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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
Izba Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 20 Apr 2017 EMEA/H/C/2738/T/07
Travatan Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 20 Apr 2017 EMEA/H/C/390/T/56
Lonquex UAB "Sicor Biotech" Centralised - Yearly update 20 Apr 2017
Mycophenolate mofetil Teva Teva B.V. Centralised - Yearly update 20 Apr 2017
Tamiflu Roche Registration Limited Centralised - Yearly update 20 Apr 2017
Cetrotide Merck Serono Europe Limited Centralised - Yearly update 20 Apr 2017
Briviact UCB Pharma S.A. PSUSA - Modification 20 Apr 2017 EMEA/H/C/3898/PSUSA/10447/201607
Vokanamet Janssen-Cilag International NV Referral 20 Apr 2017 EMEA/H/A-20/1442/C/2656-0014
Varuby TESARO UK LIMITED Centralised - Authorisation 20 Apr 2017 EMEA/H/C/4196
Eklira Genuair AstraZeneca AB Centralised - Renewal 20 Apr 2017 EMEA/H/C/2211/R/31
Bretaris Genuair AstraZeneca AB Centralised - Renewal 20 Apr 2017 EMEA/H/C/2706/R/31
Glybera uniQure biopharma B.V. Centralised - Annual reassessment 20 Apr 2017 EMEA/H/C/2145/S/57
Picato LEO Laboratories Ltd. PSUSA - Modification 20 Apr 2017 EMEA/H/C/PSUSA/00010035/201607
Myfenax Teva B.V. Centralised - Yearly update 12 Apr 2017
Tecfidera Biogen Idec Limited Centralised - Yearly update 12 Apr 2017
Eylea Bayer AG Centralised - Transfer Marketing Authorisation Holder 12 Apr 2017 EMEA/H/C/2392/T/36
Ovaleap Teva B.V. Centralised - Yearly update 12 Apr 2017
Abasaglar Eli Lilly Regional Operations GmbH. Centralised - Yearly update 11 Apr 2017
Kovaltry Bayer AG Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/003825T/09
Envarsus Chiesi Farmaceutici S.P.A. Centralised - Yearly update 11 Apr 2017
Iblias Bayer AG Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/4147/T/06
KOGENATE Bayer Bayer Pharma AG Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/275/T/0197
Chenodeoxycholic acid sigma-tau sigma-tau Arzeimittel GmbH Centralised - Authorisation 10 Apr 2017 EMEA/H/C/004061/0000
Levetiracetam Hospira Hospira UK Limited Centralised - Yearly update 6 Apr 2017
Evra Janssen-Cilag International NV Centralised - Yearly update 6 Apr 2017
Irbesartan Teva Teva B.V. Centralised - Yearly update 6 Apr 2017
Zalviso Grünenthal GmbH Centralised - Yearly update 6 Apr 2017
Fycompa Eisai Europe Limited Centralised - Renewal 6 Apr 2017 EMEA/H/C/2434/R/35
Procoralan Les Laboratoires Servier Centralised - Yearly update 3 Apr 2017
Corlentor Les Laboratoires Servier Centralised - Yearly update 3 Apr 2017
Xofigo Bayer AG Centralised - Transfer Marketing Authorisation Holder 3 Apr 2017 EMEA/H/C/2653/T/24
Vepacel Nanotherapeutics UK Limited Centralised - Transfer Marketing Authorisation Holder 3 Apr 2017 EMEA/H/C/2089/T/17
DuoPlavin Sanofi Clir SNC Centralised - 2-Monthly update 3 Apr 2017 EMEA/H/C/1143/WS/1091
Clopidogrel Zentiva Sanofi-Aventis groupe Centralised - 2-Monthly update 3 Apr 2017 EMEA/H/C/975/WS/1091
JEVTANA Sanofi-Aventis groupe Centralised - 2-Monthly update 3 Apr 2017 EMEA/H/C/2018/II/34
Imprida Novartis Europharm Limited Centralised - Withdrawal 3 Apr 2017
Levitra Bayer AG Centralised - Transfer Marketing Authorisation Holder 29 Mar 2017 EMEA/H/C/475/T/59
Descovy Gilead Sciences International Limited Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/4094/WS/1010
Iressa AstraZeneca AB Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/1016/II/26
EVARREST Omrix Biopharmaceuticals N.V. Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/2515/II/27/G
Clopidogrel/Acetylsalicylic acid Zentiva Sanofi-Aventis groupe Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/1144/WS/1091
Tafinlar Novartis Europharm Limited Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/2604/WS/0996
Plavix Sanofi Clir SNC Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/174/WS/1091
Jylamvo Therakind Ltd Centralised - Authorisation 29 Mar 2017 EMEA/H/C/3756
Mekinist Novartis Europharm Limited Centralised - 2-Monthly update 27 Mar 2017 EMEA/H/C/2643/WS/996
Nevirapine Teva Teva B.V. Centralised - Yearly update 24 Mar 2017
Pandemic influenza vaccine H5N1 BAXTER Nanotherapeutics UK Limited Centralised - Transfer Marketing Authorisation Holder 24 Mar 2017 EMEA/H/C/1200/T/24
Caelyx Janssen-Cilag International NV Centralised - Yearly update 24 Mar 2017
Truvada Gilead Sciences International Ltd. Centralised - 2-Monthly update 24 Mar 2017 EMEA/H/C/594/II/131
Odefsey Gilead Sciences International Limited Centralised - 2-Monthly update 24 Mar 2017 EMEA/H/C/4156/WS/1010
Genvoya Gilead Sciences International Limited Centralised - 2-Monthly update 24 Mar 2017 EMEA/H/C/4042/WS/1010
Vimpat UCB Pharma S.A. Centralised - 2-Monthly update 24 Mar 2017 EMEA/H/C/000863/II/0066/G
Nemdatine Actavis Group PTC ehf. Centralised - Yearly update 24 Mar 2017
Humira AbbVie Ltd Centralised - Variation 24 Mar 2017 EMEA/H/C/481/X/157
NULOJIX Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 24 Mar 2017 EMEA/H/C/2098/PSUSA/311/201606
JEVTANA Sanofi-Aventis groupe PSUSA - Modification 24 Mar 2017 EMEA/H/C/2018/PSUSA/476/201606
Opdivo Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 24 Mar 2017 EMEA/H/C/3985/PSUSA/10379/201607
Bosulif Pfizer Limited Centralised - Annual renewal 24 Mar 2017 EMEA/H/C/2373/R/23
TAGRISSO AstraZeneca AB Centralised - Yearly update 22 Mar 2017
Briviact UCB Pharma S.A. Centralised - Yearly update 22 Mar 2017
Betaferon Bayer AG Centralised - Transfer Marketing Authorisation Holder 22 Mar 2017 EMEA/H/C/000081/T/113
Latuda Sunovion Pharmaceuticals Europe Ltd Centralised - Yearly update 22 Mar 2017
Fluenz Tetra AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 22 Mar 2017 EMEA/H/C/2617/T/65
Zyclara Meda AB Centralised - Renewal 22 Mar 2017 EMEA/H/C/2387/R/12
Daptomycin Hospira Hospira UK Limited Centralised - Authorisation 22 Mar 2017 EMEA/H/C/4310
Xeljanz Pfizer Limited Centralised - Authorisation 22 Mar 2017 EMEA/H/C/004214/0000
Zykadia Novartis Europharm Limited Centralised - Annual renewal 22 Mar 2017 EMEA/H/C/3819/R/09
Pixuvri CTI Life Sciences Ltd Centralised - Annual renewal 22 Mar 2017 EMEA/H/C/2055/R/34
Yargesa JensonR+ Limited Centralised - Authorisation 22 Mar 2017 EMEA/H/C/4016/00
Tadalafil Lilly Eli Lilly Nederland B.V. Centralised - Authorisation 22 Mar 2017 EMEA/H/C/004666/0000
AMGEVITA Amgen Europe B.V. Centralised - Authorisation 22 Mar 2017 EMEA/H/C/004212/0000
SOLYMBIC Amgen Europe B.V. Centralised - Authorisation 22 Mar 2017 EMEA/H/C/4373
Ilaris Novartis Europharm Limited Centralised - Variation 22 Mar 2017 EMEA/H/C/1109/S/47
BeneFIX Pfizer Limited Centralised - Variation 22 Mar 2017 EMEA/H/C/000139/X/0139
Cosentyx Novartis Europharm Limited PSUSA - Modification 22 Mar 2017 EMEA/H/C/3729/PSUSA/10341/201606
Jentadueto Boehringer Ingelheim International GmbH Centralised - Renewal 22 Mar 2017 EMEA/H/C/002279/R/0036
Xiapex Swedish Orphan Biovitrum AB (publ) Centralised - Yearly update 20 Mar 2017
Repso Teva B.V. Centralised - Yearly update 20 Mar 2017
Unituxin United Therapeutics Europe Ltd Centralised - Withdrawal 20 Mar 2017
Benlysta Glaxo Group Ltd Centralised - Yearly update 20 Mar 2017
Entacapone Teva Teva B.V. Centralised - Yearly update 20 Mar 2017
Telmisartan Teva Teva B.V. Centralised - Yearly update 20 Mar 2017
Unituxin United Therapeutics Europe Ltd Centralised - Yearly update 20 Mar 2017
Rolufta GlaxoSmithKline Trading Services Limited Centralised - Authorisation 20 Mar 2017 EMEA/H/C/4654
Fortacin Plethora Solutions Limited Centralised - Yearly update 17 Mar 2017
Tybost Gilead Sciences International Limited Centralised - Yearly update 17 Mar 2017
Komboglyze AstraZeneca AB Rectificative Decision 10 Mar 2017
Ziagen ViiV Healthcare UK Limited Centralised - Yearly update 9 Mar 2017
Combivir ViiV Healthcare UK Limited Centralised - Yearly update 3 Mar 2017
Gardasil 9 MSD VACCINS Centralised - Yearly update 3 Mar 2017
Baraclude Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 3 Mar 2017
Synjardy Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 3 Mar 2017 EMEA/H/C/003770/II/0015
Deltyba Otsuka Novel Products GmbH Centralised - Annual renewal 3 Mar 2017 EMEA/H/C/002552/R/0017
Ledaga Actelion Registration Ltd Centralised - Authorisation 3 Mar 2017 EMEA/H/C/002826/0000
Vectibix Amgen Europe B.V. Centralised - Yearly update 27 Feb 2017
Adcirca Eli Lilly Nederland B.V. Centralised - Yearly update 27 Feb 2017
Kisplyx Eisai Europe Limited Centralised - 2-Monthly update 27 Feb 2017 EMEA/H/C/4224/II/01
Pregabalin Zentiva k.s Zentiva, k.s. Centralised - Authorisation 27 Feb 2017 EMEA/H/C/004277/0000
Revlimid Celgene Europe Limited Centralised - 2-Monthly update 23 Feb 2017 EMEA/H/C/717/II/89/G
Lamivudine Teva Teva B.V. Centralised - Yearly update 23 Feb 2017
Zinforo AstraZeneca AB Centralised - 2-Monthly update 23 Feb 2017 EMEA/H/C/2252/II/29
Ketoconazole HRA Laboratoire HRA Pharma PSUSA - Modification 23 Feb 2017 EMEA/H/C/3906/PSUSA/10316/201605
Sovaldi Gilead Sciences International Limited Referral 23 Feb 2017 EMEA/H/A-20/1438/C/2798/0029
Ilaris Novartis Europharm Limited Centralised - Variation 23 Feb 2017 EMEA/H/C/1109/X/45/G
Harvoni Gilead Sciences International Limited Referral 23 Feb 2017 EMEA/H/A-20/1438/C/3850/0027
Tivicay ViiV Healthcare UK Limited Centralised - Variation 23 Feb 2017 EMEA/H/C/2753/X/18
Vargatef Boehringer Ingelheim International GmbH PSUSA - Modification 23 Feb 2017 EMEA/H/C/PSUSA/00010318/201605
Dacogen Janssen-Cilag International NV PSUSA - Modification 23 Feb 2017 EMEA/H/C/PSUSA/00009118/201605
Docetaxel Accord Accord Healthcare Limited Centralised - Renewal 23 Feb 2017 EMEA/H/C/2539/R/30
Docetaxel Kabi Fresenius Kabi Oncology Plc. Centralised - Renewal 23 Feb 2017 EMEA/H/C/2325/R/15
Exviera AbbVie Ltd Referral 23 Feb 2017 EMEA/H/C/3837/A-20
Viekirax AbbVie Ltd Referral 23 Feb 2017 EMEA/H/A-20/1438/C/3839
OLYSIO Janssen-Cilag International NV Referral 23 Feb 2017 EMEA/H/A-20/1438/C/2777/0019
Daklinza Bristol-Myers Squibb Pharma EEIG Referral 23 Feb 2017 EMEA/H/C/3768/A-20
Emend Merck Sharp & Dohme Limited Centralised - Yearly update 17 Feb 2017
Cyramza Eli Lilly Nederland B.V. Centralised - Yearly update 17 Feb 2017
Truxima Celltrion Healthcare Hungary Kft. Centralised - Authorisation 17 Feb 2017 EMEA/H/C/4112
Caprelsa Genzyme Europe B.V. Centralised - Annual renewal 17 Feb 2017 EMEA/H/C/2315/R/23
Pioglitazone Teva Pharma Teva B.V. Centralised - Renewal 17 Feb 2017 EMEA/H/C/2410/R/13
Pioglitazone Teva Teva B.V. Centralised - Renewal 17 Feb 2017 EMEA/H/C/2297/R/16
Repatha Amgen Europe B.V. Centralised - Variation 17 Feb 2017 EMEA/H/C/3766/X/02
IMBRUVICA Janssen-Cilag International NV PSUSA - Modification 17 Feb 2017 EMEA/H/C/PSUSA/10301/201605
Repaglinide Krka Krka, d. d., Novo Mesto Centralised - Yearly update 16 Feb 2017
Twynsta Boehringer Ingelheim International GmbH Centralised - Yearly update 16 Feb 2017
Viread Gilead Sciences International Limited Centralised - Yearly update 16 Feb 2017
Nucala GlaxoSmithKline Trading Services Limited Centralised - Yearly update 16 Feb 2017
Rivastigmine Actavis Actavis Group PTC ehf. Centralised - Yearly update 16 Feb 2017
Docetaxel Teva Teva B.V. Centralised - Yearly update 16 Feb 2017
Revolade Novartis Europharm Limited Centralised - Yearly update 16 Feb 2017
Ravicti Horizon Pharma Ireland Limited Centralised - Yearly update 16 Feb 2017
INOmax Linde Healthcare AB Centralised - Yearly update 16 Feb 2017
Optimark Mallinckrodt Deutschland GmbH Centralised - Yearly update 16 Feb 2017
Nonafact Sanquin Plasma Products B.V. Centralised - Yearly update 16 Feb 2017
Kalydeco Vertex Pharmaceuticals (Europe) Limited Centralised - Yearly update 16 Feb 2017
EVOTAZ Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 16 Feb 2017
Kadcyla Roche Registration Limited Centralised - Yearly update 16 Feb 2017
Stocrin Merck Sharp & Dohme Limited Centralised - Yearly update 16 Feb 2017
Irbesartan / Hydrochlorothiazide Teva Teva B.V. Centralised - Yearly update 16 Feb 2017
Enyglid Krka, d. d., Novo Mesto Centralised - Yearly update 16 Feb 2017
Portrazza Eli Lilly Nederland B.V. Centralised - Yearly update 16 Feb 2017
Aripiprazole Sandoz Sandoz GmbH Centralised - Yearly update 16 Feb 2017
Leganto UCB Manufacturing Ireland Ltd Centralised - Yearly update 16 Feb 2017
Genvoya Gilead Sciences International Limited Centralised - Yearly update 16 Feb 2017
Zyprexa Velotab Eli Lilly Nederland B.V. Centralised - Yearly update 16 Feb 2017
Armisarte Actavis Group PTC ehf. Centralised - Yearly update 16 Feb 2017
Quinsair Horizon Pharma Europe B.V. Centralised - Yearly update 16 Feb 2017
Farydak Novartis Europharm Limited Centralised - Yearly update 16 Feb 2017
Neupro UCB Manufacturing Ireland Ltd Centralised - Yearly update 16 Feb 2017
Forsteo Eli Lilly Nederland B.V. Centralised - Yearly update 16 Feb 2017
Sifrol Boehringer Ingelheim International GmbH PSUSA - Modification 16 Feb 2017 EMEA/H/C/PSUSA/2491/201604
Mirapexin Boehringer Ingelheim International GmbH PSUSA - Modification 16 Feb 2017 EMEA/H/C/PSUSA/2491/201604
Duaklir Genuair AstraZeneca AB PSUSA - Modification 16 Feb 2017 EMEA/H/C/3745/PSUSA/10307-201605
Brimica Genuair AstraZeneca AB PSUSA - Modification 16 Feb 2017 EMEA/H/C/3969/PSUSA/10307-201605
Alecensa Roche Registration Limited Centralised - Authorisation 16 Feb 2017 EMEA/H/C/4164/00
Nimenrix Pfizer Limited Centralised - Renewal 16 Feb 2017 EMEA/H/C/2226/R/59
Revlimid Celgene Europe Limited Centralised - Renewal 16 Feb 2017 EMEA/H/C/717/R/91
Senshio Shionogi Limited Centralised - Yearly update 13 Feb 2017
Aripiprazole Zentiva Zentiva, k.s. Centralised - Yearly update 13 Feb 2017
Sustiva Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 13 Feb 2017
LIFMIOR Pfizer Limited Centralised - Authorisation 13 Feb 2017 EMEA/H/C/4167
Olumiant Eli Lilly Nederland B.V. Centralised - Authorisation 13 Feb 2017 EMEA/H/C/4085
Vihuma Octapharma AB Centralised - Authorisation 13 Feb 2017 EMEA/H/C/4459
Optruma Eli Lilly Nederland B.V. Centralised - Yearly update 8 Feb 2017
Victrelis Merck Sharp & Dohme Limited Centralised - Yearly update 6 Feb 2017
APTIVUS Boehringer Ingelheim International GmbH Centralised - Yearly update 6 Feb 2017
Amyvid Eli Lilly Nederland B.V. Centralised - Yearly update 6 Feb 2017
Scintimun CIS bio international Centralised - Yearly update 6 Feb 2017
Stribild Gilead Sciences International Limited Centralised - Yearly update 6 Feb 2017
Tolucombi Krka, d. d., Novo Mesto Centralised - Yearly update 6 Feb 2017
Alimta Eli Lilly Nederland B.V. Centralised - Yearly update 6 Feb 2017
Gardasil MSD VACCINS Centralised - Yearly update 6 Feb 2017
Silgard Merck Sharp & Dohme Limited Centralised - Yearly update 6 Feb 2017
Imvanex Bavarian Nordic A/S Centralised - Annual reassessment 6 Feb 2017 EMEA/H/C/2596/S/22
Bexsero GlaxoSmithKline Vaccines S.r.l. Corrigendum 28 Jan 2017
Jentadueto Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 27 Jan 2017 EMEA/H/C/2279/WS/0915
Xydalba Allergan Pharmaceuticals International Limited Centralised - Transfer Marketing Authorisation Holder 27 Jan 2017 EMEA/H/C/2840/T/14
Trajenta Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 27 Jan 2017 EMEA/H/C/2110/WS/0915
Benepali Samsung Bioepis UK Limited Centralised - 2-Monthly update 27 Jan 2017 EMEA/H/C/004007/II/0019/G
Docetaxel Accord Accord Healthcare Limited Centralised - Yearly update 27 Jan 2017
Vaxelis MCM Vaccine B.V. Centralised - Transfer Marketing Authorisation Holder 27 Jan 2017 EMEA/H/C/3982/T/07
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 27 Jan 2017 EMEA/H/C/3985/II/18
Ameluz Biofrontera Bioscience GmbH Centralised - 2-Monthly update 27 Jan 2017 EMEA/H/C/2204/II/24
Stivarga Bayer Pharma AG Centralised - 2-Monthly update 27 Jan 2017 EMEA/H/C/2573/II/18
Votubia Novartis Europharm Limited Centralised - 2-Monthly update 27 Jan 2017 EMEA/H/C/2311/II/41
KEYTRUDA Merck Sharp & Dohme Limited Centralised - Variation 27 Jan 2017 EMEA/H/C/3820/II/11
Orfadin Swedish Orphan Biovitrum International AB Centralised - 2-Monthly update 26 Jan 2017 EMEA/H/C/555/II/57
NovoSeven Novo Nordisk A/S Centralised - Yearly update 26 Jan 2017
Iclusig Incyte Biosciences UK Ltd Centralised - 2-Monthly update 26 Jan 2017 EMEA/H/C/2695/II/32/G
Cinryze Shire Services BVBA Centralised - 2-Monthly update 26 Jan 2017 EMEA/H/C/1207/II/45
Rezolsta Janssen-Cilag International NV Centralised - Yearly update 26 Jan 2017
Viekirax AbbVie Ltd Centralised - 2-Monthly update 26 Jan 2017 EMEA/H/C/3839/II/25
Picato LEO Laboratories Ltd. Centralised - Transfer Marketing Authorisation Holder 26 Jan 2017 EMEA/H/C/2275/T/22
Voriconazole Hikma Hikma Farmacêutica (Portugal), S.A. Centralised - Transfer Marketing Authorisation Holder 26 Jan 2017 EMEA/H/C/3737/T/05
Lymphoseek Norgine B.V. Centralised - Transfer Marketing Authorisation Holder 23 Jan 2017 EMEA/H/C/2085/T/07
Remsima Celltrion Healthcare Hungary Kft. Centralised - Yearly update 23 Jan 2017
Jardiance Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 19 Jan 2017 EMEA/H/C/002677/II/14
Atazanavir Mylan Mylan S.A.S Rectificative Decision 19 Jan 2017
Cystadrops Orphan Europe SARL Centralised - Authorisation 19 Jan 2017 EMEA/H/C/003769/0000
ZINPLAVA Merck Sharp & Dohme Limited Centralised - Authorisation 18 Jan 2017 EMEA/H/C/004136/0000
Clopidogrel Acino Acino AG Centralised - Withdrawal 18 Jan 2017
Entresto Novartis Europharm Limited Centralised - Yearly update 11 Jan 2017
Defitelio Gentium S.r.l Centralised - Yearly update 11 Jan 2017
Vimizim BioMarin Europe Ltd. Centralised - Yearly update 11 Jan 2017
Herceptin Roche Registration Limited Centralised - Yearly update 11 Jan 2017
Pregabalin Mylan Pharma Generics [UK] Limited Centralised - Yearly update 11 Jan 2017
Imatinib Accord Accord Healthcare Limited Centralised - 2-Monthly update 11 Jan 2017 EMEA/H/C/2681/IB/13
Pregabalin Mylan Generics [UK] Limited Centralised - Yearly update 11 Jan 2017
Xadago Zambon S.p.A. Centralised - Yearly update 11 Jan 2017
Invanz Merck Sharp & Dohme Limited Centralised - Yearly update 11 Jan 2017
Kuvan BioMarin International Limited Centralised - Yearly update 11 Jan 2017
Inovelon Eisai Limited Centralised - 2-Monthly update 11 Jan 2017 EMEA/H/C/660/II/37
Ivemend Merck Sharp & Dohme Limited PSUSA - Modification 11 Jan 2017 EMEA/H/C/743/PSUSA/1471/201603
Brintellix H. Lundbeck A/S PSUSA - Modification 11 Jan 2017 EMEA/H/C/2717/PSUSA/10052/201603
Bronchitol Pharmaxis Pharmaceuticals Limited Centralised - Renewal 11 Jan 2017 EMEA/H/C/1252/R/28
Suliqua Sanofi-Aventis groupe Centralised - Authorisation 11 Jan 2017 EMEA/H/C/4243
Adenuric Menarini International Operations Luxembourg S.A. PSUSA - Modification 11 Jan 2017 EMEA/H/C/PSUSA/00001353/201604
Ruconest Pharming Group N.V. Centralised - Variation 11 Jan 2017 EMEA/H/C/1223/X/34
Cometriq Ipsen Pharma Centralised - Annual renewal 11 Jan 2017 EMEA/H/C/2640/R/22
Movymia STADA Arzneimittel AG Centralised - Authorisation 11 Jan 2017 EMEA/H/C/4368/00
Foclivia Novartis Vaccines Influenza S.r.l. Centralised - Yearly update 9 Jan 2017
Naglazyme BioMarin Europe Ltd. Centralised - Yearly update 9 Jan 2017
Viagra Pfizer Limited Centralised - Yearly update 9 Jan 2017
DaTSCAN GE Healthcare Limited Centralised - Yearly update 9 Jan 2017
Viramune Boehringer Ingelheim International GmbH Centralised - Yearly update 9 Jan 2017
Vylaer Spiromax Teva Pharma B.V. Centralised - Withdrawal 9 Jan 2017
Fiasp Novo Nordisk A/S Centralised - Authorisation 9 Jan 2017 EMEA/H/C/004046/0000
Translarna PTC Therapeutics International Limited Centralised - Annual renewal 9 Jan 2017 EMEA/H/C/2720/R/22
Relistor PharmaSwiss Ceská republika s.r.o. PSUSA - Modification 9 Jan 2017 EMEA/H/C/PSUSA/00002023/201603
Ofev Boehringer Ingelheim International GmbH PSUSA - Modification 9 Jan 2017 EMEA/H/C/003821/PSUSA/00010319/201604
Capecitabine Teva Teva B.V. Centralised - Renewal 9 Jan 2017 EMEA/H/C/002362/R/0025
Capecitabine Accord Accord Healthcare Limited Centralised - Renewal 9 Jan 2017 EMEA/H/C/002386/R/0021
Xultophy Novo Nordisk A/S PSUSA - Modification 9 Jan 2017 EMEA/H/C/PSUSA/00010272/201603
Talmanco Mylan S.A.S. Centralised - Authorisation 9 Jan 2017 EMEA/H/C/004297/0000
Vemlidy Gilead Sciences International Ltd. Centralised - Authorisation 9 Jan 2017 EMEA/H/C/004169/0000
Riluzole Zentiva Aventis Pharma S.A. Centralised - Renewal 9 Jan 2017 EMEA/H/C/2622/R/21
SANCUSO Kyowa Kirin Limited Centralised - Renewal 9 Jan 2017 EMEA/H/C/2296/R/47
Imatinib Accord Accord Healthcare Limited Centralised - Yearly update 4 Jan 2017
Kolbam Retrophin Europe Limited Centralised - Yearly update 4 Jan 2017
Emadine Alcon Laboratories (UK) Ltd Centralised - Yearly update 4 Jan 2017
Vepacel Nanotherapeutics UK Limited Centralised - Renewal 4 Jan 2017 EMEA/H/C/2089/R/15
Lusduna Merck Sharp & Dohme Limited Centralised - Authorisation 4 Jan 2017 EMEA/H/C/4101
AFSTYLA CSL Behring GmbH Centralised - Authorisation 4 Jan 2017 EMEA/H/C/4075
Darunavir Mylan Mylan S.A.S Centralised - Authorisation 4 Jan 2017 EMEA/H/C/4068
Incruse Glaxo Group Ltd PSUSA - Modification 4 Jan 2017 EMEA/H/C/PSUSA/10263/201604
Terrosa Gedeon Richter Plc. Centralised - Authorisation 4 Jan 2017 EMEA/H/C/3916
Zonegran Eisai Limited PSUSA - Modification 4 Jan 2017 EMEA/H/C/PSUSA/3152/201603
Duloxetine Mylan Generics [UK] Limited Centralised - Yearly update 23 Dec 2016
Invirase Roche Registration Limited Centralised - Yearly update 23 Dec 2016
Fareston Orion Corporation Centralised - Yearly update 23 Dec 2016
Raplixa Mallinckrodt Pharmaceuticals Ireland Limited Centralised - Transfer Marketing Authorisation Holder 23 Dec 2016 EMEA/H/C/2807/T/17
Orkambi Vertex Pharmaceuticals (Europe) Limited Centralised - Yearly update 23 Dec 2016
Mepact Takeda France SAS Centralised - Yearly update 23 Dec 2016
Sirturo Janssen-Cilag International NV Centralised - Annual renewal 23 Dec 2016 EMEA/H/C/2614/R/17
Tractocile Ferring Pharmaceuticals A/S Centralised - Yearly update 19 Dec 2016
Entyvio Takeda Pharma A/S Centralised - Yearly update 19 Dec 2016
Visudyne Novartis Europharm Limited Centralised - Yearly update 19 Dec 2016
Pemetrexed Sandoz Sandoz GmbH Centralised - Yearly update 19 Dec 2016
Pemetrexed Lilly Eli Lilly Nederland B.V. Centralised - Yearly update 16 Dec 2016
Pramipexole Teva Teva B.V. Centralised - Yearly update 16 Dec 2016
Levemir Novo Nordisk A/S Centralised - Yearly update 16 Dec 2016
Mixtard Novo Nordisk A/S Centralised - Yearly update 16 Dec 2016
Atripla Bristol-Myers Squibb and Gilead Sciences Limited Centralised - Yearly update 16 Dec 2016
Budesonide/Formoterol Teva Pharma B.V. Teva Pharma B.V. Centralised - Withdrawal 16 Dec 2016
Budesonide/Formoterol Teva Teva Pharma B.V. Centralised - Withdrawal 16 Dec 2016
RotaTeq Sanofi Pasteur MSD SAS Centralised - Yearly update 16 Dec 2016
Caprelsa Genzyme Europe B.V. Centralised - Variation 16 Dec 2016 EMEA/H/C/2315/II/16
Kentera Nicobrand Limited Centralised - 2-Monthly update 16 Dec 2016 EMEA/H/C/532/II/41
Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S Centralised - Authorisation 16 Dec 2016 EMEA/H/C/004050/0000
Sebivo Novartis Europharm Limited Centralised - Renewal 16 Dec 2016 EMEA/H/C/000713/R/0045
GONAL-f Merck Serono Europe Limited Centralised - Yearly update 13 Dec 2016
Accofil Accord Healthcare Limited Centralised - Yearly update 12 Dec 2016
Pregabalin Accord Accord Healthcare Limited Centralised - Yearly update 12 Dec 2016
Torisel Pfizer Limited Centralised - Yearly update 12 Dec 2016
Crixivan Merck Sharp & Dohme Limited Centralised - Yearly update 12 Dec 2016
Colobreathe Teva B.V. Centralised - Transfer Marketing Authorisation Holder 12 Dec 2016 EMEA/H/C/1225/T/28
Orbactiv The Medicines Company UK Ltd Centralised - Yearly update 12 Dec 2016
Flebogamma DIF Instituto Grifols, S.A. Centralised - Yearly update 12 Dec 2016
NovoMix Novo Nordisk A/S Centralised - Yearly update 12 Dec 2016
Mysimba Orexigen Therapeutics Ireland Limited Centralised - Yearly update 12 Dec 2016
Inflectra Hospira UK Limited Centralised - Yearly update 12 Dec 2016
Xtandi Astellas Pharma Europe B.V. Centralised - Yearly update 12 Dec 2016
Docetaxel Kabi Fresenius Kabi Oncology Plc. Centralised - Yearly update 12 Dec 2016
Aripiprazole Accord Accord Healthcare Limited Centralised - Yearly update 12 Dec 2016
Vimpat UCB Pharma S.A. Centralised - 2-Monthly update 12 Dec 2016 EMEA/H/C/000863/II/0060/G
Optaflu Seqirus GmbH Centralised - Transfer Marketing Authorisation Holder 12 Dec 2016 EMEA/H/C/758/T/0091
Lynparza AstraZeneca AB Centralised - 2-Monthly update 12 Dec 2016 EMEA/H/C/3726/II/9/G
Nimenrix Pfizer Limited Centralised - 2-Monthly update 12 Dec 2016 EMEA/H/C/2226/II/49
Aldara Meda AB Centralised - 2-Monthly update 12 Dec 2016 EMEA/H/C/179/II/67
Humira AbbVie Ltd Centralised - 2-Monthly update 12 Dec 2016 EMEA/H/C/481/II/154
Kyprolis Amgen Europe B.V. Centralised - 2-Monthly update 12 Dec 2016 EMEA/H/C/003790/II/07/G
Zomarist Novartis Europharm Limited Referral 12 Dec 2016 EMEA/H/A-31/1432/C/001049/0056
Vipdomet Takeda Pharma A/S Referral 12 Dec 2016 EMEA/H/A-31/1432/C/002654/0015
Synjardy Boehringer Ingelheim International GmbH Referral 12 Dec 2016 EMEA/H/A-31/1432/C/003370/0013
Xigduo AstraZeneca AB Referral 12 Dec 2016 EMEA/H/A-31/1432/C/2672
Jentadueto Boehringer Ingelheim International GmbH Referral 12 Dec 2016 EMEA/H/A-31/1432/C/002279/0029
Eucreas Novartis Europharm Limited Referral 12 Dec 2016 EMEA/H/A-31/1432
Ebymect AstraZeneca AB Referral 12 Dec 2016 EMEA/H/C/4162/Art-31/1432
Competact Takeda Pharma A/S Referral 12 Dec 2016 EMEA/H/C/655/A-31/1432
Komboglyze AstraZeneca AB Referral 12 Dec 2016 EMEA/H/A-31/1432
Trulicity Eli Lilly Nederland B.V. PSUSA - Modification 12 Dec 2016 EMEA/H/C/PSUSA/10311/201603
TAGRISSO AstraZeneca AB Centralised - Annual renewal 12 Dec 2016 EMEA/H/C/4124/R/07
Rekovelle Ferring Pharmaceuticals A/S Centralised - Authorisation 12 Dec 2016 EMEA/H/C/3994
Vokanamet Janssen-Cilag International NV Referral 12 Dec 2016 EMEA/H/A-31/1432/C/2656/13
Velmetia Merck Sharp & Dohme Limited Referral 12 Dec 2016 EMEA/H/A-31/1432/C/862/81
Ristfor Merck Sharp & Dohme Limited Referral 12 Dec 2016 EMEA/H/A-31/1432/C/1235/65
Janumet Merck Sharp & Dohme Limited Referral 12 Dec 2016 EMEA/H/A-31/1432/C/861/77
Glubrava Takeda Pharma A/S Referral 12 Dec 2016 EMEA/H/A-31/1432/C/893/45
Efficib Merck Sharp & Dohme Limited Referral 12 Dec 2016 EMEA/H/A-31/1432/C/896/78
OCALIVA Intercept Pharma Ltd Centralised - Authorisation 12 Dec 2016 EMEA/H/C/004093
Cometriq Ipsen Pharma PSUSA - Modification 12 Dec 2016 EMEA/H/C/PSUSA/10180/201603
Ecansya Krka, d. d., Novo Mesto Centralised - Renewal 9 Dec 2016 EMEA/H/C/2605/R/0018
PANTOZOL Control Takeda GmbH, (HRB 701016) Centralised - Yearly update 8 Dec 2016
SOMAC Control Takeda GmbH, (HRB 701016) Centralised - Yearly update 8 Dec 2016
CONTROLOC Control Takeda GmbH, (HRB 701016) Centralised - Yearly update 8 Dec 2016
Actrapid Novo Nordisk A/S Centralised - Yearly update 8 Dec 2016
Actraphane Novo Nordisk A/S Centralised - Yearly update 8 Dec 2016
Voriconazole Accord Accord Healthcare Limited Centralised - Yearly update 8 Dec 2016
Lamivudine / Zidovudine Teva Teva B.V. Centralised - Yearly update 8 Dec 2016
Adenuric Menarini International Operations Luxembourg S.A. Centralised - Yearly update 8 Dec 2016
DuoPlavin Sanofi Clir SNC Centralised - Yearly update 8 Dec 2016
Arzerra Novartis Europharm Limited Centralised - 2-Monthly update 8 Dec 2016 EMEA/H/C/1131/II/45
Icandra Novartis Europharm Limited Referral 8 Dec 2016 EMEA/H/A-31/1432/C/001050/0056
SomaKit TOC Advanced Accelerator Applications Centralised - Authorisation 8 Dec 2016 EMEA/H/C/4140
Emtricitabine/Tenofovir disoproxil Krka Krka, d. d., Novo Mesto Centralised - Authorisation 8 Dec 2016 EMEA/H/C/4215
GILENYA Novartis Europharm Limited PSUSA - Modification 8 Dec 2016 EMEA/H/C/2202/PSUSA/1393/201602
Bosulif Pfizer Limited PSUSA - Modification 8 Dec 2016 EMEA/H/C/2373/PSUSA/10073/201603
Cystadane Orphan Europe S.A.R.L. PSUSA - Modification 8 Dec 2016 EMEA/H/C/678/PSUSA/390/201602
Otezla Celgene Europe Limited PSUSA - Modification 8 Dec 2016 EMEA/H/C/3746/PSUSA/10338/201603
Tenofovir disoproxil Mylan MYLAN S.A.S Centralised - Authorisation 8 Dec 2016 EMEA/H/C/004049/0000
Zoledronic acid Actavis Actavis Group PTC ehf. Centralised - Renewal 8 Dec 2016 EMEA/H/C/002488/R/0017
Zebinix Bial - Portela & Cª, SA Centralised - Variation 8 Dec 2016 EMEA/H/C/988/X/0050/G
Mimpara Amgen Europe B.V. PSUSA - Modification 8 Dec 2016 EMEA/H/C/570/PSUSA/00000756/201602
Holoclar Chiesi Farmaceutici S.P.A. Centralised - Annual renewal 8 Dec 2016 EMEA/H/C/002450/R/0008
Eperzan GlaxoSmithKline Trading Services Limited PSUSA - Modification 8 Dec 2016 EMEA/H/C/2735/10175/201603
Spedra Menarini International Operations Luxembourg S.A. Centralised - Yearly update 5 Dec 2016
Truberzi Allergan Pharmaceuticals International Limited Centralised - Transfer Marketing Authorisation Holder 5 Dec 2016 EMEA/H/C/4098/T/01
Pioglitazone Accord Accord Healthcare Limited Centralised - Renewal 5 Dec 2016 EMEA/H/C/2277/R/11
Venclyxto AbbVie Ltd Centralised - Authorisation 5 Dec 2016 EMEA/H/C/4106
Aclasta Novartis Europharm Limited Centralised - Yearly update 2 Dec 2016
PANTOLOC Control Takeda GmbH, (HRB 701016) Centralised - Yearly update 29 Nov 2016
Ammonaps Swedish Orphan Biovitrum International AB Referral 29 Nov 2016 EMEA/H/A-31/1444/C/000219/0048
Celvapan Nanotherapeutics Bohumil, s.r.o. Centralised - Withdrawal 21 Nov 2016
Bemfola Gedeon Richter Plc. Centralised - Transfer Marketing Authorisation Holder 21 Nov 2016 EMEA/H/C/2615/T/10
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 21 Nov 2016 EMEA/H/C/3985/II/12
Ameluz Biofrontera Bioscience GmbH Centralised - Renewal 21 Nov 2016 EMEA/H/C/2204/R/23
Ninlaro Takeda Pharma A/S Centralised - Authorisation 21 Nov 2016 EMEA/H/C/003844/0000
Cystadane Orphan Europe S.A.R.L. Centralised - Renewal 21 Nov 2016 EMEA/H/C/678/R/24
Elonva Merck Sharp & Dohme Limited Centralised - Yearly update 21 Nov 2016
Procysbi Horizon Pharma Europe B.V. Centralised - Yearly update 18 Nov 2016
Daxas AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 18 Nov 2016 EMEA/H/C/1179/T/34
Pioglitazone Teva Pharma Teva B.V. Centralised - Yearly update 18 Nov 2016
Signifor Novartis Europharm Limited Centralised - Renewal 18 Nov 2016 EMEA/H/C/2052/R/28
Thymanax Servier (Ireland) Industries Limited PSUSA - Modification 18 Nov 2016 EMEA/H/C/PSUSA/71/201602
Valdoxan Les Laboratoires Servier PSUSA - Modification 18 Nov 2016 EMEA/H/C/PSUSA/71/201602
Xaluprine Nova Laboratories Limited Centralised - Renewal 18 Nov 2016 EMEA/H/C/2022/R/12
Selincro H. Lundbeck A/S PSUSA - Modification 18 Nov 2016 EMEA/H/C/PSUSA/10120/201602
Jakavi Novartis Europharm Limited PSUSA - Modification 18 Nov 2016 EMEA/H/C/2464/PSUSA /10015/201602
Isentress Merck Sharp & Dohme Limited Corrigendum 14 Nov 2016
Iasibon Pharmathen S.A. Centralised - Yearly update 14 Nov 2016
Ribavirin Teva Teva B.V. Centralised - 2-Monthly update 14 Nov 2016 EMEA/H/C/1018/IB/19
Ribavirin Teva Pharma BV Teva B.V. Centralised - 2-Monthly update 14 Nov 2016 EMEA/H/C/1064/IB/18
Numient Impax Laboratories Ireland Limited, 56 Fitzwilliam Square, Dublin 2, Ireland Centralised - Transfer Marketing Authorisation Holder 14 Nov 2016 EMEA/H/C/2611/T/02
Clopidogrel ratiopharm Teva B.V. Centralised - Yearly update 14 Nov 2016
Duloxetine Zentiva Zentiva, k.s. Centralised - Yearly update 14 Nov 2016
Isentress Merck Sharp & Dohme Limited Centralised - 2-Monthly update 14 Nov 2016 EMEA/H/C/860/II/61
Pioglitazone Teva Teva B.V. Centralised - Yearly update 14 Nov 2016
Trisenox Teva B.V. Centralised - 2-Monthly update 14 Nov 2016 EMEA/H/C/388/II/58
Giotrif Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 14 Nov 2016 EMEA/H/C/002280/II/0017
Triumeq ViiV Healthcare UK Limited Centralised - 2-Monthly update 14 Nov 2016 EMEA/H/C/002754/II/0031
Praluent Sanofi-Aventis groupe Centralised - 2-Monthly update 14 Nov 2016 EMEA/H/C/3882/II/0009/G
Lucentis Novartis Europharm Limited Centralised - 2-Monthly update 14 Nov 2016 EMEA/H/C/715/II/61
Topotecan Hospira Hospira UK Limited Centralised - Yearly update 14 Nov 2016
Eklira Genuair AstraZeneca AB PSUSA - Modification 14 Nov 2016 EMEA/H/C/2211/PSUSA/9005/201601
Bretaris Genuair AstraZeneca AB PSUSA - Modification 14 Nov 2016 EMEA/H/C/2706/PSUSA/9005/201601
Edarbi Takeda Pharma A/S Centralised - Renewal 14 Nov 2016 EMEA/H/C/2293/R/18
Levetiracetam SUN Sun Pharmaceutical Industries Europe BV Centralised - Renewal 14 Nov 2016 EMEA/H/C/2051/R/13
Esmya Gedeon Richter Plc. Centralised - Renewal 14 Nov 2016 EMEA/H/C/2041/R/40
Pioglitazone Actavis Actavis Group PTC ehf. Centralised - 2-Monthly update 14 Nov 2016 EMEA/H/C/2324/IB/0010/G
Granpidam Accord Healthcare Limited Centralised - Authorisation 14 Nov 2016 EMEA/H/C/4289
Erivedge Roche Registration Limited Centralised - Authorisation - Switch to non-conditional 14 Nov 2016 EMEA/H/C/2602/II/25/G
Foscan biolitec Pharma Ltd.. Centralised - Yearly update 11 Nov 2016
Hexyon Sanofi Pasteur Europe Centralised - Transfer Marketing Authorisation Holder 11 Nov 2016 EMEA/H/C/2796/T/0057
Incruse Glaxo Group Ltd Centralised - Yearly update 11 Nov 2016
Translarna PTC Therapeutics International Limited Centralised - Yearly update 11 Nov 2016
Strensiq Alexion Europe SAS Centralised - Yearly update 11 Nov 2016
Taxespira Hospira UK Limited Centralised - Yearly update 11 Nov 2016
Abraxane Celgene Europe Limited PSUSA - Modification 11 Nov 2016 EMEA/H/C/778/PSUSA/10123/201601
Parsabiv Amgen Europe B.V. Centralised - Authorisation 11 Nov 2016 EMEA/H/C/3995
Glyxambi Boehringer Ingelheim International GmbH Centralised - Authorisation 11 Nov 2016 EMEA/H/C/003833/0000
Desloratadine Actavis Actavis Group PTC ehf. Centralised - Renewal 11 Nov 2016 EMEA/H/C/2435/R/08
Ivabradine JensonR JensonR+ Limited Centralised - Authorisation 11 Nov 2016 EMEA/H/C/4217
Ivabradine Zentiva Zentiva, k.s. Centralised - Authorisation 11 Nov 2016 EMEA/H/C/4117/00
XALKORI Pfizer Limited Centralised - Authorisation - Switch to non-conditional 11 Nov 2016 EMEA/H/C/2489/II/44
Neuraceq Piramal Imaging Limited PSUSA - Modification 11 Nov 2016 EMEA/H/C/2553/PSUSA/10094/201602
Erivedge Roche Registration Limited PSUSA - Modification 11 Nov 2016 EMEA/H/C/2602/PSUSA/10140-201601
Picato LEO Laboratories Ltd. PSUSA - Modification 11 Nov 2016 EMEA/H/C/2275/PSUSA/10035/201601
Lojuxta Aegerion Pharmaceuticals Limited PSUSA - Modification 11 Nov 2016 EMEA/H/C/2578/PSUSA/10112/201601
Stelara Janssen-Cilag International NV Centralised - Variation 11 Nov 2016 EMEA/H/C/958/X/49
Lucentis Novartis Europharm Limited Centralised - Renewal 11 Nov 2016 EMEA/H/C/715/R/62
Keppra UCB Pharma S.A. PSUSA - Modification 11 Nov 2016 EMEA/H/C/PSUSA/1846/201511
Teysuno Nordic Group B.V. PSUSA - Modification 11 Nov 2016 EMEA/H/C/PSUSA/2875/201601
Pregabalin Pfizer Pfizer Limited PSUSA - Modification 11 Nov 2016 EMEA/H/C/PSUSA/2511/201601
Mirvaso Galderma International PSUSA - Modification 11 Nov 2016 EMEA/H/C/2642/PSUSA/00010093/201602
Glidipion Actavis Group PTC ehf. Centralised - Renewal 11 Nov 2016 EMEA/H/C/2558/R/0009
Pioglitazone Actavis Actavis Group PTC ehf. Centralised - Renewal 11 Nov 2016 EMEA/H/C/2324/R/0009
Iclusig Incyte Biosciences UK Ltd Centralised - Transfer Marketing Authorisation Holder 9 Nov 2016 EMEA/H/C/2695/T/36
Lartruvo Eli Lilly Nederland B.V. Centralised - Authorisation 9 Nov 2016 EMEA/H/C/4216/00
Zytiga Janssen-Cilag International NV Centralised - Variation 9 Nov 2016 EMEA/H/C/2321/X/39
Lyrica Pfizer Limited PSUSA - Modification 9 Nov 2016 EMEA/H/C/PSUSA/2511/201601
Sutent Pfizer Limited Centralised - Renewal 9 Nov 2016 EMEA/H/C/687/R/62
Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. Centralised - Authorisation 9 Nov 2016 EMEA/H/C/4137
IBRANCE Pfizer Limited Centralised - Authorisation 9 Nov 2016 EMEA/H/C/3853
Libertek AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 3 Nov 2016 EMEA/H/C/2399/T/31
Daliresp AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 3 Nov 2016 EMEA/H/C/2398/T/30
Intanza Sanofi Pasteur Europe Centralised - Transfer Marketing Authorisation Holder 3 Nov 2016 EMEA/H/C/957/T/051
Vibativ Theravance Biopharma Ireland Limited Centralised - Transfer Marketing Authorisation Holder 3 Nov 2016 EMEA/H/C/1240/T/27
Vitekta Gilead Sciences International Limited Centralised - Withdrawal 3 Nov 2016
Emtriva Gilead Sciences International Limited Centralised - 2-Monthly update 3 Nov 2016 EMEA/H/C/533/II/113
Volibris Glaxo Group Ltd Centralised - Yearly update 27 Oct 2016
Privigen CSL Behring GmbH Centralised - Yearly update 27 Oct 2016
Perjeta Roche Registration Limited Centralised - Yearly update 27 Oct 2016
Vitekta Gilead Sciences International Limited Centralised - Yearly update 27 Oct 2016
Nuwiq Octapharma AB Centralised - Yearly update 26 Sep 2016
Cervarix GlaxoSmithKline Biologicals S.A. Corrigendum 29 Jul 2016
Pemetrexed Fresenius Kabi Fresenius Kabi Oncology Plc. Corrigendum 22 Jul 2016
Epclusa Gilead Sciences International Ltd. Corrigendum 6 Jul 2016
Busilvex Pierre Fabre Médicament Corrigendum 26 Aug 2014
Procedures for centrally authorised orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
20% I.V. fat emulsion consisting of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection Alan Boyd Consultants Ltd Refusal of orphan designation 20 Apr 2017 EMA/OD/062/16
EU/3/17/1870 Vall d'Hebron Institute of Research Orphan designation 20 Apr 2017 EMA//OD/317/16
EU/3/17/1869 Hôpital Foch Orphan designation 20 Apr 2017 EMA/OD/286/16
EU/3/17/1868 Sentinel Oncology Limited Orphan designation 20 Apr 2017 EMA/OD/293/16
EU/3/17/1867 PhaseRx Ireland, Ltd Orphan designation 20 Apr 2017 EMA/OD/326/16
EU/3/17/1866 Hôpital Foch Orphan designation 20 Apr 2017 EMA/OD/287/16
EU/3/17/1864 NBMI Science Limited Orphan designation 20 Apr 2017 EMA/OD/329/16
EU/3/17/1863 bluebird bio France Orphan designation 20 Apr 2017 EMA/OD/270/16
EU/3/17/1862 Igenomix, S.L. Orphan designation 20 Apr 2017 EMA/OD/313/16
EU/3/17/1861 Biological Consulting Europe Ltd Orphan designation 20 Apr 2017 EMA/OD/299/16
EU/3/16/1783 EMAS Pharma Limited Transfer of orphan designation 11 Apr 2017 EMA/OD/138/16/T/01
EU/3/14/1281 Vertex Pharmaceuticals (Europe) Limited Transfer of orphan designation 11 Apr 2017 EMA/OD/002/14/T/01
EU/3/14/1240 Istituto Europeo per la Ricerca sulla Fibrosi Cistica - ONLUS Transfer of orphan designation 6 Apr 2017 EMA/OD/159/13/T/02
EU/3/11/857 Alnylam UK Limited Amendment of orphan designation 6 Apr 2017 EMA/OD/142/10
EU/3/15/1579 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/135/15/T/01
EU/3/15/1572 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/108/15/T/01
EU/3/15/1571 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/107/15/T/01
EU/3/15/1553 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/078/15/T/01
EU/3/15/1552 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/077/15/T/01
EU/3/14/1393 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/171/14/T/01
EU/3/15/1488 Celgene Europe Limited Transfer of orphan designation 3 Apr 2017 EMA/OD/314/14/T/01
EU/3/16/1811 Centre Hospitalier Universitaire de Lille Rectificative Decision 20 Mar 2017
EU/3/12/1083 Aptevo Europe Limited Transfer of orphan designation 20 Mar 2017 EMA/OD/128/12
EU/3/17/1860 Viadoc Business Solutions Limited Orphan designation 20 Mar 2017 EMA/OD/300/16
EU/3/17/1859 Kither Biotech s.r.l. Orphan designation 20 Mar 2017 EMA/OD/303/16
EU/3/17/1858 Grupo Español de Tumores Huérfanos e Infrecuentes (GETHI) Orphan designation 20 Mar 2017 EMA/OD/236/16
EU/3/17/1857 Grupo Español de Tumores Huérfanos e Infrecuentes (GETHI) Orphan designation 20 Mar 2017 EMA/OD/234/16
EU/3/17/1856 AstraZeneca AB Orphan designation 20 Mar 2017 EMA/OD/267/16
EU/3/17/1855 GW Research Ltd Orphan designation 20 Mar 2017 EMA/OD/275/16
EU/3/17/1854 SPC GmbH Orphan designation 20 Mar 2017 EMA/OD/204/16
EU/3/17/1853 ProQR Therapeutics IV BV Orphan designation 20 Mar 2017 EMA/OD/280/16
EU/3/17/1852 Regulatory Resources Group Ltd Orphan designation 20 Mar 2017 EMA/OD/257/16
EU/3/17/1851 LYSOGENE Orphan designation 20 Mar 2017 EMA/OD/265/16
EU/3/17/1850 Dr Julien Baruteau Orphan designation 20 Mar 2017 EMA/OD/310/16
EU/3/17/1849 Freeline Therapeutics Ltd Orphan designation 20 Mar 2017 EMA/OD/277/16
EU/3/17/1848 IntraBio Ltd Orphan designation 20 Mar 2017 EMA/OD/276/16
EU/3/17/1847 Daiichi Sankyo Europe GmbH Orphan designation 20 Mar 2017 EMA/OD/201/16
EU/3/14/1357 Exvastat Limited Transfer of orphan designation 10 Mar 2017 EMA/OD/110/14/T/01
EU/3/12/1034 Novartis Europharm Limited Transfer of orphan designation 9 Mar 2017 EMA/OD/026/12/T/01
EU/3/15/1518 Spark Therapeutics Ireland Ltd Transfer of orphan designation 9 Mar 2017 EMA/OD/040/15/T/01
EU/3/08/563 Vertex Pharmaceuticals (Europe) Limited Transfer of orphan designation 9 Mar 2017 EMA/OD/012/08/T/02
EU/3/12/981 Spark Therapeutics Ireland Ltd Transfer of orphan designation 9 Mar 2017 EMA/70249/2017
EU/3/17/1846 Groupe d’étude des histiocytoses Orphan designation 27 Feb 2017 EMA/OD/281/16
EU/3/17/1845 PlumeStars s.r.l. Orphan designation 27 Feb 2017 EMA/OD/268/16
EU/3/17/1844 Bruschettini s.r.l. Orphan designation 27 Feb 2017 EMA/OD/242/16
EU/3/17/1843 TherAchon SAS Orphan designation 27 Feb 2017 EMA/OD/269/16
EU/3/17/1842 EUDRAC Limited Orphan designation 27 Feb 2017 EMA/OD/247/16
EU/3/17/1841 Consejo Superior de Investigaciones Cientificas (CSIC) Orphan designation 27 Feb 2017 EMA/OD/256/16
EU/3/17/1840 Sirius Regulatory Consulting Limited Orphan designation 27 Feb 2017 EMA/OD/228/16
EU/3/17/1839 Y-mAbs Therapeutics A/S Orphan designation 27 Feb 2017 EMA/OD/271/16
EU/3/17/1838 Opsona Therapeutics Limited Orphan designation 27 Feb 2017 EMA/OD/273/16
EU/3/17/1837 Opsona Therapeutics Limited Orphan designation 27 Feb 2017 EMA/OD/272/16
EU/3/17/1836 Zogenix International Ltd Orphan designation 27 Feb 2017 EMA/OD/233/16
EU/3/17/1835 Ser-mes Planificación SL Orphan designation 27 Feb 2017 EMA/OD/283/16
EU/3/17/1834 Polyphor UK Ltd Orphan designation 27 Feb 2017 EMA/OD/244/16
EU/3/17/1833 Dr. Michael Hudecek Orphan designation 27 Feb 2017 EMA/OD/274/16
EU/3/17/1832 Advanced Medical Projects Orphan designation 27 Feb 2017 EMA/OD/080/15
EU/3/17/1831 Voisin Consulting S.A.R.L. Orphan designation 27 Feb 2017 EMA/OD/279/16
EU/3/17/1830 Voisin Consulting S.A.R.L. Orphan designation 27 Feb 2017 EMA/OD/229/16
EU/3/17/1829 Eirgen Pharma Limited Orphan designation 27 Feb 2017 EMA/OD/221/16
EU/3/17/1828 Vertex Pharmaceuticals (Europe) Limited Orphan designation 27 Feb 2017 EMA/OD/156/16
EU/3/16/1812 Biological Consulting Europe Ltd Corrigendum 16 Feb 2017
EU/3/16/1667 AbbVie Ltd Transfer of orphan designation 8 Feb 2017 EMA/OD/015/16
EU/3/15/1589 AMMTeK Transfer of orphan designation 8 Feb 2017 EMA/OD/149/15
EU/3/02/115 Toray International Europe GmbH Transfer of orphan designation 8 Feb 2017 EMA/OD/020/02
EU/3/16/1773 Atara Biotherapeutics Ireland Limited Transfer of orphan designation 26 Jan 2017 EMA/OD/151/16/T/01
EU/3/16/1627 Atara Biotherapeutics Ireland Limited Transfer of orphan designation 26 Jan 2017 EMA/OD/210/15/T/01
EU/3/12/972 Ultragenyx Germany GmbH Transfer of orphan designation 26 Jan 2017 EMA/OD/0126/11/T/03
EU/3/11/945 Amiculum Consulting Limited Transfer of orphan designation 26 Jan 2017 EMA/OD/105/11
EU/3/16/1827 Luis Pereira de Almeida Orphan designation 12 Jan 2017 EMA/OD/209/16
EU/3/16/1826 Hansa Medical AB Orphan designation 12 Jan 2017 EMA/OD/237/16
EU/3/16/1825 Ser-mes Planificación SL Orphan designation 12 Jan 2017 EMA/OD/226/16
EU/3/16/1824 VECT-HORUS Orphan designation 12 Jan 2017 EMA/OD/220/16
EU/3/16/1823 Regiomedica GmbH Orphan designation 12 Jan 2017 EMA/OD/189/16
EU/3/16/1822 Kyoto Tech Limited Orphan designation 12 Jan 2017 EMA/OD/130/16
EU/3/16/1821 Stichting Centre for Human Drug Research (CHDR) Orphan designation 12 Jan 2017 EMA/OD/097/16
EU/3/16/1820 Centre Hospitalier Universitaire d'Angers Orphan designation 12 Jan 2017 EMA/OD/213/16
EU/3/16/1819 Oncurious NV Orphan designation 12 Jan 2017 EMA/OD/240/16
EU/3/16/1818 Hep-Art Medical Devices BV Orphan designation 12 Jan 2017 EMA/OD/222/16
EU/3/16/1817 Coté Orphan Consulting UK Limited Orphan designation 12 Jan 2017 EMA/OD/191/16
EU/3/16/1816 Clinipace GmbH Orphan designation 12 Jan 2017 EMA/OD/194/16
EU/3/16/1815 Adare Pharmaceuticals srl Orphan designation 12 Jan 2017 EMA/OD/230/16
EU/3/16/1814 TREAT U, S.A. Orphan designation 12 Jan 2017 EMA/OD/250/16
EU/3/16/1813 Idogen AB Orphan designation 12 Jan 2017 EMA/OD/238/16
EU/3/16/1812 Biological Consulting Europe Ltd Orphan designation 12 Jan 2017 EMA/OD/241/16
EU/3/16/1811 Centre Hospitalier Universitaire de Lille Orphan designation 12 Jan 2017 EMA/OD/215/16
EU/3/16/1810 ProMetic Pharma SMT Limited Orphan designation 12 Jan 2017 EMA/OD/231/16
EU/3/16/1809 Institut Pasteur Orphan designation 12 Jan 2017 EMA/OD/205/16
EU/3/16/1808 TMC Pharma Services Ltd Orphan designation 12 Jan 2017 EMA/OD/243/16
EU/3/12/1043 Voisin Consulting S.A.R.L. Transfer of orphan designation 19 Dec 2016 EMA/OD/055/12/T/01
EU/3/11/874 Astellas Pharma Europe B.V. Transfer of orphan designation 19 Dec 2016 EMA/OD/173/10/T/01
EU/3/11/942 Jazz Pharmaceuticals Ireland Ltd Transfer of orphan designation 19 Dec 2016 EMA/OD/070/11/T/01
EU/3/16/1807 Mapi Ireland Limited Orphan designation 12 Dec 2016 EMA/OD/218/16
EU/3/16/1806 Ser-mes Planificación SL Orphan designation 12 Dec 2016 EMA/OD/195/16
EU/3/16/1805 The Anticancer Fund Orphan designation 12 Dec 2016 EMA/OD/166/16
EU/3/16/1804 Larode Ltd Orphan designation 12 Dec 2016 EMA/OD/193/16
EU/3/16/1803 Centro de Investigación Biomédica en Red (CIBER) Orphan designation 12 Dec 2016 EMA/OD/179/16
EU/3/16/1802 QRC Consultants Ltd Orphan designation 12 Dec 2016 EMA/OD/197/16
EU/3/16/1801 MediciNova (Europe) Limited Orphan designation 12 Dec 2016 EMA/OD/182/16
EU/3/16/1800 Alan Boyd Consultants Ltd Orphan designation 12 Dec 2016 EMA/OD/202/16
EU/3/16/1799 Albany Regulatory Consulting Limited Orphan designation 12 Dec 2016 EMA/OD/169/16
EU/3/16/1798 Merck Serono Europe Limited Orphan designation 12 Dec 2016 EMA/OD/170/16
EU/3/16/1797 Medsenic Orphan designation 12 Dec 2016 EMA/OD/208/16
EU/3/16/1796 Fondazione Telethon Orphan designation 12 Dec 2016 EMA/OD/165/16
EU/3/16/1795 Universitätsklinikum Tübingen (UKT) Orphan designation 12 Dec 2016 EMA/OD/190/16
EU/3/16/1794 Advanced Accelerator Applications Orphan designation 12 Dec 2016 EMA/OD/206/16
EU/3/01/056 Genzyme Europe B.V. Amendment of orphan designation 5 Dec 2016 EMA/OD/004/01
Methanesulfonyl A. Carlsson Research AB Refusal of orphan designation 2 Dec 2016 EMA/OD/079/16
Naltrexone Able AB Refusal of orphan designation 2 Dec 2016 EMA/OD/035/16
EU/3/09/715 Incyte Biosciences UK Ltd Corrigendum 18 Nov 2016
EU/3/05/288 Teva GmbH Transfer of orphan designation 18 Nov 2016 EMA/OD/011/05/T/03
EU/3/15/1486 Regintel Limited Transfer of orphan designation 18 Nov 2016 EMA/OD/327/14/T/02
EU/3/16/1793 Université de Montpellier Orphan designation 18 Nov 2016 EMA/OD/176/16
EU/3/16/1792 Valcuria AB Orphan designation 18 Nov 2016 EMA/OD/162/16
EU/3/16/1791 Dr Ulrich Granzer Orphan designation 18 Nov 2016 EMA/OD/159/16
EU/3/16/1790 Dr Ulrich Granzer Orphan designation 18 Nov 2016 EMA/OD/172/16
EU/3/16/1789 EMAS Pharma Limited Orphan designation 18 Nov 2016 EMA/OD/144/16
EU/3/16/1788 Lucane Pharma SA Orphan designation 18 Nov 2016 EMA/OD/185/16
EU/3/16/1787 Lucane Pharma SA Orphan designation 18 Nov 2016 EMA/OD/184/16
EU/3/16/1786 Voisin Consulting S.A.R.L. Orphan designation 18 Nov 2016 EMA/OD/183/16
EU/3/16/1785 Sensorion Orphan designation 18 Nov 2016 EMA/OD/114/16
EU/3/16/1784 MipSalus ApS Orphan designation 18 Nov 2016 EMA/OD/061/16
EU/3/16/1783 EMAS Pharma Limited Orphan designation 18 Nov 2016 EMA/OD/138/16
EU/3/16/1782 Université de Montpellier Orphan designation 18 Nov 2016 EMA/OD/173/16
EU/3/16/1781 APCure SAS Orphan designation 18 Nov 2016 EMA/OD/160/16
EU/3/16/1780 Janssen-Cilag International NV Orphan designation 18 Nov 2016 EMA/OD/178/16
EU/3/16/1779 Regeneron Ireland Orphan designation 18 Nov 2016 EMA/OD/186/16
EU/3/16/1778 Pharmalink AB Orphan designation 18 Nov 2016 EMA/OD/139/16
EU/3/16/1777 Chimerix UK Ltd Orphan designation 18 Nov 2016 EMA/OD/180/16
EU/3/16/1776 Université de Montpellier Orphan designation 18 Nov 2016 EMA/OD/174/16
EU/3/16/1775 Université de Montpellier Orphan designation 18 Nov 2016 EMA/OD/175/16
EU/3/16/1774 Fate Therapeutics, LTD Orphan designation 18 Nov 2016 EMA/OD/149/16
EU/3/16/1773 Atara Biotherapeutics Ireland Limited Orphan designation 18 Nov 2016 EMA/OD/151/16
EU/3/16/1772 Audentes Therapeutics UK Limited Orphan designation 18 Nov 2016 EMA/OD/133/16
EU/3/16/1771 Pharma Gateway AB Orphan designation 18 Nov 2016 EMA/OD/168/16
EU/3/16/1770 Minoryx Therapeutics S.L. Orphan designation 18 Nov 2016 EMA/OD/132/16
EU/3/16/1769 SynteractHCR Deutschland GmbH Orphan designation 18 Nov 2016 EMA/OD/187/16
EU/3/11/935 Horizon Pharma Ireland Limited Transfer of orphan designation 18 Nov 2016 EMA/OD/084/11/T/01
EU/3/14/1236 Medpace Finland OY Transfer of orphan designation 18 Nov 2016 EMA/OD/149/13/T/01
EU/3/14/1421 Incyte Biosciences UK Ltd Transfer of orphan designation 18 Nov 2016 EMA/OD/212/14/T/01
EU/3/09/716 Incyte Biosciences UK Ltd Transfer of orphan designation 18 Nov 2016 EMA/OD/121/09/T/01
EU/3/09/715 Incyte Biosciences UK Ltd Transfer of orphan designation 18 Nov 2016 EMA/OD/122/09/T/01
EU/3/02/111 Lucane Pharma SA Transfer of orphan designation 18 Nov 2016 EMA/OD/017/02/T/01
EU/3/10/769 CTI Life Sciences Ltd Transfer of orphan designation 18 Nov 2016 EMA/OD/057/10/T/02
EU/3/10/768 CTI Life Sciences Ltd Transfer of orphan designation 18 Nov 2016 EMA/OD019/10/T/02
EU/3/10/767 CTI Life Sciences Ltd Transfer of orphan designation 18 Nov 2016 EMA/OD/058/10/T/02
EU/3/12/997 Sirius Regulatory Consulting Limited Corrigendum 6 Jun 2012
EU/3/12/996 Sirius Regulatory Consulting Limited Corrigendum 6 Jun 2012
EU/3/12/993 Sirius Regulatory Consulting Limited Corrigendum 26 Apr 2012
Procedures for centrally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
FORTEKOR PLUS Elanco Europe Ltd. Centralised - Yearly update 12 Apr 2017
Dexdomitor Orion Corporation Centralised - Yearly update 29 Mar 2017
Porcilis ColiClos Intervet International B.V. Centralised - Renewal 29 Mar 2017 EMEA/V/C/002011/R/0006
Nobivac L4 Intervet International B.V. Centralised - Renewal 13 Mar 2017 EMEA/V/C/2010/R/07
Rabigen SAG2 VIRBAC S.A. Centralised - Yearly update 6 Mar 2017
Equip WNV Zoetis Belgium S.A. Centralised - Yearly update 27 Feb 2017
ERYSENG PARVO Laboratorios Hipra, S.A. Centralised - Yearly update 17 Feb 2017
Vectra 3D CEVA SANTE ANIMALE Centralised - Yearly update 17 Feb 2017
Trifexis Eli Lilly and Company Ltd, Elanco Animal Health Centralised - 2-Monthly update 17 Feb 2017 EMEA/V/C/002635/II/0008
Vectormune ND CEVA-Phylaxia Co. Ltd. Centralised - Yearly update 10 Feb 2017
Stronghold Plus Zoetis Belgium S.A. Corrigendum 9 Feb 2017
Stronghold Plus Zoetis Belgium S.A. Corrigendum 9 Feb 2017
Stronghold Plus Zoetis Belgium S.A. Centralised - Authorisation 9 Feb 2017 EMEA/V/C/004194/0000
EQUIOXX Merial Centralised - Variation 9 Feb 2017 EMEA/V/C/142/X/15
VarroMed BeeVital GmbH Centralised - Authorisation 2 Feb 2017 EMEA/V/C/002723
Simparica Zoetis Belgium S.A. Centralised - Yearly update 18 Jan 2017
Nobilis IB 4-91 Intervet International B.V. Centralised - Yearly update 18 Jan 2017
Novaquin Le Vet Beheer B.V. Centralised - Yearly update 9 Jan 2017
Coliprotec F4/F18 Prevtec Microbia GmbH Centralised - Authorisation 9 Jan 2017 EMEA/V/C/004225/0000
Porcilis PCV M Hyo Intervet International B.V. Centralised - Yearly update 14 Dec 2016
Versican Plus DHPPi/L4R Zoetis Belgium S.A. Centralised - 2-Monthly update 14 Dec 2016 EMEA/V/C/2759/WS/936
Versican Plus DHPPi/L4 Zoetis Belgium S.A. Centralised - 2-Monthly update 14 Dec 2016 EMEA/V/C/3678/WS/936
Versican Plus DHPPi Zoetis Belgium S.A. Centralised - 2-Monthly update 14 Dec 2016 EMEA/V/C/3679/WS/936
Activyl Tick Plus Intervet International B.V. Centralised - Renewal 14 Dec 2016 EMEA/V/C/2234/R/09
Parvoduk Merial Centralised - Yearly update 13 Dec 2016
Cepedex CP Pharma Handelsgesellschaft mbH Centralised - Authorisation 13 Dec 2016 EMEA/V/C/4376
Halagon Emdoka bvba Centralised - Authorisation 13 Dec 2016 EMEA/V/C/4201
Zulvac 1+8 Bovis Zoetis Belgium S.A. Centralised - Renewal 13 Dec 2016 EMEA/V/C/2473/R/09
BROADLINE Merial Centralised - Yearly update 29 Nov 2016
Sileo Orion Corporation Centralised - Yearly update 11 Nov 2016
Semintra Boehringer Ingelheim Vetmedica GmbH Corrigendum 9 Nov 2016
Semintra Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 9 Nov 2016
Inflacam Chanelle Pharmaceuticals Manufacturing Limited Centralised - Renewal 9 Nov 2016 EMEA/V/C/2497/R/11
Draxxin Zoetis Belgium S.A. Centralised - Variation 9 Nov 2016 EMEA/V/C/77/X/29
Fungitraxx Avimedical B.V. Centralised - Yearly update 3 Nov 2016
Sedadex Le Vet Beheer B.V. Corrigendum 12 Aug 2016
Procedures for nationally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
dienogest/ethinylestradiol containing medicinal products indicated in acne Referral 22 Mar 2017 EMEA/H/A-31/1435
Lovenox and associated names Referral 9 Mar 2017 EMEA/H/A-30/1429
pramipexole PSUSA - Modification 16 Feb 2017 EMEA/H/C/PSUSA/2491/201604
Metformin Corrigendum 12 Dec 2016
Metformin Referral 12 Dec 2016 EMEA/H/A-31/1432
Pharmaceutics International Inc Referral 5 Dec 2016 EMEA/H/A-31/1444
levetiracetam PSUSA - Modification 14 Nov 2016 EMEA/H/C/PSUSA/1846/201511
Clenil and associated names Referral 11 Nov 2016 EMEA/H/A-30/1418
Durogesic and associated names Corrigendum 22 Sep 2016
Iron containing intravenous medicinal products Corrigendum 13 Sep 2013
Procedures for nationally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Gentamicin - Veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs Referral 27 Feb 2017 EMEA/V/A/117