/C/PSUSA/2169/201802
Fluenz Tetra AstraZeneca AB Centralised - Renewal 20 Nov 2018 EMEA/H/C/2617/R/79
Selincro H. Lundbeck A/S PSUSA - Modification 20 Nov 2018 EMEA/H/C/PSUSA/10120/201802
Zoledronic acid Accord Accord Healthcare Limited Centralised - Renewal 20 Nov 2018 EMEA/H/C/2667/R/6
Neuraceq Life Radiopharma Berlin GmbH Centralised - Renewal 20 Nov 2018 EMEA/H/C/2553/R/25
Vabomere Rempex London Limited Centralised - Authorisation 20 Nov 2018 EMEA/H/C/4669/
Apealea Oasmia Pharmaceutical AB Centralised - Authorisation 20 Nov 2018 EMEA/H/C/4154/
Pelmeg Cinfa Biotech S.L. Centralised - Authorisation 20 Nov 2018 EMEA/H/C/4700
Fulphila Mylan S.A.S. Centralised - Authorisation 20 Nov 2018 EMEA/H/C/4915
Buvidal Camurus AB Centralised - Authorisation 20 Nov 2018 EMEA/H/C/4651
Benlysta GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 14 Nov 2018 EMEA/H/C/2015/T/60
Incruse Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Yearly update 14 Nov 2018
Laventair Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 14 Nov 2018 EMEA/H/C/3754/T/26
Latuda Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Centralised - Renewal 14 Nov 2018 EMEA/H/C/2713/R/20
Emgality Eli Lilly Nederland B.V. Centralised - Authorisation 14 Nov 2018 EMEA/H/C/4648
Tecfidera Biogen Idec Limited Centralised - Transfer Marketing Authorisation Holder 14 Nov 2018 EMEA/H/C/2601/T/55
Daptomycin Hospira Hospira UK Limited Centralised - Transfer Marketing Authorisation Holder 14 Nov 2018 EMEA/H/C/4310/T/8
Izba Novartis Europharm Limited Centralised - Renewal 14 Nov 2018 EMEA/H/C/2738/R/11
Jinarc Otsuka Pharmaceutical Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 12 Nov 2018 EMEA/H/C/2788/T/20
Eperzan GlaxoSmithKline Trading Services Limited Centralised - Withdrawal 12 Nov 2018
Clopidogrel ratiopharm Teva B.V. Centralised - Yearly update 12 Nov 2018
Desloratadine ratiopharm ratiopharm GmbH Centralised - Yearly update 12 Nov 2018
Laventair Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Yearly update 12 Nov 2018
Olanzapine Mylan Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 12 Nov 2018 EMEA/H/C/961/T/45
Xigduo AstraZeneca AB Centralised - 2-Monthly update 12 Nov 2018 EMEA/H/C/2672/WS/1380/45
CABOMETYX Ipsen Pharma Centralised - 2-Monthly update 12 Nov 2018 EMEA/H/C/4163/II/5
Bemfola Gedeon Richter Plc. Centralised - Renewal 12 Nov 2018 EMEA/H/C/2615/R/19
Ebymect AstraZeneca AB Centralised - 2-Monthly update 12 Nov 2018 EMEA/H/C/4162/WS/1380
Exviera AbbVie Deutschland GmbH & Co. KG PSUSA - Modification 12 Nov 2018 EMEA/H/C/3837/PSUSA/10363/201801
Edistride AstraZeneca AB Centralised - 2-Monthly update 12 Nov 2018 EMEA/H/C/4161/WS/1380
Forxiga AstraZeneca AB Centralised - 2-Monthly update 12 Nov 2018 EMEA/H/C/2322/WS/1380
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. Centralised - Yearly update 8 Nov 2018
Xeljanz Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/4214/T/15
Ruconest Pharming Group N.V. Centralised - Yearly update 8 Nov 2018
Spinraza Biogen Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/4312/T/10
Flixabi Samsung Bioepis NL B.V. Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/4020/T/30
Ontruzant Samsung Bioepis NL B.V. Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/4323/T/12
Benepali Samsung Bioepis NL B.V. Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/4007/T/38
Neupro UCB Pharma S.A. Centralised - Yearly update 8 Nov 2018
Tracleer Janssen-Cilag International NV Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/401/T/88
Irbesartan HCT Zentiva Zentiva k.s. Centralised - Transfer Marketing Authorisation Holder 8 Nov 2018 EMEA/H/C/783/T/100
Benepali Samsung Bioepis NL B.V. Centralised - Yearly update 8 Nov 2018
Neulasta Amgen Europe B.V. Centralised - Yearly update 31 Oct 2018
Samsca Otsuka Pharmaceutical Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 31 Oct 2018 EMEA/H/C/980/T/36
Arzerra Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 31 Oct 2018 EMEA/H/C/1131/T/57
Trelegy Ellipta GlaxoSmithKline Trading Services Limited Centralised - 2-Monthly update 31 Oct 2018 EMEA/H/C/4363/WS/1369
Elebrato Ellipta GlaxoSmithKline Trading Services Limited Centralised - 2-Monthly update 31 Oct 2018 EMEA/H/C/4781/WS/1369
Symkevi Vertex Pharmaceuticals (Europe) Limited Centralised - Authorisation 31 Oct 2018 EMEA/H/C/4682
Taxespira Hospira UK Limited Centralised - Withdrawal 30 Oct 2018
Integrilin GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 29 Oct 2018 EMEA/H/C/230/T/79
Volibris GlaxoSmithKline (Ireland) Limited Centralised - Transfer Marketing Authorisation Holder 29 Oct 2018 EMEA/H/C/839/T/56
Protopic Leo Pharma A/S Centralised - Yearly update 29 Oct 2018
Evista Daiichi Sankyo Europe GmbH Centralised - Yearly update 29 Oct 2018
Lusduna Merck Sharp & Dohme B.V. Centralised - Withdrawal 29 Oct 2018
AMGEVITA Amgen Europe B.V. Centralised - Yearly update 29 Oct 2018
Venclyxto AbbVie Deutschland GmbH & Co. KG Centralised - 2-Monthly update 29 Oct 2018 EMEA/H/C/4106/II/8
Imraldi Samsung Bioepis NL B.V. Centralised - Transfer Marketing Authorisation Holder 29 Oct 2018 EMEA/H/C/4279/T/15
RoActemra Roche Registration GmbH Centralised - 2-Monthly update 29 Oct 2018 EMEA/H/C/955/II/76
Taxespira Hospira UK Limited Centralised - Yearly update 29 Oct 2018
Eporatio ratiopharm GmbH Centralised - Yearly update 29 Oct 2018
Viramune Boehringer Ingelheim International GmbH Centralised - Yearly update 29 Oct 2018
Synflorix GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 25 Oct 2018
Replagal Shire Human Genetic Therapies AB Centralised - Yearly update 25 Oct 2018
Sustiva Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/249/II/145/G
Cyltezo Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/4319/IB/5/G
Clopidogrel/Acetylsalicylic acid Zentiva Sanofi-Aventis groupe Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/1144/WS1433/51
Plavix Sanofi Clir SNC Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/174/WS/1433/130
Iscover Sanofi-Aventis groupe Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/175/WS1433/133
Clopidogrel Zentiva Zentiva, k.s. Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/975/WS1433/61
DuoPlavin Sanofi Clir SNC Centralised - 2-Monthly update 25 Oct 2018 EMEA/H/C/1143/WS/1433/50
Micardis Boehringer Ingelheim International GmbH Centralised - Yearly update 23 Oct 2018
Xtandi Astellas Pharma Europe B.V. Centralised - 2-Monthly update 23 Oct 2018 EMEA/H/C/2639/II/39G
Cosentyx Novartis Europharm Limited Centralised - 2-Monthly update 23 Oct 2018 EMEA/H/C/3729/II/33
XALKORI Pfizer Europe MA EEIG Centralised - 2-Monthly update 23 Oct 2018 EMEA/H/C/2489/II/55
Zinbryta Biogen Idec Limited Referral 23 Oct 2018 EMEA/H/C/3862/A-20/1462
Velphoro Vifor Fresenius Medical Care Renal Pharma France Centralised - Yearly update 18 Oct 2018
Evoltra Genzyme Europe B.V. Centralised - Yearly update 18 Oct 2018
Forsteo Eli Lilly Nederland B.V. Centralised - Yearly update 18 Oct 2018
Irbesartan / Hydrochlorothiazide Teva Teva B.V. Centralised - Yearly update 18 Oct 2018
Pemetrexed Hospira Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 18 Oct 2018 EMEA/H/C/3970/T/14
Kivexa ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 16 Oct 2018 EMEA/H/C/581/T/76
Leflunomide Zentiva Zentiva k.s. Centralised - Transfer Marketing Authorisation Holder 16 Oct 2018 EMEA/H/C/1129/T/32
ABILIFY MAINTENA Otsuka Pharmaceutical Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 16 Oct 2018 EMEA/H/C/2755/T/26
Rapamune Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 16 Oct 2018 EMEA/H/C/273/T/168
Sutent Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 16 Oct 2018 EMEA/H/C/687/T/72
Riximyo Sandoz GmbH Centralised - Yearly update 11 Oct 2018
Irbesartan Zentiva Zentiva k.s. Centralised - Transfer Marketing Authorisation Holder 10 Oct 2018 EMEA/H/C/785T/79
Kalydeco Vertex Pharmaceuticals (Ireland) Limited Centralised - 2-Monthly update 10 Oct 2018 EMEA/H/C/2494/II/63/G
Exviera AbbVie Deutschland GmbH & Co. KG Centralised - 2-Monthly update 4 Oct 2018 EMEA/H/C/3837/WS/1348
Palonosetron Hospira Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 4 Oct 2018 EMEA/H/C/4069/T/4
Grastofil Apotex Europe B.V. Centralised - Renewal 4 Oct 2018 EMEA/H/C/2150/R/20
Xofigo Bayer AG Corrigendum 28 Sep 2018
Telzir ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/534/T/93
Pemetrexed Pfizer Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/4488/T/4
Celsentri ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/811/T/56
Zoledronic acid Teva Teva B.V. Centralised - Yearly update 28 Sep 2018
CoAprovel Sanofi Clir SNC Centralised - Yearly update 28 Sep 2018
Lamivudine Teva Pharma B.V. Teva B.V. Centralised - Yearly update 28 Sep 2018
Retacrit Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/872/T/86
Uptravi Janssen-Cilag International NV Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/3774/T/19
Dynastat Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/381/T/73
Zavesca Janssen-Cilag International NV Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/435/T/63
Trizivir ViiV Healthcare BV Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/338/T/108
Intuniv Shire Pharmaceuticals Ireland Limited Centralised - Yearly update 28 Sep 2018
HALAVEN Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/2084/T/46
Ritemvia Celltrion Healthcare Hungary Kft. Centralised - Yearly update 28 Sep 2018
Vfend Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/387/T/130
Vimizim BioMarin International Limited Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/2779/T/26
Imraldi Samsung Bioepis NL B.V. Centralised - 2-Monthly update 28 Sep 2018 EMEA/H/C/4279/IB/14
Zoledronic acid Actavis Actavis Group PTC ehf. Centralised - Yearly update 28 Sep 2018
Metalyse Boehringer Ingelheim International GmbH Centralised - Yearly update 28 Sep 2018
Nexium Control Pfizer Healthcare Ireland Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/2618/T/23
Docetaxel Teva Teva B.V. Centralised - Yearly update 28 Sep 2018
Xigduo AstraZeneca AB Centralised - Renewal 28 Sep 2018 EMEA/H/C/2672/R/44
Xofigo Bayer AG Referral 28 Sep 2018 EMEA/H/A-20/1459/C/2653/28
NexoBrid MediWound Germany GmbH PSUSA - Modification 28 Sep 2018 EMEA/H/C/PSUSA/10028/201712
Zoledronic acid Mylan Mylan S.A.S. Centralised - Yearly update 28 Sep 2018
Rebetol Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/246/T83
PegIntron Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/280/T/135
ViraferonPeg Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/329/T/128
IntronA Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/281/T/116
Imnovid Celgene Europe B.V. Centralised - Transfer Marketing Authorisation Holder 28 Sep 2018 EMEA/H/C/2682/T/30
IONSYS Incline Therapeutics Europe Ltd Centralised - Withdrawal 27 Sep 2018
Verzenios Eli Lilly Nederland B.V. Centralised - Authorisation 27 Sep 2018 EMEA/H/C/4302
Gefitinib Mylan Mylan S.A.S. Centralised - Authorisation 27 Sep 2018 EMEA/H/C/4826
Trumenba Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 27 Sep 2018 EMEA/H/C/4051/T/9
BeneFIX Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 27 Sep 2018 EMEA/H/C/139/T/152
Ecalta Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 27 Sep 2018 EMEA/H/C/788/T/37
Vimizim BioMarin International Limited Centralised - Yearly update 27 Sep 2018
Prevenar 13 Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 27 Sep 2018 EMEA/H/C/1104/T/170
Fycompa Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 21 Sep 2018 EMEA/H/C/2434/T/40
Opsumit Janssen-Cilag International NV Centralised - Transfer Marketing Authorisation Holder 21 Sep 2018 EMEA/H/C/2697/T/28
Zonegran Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 21 Sep 2018 EMEA/H/C/577/T/90
Voriconazole Hikma Hikma Farmacêutica (Portugal), S.A. Centralised - Yearly update 21 Sep 2018
Inovelon Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 21 Sep 2018 EMEA/H/C/660/T/48
Imfinzi AstraZeneca AB Centralised - Authorisation 21 Sep 2018 EMEA/H/C/4771
Pelgraz Accord Healthcare Limited Centralised - Authorisation 21 Sep 2018 EMEA/H/C/3961
Udenyca ERA Consulting GmbH Centralised - Authorisation 21 Sep 2018 EMEA/H/C/4413/
Tivicay ViiV Healthcare BV Centralised - Renewal 21 Sep 2018 EMEA/H/C/2753/R/40
Brilique AstraZeneca AB PSUSA - Modification 21 Sep 2018 EMEA/H/C/1241/PSUSA/2948/201712
Kanuma Alexion Europe SAS Centralised - Yearly update 20 Sep 2018
Cyramza Eli Lilly Nederland B.V. Centralised - Yearly update 20 Sep 2018
Atazanavir Mylan Mylan S.A.S. Centralised - 2-Monthly update 20 Sep 2018 EMEA/H/C/4048/IB/5
Karvezide Sanofi-Aventis groupe Centralised - Yearly update 20 Sep 2018
Rixathon Sandoz GmbH Centralised - Yearly update 20 Sep 2018
Rasilez Noden Pharma DAC Centralised - Yearly update 20 Sep 2018
Ovitrelle Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 20 Sep 2018 EMEA/H/C/320/T/75
NeuroBloc Sloan Pharma S.a.r.l. Centralised - Transfer Marketing Authorisation Holder 20 Sep 2018 EMEA/H/C/301/T/101
Cinqaero Teva B.V. Centralised - Transfer Marketing Authorisation Holder 20 Sep 2018 EMEA/H/C/3912T/18
Topotecan Hospira Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 20 Sep 2018 EMEA/H/C/1192/T/33
Zoledronic acid Hospira Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 20 Sep 2018 EMEA/H/C/2365/T/33
INCRELEX Ipsen Pharma Centralised - Yearly update 20 Sep 2018
Tresiba Novo Nordisk A/S Centralised - Yearly update 20 Sep 2018
Nitisinone MDK MendeliKABS Europe Limited Centralised - Yearly update 20 Sep 2018
Ryzodeg Novo Nordisk A/S Centralised - Yearly update 20 Sep 2018
Blitzima Celltrion Healthcare Hungary Kft. Centralised - Yearly update 20 Sep 2018
Sevelamer carbonate Winthrop Genzyme Europe B.V. Centralised - Variation 20 Sep 2018 EMEA/H/C/3971/X/11
EndolucinBeta ITG Isotope Technologies Garching GmbH PSUSA - Modification 20 Sep 2018 EMEA/H/C/3999/PSUSA/10391/201712
Tecfidera Biogen Idec Limited Centralised - Renewal 20 Sep 2018 EMEA/H/C/2601/R/53
Cosentyx Novartis Europharm Limited PSUSA - Modification 20 Sep 2018 EMEA/H/C/PSUSA/10341/201712
Lumark IDB Holland B.V. PSUSA - Modification 20 Sep 2018 EMEA/H/C/PSUSA/10391/201712
Renvela Genzyme Europe B.V. Centralised - Variation 20 Sep 2018 EMEA/H/C/993/X/39
Dexxience Portola Pharma UK Limited Centralised - Refusal of marketing authorisation 20 Sep 2018 EMEA/H/C/4309
Lenalidomide Accord Accord Healthcare Limited Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4857
Slenyto RAD Neurim Pharmaceuticals EEC Limited Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4425
Kigabeq ORPHELIA Pharma SAS Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4534
Braftovi Pierre Fabre Médicament Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4580/
Mektovi Pierre Fabre Médicament Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4579
Diacomit Biocodex Centralised - Renewal 20 Sep 2018 EMEA/H/C/664/R/21
Iclusig Incyte Biosciences Distribution B.V. PSUSA - Modification 20 Sep 2018 EMEA/H/C/2695/PSUSA/10128/201712
Xerava Tetraphase Pharmaceuticals Ireland Limited Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4237
Deferiprone Lipomed Lipomed GmbH Centralised - Authorisation 20 Sep 2018 EMEA/H/C/4710
Opdivo Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 20 Sep 2018 EMEA/H/C/3985/PSUSA/10379/201801
Neofordex Laboratoires CTRS Centralised - Yearly update 20 Sep 2018
Targretin Eisai GmbH Centralised - Transfer Marketing Authorisation Holder 17 Sep 2018 EMEA/H/C/326/T/50
CRYSVITA Kyowa Kirin Holdings B.V. Centralised - Transfer Marketing Authorisation Holder 17 Sep 2018 EMEA/H/C/4275/T/1
Pregabalin Mylan Pharma Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 17 Sep 2018 EMEA/H/C/3962/T/8
Inhixa Techdow Europe AB Centralised - Variation 17 Sep 2018 EMEA/H/C/4264/X/18, 26
Stelara Janssen-Cilag International NV PSUSA - Modification 17 Sep 2018 EMEA/H/C/PSUSA/3085/201712
Ninlaro Takeda Pharma A/S Centralised - Annual renewal 17 Sep 2018 EMEA/H/C/3844/R/12
Kadcyla Roche Registration GmbH Centralised - Renewal 17 Sep 2018 EMEA/H/C/2389/R/39
Fortacin Recordati Ireland Ltd Centralised - Renewal 17 Sep 2018 EMEA/H/C/2693/R/23
Ilumetri Almirall, S.A. Centralised - Authorisation 17 Sep 2018 EMEA/H/C/4514
Sovaldi Gilead Sciences Ireland UC Centralised - Renewal 17 Sep 2018 EMEA/H/C/2798/R/50
Hulio Mylan S.A.S. Centralised - Authorisation 17 Sep 2018 EMEA/H/C/4429
Lartruvo Eli Lilly Nederland B.V. Centralised - Annual renewal 17 Sep 2018 EMEA/H/C/4216/R/10
Tegsedi Akcea Therapeutics UK Ltd. Centralised - Transfer Marketing Authorisation Holder 12 Sep 2018 EMEA/H/C/4782/T/1
Memantine Mylan Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 10 Sep 2018 EMEA/H/C/2660/T/12
Pregabalin Mylan Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 10 Sep 2018 EMEA/H/C/4078/T/10
ADCETRIS Takeda Pharma A/S Centralised - Annual renewal 10 Sep 2018 EMEA/H/C/2455/R/58
Imnovid Celgene Europe B.V. Centralised - Variation - Decision addressed to Member States 10 Sep 2018 EMEA/H/C/2682/R/28
Akynzeo Helsinn Birex Pharmaceuticals Ltd Centralised - Yearly update 6 Sep 2018
Alkindi Diurnal Europe B.V. Centralised - Transfer Marketing Authorisation Holder 6 Sep 2018 EMEA/H/C/4416/T/3
Retacrit Pfizer Europe MA EEIG Centralised - Yearly update 6 Sep 2018
Silapo STADA Arzneimittel AG Centralised - Yearly update 6 Sep 2018
Venclyxto AbbVie Deutschland GmbH & Co. KG Centralised - Annual renewal 6 Sep 2018 EMEA/H/C/4106/R/13
Olumiant Eli Lilly Nederland B.V. Corrigendum 4 Sep 2018
KEYTRUDA Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 4 Sep 2018 EMEA/H/C/3820/II/43, EMEA/H/C/3820/II42
Olumiant Eli Lilly Nederland B.V. Centralised - 2-Monthly update 4 Sep 2018 EMEA/H/C/4085/II/6
Invokana Janssen-Cilag International NV Centralised - 2-Monthly update 4 Sep 2018 EMEA/H/C/2649/II/34
Epoetin alfa Hexal Hexal AG Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/726/II/WS/1406
Binocrit Sandoz GmbH Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/725/II/WS/1406
XALKORI Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 31 Aug 2018 EMEA/H/C/2489/T/59
Viekirax AbbVie Deutschland GmbH & Co. KG Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/3839/WS/1348
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Krka d. d., Novo mesto Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/4274/IB/2/G
Abseamed Medice Arzneimittel Pütter GmbH & Co KG Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/727/WS/1406
Darzalex Janssen-Cilag International NV Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/4077/II/11
TAGRISSO AstraZeneca AB Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/4124/II/24
Spinraza Biogen Netherlands B.V. Centralised - 2-Monthly update 31 Aug 2018 EMEA/H/C/4312/II/4
Nerlynx Puma Biotechnology, Ltd. Centralised - Authorisation 31 Aug 2018 EMEA/H/C/4030
Cablivi Ablynx N.V. Centralised - Authorisation 31 Aug 2018 EMEA/H/C/4426
VEYVONDI Baxalta Innovations GmbH Centralised - Authorisation 31 Aug 2018 EMEA/H/C/4454
Bavencio Merck Europe B.V. Centralised - Annual renewal 31 Aug 2018 EMEA/H/C/4338/R/3
Fluenz Tetra AstraZeneca AB Centralised - Variation 28 Aug 2018 EMEA/H/C/2617/II/82
Steglatro Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 28 Aug 2018 EMEA/H/C/4315/T/2
Victoza Novo Nordisk A/S Centralised - Yearly update 27 Aug 2018
Cinryze Shire Services BVBA Centralised - Yearly update 27 Aug 2018
Zarzio Sandoz GmbH Centralised - Yearly update 27 Aug 2018
Filgrastim Hexal Hexal AG Centralised - Yearly update 27 Aug 2018
Varuby TESARO U.K. Limited Centralised - Yearly update 27 Aug 2018
Tafinlar Novartis Europharm Limited Centralised - 2-Monthly update 27 Aug 2018 EMEA/H/C/2604/WS/1274
Lojuxta Amryt Pharmaceuticals DAC Centralised - Transfer Marketing Authorisation Holder 27 Aug 2018 EMEA/H/C/2578/T/31
Coagadex Bio Products Laboratory Ltd Centralised - 2-Monthly update 27 Aug 2018 EMEA/H/C/3855/II/7
Vokanamet Janssen-Cilag International NV Centralised - 2-Monthly update 27 Aug 2018 EMEA/H/C/2656/II/34
Nucala GlaxoSmithKline Trading Services Limited Centralised - 2-Monthly update 27 Aug 2018 EMEA/H/C/3860/II/13/G
Fulvestrant Mylan Mylan S.A.S. Centralised - 2-Monthly update 27 Aug 2018 EMEA/H/C/4649/IB/1
Mekinist Novartis Europharm Limited Centralised - 2-Monthly update 27 Aug 2018 EMEA/H/C/2643/WS/1274
Onpattro Alnylam Netherlands B.V. Centralised - Authorisation 27 Aug 2018 EMEA/H/C/4699
Xarelto Bayer AG PASS - Modification 27 Aug 2018 EMEA/H/C/944/PSR/S/12
Ulipristal Acetate Gedeon Richter Gedeon Richter Plc. Centralised - Authorisation 27 Aug 2018 EMEA/H/C/5017
BYDUREON AstraZeneca AB Centralised - Variation 27 Aug 2018 EMEA/H/C/2020/X/48/G
Cometriq Ipsen Pharma PSUSA - Modification 27 Aug 2018 EMEA/H/C/PSUSA/10180/201711
ABILIFY MAINTENA Otsuka Pharmaceutical Netherlands B.V. Centralised - Renewal 27 Aug 2018 EMEA/H/C/2755/R/25
Rasilez HCT Noden Pharma DAC Centralised - Renewal 27 Aug 2018 EMEA/H/C/964/R/87
Aranesp Amgen Europe B.V. Centralised - Yearly update 23 Aug 2018
Strimvelis Orchard Therapeutics (Netherlands) B.V. Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/3854/T/14
LIFMIOR Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/4167T/17
Firazyr Shire Pharmaceuticals Ireland Limited Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/899T/41
Steglujan Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/4313/T/4
Beromun BELPHARMA s.a. Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/206/T/40
Temodal Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/229/T/83
Ristaben Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/1234/T/57
Lemtrada Sanofi Belgium Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/3718/T/24
Biktarvy Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/4449/T/1
Nivestim Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/1142/T/51
Xagrid Shire Pharmaceuticals Ireland Limited Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/480/T/82
Xarelto Bayer AG Centralised - 2-Monthly update 23 Aug 2018 EMEA/H/C/944/II/58
Abilify Otsuka Pharmaceutical Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/471/T/131
Somavert Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 23 Aug 2018 EMEA/H/C/409/T/87
Blincyto Amgen Europe B.V. Centralised - 2-Monthly update 23 Aug 2018 EMEA/H/C/3731/II/18
Yescarta Kite Pharma EU B.V. Centralised - Authorisation 23 Aug 2018 EMEA/H/C/4480
Kymriah Novartis Europharm Limited Centralised - Authorisation 23 Aug 2018 EMEA/H/C/4090
Kalydeco Vertex Pharmaceuticals (Ireland) Limited PASS - Modification 23 Aug 2018 EMEA/H/C/2494/RSR/S/14
RoActemra Roche Registration GmbH Centralised - 2-Monthly update 23 Aug 2018 EMEA/H/C/955/II/78
Evicel Omrix Biopharmaceuticals N.V. Centralised - Renewal 23 Aug 2018 EMEA/H/C/898/R/54
Intelence Janssen-Cilag International NV Centralised - Renewal 23 Aug 2018 EMEA/H/C/900/R/52
Arixtra Aspen Pharma Trading Limited PSUSA - Modification 23 Aug 2018 EMEA/H/C/403/PSUSA/1467-201712
Parsabiv Amgen Europe B.V. PSUSA - Modification 23 Aug 2018 EMEA/H/C/3995/PSUSA/10533/201711
Duzallo Grünenthal GmbH Centralised - Authorisation 23 Aug 2018 EMEA/H/C/4412
Vyxeos Jazz Pharmaceuticals Ireland Ltd Centralised - Authorisation 23 Aug 2018 EMEA/H/C/4282
Opsumit Janssen-Cilag International NV Centralised - Renewal 23 Aug 2018 EMEA/H/C/2697/R/27
Entyvio Takeda Pharma A/S PSUSA - Modification 23 Aug 2018 EMEA/H/C/PSUSA/10186/201711
IMBRUVICA Janssen-Cilag International NV PSUSA - Modification 23 Aug 2018 EMEA/H/C/PSUSA/10301/201711
Mepsevii Ultragenyx Germany GmbH Centralised - Authorisation 23 Aug 2018 EMEA/H/C/4438
Venclyxto AbbVie Deutschland GmbH & Co. KG PSUSA - Modification 23 Aug 2018 EMEA/H/C/PSUSA/10556/201712
Orkambi Vertex Pharmaceuticals (Ireland) Limited PSUSA - Modification 23 Aug 2018 EMEA/H/C/PSUSA/10455/201711
Pixuvri CTI Life Sciences Ltd PSUSA - Modification 23 Aug 2018 EMEA/H/C/PSUSA/9261/201711
CABOMETYX Ipsen Pharma PSUSA - Modification 23 Aug 2018 EMEA/H/C/4163/PSUSA/10180/201711
Sovaldi Gilead Sciences Ireland UC PSUSA - Modification 23 Aug 2018 EMEA/H/C/PSUSA/10134/201712
Cholib Mylan IRE Healthcare Ltd Centralised - Transfer Marketing Authorisation Holder 20 Aug 2018 EMEA/H/C/2559/T/20
Luveris Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 20 Aug 2018 EMEA/H/C/292/T/77
Pergoveris Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 20 Aug 2018 EMEA/H/C/714/T/59
Xelevia Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 20 Aug 2018 EMEA/H/C/762/T/69
Lenvima Eisai Europe Limited Centralised - 2-Monthly update 20 Aug 2018 EMEA/H/C/3727/II/11/G
Komboglyze AstraZeneca AB Centralised - 2-Monthly update 13 Aug 2018 EMEA/H/C/2059/WS/1289
Ivabradine Zentiva Zentiva, k.s. Centralised - Yearly update 13 Aug 2018
Orbactiv Rempex London Ltd Centralised - Transfer Marketing Authorisation Holder 13 Aug 2018 EMEA/H/C/3785/T/20
Xyrem UCB Pharma S.A. PSUSA - Modification 13 Aug 2018 EMEA/H/C/593/PSUSA/10612/201710
Thalidomide Celgene Celgene Europe B.V. Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/823/T/57
Lymphoseek Norgine B.V. Centralised - Yearly update 8 Aug 2018
Cubicin Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/637/T/69
Brinavess Correvio Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/1215/T/31
Sivextro Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/2846/T/28
Tesavel Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/910/T/65
CANCIDAS Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/379/T/67
Torisel Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/799/T/71
Januvia Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/722/T/65
Bortezomib Hospira Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 8 Aug 2018 EMEA/H/C/4207/T/10
GONAL-f Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 6 Aug 2018 EMEA/H/C/71/T/140
Tadalafil Mylan Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/3787/T/11
Ribavirin Mylan Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/1185/T/29
Crixivan Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/128/T/104
Duloxetine Mylan Mylan S.A.S. Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/3981/T/14
Numient Amneal Pharma Europe Ltd Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/2611/T/5
Vyndaqel Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/2294/T/45
Inlyta Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/H/C/2406/T/24
Accofil Accord Healthcare Limited Centralised - Yearly update 3 Aug 2018
Duaklir Genuair AstraZeneca AB Centralised - Yearly update 3 Aug 2018
Brimica Genuair AstraZeneca AB Centralised - Yearly update 3 Aug 2018
Intanza Sanofi Pasteur Europe Centralised - Withdrawal 3 Aug 2018
Inovelon Eisai GmbH Centralised - 2-Monthly update 3 Aug 2018 EMEA/H/C/660/II/45
Memantine Accord Accord Healthcare Limited Centralised - Renewal 3 Aug 2018 EMEA/H/C/2766/R/10
Kyntheum Leo Pharma A/S Centralised - Yearly update 2 Aug 2018
Tepadina ADIENNE S.r.l. Centralised - Yearly update 2 Aug 2018
Insulin lispro Sanofi Sanofi-Aventis groupe Centralised - Yearly update 2 Aug 2018
Cetrotide Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/233/T/67
DUAVIVE Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/2314/T/18
Bosulif Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/2373/T/32
ReFacto AF Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/232/T/146
Conbriza Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/913/T/47
Tysabri Biogen Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/603/T/110
Avonex Biogen Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/102/T/178
Otezla Celgene Europe B.V. Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/3746/T/20
Siklos Addmedica Centralised - Yearly update 2 Aug 2018
Zoledronic acid Accord Accord Healthcare Limited Centralised - Yearly update 2 Aug 2018
Fampyra Biogen Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 2 Aug 2018 EMEA/H/C/2097/T/43
Onglyza AstraZeneca AB Centralised - 2-Monthly update 2 Aug 2018 EMEA/H/C/1039/WS/1289/45
Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 2 Aug 2018
KEYTRUDA Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 2 Aug 2018 EMEA/H/C/3820/II/48
Dexdor Orion Corporation Centralised - 2-Monthly update 2 Aug 2018 EMEA/H/C/2268/II/26
Rapamune Pfizer Europe MA EEIG Centralised - 2-Monthly update 2 Aug 2018 EMEA/H/C/273/II/164
Ucedane Lucane Pharma Centralised - Yearly update 30 Jul 2018
Inflectra Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/2778/T/64
Champix Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/699/T/71
HALAVEN Eisai GmbH Centralised - Yearly update 30 Jul 2018
Grastofil Apotex Europe B.V. Centralised - Yearly update 30 Jul 2018
Nimenrix Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/2226/T/80
Arzerra Novartis Europharm Limited Centralised - Yearly update 30 Jul 2018
Lyrica Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/546/T/95
Cyanokit SERB S.A. Centralised - Yearly update 30 Jul 2018
Enbrel Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/262/T/222
Strimvelis Orchard Therapeutics (Netherlands) B.V. Centralised - Yearly update 30 Jul 2018
Viagra Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/202/T/98
IBRANCE Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/3853/T/14
Abraxane Celgene Europe B.V. Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/778/T/91
Vidaza Celgene Europe B.V. Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/978/T/42
Bridion Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/885/T/30
Aprovel Sanofi Clir SNC Centralised - Yearly update 30 Jul 2018
Tygacil Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/644/T/104
Pregabalin Pfizer Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/3880/T/24
Revatio Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/638/T/82
Temozolomide Teva Teva B.V. Centralised - Yearly update 30 Jul 2018
Temozolomide SUN Sun Pharmaceutical Industries Europe BV Centralised - Yearly update 30 Jul 2018
Toviaz Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/723/T/52
Mylotarg Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/4204/T/1
Arava Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 30 Jul 2018
Ilaris Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 30 Jul 2018 EMEA/H/C/1109/T/58
Intelence Janssen-Cilag International NV Centralised - Yearly update 30 Jul 2018
Stocrin Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 30 Jul 2018 EMEA/H/C/250/II/114
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 30 Jul 2018 EMEA/H/C/3985/II/41
Tyverb Novartis Europharm Limited Centralised - 2-Monthly update 30 Jul 2018 EMEA/H/C/795/II/51
Eylea Bayer AG Centralised - 2-Monthly update 30 Jul 2018 EMEA/H/C/2392/II/45
Imlygic Amgen Europe B.V. PSUSA - Modification 30 Jul 2018 EMEA/H/C/PSUSA/10459/201710
NovoEight Novo Nordisk A/S Centralised - Renewal 30 Jul 2018 EMEA/H/C/2719/R/25
Myalepta Aegerion Pharmaceuticals B.V. Centralised - Authorisation 30 Jul 2018 EMEA/H/C/4218
Thalidomide Celgene Celgene Europe B.V. PSUSA - Modification 30 Jul 2018 EMEA/H/C/PSUSA/2919/201710
Besponsa Pfizer Europe MA EEIG Centralised - Transfer Marketing Authorisation Holder 26 Jul 2018 EMEA/H/C/4119/T/7
Segluromet Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 26 Jul 2018 EMEA/H/C/4314/T/2
Rasagiline ratiopharm Teva B.V. Centralised - Yearly update 26 Jul 2018
Jinarc Otsuka Pharmaceutical Netherlands B.V. Centralised - 2-Monthly update 26 Jul 2018 EMEA/H/C/2788/II/9
Ceplene Noventia Pharma Srl Centralised - Renewal 26 Jul 2018 EMEA/H/C/796/R/36
Zalmoxis MolMed S.p.A. Centralised - Annual renewal 26 Jul 2018 EMEA/H/C/2801/R/10
Xeljanz Pfizer Europe MA EEIG Centralised - Variation 26 Jul 2018 EMEA/H/C/4214/X/5/G
Roteas Daiichi Sankyo Europe GmbH PSUSA - Modification 26 Jul 2018 EMEA/H/C/PSUSA/10387/201710
Ofev Boehringer Ingelheim International GmbH PSUSA - Modification 26 Jul 2018 EMEA/H/C/PSUSA/10319/201710
Trazimera Pfizer Europe MA EEIG Centralised - Authorisation 26 Jul 2018 EMEA/H/C/4463
Mycamine Astellas Pharma Europe B.V. PSUSA - Modification 26 Jul 2018 EMEA/H/C/PSUSA/2051/201710
Tybost Gilead Sciences Ireland UC Centralised - Renewal 26 Jul 2018 EMEA/H/C/2572/R/41
Nityr Cycle Pharmaceuticals Ltd Centralised - Authorisation 26 Jul 2018 EMEA/H/C/4582
RXULTI Otsuka Pharmaceutical Netherlands B.V. Centralised - Authorisation 26 Jul 2018 EMEA/H/C/3841
Lixiana Daiichi Sankyo Europe GmbH PSUSA - Modification 26 Jul 2018 EMEA/H/C/2629/PSUSA/10387/201710
Trisenox Teva B.V. PSUSA - Modification 26 Jul 2018 EMEA/H/C/PSUSA/235/201709
Fareston Orion Corporation PSUSA - Modification 26 Jul 2018 EMEA/H/C/PSUSA/2999/201709
Esmya Gedeon Richter Plc. Referral 26 Jul 2018 EMEA/H/C/2041/A-20
NovoEight Novo Nordisk A/S Centralised - 2-Monthly update 26 Jul 2018 EMEA/H/C/2719/II/23
Hefiya Sandoz GmbH Centralised - Authorisation 26 Jul 2018 EMEA/H/C/4865
Aimovig Novartis Europharm Limited Centralised - Authorisation 26 Jul 2018 EMEA/H/C/4447
Procysbi Chiesi Farmaceutici S.p.A. Centralised - Renewal 26 Jul 2018 EMEA/H/C/2465/R/19
Halimatoz Sandoz GmbH Centralised - Authorisation 26 Jul 2018 EMEA/H/C/4866
Hyrimoz Sandoz GmbH Centralised - Authorisation 26 Jul 2018 EMEA/H/C/4320
Revinty Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Renewal 26 Jul 2018 EMEA/H/C/2745/R/33
Relvar Ellipta GlaxoSmithKline (Ireland) Limited Centralised - Renewal 26 Jul 2018 EMEA/H/C/2673/R/37
Genvoya Gilead Sciences Ireland UC PSUSA - Modification 26 Jul 2018 EMEA/H/C/4042/PSUSA/10449/201711
Invokana Janssen-Cilag International NV Centralised - Renewal 26 Jul 2018 EMEA/H/C/2649/R/37
Alsitek AB Science Centralised - Refusal of marketing authorisation 26 Jul 2018 EMEA/H/C/4398
Defitelio Gentium S.r.I. Centralised - Renewal 26 Jul 2018 EMEA/H/C/2393/R/32
Ivemend Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 23 Jul 2018 EMEA/H/C/743/T/39
Eperzan GlaxoSmithKline Trading Services Limited Centralised - Yearly update 23 Jul 2018
Parsabiv Amgen Europe B.V. Centralised - Yearly update 23 Jul 2018
Xoterna Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Jul 2018 EMEA/H/C/3755/T/28
Moventig Kyowa Kirin Holdings B.V. Centralised - Transfer Marketing Authorisation Holder 23 Jul 2018 EMEA/H/C/2810/T/23
Viread Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 23 Jul 2018 EMEA/H/C/419/T/187
PREVYMIS Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 23 Jul 2018 EMEA/H/C/4536/T/2
Ultibro Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 23 Jul 2018 EMEA/H/C/2679/T/25
Vargatef Boehringer Ingelheim International GmbH PSUSA - Modification 23 Jul 2018 EMEA/H/C/2569/PSUSA/10318/201710
Bemfola Gedeon Richter Plc. Centralised - Yearly update 23 Jul 2018
Exjade Novartis Europharm Limited PSUSA - Modification 23 Jul 2018 EMEA/H/C/PSUSA/939/201710
Translarna PTC Therapeutics International Limited Centralised - 2-Monthly update 23 Jul 2018 EMEA/H/C/2720/II/37
Dificlir Astellas Pharma Europe B.V. Centralised - Yearly update 19 Jul 2018
Lopinavir/Ritonavir Mylan Mylan S.A.S. Centralised - Yearly update 19 Jul 2018
Irbesartan Zentiva Zentiva k.s. Centralised - Yearly update 19 Jul 2018
Plegridy Biogen Netherlands B.V. Centralised - Transfer Marketing Authorisation Holder 19 Jul 2018 EMEA/H/C/2827/T/49
Optruma Eli Lilly Nederland B.V. Centralised - Yearly update 19 Jul 2018
PecFent Kyowa Kirin Holdings B.V. Centralised - Transfer Marketing Authorisation Holder 19 Jul 2018 EMEA/H/C/1164/T/46
SANCUSO Kyowa Kirin Holdings B.V. Centralised - Transfer Marketing Authorisation Holder 19 Jul 2018 EMEA/H/C/2296/T/52
Qarziba EUSA Pharma (UK) Limited Centralised - Yearly update 19 Jul 2018
Rituzena Celltrion Healthcare Hungary Kft. Centralised - Yearly update 19 Jul 2018
Trobalt Glaxo Group Ltd Centralised - Withdrawal 19 Jul 2018
Taxespira Hospira UK Limited Centralised - Yearly update 19 Jul 2018
Translarna PTC Therapeutics International Limited Centralised - Annual renewal 19 Jul 2018 EMEA/H/C/2720/R/41
Carmustine Obvius Obvius Investment B.V. Centralised - Authorisation 19 Jul 2018 EMEA/H/C/4326
Aplidin Pharma Mar S.A. Centralised - Refusal of marketing authorisation 17 Jul 2018 EMEA/H/C/4354
Naglazyme BioMarin International Limited Centralised - Transfer Marketing Authorisation Holder 13 Jul 2018 EMEA/H/C/640/T/72
Rebif Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 13 Jul 2018 EMEA/H/C/136/T/135
Firdapse BioMarin International Limited Centralised - Transfer Marketing Authorisation Holder 13 Jul 2018 EMEA/H/C/1032/T/57
Karvea Sanofi-Aventis groupe Centralised - Yearly update 13 Jul 2018
Vizamyl GE Healthcare Ltd Centralised - Yearly update 11 Jul 2018
Byetta AstraZeneca AB Centralised - Yearly update 11 Jul 2018
Erelzi Sandoz GmbH Centralised - Yearly update 11 Jul 2018
Briviact UCB Pharma S.A. Centralised - 2-Monthly update 11 Jul 2018 EMEA/H/C/3898/II/10/G
Imnovid Celgene Europe B.V. Centralised - Renewal 11 Jul 2018 EMEA/H/C/2682/R/28
Xagrid Shire Pharmaceuticals Ireland Limited Centralised - Variation 11 Jul 2018 EMEA/H/C/480/S/81
MAVENCLAD Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 9 Jul 2018 EMEA/H/C/4230/T/4
Betaferon Bayer AG Centralised - Yearly update 9 Jul 2018
Tovanor Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 9 Jul 2018 EMEA/H/C/2690/T/30
Fosavance Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 9 Jul 2018 EMEA/H/C/619/T/42
Seebri Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 9 Jul 2018 EMEA/H/C/2430/T/27
Ariclaim Eli Lilly Nederland B.V. Centralised - Withdrawal 9 Jul 2018
Zavesca Janssen-Cilag International NV Centralised - Yearly update 9 Jul 2018
Qutenza Grünenthal GmbH Centralised - Yearly update 9 Jul 2018
Pylobactell Torbet Laboratories Limited Centralised - Yearly update 9 Jul 2018
Vantavo Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 9 Jul 2018 EMEA/H/C/1180/T/30
Ninlaro Takeda Pharma A/S Corrigendum 6 Jul 2018
Fertavid Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/1042/T/39
Pemetrexed Fresenius Kabi Fresenius Kabi Deutschland GmbH Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/3895/T/7
Ariclaim Eli Lilly Nederland B.V. Centralised - Yearly update 6 Jul 2018
Praxbind Boehringer Ingelheim International GmbH Centralised - Yearly update 6 Jul 2018
Puregon Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/86/T/97
Noxafil Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/610/T/54
Adrovance Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/759/T/39
DepoCyte Pacira Limited Centralised - Withdrawal 6 Jul 2018
Symtuza Janssen-Cilag International NV Centralised - 2-Monthly update 6 Jul 2018 EMEA/H/C/4391/WS/1312
PREZISTA Janssen-Cilag International NV Centralised - 2-Monthly update 6 Jul 2018 EMEA/H/C/707/WS/1312
Zykadia Novartis Europharm Limited Centralised - 2-Monthly update 6 Jul 2018 EMEA/H/C/3819/II/16
Temozolomide HEXAL Hexal AG Centralised - Yearly update 6 Jul 2018
Temozolomide Sandoz Sandoz GmbH Centralised - Yearly update 6 Jul 2018
Pemetrexed Sandoz Sandoz GmbH Centralised - Yearly update 6 Jul 2018
Ninlaro Takeda Pharma A/S Centralised - Yearly update 6 Jul 2018
KEYTRUDA Merck Sharp & Dohme B.V. Centralised - 2-Monthly update 6 Jul 2018 EMEA/H/C/3820/II/52
Hirobriz Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/1211/T/47
Tafinlar Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/2604/T/32
Tegsedi Akcea Therapeutics UK Ltd. Centralised - Authorisation 6 Jul 2018 EMEA/H/C/4782
Visudyne Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/305/T/96
Sovaldi Gilead Sciences Ireland UC Centralised - Transfer Marketing Authorisation Holder 6 Jul 2018 EMEA/H/C/2798/T/51
Ammonaps Swedish Orphan Biovitrum International AB Centralised - Yearly update 6 Jul 2018
Corbilta Orion Corporation Centralised - Renewal 6 Jul 2018 EMEA/H/C/2785/R/15
ALPROLIX Swedish Orphan Biovitrum AB (publ) PSUSA - Modification 6 Jul 2018 EMEA/H/C/PSUSA/10499/201709
Revolade Novartis Europharm Limited PSUSA - Modification 6 Jul 2018 EMEA/H/C/PSUSA/1205/201709
Verkazia Santen Oy Centralised - Authorisation 6 Jul 2018 EMEA/H/C/4411
Docetaxel Accord Accord Healthcare Limited Centralised - Yearly update 2 Jul 2018
Enurev Breezhaler Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 2 Jul 2018 EMEA/H/C/2691/T/27
Ifirmacombi Krka d. d., Novo mesto Centralised - Yearly update 2 Jul 2018
DepoCyte Pacira Limited Centralised - Yearly update 2 Jul 2018
Bavencio Merck Europe B.V. Centralised - Transfer Marketing Authorisation Holder 2 Jul 2018 EMEA/H/C/4338/T/4
Prialt RIEMSER Pharma GmbH Centralised - Transfer Marketing Authorisation Holder 2 Jul 2018 EMEA/H/C/551/T/56
Simponi Janssen Biologics B.V. Centralised - 2-Monthly update 2 Jul 2018 EMEA/H/C/992/II/79
Tecentriq Roche Registration GmbH Centralised - 2-Monthly update 2 Jul 2018 EMEA/H/C/4143/II/10
Lemtrada Sanofi Belgium Centralised - Renewal 2 Jul 2018 EMEA/H/C/3718/R/20
Sprycel Bristol-Myers Squibb Pharma EEIG Centralised - Variation 2 Jul 2018 EMEA/H/C/709/X/56/G
Mysimba Orexigen Therapeutics Ireland Limited PSUSA - Modification 2 Jul 2018 EMEA/H/C/3687/PSUSA/10366/201709
Xarelto Bayer AG PSUSA - Modification 2 Jul 2018 EMEA/H/C/944/PSUSA/2653/201709
PANTOZOL Control Takeda GmbH PSUSA - Modification 2 Jul 2018 EMEA/H/C/1013/PSUSA/2285/201708
CONTROLOC Control Takeda GmbH PSUSA - Modification 2 Jul 2018 EMEA/H/C/1097/PSUSA/2285/201708
SOMAC Control Takeda GmbH PSUSA - Modification 2 Jul 2018 EMEA/H/C/1098/PSUSA/2285/201708
Trulicity Eli Lilly Nederland B.V. PSUSA - Modification 2 Jul 2018 EMEA/H/C/2825/PSUSA/10311/201709
Revlimid Celgene Europe B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/717/T/101
Spectrila medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 29 Jun 2018
Olumiant Eli Lilly Nederland B.V. Centralised - Yearly update 29 Jun 2018
Victrelis Merck Sharp & Dohme Limited Centralised - Withdrawal 29 Jun 2018
Samsca Otsuka Pharmaceutical Netherlands B.V. Centralised - 2-Monthly update 29 Jun 2018 EMEA/H/C/980/II/31
Edistride AstraZeneca AB Centralised - Yearly update 29 Jun 2018
Ristfor Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/1235/T/77
Velmetia Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/862/T/93
Janumet Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/861/T/90
Efficib Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/896/T/90
Aerius Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/313/T/90
Azomyr Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/310/T/94
Granupas Eurocept International B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/2709/T/25
Temozolomide Accord Accord Healthcare Limited Centralised - Yearly update 29 Jun 2018
Rezolsta Janssen-Cilag International NV Centralised - 2-Monthly update 29 Jun 2018 EMEA/H/C/2819/WS/1312
Jinarc Otsuka Pharmaceutical Netherlands B.V. Centralised - 2-Monthly update 29 Jun 2018 EMEA/H/C/2788/II/16
IMBRUVICA Janssen-Cilag International NV Centralised - Variation 29 Jun 2018 EMEA/H/C/3791/X/37
Orgalutran Merck Sharp & Dohme B.V. Centralised - Transfer Marketing Authorisation Holder 29 Jun 2018 EMEA/H/C/274/T/40
Glivec Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 25 Jun 2018 EMEA/H/C/406/T/110
Exforge Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 25 Jun 2018 EMEA/H/C/716/T/96
Copalia HCT Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 25 Jun 2018 EMEA/H/C/1159/T/67
Dafiro HCT Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 25 Jun 2018 EMEA/H/C/1160/T/68
Darzalex Janssen-Cilag International NV Centralised - Yearly update 25 Jun 2018
Leflunomide Zentiva Zentiva k.s. Centralised - Yearly update 25 Jun 2018
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S. Centralised - 2-Monthly update 25 Jun 2018 EMEA/H/C/4240/IB/1/G
Xgeva Amgen Europe B.V. PSUSA - Modification 25 Jun 2018 EMEA/H/C/2173/PSUSA/9119/201709
PANTOLOC Control Takeda GmbH PSUSA - Modification 25 Jun 2018 EMEA/H/C/1100/PSUSA/2285/201708
Stivarga Bayer AG PSUSA - Modification 25 Jun 2018 EMEA/H/C/PSUSA/10133/201709
Cubicin Merck Sharp & Dohme B.V. PSUSA - Modification 25 Jun 2018 EMEA/H/C/637/PSUSA/931/201709
Nexium Control Pfizer Healthcare Ireland Centralised - Renewal 25 Jun 2018 EMEA/H/C/2618/R/21
Dzuveo FGK Representative Service GmbH Centralised - Authorisation 25 Jun 2018 EMEA/H/C/4335
Orbactiv Rempex London Ltd PSUSA - Modification 25 Jun 2018 EMEA/H/C/PSUSA/10368/201709
Yondelis Pharma Mar S.A. PSUSA - Modification 25 Jun 2018 EMEA/H/C/PSUSA/3001/201709
Xeljanz Pfizer Europe MA EEIG Centralised - 2-Monthly update 25 Jun 2018 EMEA/H/C/4214/II/6
Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 21 Jun 2018
Rolufta GlaxoSmithKline Trading Services Limited Centralised - Yearly update 21 Jun 2018
Angiox The Medicines Company UK Ltd Centralised - Withdrawal 21 Jun 2018
Inflectra Pfizer Europe MA EEIG Centralised - Renewal 21 Jun 2018 EMEA/H/C/2778/R/56
Remsima Celltrion Healthcare Hungary Kft. Centralised - Renewal 21 Jun 2018 EMEA/H/C/2576/R/47
KEYTRUDA Merck Sharp & Dohme B.V. PSUSA - Modification 21 Jun 2018 EMEA/H/C/3820/PSUSA/10403/201709
Xeljanz Pfizer Europe MA EEIG Centralised - Yearly update 21 Jun 2018
Xofigo Bayer AG Centralised - Renewal 21 Jun 2018 EMEA/H/C/2653/R/30
Biktarvy Gilead Sciences Ireland UC Centralised - Authorisation 21 Jun 2018 EMEA/H/C/4449
Targretin Eisai GmbH Referral 21 Jun 2018 EMEA/H/A-31/1446/C/326/43
Panretin Eisai Limited Referral 21 Jun 2018 EMEA/H/A-31/1446/C/279/37
Insuman Sanofi-Aventis Deutschland GmbH Corrigendum 14 Jun 2018
Bosulif Pfizer Europe MA EEIG Corrigendum 22 May 2018
Juluca ViiV Healthcare UK Limited Corrigendum 16 May 2018
Hemlibra Roche Registration GmbH Corrigendum 23 Feb 2018
Revinty Ellipta GlaxoSmithKline (Ireland) Limited Corrigendum 2 May 2014
Relvar Ellipta GlaxoSmithKline (Ireland) Limited Corrigendum 13 Nov 2013
Procedures for centrally authorised orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
EU/3/10/760 TESARO Bio Netherlands B.V. Transfer of orphan designation 6 Dec 2018 EMA/OD/0000002385
EU/3/16/1802 FGK Representative Service GmbH Transfer of orphan designation 6 Dec 2018 EMA/OD/0000002422
EU/3/16/1662 QRC Ireland Transfer of orphan designation 6 Dec 2018 EMA/OD/011/16/T/01
EU/3/11/933 Les Laboratoires Servier Transfer of orphan designation 6 Dec 2018 EMA/OD/051/11/T/02
EU/3/17/1933 Emerald Health Pharmaceuticals España, S.L. Transfer of orphan designation 19 Nov 2018 EMA/OD/0000001966
EU/3/18/2102 IQVIA RDS Ireland Limited Orphan designation 19 Nov 2018 EMA/OD/115/18
EU/3/18/2101 TMC Pharma Services Ltd Orphan designation 19 Nov 2018 EMA/OD/143/18
EU/3/18/2100 Quality Regulatory Clinical Ireland Limited Orphan designation 19 Nov 2018 EMA/OD/103/18
EU/3/18/2099 Celgene Europe Limited Orphan designation 19 Nov 2018 EMA/OD/124/18
EU/3/18/2098 Bayer AG Orphan designation 19 Nov 2018 EMA/OD/117/18
EU/3/18/2097 Bayer AG Orphan designation 19 Nov 2018 EMA/OD/116/18
EU/3/18/2096 Hansa Medical AB Orphan designation 19 Nov 2018 EMA/OD/093/18
EU/3/18/2095 United Neuroscience Limited Orphan designation 19 Nov 2018 EMA/OD/146/18
EU/3/18/2094 Y-mAbs Therapeutics A/S Orphan designation 19 Nov 2018 EMA/OD/126/18
EU/3/18/2093 Sanquin Plasma Products B.V. Orphan designation 19 Nov 2018 EMA/OD/109/18
EU/3/18/2092 Dr Regenold GmbH Orphan designation 19 Nov 2018 EMA/OD/145/18
EU/3/18/2091 Pharma Gateway AB Orphan designation 19 Nov 2018 EMA/OD/108/18
EU/3/18/2090 Pfizer Europe MA EEIG Orphan designation 19 Nov 2018 EMA/OD/112/18
EU/3/18/2089 Dystrogen Therapeutics S.A. Orphan designation 19 Nov 2018
EU/3/18/2088 Dystrogen Therapeutics S.A. Orphan designation 19 Nov 2018 EMA/OD/134/18
EU/3/18/2087 Consejo Superior de Investigaciones Cientificas (CSIC) Orphan designation 19 Nov 2018 EMA/OD/135/18
EU/3/18/2086 Santhera Pharmaceuticals (Deutschland) GmbH Orphan designation 19 Nov 2018 EMA/OD/106/18
EU/3/18/2085 Rigenerand S.r.l. Orphan designation 19 Nov 2018 EMA/OD/110/18
EU/3/18/2084 Bayer AG Orphan designation 19 Nov 2018 EMA/OD/258/17
EU/3/18/2083 MaaT PHARMA Orphan designation 19 Nov 2018 EMA/OD/123/18
EU/3/18/2082 Takeda Pharma A/S Orphan designation 19 Nov 2018 EMA/OD/040/18
EU/3/18/2081 Pharma Gateway AB Orphan designation 19 Nov 2018 EMA/OD/096/18
EU/3/08/556 Vertex Pharmaceuticals (Ireland) Limited Transfer of orphan designation 19 Nov 2018 EMA/OD/010/08/T/03
EU/3/17/1923 Pfizer Europe MA EEIG Transfer of orphan designation 19 Nov 2018 EMA/OD/106/17/T/01
EU/3/16/1752 Pfizer Europe MA EEIG Transfer of orphan designation 19 Nov 2018 EMA/OD/093/16/T/01
EU/3/16/1716 Pfizer Europe MA EEIG Transfer of orphan designation 19 Nov 2018 EMA/OD/096/16/T/02
EU/3/13/1184 Pfizer Europe MA EEIG Transfer of orphan designation 19 Nov 2018 EMA/OD/084/13/T/01
EU/3/13/1105 Pfizer Europe MA EEIG Transfer of orphan designation 19 Nov 2018 EMA/OD/164/12/T/01
EU/3/10/726 Pfizer Europe MA EEIG Transfer of orphan designation 19 Nov 2018 EMEA/OD/125/09/T/02
EU/3/15/1567 TMC Pharma (EU) Limited Transfer of orphan designation 19 Nov 2018 EMA/OD/064/15/T/02
EU/3/17/1962 MWB Consulting S.A.R.L. Transfer of orphan designation 19 Nov 2018 EMA/OD/155/17/T/01
EU/3/17/1863 Celgene Europe B.V. Transfer of orphan designation 9 Nov 2018 EMA/OD/270/16/T/02
EU/3/17/1964 Incyte Biosciences Distribution B.V. Transfer of orphan designation 9 Nov 2018 EMA/OD/169/17/T/01
EU/3/17/1836 Zogenix GmbH Transfer of orphan designation 9 Nov 2018 EMA/OD/233/16/T/01
EU/3/13/1219 Zogenix GmbH Transfer of orphan designation 9 Nov 2018 EMA/OD/140/13/T/01
EU/3/18/2080 Freeline Therapeutics Ltd Orphan designation 26 Oct 2018 EMA/OD/127/18
EU/3/18/2079 Spark Therapeutics Ireland Ltd Orphan designation 26 Oct 2018 EMA/OD/104/18
EU/3/18/2078 Sellas Life Sciences Limited Orphan designation 26 Oct 2018 EMA/OD/091/18
EU/3/18/2077 Worphmed Srl Orphan designation 26 Oct 2018 EMA/OD/077/18
EU/3/18/2076 Orphan Europe S.A.R.L. Orphan designation 26 Oct 2018 EMA/OD/100/18
EU/3/18/2075 Consorcio Centro de Investigación Biomédica en Red M.P. Orphan designation 26 Oct 2018 EMA/OD/090/18
EU/3/18/2074 PhaRA bvba Orphan designation 26 Oct 2018 EMA/OD/079/18
EU/3/18/2073 Fondazione Telethon Orphan designation 26 Oct 2018 EMA/OD/113/18
EU/3/18/2072 FGK Representative Service GmbH Orphan designation 26 Oct 2018 EMA/OD/102/18
EU/3/18/2071 Loxo Oncology Limited Orphan designation 26 Oct 2018 EMA/OD/125/18
EU/3/18/2070 Accelsiors CRO and Consultancy Services Ltd Orphan designation 26 Oct 2018 EMA/OD/114/18
EU/3/14/1250 Akcea Therapeutics UK Ltd Transfer of orphan designation 26 Oct 2018 EMA/OD/098/13/T/01
EU/3/17/1966 Sirius Regulatory Consulting EU Limited Transfer of orphan designation 18 Oct 2018
EU/3/15/1532 Sirius Regulatory Consulting EU Limited Transfer of orphan designation 18 Oct 2018
EU/3/16/1689 Alan Boyd Consultants Ltd Transfer of orphan designation 18 Oct 2018 EMA/OD/031/16/T/01
EU/3/16/1704 Drug Development and Regulation S.L. Transfer of orphan designation 18 Oct 2018 EMA/OD/045/16/T/01
EU/3/11/901 Merck Sharp & Dohme B.V. Transfer of orphan designation 18 Oct 2018 EMA/OD/052/11/T/01
EU/3/16/1640 Celgene Europe B.V. Transfer of orphan designation 18 Oct 2018 EMA/OD/253/15/T/01
EU/3/16/1804 Eli Lilly Nederland B.V. Transfer of orphan designation 18 Oct 2018
EU/3/01/075 Eisai GmbH Transfer of orphan designation 18 Oct 2018 EMA/OD/038/01/T/02
EU/3/10/815 Pfizer Europe MA EEIG Transfer of orphan designation 18 Oct 2018 EMA/OD/068/10/T/01
EU/3/15/1495 Ultragenyx Netherlands B.V. Transfer of orphan designation 18 Oct 2018 EMA/OD/007/15/T/02
EU/3/05/264 Roche Registration GmbH Transfer of orphan designation 18 Oct 2018 EMEA/OD/081/04/T/02
EU/3/16/1622 BioMarin International Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/230/15/T/01
EU/3/14/1331 Celgene Europe B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/048/14/T/02
EU/3/14/1300 Celgene Europe B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/047/14/T/02
EU/3/16/1762 Pharma Gateway AB Transfer of orphan designation 27 Sep 2018 EMA/OD/107/16/T/01
EU/3/17/1856 Quality Regulatory Clinical Ireland Ltd Transfer of orphan designation 27 Sep 2018 EMA/OD/267/16/T/01
EU/3/11/909 Janssen-Cilag International NV Transfer of orphan designation 27 Sep 2018 EMA/OD/023/11/T/01
EU/3/09/707 Janssen-Cilag International NV Transfer of orphan designation 27 Sep 2018 EMA/OD/104/09/T/01
EU/3/06/351 Janssen-Cilag International NV Transfer of orphan designation 27 Sep 2018 EMA/OD/090/05/T/01
EU/3/14/1242 Neurolixis SAS Transfer of orphan designation 27 Sep 2018 EMA/OD/163/13/T/01
EU/3/11/895 Alan Boyd Consultants Ltd Transfer of orphan designation 27 Sep 2018 EMA/OD/033/11/T/02
EU/3/16/1786 Voisin Consulting S.A.R.L. Transfer of orphan designation 27 Sep 2018 EMA/OD/183/16/T/02
EU/3/17/1902 Eisai GmbH Transfer of orphan designation 27 Sep 2018 EMA/OD/052/17/T/01
EU/3/13/1222 Eisai GmbH Transfer of orphan designation 27 Sep 2018 EMA/OD/108/13/T/01
EU/3/08/535 Eisai GmbH Transfer of orphan designation 27 Sep 2018 EMA/OD/110/07/T/02
EU/3/08/550 Oncoscience GmbH Transfer of orphan designation 27 Sep 2018 EMA/OD/006/08/T/01
EU/3/04/220 Oncoscience GmbH Transfer of orphan designation 27 Sep 2018 EMA/OD/038/04/T/01
EU/3/08/582 Shire Pharmaceuticals Ireland Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/052/08/T/01
EU/3/12/976 Biogen Netherlands B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/141/11/T/02
EU/3/15/1509 Avexis Netherlands B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/028/15/T/01
EU/3/08/581 Novartis Europharm Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/051/08/T/02
EU/3/11/943 Kyowa Kirin Holdings B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/104/11/T/02
EU/3/09/647 Shire Pharmaceuticals Ireland Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/008/09/T/02
EU/3/05/328 Celgene Europe B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/056/05/T/03
EU/3/05/279 Celgene Europe B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/001/05/T/03
EU/3/16/1654 TM3 Therapeutics B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/250/15/T/01
EU/3/05/313 Orchard Therapeutics (Netherlands) B.V. Transfer of orphan designation 27 Sep 2018 EMA/OD/053/05/T/03
EU/3/09/657 BioMarin International Limited Transfer of orphan designation 27 Sep 2018 EMEA/OD/017/09/T/01
EU/3/18/1997 QRC Ireland Transfer of orphan designation 27 Sep 2018 EMA/OD/226/17/T/01
EU/3/13/1124 Mallinckrodt Pharmaceuticals Ireland Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/191/12/T/02
EU/3/03/133 Shire Pharmaceuticals Ireland Limited Transfer of orphan designation 27 Sep 2018 EMA/OD/054/02/T/01
EU/3/18/2062 IQVIA RDS Ireland Limited Orphan designation 24 Aug 2018 EMA/OD/098/18
EU/3/18/2061 Pharma Gateway AB Orphan designation 24 Aug 2018 EMA/OD/049/18
EU/3/18/2069 Professor Marjukka Myllärniemi Orphan designation 24 Aug 2018 EMA/OD/039/18
EU/3/18/2068 Novo Nordisk A/S Orphan designation 24 Aug 2018 EMA/OD/041/18
EU/3/18/2060 Biogen Idec Limited Orphan designation 24 Aug 2018 EMA/OD/065/18
EU/3/18/2067 Omeros London Limited Orphan designation 24 Aug 2018 EMA/OD/044/18
EU/3/18/2059 IntraBio Ltd Orphan designation 24 Aug 2018 EMA/OD/095/18
EU/3/18/2058 IQVIA RDS Ireland Limited Orphan designation 24 Aug 2018 EMA/OD/099/18
EU/3/18/2057 Pharm Research Associates (UK) Limited Orphan designation 24 Aug 2018 EMA/OD/051/18
EU/3/18/2056 Nogra Pharma Limited Orphan designation 24 Aug 2018 EMA/OD/075/18
EU/3/18/2055 IQVIA RDS Ireland Limited Orphan designation 24 Aug 2018 EMA/OD/060/18
EU/3/18/2066 Incyte Biosciences Distribution B.V. Orphan designation 24 Aug 2018 EMA/OD/038/18
EU/3/18/2065 SFL Regulatory Services GmbH Orphan designation 24 Aug 2018 EMA/OD/080/18
EU/3/18/2064 Bayer AG Orphan designation 24 Aug 2018 EMA/OD/071/18
EU/3/18/2063 IQVIA RDS Ireland Limited Orphan designation 24 Aug 2018 EMA/OD/088/18
EU/3/18/1994 Quality Regulatory Clinical Ireland Limited Transfer of orphan designation 13 Aug 2018 EMA/OD/172/17/T/01
EU/3/17/1870 Pharma Gateway AB Transfer of orphan designation 3 Aug 2018 EMA/OD/317/16/T/01
EU/3/16/1756 Kyowa Kirin Holdings B.V. Transfer of orphan designation 3 Aug 2018 EMA/OD/091/16/T/01
EU/3/16/1694 GlaxoSmithKline Trading Services Limited Transfer of orphan designation 3 Aug 2018 EMA/OD/064/16/T/01
EU/3/18/1996 Worphmed Srl Transfer of orphan designation 3 Aug 2018 EMA/OD/227/17/T/01
EU/3/16/1755 Worphmed Srl Transfer of orphan designation 3 Aug 2018 EMA/OD/127/16/T/01
EU/3/16/1683 Worphmed Srl Transfer of orphan designation 3 Aug 2018 EMA/OD/007/16/T/01
EU/3/16/1682 Worphmed Srl Transfer of orphan designation 3 Aug 2018 EMA/OD/001/16/T/01
EU/3/14/1351 Kyowa Kirin Holdings B.V. Transfer of orphan designation 31 Jul 2018 EMA/OD/133/14/T/02
EU/3/16/1660 Orchard Therapeutics Ltd Transfer of orphan designation 31 Jul 2018 EMA/OD/024/16/T/02
EU/3/07/446 Orchard Therapeutics Ltd Transfer of orphan designation 31 Jul 2018 EMA/OD/102/06/T/02
EU/3/18/2054 Mallinckrodt Specialty Pharmaceuticals Ireland Limited Orphan designation 31 Jul 2018 EMA/OD/043/18
EU/3/18/2053 Lakeside Regulatory Consulting Services Ltd Orphan designation 31 Jul 2018 EMA/OD/026/18
EU/3/18/2052 Dicerna EU Limited Orphan designation 31 Jul 2018 EMA/OD/052/18
EU/3/18/2051 Wave life Sciences Ireland Limited Orphan designation 31 Jul 2018 EMA/OD/032/18
EU/3/18/2050 AstraZeneca AB Orphan designation 31 Jul 2018 EMA/OD/045/18
EU/3/18/2049 Inozyme Pharma Ireland Ltd Orphan designation 31 Jul 2018 EMA/OD/053/18
EU/3/18/2048 Pharma Gateway AB Orphan designation 31 Jul 2018 EMA/OD/061/18
EU/3/18/2047 Glycomine SARL Orphan designation 31 Jul 2018 EMA/OD/055/18
EU/3/18/2046 Italfarmaco S.p.A. Orphan designation 31 Jul 2018 EMA/OD/062/18
EU/3/18/2045 Dystrogen Therapeutics S.A. Orphan designation 31 Jul 2018 EMA/OD/028/18
EU/3/18/2044 medac Gesellschaft für klinische Spezialpräparate mbH Orphan designation 31 Jul 2018 EMA/OD/023/18
EU/3/18/2043 Dr Ulrich Granzer Orphan designation 31 Jul 2018 EMA/OD/036/18
EU/3/18/2042 MeiraGTx UK II Limited Orphan designation 31 Jul 2018 EMA/OD/048/18
EU/3/18/2041 Ionis USA Limited Orphan designation 31 Jul 2018 EMA/OD/050/18
EU/3/12/998 Orchard Therapeutics Ltd Transfer of orphan designation 25 Jul 2018 EMA/OD/014/12/T/02
EU/3/14/1295 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMA/OD/035/14/T/02
EU/3/11/890 Kowa Pharmaceutical Europe GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/003/11/T/01
EU/3/09/645 Camurus AB Transfer of orphan designation 25 Jul 2018 EMA/OD/010/09/T/03
EU/3/16/1635 Leadiant GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/228/15/T/01
EU/3/18/2013 Roche Registration GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/231/17/T/01
EU/3/13/1127 Pfizer Europe MA EEIG Transfer of orphan designation 25 Jul 2018 EMA/OD/194/12/T/01
EU/3/02/103 Chiesi Farmaceutici S.p.A. Transfer of orphan designation 25 Jul 2018 EMEA/OD/083/01/T/01
EU/3/17/1932 Millendo Therapeutics SAS Transfer of orphan designation 25 Jul 2018 EMA/OD/066/17/T/01
EU/3/14/1410 Chiesi Farmaceutici S.p.A. Transfer of orphan designation 25 Jul 2018 EMA/OD/172/14/T/01
EU/3/11/911 Chiesi Farmaceutici S.p.A. Transfer of orphan designation 25 Jul 2018 EMA/OD/042/11/T/01
EU/3/18/2019 Reata UK Limited Transfer of orphan designation 25 Jul 2018 EMA/OD/011/18/T/01
EU/3/15/1473 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMA/OD/284/14/T/01
EU/3/12/1097 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMA/OD/158/12/T/01
EU/3/11/924 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMA/OD/078/11/T/01
EU/3/11/868 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMA/OD/160/10/T/01
EU/3/09/672 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMEA/OD/053/09/T/01
EU/3/07/494 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMEA/OD/068/07/T/01
EU/3/04/192 Celgene Europe B.V. Transfer of orphan designation 25 Jul 2018 EMEA/OD/083/03/T/02
EU/3/14/1263 bluebird bio (Germany) GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/184/13/T/01
EU/3/12/1091 bluebird bio (Germany) GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/146/12/T/01
EU/3/12/1003 bluebird bio (Germany) GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/009/12/T/01
EU/3/06/363 Telix Pharmaceuticals Holdings Germany GmbH Transfer of orphan designation 25 Jul 2018 EMA/OD/110/05/T/02
EU/3/12/1066 Pfizer Europe MA EEIG Transfer of orphan designation 25 Jul 2018 EMA/OD/115/12/T/01
EU/3/06/420 Pfizer Europe MA EEIG Transfer of orphan designation 25 Jul 2018 EMA/OD/058/06/T/02
EU/3/06/401 Pfizer Europe MA EEIG Transfer of orphan designation 25 Jul 2018 EMA/OD/032/06/T/03
EU/3/00/005 Pfizer Europe MA EEIG Transfer of orphan designation 25 Jul 2018 EMA/OD/022/00/T/02
EU/3/12/1083 Global Regulatory Limited Transfer of orphan designation 17 Jul 2018 EMA/OD/128/12/T/02
EU/3/16/1783 Reglntel Ltd Transfer of orphan designation 16 Jul 2018 EMA/OD/138/16/T/02
EU/3/16/1686 Mereo Biopharma Ireland Ltd Transfer of orphan designation 16 Jul 2018 EMA/OD/052/16/T/02
EU/3/16/1718 Salzman Group Ltd Transfer of orphan designation 16 Jul 2018 EMA/OD/110/16/T/01
EU/3/16/1645 Salzman Group Ltd Transfer of orphan designation 16 Jul 2018 EMA/OD/248/15/T/01
EU/3/07/505 Faron Pharmaceuticals Limited Amendment of orphan designation 27 Jun 2018 EMA/OD/080/17
EU/3/18/2040 IQVIA RDS Ireland Limited Orphan designation 27 Jun 2018 EMA/OD/035/18
EU/3/18/2039 REGENXBIO EU Limited Orphan designation 27 Jun 2018 EMA/OD/027/18
EU/3/18/2038 PPD Global Ltd Orphan designation 27 Jun 2018 EMA/OD/025/18
EU/3/18/2037 Dr Stefan Blesse Orphan designation 27 Jun 2018 EMA/OD/033/18
EU/3/18/2036 PharmaKrysto Ltd Orphan designation 27 Jun 2018 EMA/OD/012/18
EU/3/18/2035 Hanmi Europe Limited Orphan designation 27 Jun 2018 EMA/OD/009/18
EU/3/18/2034 Apotex Europe B.V. Orphan designation 27 Jun 2018 EMA/OD/006/18
EU/3/18/2033 Real Regulatory Limited Orphan designation 27 Jun 2018 EMA/OD/022/18
EU/3/18/2032 ADIENNE S.r.l.S.U. Orphan designation 27 Jun 2018 EMA/OD/007/18
EU/3/18/2031 Air Liquide Santé (International) Orphan designation 27 Jun 2018 EMA/OD/031/18
EU/3/18/2030 Biophytis Orphan designation 27 Jun 2018 EMA/OD/020/18
EU/3/18/2029 Klinikum der Universität München Orphan designation 27 Jun 2018 EMA/OD/004/18
EU/3/18/2028 BioCryst UK Ltd Orphan designation 27 Jun 2018 EMA/OD/003/18
EU/3/15/1460 Eisai GmbH Transfer of orphan designation 25 Jun 2018 EMA/OD/287/14/T/01
EU/3/13/1121 Eisai GmbH Transfer of orphan designation 25 Jun 2018 EMA/OD/173/12/T/01
EU/3/13/1119 Eisai GmbH Transfer of orphan designation 25 Jun 2018 EMA/OD/019/13/T/01
EU/3/04/240 Eisai GmbH Transfer of orphan designation 25 Jun 2018 EMA/OD/047/04/T/01
EU/3/12/999 Merck Sharp & Dohme B.V. Transfer of orphan designation 25 Jun 2018 EMA/OD/008/12/T/02
EU/3/11/849 Merck Sharp & Dohme B.V. Transfer of orphan designation 25 Jun 2018 EMA/OD/090/10/T/02
EU/3/07/509 Celgene Europe B.V. Transfer of orphan designation 25 Jun 2018 EMEA/OD/085/07/T/02
EU/3/01/084 Celgene Europe B.V. Transfer of orphan designation 25 Jun 2018 EMEA/OD/059/01/T/02
EU/3/18/1995 Bayer AG Transfer of orphan designation 25 Jun 2018 EMA/OD/213/17/T/01
EU/3/15/1606 Bayer AG Transfer of orphan designation 25 Jun 2018 EMA/OD/184/15/T/02
EU/3/16/1798 Merck Europe B.V. Transfer of orphan designation 25 Jun 2018 EMA/OD/170/16/T/01
EU/3/15/1590 Merck Europe B.V. Transfer of orphan designation 25 Jun 2018 EMA/OD/150/15/T/02
EU/3/02/124 BioMarin International Limited Transfer of orphan designation 25 Jun 2018 EMA/OD/050/02/T/03
EU/3/17/1874 Sangamo Therapeutics UK LTD Transfer of orphan designation 25 Jun 2018 EMA/OD/019/17/T/01
EU/3/18/1979 Bayer AG Corrigendum 22 Feb 2018
EU/3/17/1969 University of Cambridge Corrigendum 17 Jan 2018
Procedures for centrally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Aivlosin ECO Animal Health Ltd Centralised - Yearly update 7 Dec 2018
Econor Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 26 Nov 2018 EMEA/V/C/42/T/54
Inflacam Chanelle Pharmaceuticals Manufacturing Limited Centralised - Variation 26 Nov 2018 EMEA/V/C/2497/X/15
Osurnia Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 19 Nov 2018 EMEA/V/C/3753/T/10
Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Centralised - Variation 19 Nov 2018 EMEA/V/C/121/X/22
Improvac Zoetis Belgium S.A. Centralised - Yearly update 30 Oct 2018
Zolvix Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 30 Oct 2018 EMEA/V/C/154/T/24
Dexdomitor Orion Corporation Centralised - Yearly update 30 Oct 2018
Canigen L4 Intervet International B.V. Centralised - Yearly update 23 Oct 2018
NexGard Merial Centralised - 2-Monthly update 18 Oct 2018 EMEA/V/C/2729/WS/1338/18/G
NEXGARD SPECTRA Merial Centralised - 2-Monthly update 18 Oct 2018 EMEA/V/C/3842/WS/1338/15/G
Recocam Bimeda Animal Health Limited Centralised - Transfer Marketing Authorisation Holder 17 Oct 2018 EMEA/V/C/2247/T/10
MS-H vaccine Pharmsure Veterinary Products Europe Ltd Centralised - Transfer Marketing Authorisation Holder 27 Sep 2018 EMEA/V/C/161/T/11
Credelio Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 27 Sep 2018 EMEA/V/C/4247/T/4
Ingelvac PCV FLEX Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 27 Sep 2018
Comfortis Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 24 Sep 2018 EMEA/V/C/2233/T/18
FORTEKOR PLUS Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 24 Sep 2018 EMEA/V/C/2804/T/11
Kexxtone Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 24 Sep 2018 EMEA/V/C/2235/T/10
Sileo Orion Corporation Centralised - Yearly update 24 Sep 2018
BROADLINE Merial Centralised - Renewal 24 Sep 2018 EMEA/V/C/2700/R/20
Prac-Tic Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 27 Aug 2018 EMEA/V/C/103/T/25
Vectra 3D Ceva Santé Animale Centralised - Renewal 27 Aug 2018 EMEA/V/C/2555/R/9
Cortacare Ecuphar NV Centralised - Authorisation 27 Aug 2018 EMEA/V/C/4689
Gripovac 3 Merial Centralised - Withdrawal 20 Aug 2018
CLYNAV Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 20 Aug 2018 EMEA/V/C/2390/T/2
Leucogen Virbac Centralised - 2-Monthly update 20 Aug 2018 EMEA/V/C/144/WS1282/6
BTVPUR Merial Centralised - 2-Monthly update 20 Aug 2018 EMEA/V/C/2231/II/10
Leucofeligen FeLV/RCP Virbac Centralised - 2-Monthly update 9 Aug 2018 EMEA/V/C/143/WS/1282/7
Nobivac LeuFel Virbac Centralised - 2-Monthly update 9 Aug 2018 EMEA/V/C/4778/WS/1282/1
Novem Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 3 Aug 2018
Cerenia Zoetis Belgium S.A. Centralised - Yearly update 3 Aug 2018
Onsior Elanco GmbH Centralised - Transfer Marketing Authorisation Holder 3 Aug 2018 EMEA/V/C/127/T/19
LETIFEND Laboratorios LETI, S.L.unipersonal Centralised - Yearly update 3 Aug 2018
Apoquel Zoetis Belgium S.A. Centralised - Renewal 26 Jul 2018 EMEA/V/C/2688/R/13
UBAC Laboratorios Hipra, S.A. Centralised - Authorisation 26 Jul 2018 EMEA/V/C/4595
Respiporc Flu3 IDT Biologika GmbH Centralised - Yearly update 23 Jul 2018
Nobivac L4 Intervet International B.V. Centralised - Yearly update 23 Jul 2018
Reconcile Nexcyon Pharmaceuticals Ltd Centralised - Renewal 13 Jul 2018 EMEA/V/C/133/R-18
Procox Bayer Animal Health GmbH Centralised - Yearly update 12 Jul 2018
Econor Elanco GmbH Centralised - Yearly update 10 Jul 2018
Hiprabovis IBR Marker Live Laboratorios Hipra, S.A. Centralised - Yearly update 9 Jul 2018
ERYSENG Laboratorios Hipra, S.A. Centralised - Yearly update 9 Jul 2018
Coliprotec F4/F18 Prevtec Microbia GmbH Centralised - Yearly update 9 Jul 2018
Trocoxil Zoetis Belgium S.A. Centralised - Yearly update 9 Jul 2018
Credelio Elanco GmbH Centralised - Variation 9 Jul 2018 EMEA/V/C/4247/X/1
Pexion Boehringer Ingelheim Vetmedica GmbH Centralised - 2-Monthly update 5 Jul 2018 EMEA/V/C/2543/II/11/G
Zolvix Elanco GmbH Centralised - Yearly update 2 Jul 2018
ERYSENG PARVO Laboratorios Hipra, S.A. Centralised - Yearly update 2 Jul 2018
Evalon Laboratorios Hipra, S.A. Centralised - Yearly update 27 Jun 2018
BROADLINE Merial Centralised - Yearly update 27 Jun 2018
Porcilis PCV M Hyo Intervet International B.V. Centralised - 2-Monthly update 27 Jun 2018 EMEA/V/C/3796/II/7
Procedures for nationally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
voriconazole PSUSA - Modification 12 Dec 2018 EMEA/H/C/PSUSA/3127/201802
alitretinoin PSUSA - Modification 14 Nov 2018 EMEA/H/C/PSUSA/90/201801
Retinoids (acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene, tretinoin) Rectificative Decision 11 Oct 2018
Lutetium (177 Lu) chloride PSUSA - Modification 28 Sep 2018 EMEA/H/C/PSUSA/10391/201712
Scandonest and associated names Septodont Referral 2 Aug 2018 EMEA/H/A-30/1455
Sodium oxybate PSUSA - Modification 2 Aug 2018 EMEA/H/C/PSUSA/10612/201710
HES (hydroxyethyl starch) Referral 17 Jul 2018 EMEA/H/A-107i/1457
pantoprazole PSUSA - Modification 25 Jun 2018 EMEA/H/C/PSUSA/2285/201708
Retinoids (acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene, tretinoin) Referral 21 Jun 2018 EMEA/H/A-31/1446
Vancomycin Corrigendum 21 Sep 2017