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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
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
Kalydeco Vertex Pharmaceuticals (Europe) 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
Quinsair Horizon Pharma Europe B.V. Centralised - Yearly update 16 Feb 2017
Forsteo Eli Lilly Nederland B.V. Centralised - Yearly update 16 Feb 2017
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
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 Sanofi Pasteur MSD SAS 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
Picato LEO Laboratories Ltd. Centralised - Transfer Marketing Authorisation Holder 26 Jan 2017 EMEA/H/C/2275/T/22
Voriconazole Hikma Hikma Farmacęutica (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
Tadalafil Generics 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 Bohumil, s.r.o. 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
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
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 & CŞ, 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
Somatropin Biopartners BioPartners GmbH Centralised - Yearly update 24 Oct 2016
Evicel Omrix Biopharmaceuticals N.V. Centralised - Yearly update 24 Oct 2016
Raplixa Mallinckrodt Pharmaceuticals Ireland Limited Centralised - Yearly update 24 Oct 2016
ZALTRAP Sanofi-Aventis groupe Centralised - 2-Monthly update 24 Oct 2016 EMEA/H/C/2532/II/26
Cholib Mylan Products Limited Centralised - Transfer Marketing Authorisation Holder 21 Oct 2016 EMEA/H/C/2559/T/15
Glybera uniQure biopharma B.V. Corrigendum 21 Oct 2016
Caprelsa Genzyme Europe B.V. Rectificative Decision 21 Oct 2016
Olanzapine Teva Teva B.V. Centralised - Yearly update 21 Oct 2016
NovoRapid Novo Nordisk A/S Centralised - 2-Monthly update 21 Oct 2016 EMEA/H/C/258/II/112
Blincyto Amgen Europe B.V. Centralised - 2-Monthly update 21 Oct 2016 EMEA/H/C/3731/II/03
Lynparza AstraZeneca AB Centralised - 2-Monthly update 21 Oct 2016 EMEA/H/C/3726/II/8
BeneFIX Pfizer Limited Centralised - Yearly update 21 Oct 2016
Metalyse Boehringer Ingelheim International GmbH Centralised - Yearly update 21 Oct 2016
Prevenar 13 Pfizer Limited Centralised - Yearly update 21 Oct 2016
ADCETRIS Takeda Pharma A/S Centralised - Annual reassessment 21 Oct 2016 EMEA/H/C/2455/R/35
Zerbaxa Merck Sharp & Dohme Limited Centralised - Yearly update 14 Oct 2016
Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 14 Oct 2016
Stivarga Bayer Pharma AG Centralised - Yearly update 14 Oct 2016
Lixiana Daiichi Sankyo Europe GmbH Centralised - Yearly update 14 Oct 2016
Ristempa Amgen Europe B.V. Centralised - Yearly update 14 Oct 2016
Pegasys Roche Registration Limited Centralised - 2-Monthly update 14 Oct 2016 EMEA/H/C/395/II/89
VPRIV Shire Pharmaceuticals Ireland Limited Rectificative Decision 14 Oct 2016
Onivyde Baxalta Innovations GmbH Centralised - Authorisation 14 Oct 2016 EMEA/H/C/4125
Replagal Shire Human Genetic Therapies AB Centralised - Yearly update 6 Oct 2016
Imatinib Teva Teva B.V. Centralised - 2-Monthly update 6 Oct 2016 EMEA/H/C/2585/IB/18
Pregabalin Sandoz Sandoz GmbH Centralised - Yearly update 6 Oct 2016
Cometriq Ipsen Pharma Centralised - Transfer Marketing Authorisation Holder 30 Sep 2016 EMEA/H/C/2640/T/23
Moventig Kyowa Kirin Limited Centralised - Transfer Marketing Authorisation Holder 30 Sep 2016 EMEA/H/C/2810/T/11
Vantobra PARI Pharma GmbH Centralised - Yearly update 30 Sep 2016
ALPROLIX Swedish Orphan Biovitrum AB (publ) Centralised - Transfer Marketing Authorisation Holder 30 Sep 2016 EMEA/H/C/4142/T/0001
Trajenta Boehringer Ingelheim International GmbH Rectificative Decision 30 Sep 2016
Tivicay ViiV Healthcare UK Limited Centralised - Yearly update 26 Sep 2016
Nuwiq Octapharma AB Centralised - Yearly update 26 Sep 2016
Colobreathe Teva B.V. Centralised - Renewal 26 Sep 2016 EMEA/H/C/1225/R/24
Pregabalin Sandoz GmbH Sandoz GmbH Centralised - Yearly update 22 Sep 2016
EVARREST Omrix Biopharmaceuticals N.V. Centralised - Yearly update 22 Sep 2016
Leflunomide ratiopharm ratiopharm GmbH Centralised - Yearly update 22 Sep 2016
Instanyl Takeda Pharma A/S Centralised - Yearly update 22 Sep 2016
Stayveer Marklas Nederland B.V. PSUSA - Modification 22 Sep 2016 EMEA/H/C/2644/PSUSA/425/201511
Blincyto Amgen Europe B.V. Centralised - Annual renewal 22 Sep 2016 EMEA/H/C/3731/R/04
Zelboraf Roche Registration Limited Centralised - Renewal 22 Sep 2016 EMEA/H/C/2409/R/34
Anoro Glaxo Group Ltd PSUSA - Modification 22 Sep 2016 EMEA/H/C/2751/PSUSA/10264/201512
Victoza Novo Nordisk A/S PSUSA - Modification 22 Sep 2016 EMEA/H/C/1026/PSUSA/1892/201512
Saxenda Novo Nordisk A/S PSUSA - Modification 22 Sep 2016 EMEA/H/C/3780/PSUSA/1892/201512
Vantavo Merck Sharp & Dohme Limited Centralised - Yearly update 19 Sep 2016
Soliris Alexion Europe SAS Centralised - Yearly update 19 Sep 2016
PANTECTA Control Takeda GmbH, (HRB 701016) Centralised - Withdrawal 19 Sep 2016
Enbrel Pfizer Limited Centralised - Yearly update 19 Sep 2016
Protopic Leo Pharma A/S Rectificative Decision 19 Sep 2016 EMEA/H/C/374/T/64
Truberzi Allergan Pharmaceuticals International Limited Centralised - Authorisation 19 Sep 2016 EMEA/H/C/4098
Repaglinide Accord Accord Healthcare Limited Centralised - Renewal 19 Sep 2016 EMEA/H/C/2318/R/05
Sovaldi Gilead Sciences International Limited PSUSA - Modification 19 Sep 2016 EMEA/H/C/2798/PSUSA/10134/201512
Adrovance Merck Sharp & Dohme Limited Centralised - Renewal 19 Sep 2016 EMEA/H/C/759/R/36
Fycompa Eisai Europe Limited Centralised - Variation 19 Sep 2016 EMEA/H/C/2434/X/25
Zydelig Gilead Sciences International Limited Centralised - 2-Monthly update 19 Sep 2016 EMEA/H/C/3843/II/11
Lamivudine Teva Pharma B.V. Teva B.V. Centralised - 2-Monthly update 16 Sep 2016 EMEA/H/C/1111/IB/17/G
PANTECTA Control Takeda GmbH, (HRB 701016) Centralised - Yearly update 15 Sep 2016
Trulicity Eli Lilly Nederland B.V. Centralised - Yearly update 15 Sep 2016
Arava Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 15 Sep 2016
Intelence Janssen-Cilag International NV Centralised - Yearly update 15 Sep 2016
Ibandronic Acid Teva Teva B.V. Centralised - Yearly update 15 Sep 2016
Fosavance Merck Sharp & Dohme Limited Centralised - Yearly update 15 Sep 2016
Arixtra Aspen Pharma Trading Limited PSUSA - Modification 15 Sep 2016 EMEA/H/C/PSUSA/1467/201512
Mysildecard Mylan S.A.S Centralised - Authorisation 15 Sep 2016 EMEA/H/C/4186/00
Inhixa Techdow Europe AB Centralised - Authorisation 15 Sep 2016 EMEA/H/C/004264/0000
Thorinane Pharmathen S.A. Centralised - Authorisation 15 Sep 2016 EMEA/H/C/003795/0000
Tenofovir disoproxil Zentiva Zentiva, k.s. Centralised - Authorisation 15 Sep 2016 EMEA/H/C/4120
Sialanar Proveca Limited Centralised - Authorisation 15 Sep 2016 EMEA/H/C/3883
Evoltra Genzyme Europe B.V. PSUSA - Modification 15 Sep 2016 EMEA/H/C/PSUSA/805/201512
Ganfort Allergan Pharmaceuticals Ireland, (514125) PSUSA - Modification 15 Sep 2016 EMEA/H/C/668/PSUSA/2961/201511
Zydelig Gilead Sciences International Limited Referral 15 Sep 2016 : EMEA/H/A-20/1439/C/3843/0023
Velphoro Vifor Fresenius Medical Care Renal Pharma France Centralised - Yearly update 9 Sep 2016
Tracleer Actelion Registration Ltd PSUSA - Modification 9 Sep 2016 EMEA/H/C/401/PSUSA/425/201511
Ameluz Biofrontera Bioscience GmbH Centralised - 2-Monthly update 9 Sep 2016 EMEA/H/C/2204/II/20
Elaprase Shire Human Genetic Therapies AB Centralised - Renewal 9 Sep 2016 EMEA/H/C/700/R/65
CABOMETYX Ipsen Pharma Centralised - Authorisation 9 Sep 2016 EMEA/H/C/4163
Efavirenz Teva Teva B.V. Centralised - Renewal 9 Sep 2016 EMEA/H/C/2352/R/18
Tandemact Takeda Pharma A/S Centralised - Renewal 9 Sep 2016 EMEA/H/C/680/R/49
Laventair Glaxo Group Ltd PSUSA - Modification 9 Sep 2016 EMEA/H/C/3754/00010264/201512
Revlimid Celgene Europe Limited PSUSA - Modification 9 Sep 2016 EMEA/H/C/PSUSA/1838/201512
Eurartesim Sigma-Tau Industrie Farmaceutiche Riunite S.p.A Centralised - Renewal 9 Sep 2016 EMEA/H/C/1199/R/23
Xolair Novartis Europharm Limited PSUSA - Modification 9 Sep 2016 EMEA/H/C/606/PSUSA/2214/201512
Caprelsa Genzyme Europe B.V. Centralised - Transfer Marketing Authorisation Holder 8 Sep 2016 EMEA/H/C/2315/T/22
Lucentis Novartis Europharm Limited Centralised - Yearly update 8 Sep 2016
Betaferon Bayer Pharma AG Centralised - Yearly update 8 Sep 2016
Budesonide/Formoterol Teva Pharma B.V. Teva Pharma B.V. Centralised - Yearly update 8 Sep 2016
DUAVIVE Pfizer Limited Centralised - Yearly update 8 Sep 2016
Panretin Eisai Limited Centralised - Yearly update 8 Sep 2016
Plegridy Biogen Idec Limited Centralised - Yearly update 8 Sep 2016
Protaphane Novo Nordisk A/S Centralised - Yearly update 8 Sep 2016
Insulatard Novo Nordisk A/S Centralised - Yearly update 8 Sep 2016
Levetiracetam Actavis Actavis Group PTC ehf. Centralised - Renewal 8 Sep 2016 EMEA/H/C/2355/R/13
Nimvastid Krka, d. d., Novo Mesto Centralised - Yearly update 5 Sep 2016
Ofev Boehringer Ingelheim International GmbH Corrigendum 2 Sep 2016
Extavia Novartis Europharm Limited Centralised - Yearly update 2 Sep 2016
Kengrexal Chiesi Farmaceutici S.P.A. Centralised - Transfer Marketing Authorisation Holder 2 Sep 2016 EMEA/H/C/3773/T/0004
Enzepi Allergan Pharmaceuticals International Limited Centralised - Transfer Marketing Authorisation Holder 2 Sep 2016 EMEA/H/C/2070/T/0001
Ofev Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 2 Sep 2016 EMEA/H/C/003821/II/0006
Ketoconazole HRA Laboratoire HRA Pharma PSUSA - Modification 31 Aug 2016 EMEA/H/C/3906/PSUSA/10316/201511
Renagel Genzyme Europe B.V. PSUSA - Modification 31 Aug 2016 EMEA/H/C/254/PSUSA/00002697/201510
Zurampic Grünenthal GmbH Centralised - Transfer Marketing Authorisation Holder 25 Aug 2016 EMEA/H/C/3932/T/03
Revestive Shire Pharmaceuticals Ireland Limited Centralised - Transfer Marketing Authorisation Holder 25 Aug 2016 EMEA/H/C/2345/T/30
Kisplyx Eisai Europe Limited Centralised - Authorisation 25 Aug 2016 EMEA/H/C/4224/00
XALKORI Pfizer Limited Centralised - 2-Monthly update 25 Aug 2016 EMEA/H/C/2489/II/39
IMBRUVICA Janssen-Cilag International NV Centralised - 2-Monthly update 25 Aug 2016 EMEA/H/C/3791/II/17/G
Iclusig Incyte Biosciences UK Ltd Centralised - 2-Monthly update 25 Aug 2016 EMEA/H/C/2695/II/27
VPRIV Shire Pharmaceuticals Ireland Limited Centralised - 2-Monthly update 25 Aug 2016 EMEA/H/C/1249/II/32
Orencia Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 25 Aug 2016 EMEA/H/C/701/II/97
Tasermity Genzyme Europe B.V. PSUSA - Modification 25 Aug 2016 EMEA/H/C/PSUSA/2697/201510
Renvela Genzyme Europe B.V. PSUSA - Modification 25 Aug 2016 EMEA/H/C/993/PSUSA/2697/201510
Eylea Bayer Pharma AG Corrigendum 16 Aug 2016
Cervarix GlaxoSmithKline Biologicals S.A. Corrigendum 29 Jul 2016
Pemetrexed Fresenius Kabi Fresenius Kabi Oncology Plc. Corrigendum 22 Jul 2016
Pemetrexed Fresenius Kabi Fresenius Kabi Oncology Plc. Corrigendum 22 Jul 2016
Sprycel Bristol-Myers Squibb Pharma EEIG Corrigendum 15 Jul 2016
Luminity Lantheus MI UK Limited Corrigendum 15 Jul 2016
Zinbryta Biogen Idec Limited Corrigendum 1 Jul 2016
Zinbryta Biogen Idec Limited Corrigendum 1 Jul 2016
Neparvis Novartis Europharm Limited Corrigendum 26 May 2016
Trevicta Janssen-Cilag International NV Corrigendum 26 May 2016
Trevicta Janssen-Cilag International NV Corrigendum 13 Apr 2016
Kadcyla Roche Registration Limited Corrigendum 22 Jan 2016
Yellox PharmaSwiss Ceská republika s.r.o. Corrigendum 11 Jan 2016
Votubia Novartis Europharm Limited Corrigendum 10 Dec 2015
Entresto Novartis Europharm Limited Corrigendum 19 Nov 2015
Trevicta Janssen-Cilag International NV Corrigendum 5 Dec 2014
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
EU/3/16/1812 Biological Consulting Europe Ltd Corrigendum 16 Feb 2017
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
EU/3/16/1627 Atara Biotherapeutics Ireland Limited Transfer of orphan designation 26 Jan 2017
EU/3/12/972 Ultragenyx Germany GmbH Transfer of orphan designation 26 Jan 2017
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/3/10/798 Diurnal Limited Transfer of orphan designation 14 Oct 2016 EMA/OD/038/10/T/02
EU/3/16/1768 Neuroprotexeon Ltd Orphan designation 14 Oct 2016 EMA/OD/109/16
EU/3/16/1767 AbbVie Ltd Orphan designation 14 Oct 2016 EMA/OD/121/16
EU/3/16/1766 AbbVie Ltd Orphan designation 14 Oct 2016 EMA/OD/122/16
EU/3/16/1765 Centro de Investigación Biomédica en Red (CIBER) Orphan designation 14 Oct 2016 EMA/OD/153/16
EU/3/16/1764 ProActina Orphan designation 14 Oct 2016 EMA/OD/143/16
EU/3/16/1763 Coté Orphan Consulting UK Limited Orphan designation 14 Oct 2016 EMA/OD/150/16
EU/3/16/1762 Ra Europe Limited Orphan designation 14 Oct 2016 EMA/OD/107/16
EU/3/16/1761 Ser-mes Planificación SL Orphan designation 14 Oct 2016 EMA/OD/164/16
EU/3/16/1760 PharmaLex UK Services Limited Orphan designation 14 Oct 2016 EMA/OD/090/16
EU/3/16/1759 Pharma Gateway AB Orphan designation 14 Oct 2016 EMA/OD/161/16
EU/3/16/1758 Clinical Network Services (UK) Ltd Orphan designation 14 Oct 2016 EMA/OD/155/16
EU/3/16/1757 Imago BioSciences Ltd. Orphan designation 14 Oct 2016 EMA/OD/115/16
EU/3/16/1756 Kyowa Kirin Limited Orphan designation 14 Oct 2016 EMA/OD/091/16
EU/3/16/1755 Therapicon Srl Orphan designation 14 Oct 2016 EMA/OD/127/16
EU/3/16/1754 Ipsen Pharma Orphan designation 14 Oct 2016 EMA/OD/089/16
EU/3/16/1753 Centro de Investigación Biomédica en Red (CIBER) Orphan designation 14 Oct 2016 EMA/OD/154/16
EU/3/16/1752 Pfizer Limited Orphan designation 14 Oct 2016 EMA/OD/093/16
EU/3/16/1751 Clinipace GmbH Orphan designation 14 Oct 2016 EMA/OD/131/16
EU/3/16/1750 Eiger Biopharmaceuticals Europe Limited Orphan designation 14 Oct 2016 EMA/OD/065/16
EU/3/16/1749 Arog Pharmaceuticals Europe Ltd Orphan designation 14 Oct 2016 EMA/OD/129/16
EU/3/16/1748 Arog Pharmaceuticals Europe Ltd Orphan designation 14 Oct 2016 EMA/OD/147/16
EU/3/16/1747 Swedish Orphan Biovitrum AB (publ) Orphan designation 14 Oct 2016 EMA/OD/142/16
EU/3/16/1746 University of Newcastle upon Tyne Orphan designation 14 Oct 2016 EMA/OD/148/16
EU/3/16/1745 Novartis Europharm Limited Orphan designation 14 Oct 2016 EMA/OD/087/16
EU/3/16/1744 BrainRepair UG (haftungsbeschränkt) Orphan designation 14 Oct 2016 EMA/OD/099/16
EU/3/16/1743 BrainRepair UG (haftungsbeschränkt) Orphan designation 14 Oct 2016 EMA/OD/141/16
EU/3/16/1742 Therapicon Srl Orphan designation 14 Oct 2016 EMA/OD/128/16
EU/3/16/1741 HORAMA SA Orphan designation 14 Oct 2016 EMA/OD/146/16
EU/3/16/1740 Alacrita LLP Orphan designation 14 Oct 2016 EMA/OD/158/16
EU/3/16/1739 Philogen S.p.A. Orphan designation 14 Oct 2016 EMA/OD/108/16
EU/3/16/1738 F2G Ltd Orphan designation 14 Oct 2016 EMA/OD/104/16
EU/3/16/1737 Voisin Consulting S.A.R.L. Orphan designation 14 Oct 2016 EMA/OD/123/16
EU/3/16/1736 TMC Pharma Services Ltd Orphan designation 14 Oct 2016 EMA/OD/100/16
EU/3/14/1240 Horizon Pharma Europe B.V. Transfer of orphan designation 6 Oct 2016 EMA/OD/159/13/T/01
EU/3/13/1122 Vudbenk Life Science Kft. Transfer of orphan designation 29 Sep 2016 EMA/OD/183/12/T/01
EU/3/15/1474 Dorian Regulatory Affairs BV Transfer of orphan designation 26 Sep 2016 EMA/OD/295/14/T/01
EU/3/08/610 Ipsen Pharma Transfer of orphan designation 26 Sep 2016 EMA/OD/088/08/T/02
EU/3/12/973 Ultragenyx Germany GmbH Transfer of orphan designation 26 Sep 2016 EMA/OD/127/11/T/03
EU/3/11/850 IDEA Innovative Drug European Associates Limited Transfer of orphan designation 26 Sep 2016 EMA/OD/112/10/T/01
EU/3/15/1455 Kamada BioPharma Limited Transfer of orphan designation 26 Sep 2016 EMA/OD/267/14
EU/3/13/1157 Voisin Consulting S.A.R.L. Transfer of orphan designation 26 Sep 2016 EMA/OD/047/13/T/02
EU/3/13/1125 Voisin Consulting S.A.R.L. Transfer of orphan designation 26 Sep 2016 EMA/OD/196/12/T/02
EU/3/07/453 Swedish Orphan Biovitrum AB (publ) Transfer of orphan designation 26 Sep 2016 EMA/OD/012/07/T/02
EU/3/05/333 Savara ApS Transfer of orphan designation 26 Sep 2016 EMA/OD/063/05/T/02
EU/3/08/565 Savara ApS Transfer of orphan designation 26 Sep 2016 EMA/OD/099/06/T/01
EU/3/16/1685 Savara ApS Transfer of orphan designation 26 Sep 2016
EU/3/13/1147 Savara ApS Transfer of orphan designation 26 Sep 2016 EMA/OD/106/12/T/01
EU/3/13/1136 Sirius Regulatory Consulting Limited Transfer of orphan designation 26 Sep 2016 EMA/OD/034/13/T/02
EU/3/15/1589 AMMTeK Transfer of orphan designation 26 Sep 2016 EMA/OD/149/15/T/01
EU/3/13/1215 Shire Pharmaceutical Ireland limited Transfer of orphan designation 5 Sep 2016 EMA/OD/121/13/T/01
EU/3/13/1214 Shire Pharmaceutical Ireland limited Transfer of orphan designation 5 Sep 2016 EMA/OD/120/13/T/01
EU/3/02/091 Dr Ulrich Granzer Transfer of orphan designation 5 Sep 2016 EMEA/OD/073/01/T/01
EU/3/15/1486 Regintel Limited Transfer of orphan designation 5 Sep 2016 EMA/OD/327/14/T/01
EU/3/13/1217 Shire Pharmaceutical Ireland limited Transfer of orphan designation 5 Sep 2016 EMA/OD/127/13/T/01
EU/3/13/1216 Shire Pharmaceutical Ireland limited Transfer of orphan designation 5 Sep 2016 EMA/OD/123/13/T/01
EU/3/09/660 Dr Ulrich Granzer Transfer of orphan designation 5 Sep 2016 EMEA/OD/030/09/T/01
EU/3/15/1457 Daiichi Sankyo Europe GmbH Transfer of orphan designation 5 Sep 2016 EMA/OD/279/14/T/01
EU/3/16/1726 NanoMedSyn Corrigendum 29 Aug 2016
EU/3/16/1735 Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A. Orphan designation 29 Aug 2016 EMA/OD/067/16
EU/3/16/1734 Vall d'Hebron Institute of Research Orphan designation 29 Aug 2016 EMA/OD/073/16
EU/3/16/1733 Double Bond Pharmaceutical AB Orphan designation 29 Aug 2016 EMA/OD/085/16
EU/3/16/1732 Biogen Idec Limited Orphan designation 29 Aug 2016 EMA/OD/120/16
EU/3/16/1731 Alnylam UK Limited Orphan designation 29 Aug 2016 EMA/OD/125/16
EU/3/16/1730 Lucane Pharma SA Orphan designation 29 Aug 2016 EMA/OD/056/16
EU/3/16/1729 Lucane Pharma SA Orphan designation 29 Aug 2016 EMA/OD/055/16
EU/3/16/1728 Alexion Europe SAS Orphan designation 29 Aug 2016 EMA/OD/118/16
EU/3/16/1727 Coté Orphan Consulting UK Limited Orphan designation 29 Aug 2016 EMA/OD/116/16
EU/3/16/1726 NanoMedSyn Orphan designation 29 Aug 2016 EMA/OD/098/16
EU/3/16/1725 Akari Therapeutics Plc Orphan designation 29 Aug 2016 EMA/OD/077/16
EU/3/16/1724 Boehringer Ingelheim International GmbH Orphan designation 29 Aug 2016 EMA/OD/095/16
EU/3/16/1723 aimAKU (Associazione Italiana Malati di Alcaptonuria) Orphan designation 29 Aug 2016 EMA/OD/086/16
EU/3/16/1722 AB Science Orphan designation 29 Aug 2016 EMA/OD/081/16
EU/3/16/1721 Araim Pharma Europe Ltd Orphan designation 29 Aug 2016 EMA/OD/094/16
EU/3/16/1720 PCI Biotech AS Orphan designation 29 Aug 2016 EMA/OD/111/16
EU/3/16/1719 PlumeStars s.r.l. Orphan designation 29 Aug 2016 EMA/OD/101/16
EU/3/16/1718 Richardson Associates Regulatory Affairs Ltd Orphan designation 29 Aug 2016 EMA/OD/110/16
EU/3/16/1717 Videregen Ltd Orphan designation 29 Aug 2016 EMA/OD/069/16
EU/3/16/1716 Advanced Biotherapeutics Consulting SARL Orphan designation 29 Aug 2016 EMA/OD/096/16
EU/3/16/1715 MeiraGTx UK II Limited Orphan designation 29 Aug 2016 EMA/OD/102/16
EU/3/16/1714 Coté Orphan Consulting UK Limited Orphan designation 29 Aug 2016 EMA/OD/119/16
EU/3/16/1713 F2G Ltd Orphan designation 29 Aug 2016 EMA/OD/106/16
EU/3/16/1712 Galapagos NV Orphan designation 29 Aug 2016 EMA/OD/088/16
EU/3/14/1353 Lupin (Europe) Limited Corrigendum 18 Aug 2016
Procedures for centrally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Vectormune ND CEVA-Phylaxia Co. Ltd. Centralised - Yearly update 10 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 EMA/CVMP/618757/2016
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
Meloxidyl CEVA SANTE ANIMALE Centralised - Yearly update 3 Oct 2016
Hiprabovis IBR Marker Live Laboratorios Hipra, S.A. Centralised - Yearly update 3 Oct 2016
Coliprotec F4 Prevtec Microbia GmbH Centralised - Yearly update 28 Sep 2016
ERAVAC Laboratorios Hipra, S.A. Centralised - Authorisation 22 Sep 2016 EMEA/V/C/4239/00
Reconcile Nexcyon Pharmaceuticals Ltd Centralised - Transfer Marketing Authorisation Holder 19 Sep 2016 EMEA/V/C/133/T/16
Panacur AquaSol Intervet International B.V. Centralised - Renewal 26 Aug 2016 EMEA/V/C/2008/R/11
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
pramipexole PSUSA - Modification 16 Feb 2017 EMEA/H/C/PSUSA/2491/201604
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
Saizen (and associated names) and Humatrope (and associated names) Corrigendum 10 Oct 2016
bosentan PSUSA - Modification 6 Oct 2016 EMEA/H/C/PSUSA/425/201511
Durogesic and associated names Corrigendum 22 Sep 2016
Diclofenac 50 mg tablets Referral 22 Sep 2016 EMEA/H/A-29(4)/1434
Durogesic and associated names Referral 22 Sep 2016 EMEA/H/A-30/1413
Semler Referral 22 Sep 2016 EMEA/H/A-31/1443
Alkem Referral 8 Sep 2016 EMEA/H/A-31/1436
Sevelamer PSUSA - Modification 25 Aug 2016 EMEA/H/C/PSUSA/2697/201510