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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
Evra Janssen-Cilag International NV Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/410/II/41
Rapamune Pfizer Limited Centralised - Yearly update 23 Jun 2017
Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 23 Jun 2017 EMEA/H/C/3963/T/05
Clopidogrel Teva Teva B.V. Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/1053/IB/42/G
Izba Novartis Europharm Limited Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/002738/II/0005
KEYTRUDA Merck Sharp & Dohme Limited Centralised - 2-Monthly update 23 Jun 2017 EMEA/H/C/003820/II/0025
Revestive Shire Pharmaceuticals Ireland Limited Centralised - Renewal 23 Jun 2017 EMEA/H/C/2345/R/38, EMEA/H/C/2345/X/29
Farydak Novartis Europharm Limited PSUSA - Modification 23 Jun 2017 EMEA/H/C/PSUSA/00010409/201608
Sebivo Novartis Europharm Limited PSUSA - Modification 23 Jun 2017 EMEA/H/C/PSUSA/00002880/201608
Mysimba Orexigen Therapeutics Ireland Limited PSUSA - Modification 23 Jun 2017 EMEA/H/C/3687/PSUSA/10366/201609
Xarelto Bayer AG PSUSA - Modification 23 Jun 2017 EMEA/H/C/944/PSUSA/2653/201609
Prolia Amgen Europe B.V. PSUSA - Modification 23 Jun 2017 EMEA/H/C/1120/PSUSA/954/201609
Skilarence Almirall, S.A. Centralised - Authorisation 23 Jun 2017 EMEA/H/C/2157
Ucedane Lucane Pharma Centralised - Authorisation 23 Jun 2017 EMEA/H/C/4019
Kevzara Sanofi-Aventis groupe Centralised - Authorisation 23 Jun 2017 EMEA/H/C/004254/0000
Erelzi Sandoz GmbH Centralised - Authorisation 23 Jun 2017 EMEA/H/C/004192/0000
Tadalafil Mylan Generics [UK] Limited Referral 23 Jun 2017 EMEA/H/A31/1450/C/3787/05
Sivextro Merck Sharp & Dohme Limited Centralised - Yearly update 16 Jun 2017
Trizivir ViiV Healthcare UK Limited Centralised - Yearly update 16 Jun 2017
Cubicin Merck Sharp & Dohme Limited PSUSA - Modification 16 Jun 2017 EMEA/H/C/PSUSA/00000931/201609
Xgeva Amgen Europe B.V. PSUSA - Modification 16 Jun 2017 EMEA/H/C/2173/PSUSA/9119/201609
Intuniv Shire Pharmaceuticals Ireland Limited PSUSA - Modification 16 Jun 2017 EMEA/H/C/3759/PSUSA/10413/201609
Sirturo Janssen-Cilag International NV PSUSA - Modification 16 Jun 2017
Atriance Novartis Europharm Limited Centralised - Renewal 16 Jun 2017 EMEA/H/C/752/R/37
Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Renewal 16 Jun 2017 EMEA/H/C/2568/R/17
KEYTRUDA Merck Sharp & Dohme Limited PSUSA - Modification 16 Jun 2017 EMEA/H/C/3820/PSUSA/00010403/201609
Translarna PTC Therapeutics International Limited Centralised - Annual renewal 16 Jun 2017 EMEA/H/C/2720/R/32
Xagrid Shire Pharmaceutical Contracts Ltd PSUSA - Modification 16 Jun 2017 EMEA/H/C/480/PSUSA/208/201609
Eporatio ratiopharm GmbH Centralised - Yearly update 15 Jun 2017
Clopidogrel Mylan Mylan S.A.S Centralised - 2-Monthly update 15 Jun 2017 EMEA/H/C/1134/IB/35/G
Clopidogrel Teva Pharma Teva B.V. Centralised - Withdrawal 15 Jun 2017
Riximyo Sandoz GmbH Centralised - Authorisation 15 Jun 2017 EMEA/H/C/004729/0000
Febuxostat Mylan Mylan S.A.S. Centralised - Authorisation 15 Jun 2017 EMEA/H/C/4374
Rixathon Sandoz GmbH Centralised - Authorisation 15 Jun 2017 EMEA/H/C/3903
Zometa Novartis Europharm Limited PSUSA - Modification 15 Jun 2017 EMEA/H/C/336/PSUSA/3149/201608
AUBAGIO Sanofi-Aventis groupe PSUSA - Modification 15 Jun 2017 EMEA/H/C/PSUSA/00010135/201609
Nexium Control Pfizer Consumer Healthcare Limited Centralised - Variation 15 Jun 2017 EMEA/H/C/2618/X/16
Biopoin Teva GmbH Centralised - Yearly update 12 Jun 2017
Stivarga Bayer Pharma AG PSUSA - Modification 12 Jun 2017 EMEA/H/C/PSUSA/00010133/201609
ellaOne Laboratoire HRA Pharma Centralised - Yearly update 8 Jun 2017
Nplate Amgen Europe B.V. Centralised - Yearly update 2 Jun 2017
Cerezyme Genzyme Europe B.V. Centralised - Yearly update 2 Jun 2017
Caspofungin Accord Accord Healthcare Limited Centralised - Yearly update 2 Jun 2017
Somavert Pfizer Limited Centralised - Yearly update 2 Jun 2017
PecFent Archimedes Development Ltd Centralised - Yearly update 2 Jun 2017
Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/004050/II/0001
Removab Neovii Biotech GmbH Centralised - Withdrawal 2 Jun 2017
Pregabalin Mylan Pharma Generics [UK] Limited Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/003962/IB/0004/G
Pregabalin Mylan Generics [UK] Limited Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/004078/IB/0004/G
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/3985/II/19
Norvir AbbVie Ltd Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/127/WS/1077/143/G
Avastin Roche Registration Limited Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/582/II/92
INCRELEX Ipsen Pharma Centralised - 2-Monthly update 2 Jun 2017 EMEA/H/C/704/II/40
Elmiron bene-Arzneimittel GmbH Centralised - Authorisation 2 Jun 2017 EMEA/H/C/4246/00
Refixia Novo Nordisk A/S Centralised - Authorisation 2 Jun 2017 EMEA/H/C/4178
Clopidogrel Apotex Apotex Europe B.V. Centralised - 2-Monthly update 31 May 2017 EMEA/H/C/1189/IB/27/G
Lopinavir/Ritonavir Mylan Mylan S.A.S Centralised - Yearly update 31 May 2017
Chenodeoxycholic acid Leadiant Leadiant GmbH Centralised - Transfer Marketing Authorisation Holder 31 May 2017 EMEA/H/C/004061/T/01
Yervoy Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 31 May 2017
Elocta Swedish Orphan Biovitrum AB (publ) Centralised - Yearly update 31 May 2017
Odomzo Sun Pharmaceutical Industries Europe BV Centralised - Transfer Marketing Authorisation Holder 31 May 2017 EMEA/H/C/002839/T/0012
Azopt Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 31 May 2017 EMEA/H/C/000267/T/0066
Sycrest Organon N.V. Centralised - Yearly update 31 May 2017
InductOs Medtronic BioPharma B.V. Centralised - 2-Monthly update 31 May 2017 EMEA/H/C/408/IB/85
Benepali Samsung Bioepis UK Limited Centralised - Variation 31 May 2017 EMEA/H/C/004007/X/0016
Brineura BioMarin International Limited Centralised - Authorisation 30 May 2017 EMEA/H/C/4065
Spinraza Biogen Idec Limited Centralised - Authorisation 30 May 2017 EMEA/H/C/4312/00
Memantine LEK Pharmathen S.A. Centralised - Yearly update 24 May 2017
Fasturtec Sanofi-Aventis groupe Centralised - Yearly update 24 May 2017
Epivir ViiV Healthcare UK Limited Centralised - Yearly update 24 May 2017
Imnovid Celgene Europe Limited Centralised - Yearly update 24 May 2017
Ecalta Pfizer Limited Centralised - Yearly update 24 May 2017
Harvoni Gilead Sciences International Limited Centralised - 2-Monthly update 24 May 2017 EMEA/H/C/3850/II/35
Tasigna Novartis Europharm Limited Centralised - 2-Monthly update 24 May 2017 EMEA/H/C/798/II/84/G
Kaletra AbbVie Ltd Centralised - 2-Monthly update 24 May 2017 EMEA/H/C/368/WS/1077/163/G
Neoclarityn Merck Sharp & Dohme Limited PSUSA - Modification 24 May 2017 EMEA/H/C/PSUSA/962/201607
Azomyr Merck Sharp & Dohme Limited PSUSA - Modification 24 May 2017 EMEA/H/C/310/PSUSA/962/201607
Aerius Merck Sharp & Dohme Limited PSUSA - Modification 24 May 2017 EMEA/H/C/313/PSUSA/962/201607
Desloratadine Teva Teva B.V. PSUSA - Modification 24 May 2017 EMEA/H/C/2419/PSUSA/962/201607
Busilvex Pierre Fabre Médicament PSUSA - Modification 24 May 2017 EMEA/H/C/472/PSUSA/00000464/201607
NovoThirteen Novo Nordisk A/S Centralised - Renewal 24 May 2017 EMEA/H/C/002284/R/0020
Trumenba Pfizer Limited Centralised - Authorisation 24 May 2017 EMEA/H/C/004051/0000
Cotellic Roche Registration Limited PSUSA - Modification 24 May 2017 EMEA/H/C/PSUSA/10450/201608
Mirvaso Galderma International PSUSA - Modification 24 May 2017 EMEA/H/C/PSUSA/00010093/201608
Tafinlar Novartis Europharm Limited PSUSA - Modification 24 May 2017 EMEA/H/C/PSUSA/00010084/201608
Ferriprox Apotex Europe B.V. PSUSA - Modification 24 May 2017 EMEA/H/C/PSUSA/00000940/201608
Zoledronic acid Mylan Mylan S.A.S Centralised - Renewal 24 May 2017 EMEA/H/C/002482/R/0013
Respreeza CSL Behring GmbH Centralised - Yearly update 22 May 2017
Faslodex AstraZeneca UK Limited Centralised - Yearly update 22 May 2017
Clopidogrel BGR Laboratoires BIOGARAN Centralised - Yearly update 22 May 2017
IntronA Merck Sharp & Dohme Limited Centralised - Yearly update 22 May 2017
Tasigna Novartis Europharm Limited Centralised - Yearly update 22 May 2017
Zeffix Glaxo Group Ltd Centralised - Yearly update 22 May 2017
Temozolomide Accord Accord Healthcare Limited Centralised - Yearly update 22 May 2017
PHEBURANE Lucane Pharma Centralised - Yearly update 22 May 2017
Sildenafil Actavis Actavis Group PTC ehf. Centralised - Yearly update 22 May 2017
Fampyra Biogen Idec Limited Centralised - Authorisation - Switch to non-conditional 22 May 2017 EMEA/H/C/2097/II/36/G
Axumin Blue Earth Diagnostics Ltd Centralised - Authorisation 22 May 2017 EMEA/H/C/004197/0000
Rasilez Novartis Europharm Limited Centralised - Renewal 22 May 2017 EMEA/H/C/780/R/112
Aerinaze Merck Sharp & Dohme Limited PSUSA - Modification 22 May 2017 EMEA/H/C/PSUSA/00000963/201607
Zoledronic acid Teva Pharma Teva B.V. Centralised - Renewal 22 May 2017 EMEA/H/C/2437/R/14
Zoledronic acid Teva Teva B.V. Centralised - Renewal 22 May 2017 EMEA/H/C/2439/R/18
Inlyta Pfizer Limited Centralised - Renewal 22 May 2017 EMEA/H/C/2406/R/21
Dacogen Janssen-Cilag International NV Centralised - Renewal 22 May 2017 EMEA/H/C/2221/R/30
Ivabradine Accord Accord Healthcare Limited Centralised - Authorisation 22 May 2017 EMEA/H/C/4241
Ratiograstim ratiopharm GmbH Centralised - Yearly update 18 May 2017
Zalasta Krka, d. d., Novo Mesto Centralised - Yearly update 18 May 2017
Taxotere Aventis Pharma S.A. Centralised - Yearly update 18 May 2017
Fampyra Biogen Idec Limited Centralised - Annual renewal 18 May 2017 EMEA/H/C/2097/R/37
Desloratadine ratiopharm ratiopharm GmbH PSUSA - Modification 18 May 2017 EMEA/H/C/2404/PSUSA/962/201607
Desloratadine Actavis Actavis Group PTC ehf. PSUSA - Modification 18 May 2017 EMEA/H/C/2435/PSUSA/962/201607
Zelboraf Roche Registration Limited PSUSA - Modification 18 May 2017 EMEA/H/C/2409/PSUSA/9329/201608
Brilique AstraZeneca AB Centralised - Variation 18 May 2017 EMEA/H/C/1241/X/34
Nevanac Alcon Laboratories (UK) Ltd Centralised - Transfer Marketing Authorisation Holder 16 May 2017 EMEA/H/C/818/T/35
Emadine Alcon Laboratories (UK) Ltd Centralised - Transfer Marketing Authorisation Holder 16 May 2017 EMEA/H/C/223/T/44
Azarga Alcon Laboratories (UK) Ltd Centralised - Transfer Marketing Authorisation Holder 16 May 2017 EMEA/H/C/960/T/37
DuoTrav Alcon Laboratories (UK) Ltd Centralised - Transfer Marketing Authorisation Holder 16 May 2017 EMEA/H/C/665/T/49
Mabthera Roche Registration Limited Centralised - Yearly update 16 May 2017
Tygacil Pfizer Limited Centralised - Yearly update 16 May 2017
Marixino Consilient Health Ltd Centralised - Yearly update 16 May 2017
Lysodren Laboratoire HRA Pharma Centralised - Yearly update 16 May 2017
Obizur Baxalta Innovations GmbH Centralised - Yearly update 16 May 2017
Feraccru Shield TX (UK) Limited Centralised - Yearly update 16 May 2017
Akynzeo Helsinn Birex Pharmaceuticals Ltd Centralised - Yearly update 8 May 2017
Glivec Novartis Europharm Limited Centralised - Yearly update 8 May 2017
Ivabradine Anpharm ANPHARM Przedsiebiorstwo Farmaceutyczne S.A. Centralised - Yearly update 8 May 2017
Simbrinza Alcon Laboratories (UK) Ltd Centralised - Transfer Marketing Authorisation Holder 8 May 2017 EMEA/H/C/3698/T/09
Xarelto Bayer AG Centralised - Transfer Marketing Authorisation Holder 8 May 2017 EMEA/H/C/944/T/54
Rasagiline Mylan Mylan S.A.S Centralised - Yearly update 8 May 2017
Dinutuximab beta Apeiron APEIRON Biologics AG Centralised - Authorisation 8 May 2017 EMEA/H/C/3918
Pergoveris Merck Serono Europe Limited Centralised - Renewal 8 May 2017 EMEA/H/C/000714/R/0050, EMEA/H/C/000714/X/0047
Qutenza Grünenthal GmbH Centralised - Transfer Marketing Authorisation Holder 4 May 2017 EMEA/H/C/909/T/43
Imatinib Accord Accord Healthcare Limited Centralised - 2-Monthly update 4 May 2017 EMEA/H/C/2681/IB/15
Ebymect AstraZeneca AB Referral 4 May 2017 EMEA/H/C/4162/A-20/013
Adempas Bayer AG Centralised - Transfer Marketing Authorisation Holder 2 May 2017 EMEA/H/C/2737/T/22
Prolia Amgen Europe B.V. Centralised - Yearly update 2 May 2017
Xenical CHEPLAPHARM Arzneimittel GmbH Centralised - Transfer Marketing Authorisation Holder 2 May 2017 EMEA/H/C/154/T/76
KEYTRUDA Merck Sharp & Dohme Limited Centralised - 2-Monthly update 2 May 2017 EMEA/H/C/003820/II/14
Emtricitabine/Tenofovir disoproxil Krka Krka, d. d., Novo Mesto Centralised - 2-Monthly update 2 May 2017 EMEA/H/C/4215/IB/02
Glustin Takeda Pharma A/S Centralised - Yearly update 28 Apr 2017
Actos Takeda Pharma A/S Centralised - Yearly update 28 Apr 2017
Cimzia UCB Pharma S.A. Centralised - Yearly update 28 Apr 2017
Vizarsin Krka, d. d., Novo Mesto Centralised - Yearly update 28 Apr 2017
Temozolomide Teva Teva B.V. Centralised - Yearly update 28 Apr 2017
SOMAC Control Takeda GmbH, (HRB 701016) Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/1098/WS/1041
Xeplion Janssen-Cilag International NV Centralised - Yearly update 28 Apr 2017
Prandin Novo Nordisk A/S Centralised - Yearly update 28 Apr 2017
Fertavid Merck Sharp & Dohme Limited Centralised - Yearly update 28 Apr 2017
PANTOZOL Control Takeda GmbH, (HRB 701016) Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/1013/WS/1041
Vokanamet Janssen-Cilag International NV Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/2656/II/23
Trobalt Glaxo Group Ltd Centralised - Yearly update 28 Apr 2017
Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 28 Apr 2017
Cholestagel Genzyme Europe B.V. Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/512/IB/37
NovoNorm Novo Nordisk A/S Centralised - Yearly update 28 Apr 2017
Ixiaro Valneva Austria GmbH Centralised - Yearly update 28 Apr 2017
Puregon Merck Sharp & Dohme Limited Centralised - Yearly update 28 Apr 2017
Repaglinide Teva Teva B.V. Centralised - Yearly update 28 Apr 2017
Tresiba Novo Nordisk A/S Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/2498/II/24/G
CONTROLOC Control Takeda GmbH, (HRB 701016) Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/1097/WS/1041
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/3985/II/17
Invokana Janssen-Cilag International NV Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/2649/II/26
PANTOLOC Control Takeda GmbH, (HRB 701016) Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/1100/WS/1041
Cinqaero Teva Pharmaceuticals Limited Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/003912/II/05/G
Zebinix Bial - Portela & Cª, SA Centralised - 2-Monthly update 28 Apr 2017 EMEA/H/C/000988/II/0053
Kalydeco Vertex Pharmaceuticals (Europe) Limited Centralised - Renewal 28 Apr 2017 EMEA/H/C/2494/R/52
Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Renewal 28 Apr 2017 EMEA/H/C/2359/R/18
Darzalex Janssen-Cilag International NV Centralised - Authorisation - Switch to non-conditional 28 Apr 2017 EMEA/H/C/004077/II/02
Emtricitabine /Tenofovir disoproxil Krka d.d. KRKA, d.d. Centralised - Authorisation 28 Apr 2017 EMEA/H/C/004686/0000
Opatanol Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 24 Apr 2017 EMEA/H/C/407/T/34
Imatinib Actavis Actavis Group PTC ehf. Centralised - Yearly update 24 Apr 2017
CANCIDAS Merck Sharp & Dohme Limited Centralised - Yearly update 24 Apr 2017
Docetaxel Winthrop Aventis Pharma S.A. Centralised - Yearly update 24 Apr 2017
DUTREBIS Merck Sharp & Dohme Limited Centralised - Withdrawal 24 Apr 2017
TAGRISSO AstraZeneca AB Centralised - Authorisation - Switch to non-conditional 24 Apr 2017 EMEA/H/C/4124/II/09/G
Siklos Addmedica Centralised - Renewal 24 Apr 2017 EMEA/H/C/689/R/30
Natpar Shire Pharmaceuticals Ireland Limited Centralised - Authorisation 24 Apr 2017 EMEA/H/C/3861/00
Flebogamma DIF Instituto Grifols, S.A. Centralised - Renewal 24 Apr 2017 EMEA/H/C/781/R/48
Darzalex Janssen-Cilag International NV Centralised - Annual renewal 24 Apr 2017 EMEA/H/C/004077/R/0003
Esbriet Roche Registration Limited Centralised - Variation 24 Apr 2017 EMEA/H/C/002154/X/0035/G
Jakavi Novartis Europharm Limited Centralised - Renewal 24 Apr 2017 EMEA/H/C/2464/R/32
Zinforo AstraZeneca AB Centralised - Renewal 24 Apr 2017 EMEA/H/C/2252/R-31
Pemetrexed Hospira UK Limited Hospira UK Limited Centralised - Authorisation 24 Apr 2017 EMEA/H/C/4488
Travatan Novartis Europharm Limited Corrigendum 20 Apr 2017
Izba Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 20 Apr 2017 EMEA/H/C/2738/T/07
Travatan Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 20 Apr 2017 EMEA/H/C/390/T/56
Lonquex UAB "Sicor Biotech" Centralised - Yearly update 20 Apr 2017
Mycophenolate mofetil Teva Teva B.V. Centralised - Yearly update 20 Apr 2017
Tamiflu Roche Registration Limited Centralised - Yearly update 20 Apr 2017
Cetrotide Merck Serono Europe Limited Centralised - Yearly update 20 Apr 2017
Briviact UCB Pharma S.A. PSUSA - Modification 20 Apr 2017 EMEA/H/C/3898/PSUSA/10447/201607
EVOTAZ Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 20 Apr 2017 EMEA/H/C/3904/PSUSA/10404/201607
Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB Centralised - Annual renewal 20 Apr 2017 EMEA/H/C/3963/R/03
Vokanamet Janssen-Cilag International NV Referral 20 Apr 2017 EMEA/H/A-20/1442/C/2656-0014
Varuby TESARO UK LIMITED Centralised - Authorisation 20 Apr 2017 EMEA/H/C/4196
Eklira Genuair AstraZeneca AB Centralised - Renewal 20 Apr 2017 EMEA/H/C/2211/R/31
Bretaris Genuair AstraZeneca AB Centralised - Renewal 20 Apr 2017 EMEA/H/C/2706/R/31
Forxiga AstraZeneca AB Referral 20 Apr 2017 EMEA/H/A-20/1442/C/2322/0029
Synjardy Boehringer Ingelheim International GmbH Referral 20 Apr 2017 EMEA/H/A-20/1442/C/3770/0022
Jardiance Boehringer Ingelheim International GmbH Referral 20 Apr 2017 EMEA/H/A-20/1442/C/2677/23
Edistride AstraZeneca AB Referral 20 Apr 2017 EMEA/H/A-20/1442/C/4161/10
Glybera uniQure biopharma B.V. Centralised - Annual reassessment 20 Apr 2017 EMEA/H/C/2145/S/57
Picato LEO Laboratories Ltd. PSUSA - Modification 20 Apr 2017 EMEA/H/C/PSUSA/00010035/201607
Xigduo AstraZeneca AB Referral 20 Apr 2017 EMEA/H/A-20/1442/C/2672/24
Roteas Daiichi Sankyo Europe GmbH Centralised - Authorisation 20 Apr 2017 EMEA/H/C/004339/0000
Invokana Janssen-Cilag International NV Referral 20 Apr 2017 EMEA/H/A-20/1442/C/2649/18
Rotarix GlaxoSmithKline Biologicals S.A. PSUSA - Modification 20 Apr 2017 EMEA/H/C/PSUSA/2665/201607
Myfenax Teva B.V. Centralised - Yearly update 12 Apr 2017
Tecfidera Biogen Idec Limited Centralised - Yearly update 12 Apr 2017
Eylea Bayer AG Centralised - Transfer Marketing Authorisation Holder 12 Apr 2017 EMEA/H/C/2392/T/36
Ovaleap Teva B.V. Centralised - Yearly update 12 Apr 2017
Abasaglar Eli Lilly Regional Operations GmbH. Centralised - Yearly update 11 Apr 2017
Kovaltry Bayer AG Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/003825T/09
Envarsus Chiesi Farmaceutici S.p.A. Centralised - Yearly update 11 Apr 2017
Iblias Bayer AG Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/4147/T/06
Helixate NexGen Bayer AG Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/276/T/0189
KOGENATE Bayer Bayer AG Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/275/T/0197
Optimark Guerbet Centralised - Transfer Marketing Authorisation Holder 11 Apr 2017 EMEA/H/C/000745/T/0037
Constella Allergan Pharmaceuticals International Limited Centralised - Yearly update 11 Apr 2017
Hexacima Sanofi Pasteur SA Centralised - Yearly update 11 Apr 2017
Onglyza AstraZeneca AB Centralised - Yearly update 11 Apr 2017
Orgalutran Merck Sharp & Dohme Limited Centralised - Yearly update 11 Apr 2017
Sylvant Janssen-Cilag International NV Centralised - Yearly update 11 Apr 2017
Chenodeoxycholic acid Leadiant Leadiant GmbH Centralised - Authorisation 10 Apr 2017 EMEA/H/C/004061/0000
Levetiracetam Hospira Hospira UK Limited Centralised - Yearly update 6 Apr 2017
Evra Janssen-Cilag International NV Centralised - Yearly update 6 Apr 2017
Irbesartan Teva Teva B.V. Centralised - Yearly update 6 Apr 2017
Zalviso Grünenthal GmbH Centralised - Yearly update 6 Apr 2017
Vivanza Bayer AG Centralised - Transfer Marketing Authorisation Holder 6 Apr 2017 EMEA/H/C/488/T/55
Fycompa Eisai Europe Limited Centralised - Renewal 6 Apr 2017 EMEA/H/C/2434/R/35
Procoralan Les Laboratoires Servier Centralised - Yearly update 3 Apr 2017
Corlentor Les Laboratoires Servier Centralised - Yearly update 3 Apr 2017
Xofigo Bayer AG Centralised - Transfer Marketing Authorisation Holder 3 Apr 2017 EMEA/H/C/2653/T/24
Vepacel Nanotherapeutics UK Limited Centralised - Transfer Marketing Authorisation Holder 3 Apr 2017 EMEA/H/C/2089/T/17
DuoPlavin Sanofi Clir SNC Centralised - 2-Monthly update 3 Apr 2017 EMEA/H/C/1143/WS/1091
Clopidogrel Zentiva Sanofi-Aventis groupe Centralised - 2-Monthly update 3 Apr 2017 EMEA/H/C/975/WS/1091
JEVTANA Sanofi-Aventis groupe Centralised - 2-Monthly update 3 Apr 2017 EMEA/H/C/2018/II/34
Imprida Novartis Europharm Limited Centralised - Withdrawal 3 Apr 2017
Levitra Bayer AG Centralised - Transfer Marketing Authorisation Holder 29 Mar 2017 EMEA/H/C/475/T/59
Descovy Gilead Sciences International Limited Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/4094/WS/1010
Iressa AstraZeneca AB Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/1016/II/26
EVARREST Omrix Biopharmaceuticals N.V. Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/2515/II/27/G
Clopidogrel/Acetylsalicylic acid Zentiva Sanofi-Aventis groupe Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/1144/WS/1091
Tafinlar Novartis Europharm Limited Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/2604/WS/0996
Plavix Sanofi Clir SNC Centralised - 2-Monthly update 29 Mar 2017 EMEA/H/C/174/WS/1091
Jylamvo Therakind Ltd Centralised - Authorisation 29 Mar 2017 EMEA/H/C/3756
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
Iscover Sanofi-Aventis groupe Centralised - 2-Monthly update 24 Mar 2017 EMEA/H/C/175/WS/1091
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
Docetaxel Kabi Fresenius Kabi Oncology Plc. Corrigendum 23 Feb 2017
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 Guerbet 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
Pemetrexed Fresenius Kabi Fresenius Kabi Oncology Plc. Corrigendum 22 Jul 2016
Epclusa Gilead Sciences International Ltd. Corrigendum 6 Jul 2016
Binocrit Sandoz GmbH Corrigendum 31 Mar 2016
Abseamed Medice Arzneimittel Pütter GmbH & Co KG Corrigendum 30 Mar 2016
Dexdor Orion Corporation Corrigendum 16 Sep 2011
Procedures for centrally authorised orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
EU/3/17/1888 Advicenne Pharma SA Orphan designation 20 Jun 2017 EMA/OD/016/17
EU/3/17/1887 Zealand Pharma A/S Orphan designation 20 Jun 2017 EMA/OD/002/17
EU/3/17/1886 Vale Pharmaceuticals Limited Orphan designation 20 Jun 2017 EMA/OD/007/17
EU/3/17/1885 Avivia Beheer BV Orphan designation 20 Jun 2017 EMA/OD/304/16
EU/3/17/1884 Voisin Consulting S.A.R.L. Orphan designation 20 Jun 2017 EMA/OD/018/17
EU/3/17/1883 NeuroScios GmbH Orphan designation 20 Jun 2017 EMA/OD/034/17
EU/3/17/1882 Richardson Associates Regulatory Affairs Ltd Orphan designation 20 Jun 2017 EMA/OD/013/17
EU/3/17/1881 Ulrich Muehlner Orphan designation 20 Jun 2017 EMA/OD/008/17
EU/3/17/1880 ChemoCentryx Limited Orphan designation 20 Jun 2017 EMA/OD/028/17
EU/3/17/1879 Envigo Pharma Consulting Ltd Orphan designation 20 Jun 2017 EMA/OD/031/17
EU/3/14/1307 orphanix GmbH Transfer of orphan designation 8 Jun 2017 EMA/OD/018/14/T/01
EU/3/14/1243 Enzyvant Farber Ireland Limited Transfer of orphan designation 8 Jun 2017 EMA/OD/167/13/T/02
EU/3/14/1406 Leadiant GmbH Transfer of orphan designation 8 Jun 2017 EMA/OD/196/14/T/02
EU/3/07/462 Baxalta Innovations GmbH Transfer of orphan designation 8 Jun 2017 EMA/OD/028/07/T/01
EU/3/04/210 PARI Pharma GmbH Amendment of orphan designation 24 May 2017 EMEA/OD/022/04
EU/3/17/1878 IntraBio Ltd Orphan designation 22 May 2017 EMA/OD/316/16
EU/3/17/1877 GB Pharma Srl Orphan designation 22 May 2017 EMA/OD/006/17
EU/3/17/1876 TMC Pharma Services Ltd Orphan designation 22 May 2017 EMA/OD/010/17
EU/3/17/1875 NeoImmuneTech, INC., Spólka Akcyjna, Oddzial w Polsce Orphan designation 22 May 2017 EMA/OD/321/16
EU/3/17/1874 Coté Orphan Consulting UK Limited Orphan designation 22 May 2017 EMA/OD/019/17
EU/3/17/1873 Best Regulatory Consulting Ltd Orphan designation 22 May 2017 EMA/OD/004/17
EU/3/17/1872 Miragen Therapeutics Europe Ltd Orphan designation 22 May 2017 EMA/OD/011/17
EU/3/17/1871 Voisin Consulting S.A.R.L. Orphan designation 22 May 2017 EMA/OD/319/16
EU/3/16/1822 HV-Polysaccharides GmbH & Co. KG Transfer of orphan designation 22 May 2017 EMA/OD/130/16/T/01
EU/3/16/1716 Pfizer Limited Transfer of orphan designation 22 May 2017 EMA/OD/096/16/T/01
EU/3/16/1674 Bellicum Pharma Limited Transfer of orphan designation 8 May 2017 EMA/OD/020/16/T/01
EU/3/16/1666 Bellicum Pharma Limited Transfer of orphan designation 8 May 2017 EMA/OD/017/16/T/01
EU/3/16/1663 NextraResearch S.r.l. Transfer of orphan designation 8 May 2017 EMA/OD/003/16/T/01
EU/3/17/1865 Mithra Pharmaceuticals S.A. Orphan designation 28 Apr 2017 EMA/OD/309/16
20% I.V. fat emulsion consisting of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection Alan Boyd Consultants Ltd Refusal of orphan designation 20 Apr 2017 EMA/OD/062/16
EU/3/17/1870 Vall d'Hebron Institute of Research Orphan designation 20 Apr 2017 EMA//OD/317/16
EU/3/17/1869 Hôpital Foch Orphan designation 20 Apr 2017 EMA/OD/286/16
EU/3/17/1868 Sentinel Oncology Limited Orphan designation 20 Apr 2017 EMA/OD/293/16
EU/3/17/1867 PhaseRx Ireland, Ltd Orphan designation 20 Apr 2017 EMA/OD/326/16
EU/3/17/1866 Hôpital Foch Orphan designation 20 Apr 2017 EMA/OD/287/16
EU/3/17/1864 NBMI Science Limited Orphan designation 20 Apr 2017 EMA/OD/329/16
EU/3/17/1863 bluebird bio France Orphan designation 20 Apr 2017 EMA/OD/270/16
EU/3/17/1862 Igenomix, S.L. Orphan designation 20 Apr 2017 EMA/OD/313/16
EU/3/17/1861 Biological Consulting Europe Ltd Orphan designation 20 Apr 2017 EMA/OD/299/16
EU/3/16/1783 Cogas Pharma Limited Transfer of orphan designation 11 Apr 2017 EMA/OD/138/16/T/01
EU/3/14/1281 Vertex Pharmaceuticals (Europe) Limited Transfer of orphan designation 11 Apr 2017 EMA/OD/002/14/T/01
EU/3/14/1240 Istituto Europeo per la Ricerca sulla Fibrosi Cistica - ONLUS Transfer of orphan designation 6 Apr 2017 EMA/OD/159/13/T/02
EU/3/11/857 Alnylam UK Limited Amendment of orphan designation 6 Apr 2017 EMA/OD/142/10
EU/3/15/1579 Kite Pharma EU B.V. Corrigendum 3 Apr 2017
EU/3/15/1572 Kite Pharma EU B.V. Corrigendum 3 Apr 2017
EU/3/15/1571 Kite Pharma EU B.V. Corrigendum 3 Apr 2017
EU/3/15/1553 Kite Pharma EU B.V. Corrigendum 3 Apr 2017
EU/3/15/1552 Kite Pharma EU B.V. Corrigendum 3 Apr 2017
EU/3/14/1393 Kite Pharma EU B.V. Corrigendum 3 Apr 2017
EU/3/15/1579 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/135/15/T/01
EU/3/15/1572 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/108/15/T/01
EU/3/15/1571 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/107/15/T/01
EU/3/15/1553 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/078/15/T/01
EU/3/15/1552 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/077/15/T/01
EU/3/14/1393 Kite Pharma EU B.V. Transfer of orphan designation 3 Apr 2017 EMA/OD/171/14/T/01
EU/3/15/1488 Celgene Europe Limited Transfer of orphan designation 3 Apr 2017 EMA/OD/314/14/T/01
EU/3/16/1811 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 HV-Polysaccharides GmbH & Co. KG 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/3/09/715 Incyte Biosciences UK Ltd Corrigendum 18 Nov 2016
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
Prevomax Le Vet Beheer B.V. Centralised - Authorisation 19 Jun 2017 EMEA/V/C/4331
Circovac Ceva-Phylaxia Zrt. Centralised - Transfer Marketing Authorisation Holder 13 Jun 2017 EMEA/V/C/114/T/14
Clomicalm Elanco Europe Ltd. Centralised - Yearly update 13 Jun 2017
BROADLINE Merial Centralised - 2-Monthly update 13 Jun 2017 EMEA/V/C/2700/II/13
Veraflox Bayer Animal Health GmbH Centralised - Yearly update 13 Jun 2017
Cardalis CEVA SANTE ANIMALE Centralised - Renewal 8 Jun 2017 EMEA/V/C/2524/R/09
Econor Elanco Europe Ltd. Centralised - Yearly update 7 Jun 2017
Advocate Bayer Animal Health GmbH Centralised - Yearly update 6 Jun 2017
Profender Bayer Animal Health GmbH Centralised - Yearly update 24 May 2017
Activyl Tick Plus Intervet International B.V. Centralised - 2-Monthly update 24 May 2017 EMEA/V/C/2234/II/08
Ingelvac PCV FLEX Boehringer Ingelheim Vetmedica GmbH Centralised - Authorisation 24 May 2017 EMA/CVMP/132446/2017
Suvaxyn Circo + MH RTU Zoetis Belgium S.A. Centralised - 2-Monthly update 17 May 2017 EMEA/V/C/3924/II/04/G
Suprelorin VIRBAC S.A. Centralised - Renewal 17 May 2017 EMEA/V/C/109/R/16
RESPIPORC FLUpan H1N1 IDT Biologika GmbH Centralised - Authorisation 17 May 2017 EMEA/V/C/3993
NEXGARD SPECTRA Merial Centralised - 2-Monthly update 15 May 2017 EMEA/V/C/3842/II/08
Novem Boehringer Ingelheim Vetmedica GmbH Centralised - Variation 15 May 2017 EMEA/V/C/000086/X/0018
Zeleris Ceva Santé Animale Centralised - Authorisation 15 May 2017 EMEA/V/C/69358
Zactran Merial Centralised - Variation 15 May 2017 EMEA/V/C/129/X/34
Poulvac E. coli Zoetis Belgium S.A. Centralised - Renewal 15 May 2017 EMEA/V/C/2007/R/12
Activyl Intervet International B.V. Centralised - Yearly update 5 May 2017
Kexxtone Eli Lilly and Company Limited Centralised - Yearly update 5 May 2017
Versican Plus Pi/L4R Zoetis Belgium S.A. Centralised - Yearly update 5 May 2017
Quadrisol VETCOOL B.V. Centralised - Transfer Marketing Authorisation Holder 25 Apr 2017 EMEA/V/C/32/T/37
Cerenia Zoetis Belgium S.A. Centralised - Yearly update 25 Apr 2017
Zulvac BTV Ovis Zoetis Belgium S.A. Centralised - Authorisation 25 Apr 2017 EMEA/V/C/4185
Credelio Elanco Europe Ltd. Centralised - Authorisation 25 Apr 2017 EMEA/V/C/004247/0000
CYTOPOINT Zoetis Belgium S.A. Centralised - Authorisation 25 Apr 2017 EMEA/V/C/3939
FORTEKOR PLUS Elanco Europe Ltd. Centralised - Yearly update 12 Apr 2017
Procox Bayer Animal Health GmbH Centralised - Yearly update 11 Apr 2017
Dexdomitor Orion Corporation Centralised - Yearly update 29 Mar 2017
Porcilis ColiClos Intervet International B.V. Centralised - Renewal 29 Mar 2017 EMEA/V/C/002011/R/0006
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
Vectra Felis CEVA SANTE ANIMALE Corrigendum 6 Jun 2014
Procedures for nationally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Vepesid and associated names Referral 26 Jun 2017 EMEA/H/A-30/1425
Etopophos and associated names Referral 26 Jun 2017 EMEA/H/A-30/1417
Haldol and associated names Corrigendum 12 Jun 2017
desloratadine PSUSA - Modification 24 May 2017 EMEA/H/C/PSUSA/962/201607
Saroten and associated names Referral 8 May 2017 EMEA/H/A-30/1430
Haldol Decanoate and associated names Referral 28 Apr 2017 EMEA/H/A-30/1405
Haldol and associated names Referral 28 Apr 2017 EMEA/H/R/A-30/1393
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
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
Veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for use in target species cattle Zoetis France Referral 20 Jun 2017 EMEA/V/A/119
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