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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
Rasilamlo Novartis Europharm Limited Centralised - Withdrawal 25 Jun 2015
Ibandronic Acid Teva Teva B.V. Centralised - Renewal 25 Jun 2015 EMEA/H/C/1195/R/12
Kuvan Merck Serono Europe Limited Centralised - 2-Monthly update 22 Jun 2015 EMEA/H/C/943/II/33
Fycompa Eisai Europe Limited Centralised - 2-Monthly update 22 Jun 2015 EMEA/H/C/2434/II/16
Xtandi Astellas Pharma Europe B.V. Centralised - 2-Monthly update 22 Jun 2015 EMEA/H/C/2639/II/15
JEVTANA Sanofi-Aventis groupe Centralised - 2-Monthly update 22 Jun 2015 EMEA/H/C/2018/II/28
Stelara Janssen-Cilag International NV Centralised - 2-Monthly update 22 Jun 2015 EMEA/H/C/958/II/42
Kivexa ViiV Healthcare UK Limited Centralised - 2-Monthly update 22 Jun 2015 EMEA/H/C/581/II/57
Xolair Novartis Europharm Limited Centralised - Renewal 22 Jun 2015 EMEA/H/C/606/R/68
Rasilamlo Novartis Europharm Limited PSUSA - Modification 19 Jun 2015 EMEA/H/C/2073/PSUSA/89/201409
Yervoy Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 19 Jun 2015 EMEA/H/C/2213/PSUSA/9200/201409
VPRIV Shire Pharmaceuticals Ireland Limited Centralised - Renewal 19 Jun 2015 EMEA/H/C/1249/R/21
AUBAGIO Sanofi-Aventis groupe PSUSA - Modification 19 Jun 2015 EMEA/H/C/2514/PSUSA/10135
SonoVue Bracco International B.V. PSUSA - Modification 19 Jun 2015 EMEA/H/C/303/PSUSA/2822
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - Authorisation 19 Jun 2015 EMEA/H/C/3985
Lumark IDB Radiopharmacy B.V. Centralised - Authorisation 19 Jun 2015 EMEA/H/C/002749/0000
Leflunomide ratiopharm ratiopharm GmbH Centralised - Renewal 19 Jun 2015 EMEA/H/C/2035/R/15
Lixiana Daiichi Sankyo Europe GmbH Centralised - Authorisation 19 Jun 2015 EMEA/H/C/2629
Duloxetine Mylan Generics [UK] Limited Centralised - Authorisation 19 Jun 2015 EMEA/H/C/3981
Telmisartan Actavis Actavis Group PTC ehf. Centralised - Renewal 19 Jun 2015 EMEA/H/C/1168/R/14
Pregabalin Sandoz GmbH Sandoz GmbH Centralised - Authorisation 19 Jun 2015 EMEA/H/C/4070
Pregabalin Sandoz Sandoz GmbH Centralised - Authorisation 19 Jun 2015 EMEA/H/C/4010
Rasilez Novartis Europharm Limited PSUSA - Modification 19 Jun 2015 EMEA/H/C/780/PSUSA/89/201409
Yondelis Pharma Mar S.A. PSUSA - Modification 19 Jun 2015 EMEA/H/C/PSUSA/00003001/201409
Orfadin Swedish Orphan Biovitrum International AB Centralised - Variation 19 Jun 2015 EMEA/H/C/555/X/41
APTIVUS Boehringer Ingelheim International GmbH Centralised - Renewal 19 Jun 2015 EMEA/H/C/631/R/70
Tyverb Novartis Europharm Limited PSUSA - Modification 19 Jun 2015 EMEA/H/C/795/PSUSA/1829/201409
Clopidogrel HCS HCS bvba Centralised - Renewal 16 Jun 2015 EMEA/H/C/2255/R/19
Protaphane Novo Nordisk A/S Centralised - Yearly update 11 Jun 2015
Insulatard Novo Nordisk A/S Centralised - Yearly update 11 Jun 2015
Adjupanrix GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 11 Jun 2015
IKERVIS Santen Oy Centralised - Transfer Marketing Authorisation Holder 11 Jun 2015 EMEA/H/C/2066/T/01
CANCIDAS Merck Sharp & Dohme Limited Centralised - Yearly update 10 Jun 2015
Clopidogrel Krka d.d. Krka, d. d., Novo Mesto Centralised - Yearly update 10 Jun 2015
Tesavel Merck Sharp & Dohme Limited PSUSA - Modification 10 Jun 2015 EMEA/H/C/PSUSA/2711/201408
Gardasil 9 Sanofi Pasteur MSD SNC Centralised - Authorisation 10 Jun 2015 EMEA/H/C/3852
Kolbam Retrophin Europe Limited Centralised - Transfer Marketing Authorisation Holder 5 Jun 2015 EMEA/H/C/2081/T/11
Mirvaso Galderma International PSUSA - Modification 2 Jun 2015 EMEA/H/C/2642
Dificlir Astellas Pharma Europe B.V. Centralised - Yearly update 28 May 2015
alli Glaxo Group Ltd Centralised - Yearly update 28 May 2015
Lonquex UAB "Sicor Biotech" Centralised - Yearly update 28 May 2015
Invega Janssen-Cilag International NV Centralised - 2-Monthly update 28 May 2015 EMEA/H/C/746/II/43
Tygacil Pfizer Limited Centralised - 2-Monthly update 28 May 2015 EMEA/H/C/644/II/92
Lenvima Eisai Europe Limited Centralised - Authorisation 28 May 2015 EMEA/H/C/3727/
Januvia Merck Sharp & Dohme Limited PSUSA - Modification 28 May 2015 EMEA/H/C/722PSUSA/2711/201408
Ristaben Merck Sharp & Dohme Limited PSUSA - Modification 28 May 2015 EMEA/H/C/1234/PSUSA/2711/201408
Topotecan Hospira Hospira UK Limited Centralised - Renewal 28 May 2015 EMEA/H/C/1192/R/19
Aclasta Novartis Europharm Limited PSUSA - Modification 28 May 2015 EMEA/H/C/PSUSA/9334/201408
Volibris Glaxo Group Ltd Centralised - Yearly update 27 May 2015
Thalidomide Celgene Celgene Europe Limited Centralised - Yearly update 27 May 2015
Silgard Merck Sharp & Dohme Limited Centralised - Yearly update 27 May 2015
Sovaldi Gilead Sciences International Limited Centralised - Yearly update 27 May 2015
Nexium Control Pfizer Consumer Healthcare Limited Centralised - Yearly update 27 May 2015
Aflunov Novartis Vaccines Influenza S.r.l. Centralised - Transfer Marketing Authorisation Holder 27 May 2015 EMEA/H/C/2094/T/23
Temozolomide Accord Accord Healthcare Limited Centralised - Transfer Marketing Authorisation Holder 27 May 2015 EMEA/H/C/1125/T/29
Prepandrix GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 27 May 2015
Esmya Gedeon Richter Plc. Centralised - 2-Monthly update 27 May 2015 EMEA/H/C/2041/II/28
Clopidogrel TAD TAD Pharma GmbH Centralised - Yearly update 27 May 2015
Resolor Shire Pharmaceuticals Ireland Limited Centralised - Variation 27 May 2015 EMEA/H/C/1012/II/34
Raloxifene Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 27 May 2015 EMEA/H/C/1075/T/17
Levetiracetam Accord Accord Healthcare Limited Centralised - Yearly update 27 May 2015
Gardasil Sanofi Pasteur MSD SNC Centralised - Yearly update 27 May 2015
Jentadueto Boehringer Ingelheim International GmbH Centralised - Yearly update 27 May 2015
Tolucombi Krka, d. d., Novo Mesto Centralised - Yearly update 27 May 2015
Relistor TMC Pharma Services Ltd Centralised - Variation 27 May 2015 EMEA/H/C/870/II/0030
Levemir Novo Nordisk A/S Centralised - 2-Monthly update 27 May 2015 EMEA/H/C/528/II/71
Cometriq TMC Pharma Services Ltd Centralised - 2-Monthly update 27 May 2015 EMEA/H/C/2640/II/11/G
Foclivia Novartis Vaccines Influenza S.r.l. Centralised - Transfer Marketing Authorisation Holder 27 May 2015 EMEA/H/C/1208/T/17
Synjardy Boehringer Ingelheim International GmbH Centralised - Authorisation 27 May 2015
Xtandi Astellas Pharma Europe B.V. PSUSA - Modification 27 May 2015 EMEA/H/C/2639/PSUSA/10095/201408
Nivestim Hospira UK Limited Centralised - Renewal 27 May 2015 EMEA/H/C/1142/R/25
Yentreve Eli Lilly Nederland B.V. PSUSA - Modification 27 May 2015 EMEA/H/C/545/PSUSA/1187/201408
Sonata Meda AB PSUSA - Modification 27 May 2015 EMEA/H/C/227/PSUSA/3140
Akynzeo Helsinn Birex Pharmaceuticals Ltd Centralised - Authorisation 27 May 2015 EMEA/H/C/3728
Xeristar Eli Lilly Nederland B.V. PSUSA - Modification 27 May 2015 EMEA/H/C/573/PSUSA/1187
Cymbalta Eli Lilly Nederland B.V. PSUSA - Modification 27 May 2015 EMEA/H/C/572/PSUSA/1187
Yondelis Pharma Mar S.A. Centralised - Annual reassessment 27 May 2015 EMEA/H/C/773/S/42
Myclausen Herbert J. Passauer GmbH & Co. KG Centralised - Renewal 27 May 2015 EMEA/H/C/1218/R/23
Temodal Merck Sharp & Dohme Limited PSUSA - Modification 27 May 2015 EMEA/H/C/229/2886/201407
Ariclaim Eli Lilly Nederland B.V. PSUSA - Modification 27 May 2015 EMEA/H/C/PSUSA/1187/201408
INCRELEX Ipsen Pharma PSUSA - Modification 27 May 2015 EMEA/H/C/PSUSA/1942/201408
Selincro H. Lundbeck A/S PSUSA - Modification 27 May 2015 EMEA/H/C/PSUSA/10120/201408
Voriconazole Hospira Hospira UK Limited Centralised - Authorisation 27 May 2015 EMEA/H/C/3737
Targretin Eisai Limited PSUSA - Modification 27 May 2015 EMEA/H/C/326/PSUSA/404
Brinavess Cardiome UK Limited PSUSA - Modification 27 May 2015 EMEA/H/C/1215/PSUSA/3109
Erivedge Roche Registration Limited Centralised - Annual renewal 27 May 2015 EMEA/H/C/2602/R/16
Jinarc Otsuka Pharmaceutical Europe Ltd. Centralised - Authorisation 27 May 2015 EMEA/H/C/2788
Imnovid Celgene Europe Limited PSUSA - Modification 27 May 2015 EMEA/H/C/2682/PSUSA/10127/201408
Vyndaqel Pfizer Limited Centralised - Yearly update 13 May 2015
Efficib Merck Sharp & Dohme Limited Centralised - Yearly update 13 May 2015
Janumet Merck Sharp & Dohme Limited Centralised - Yearly update 13 May 2015
Velmetia Merck Sharp & Dohme Limited Centralised - Yearly update 13 May 2015
Cayston Gilead Sciences International Limited Centralised - Yearly update 13 May 2015
Granupas Lucane Pharma Centralised - Yearly update 13 May 2015
Ovitrelle Merck Serono Europe Limited Centralised - Yearly update 13 May 2015
Luminity Lantheus MI UK Limited Centralised - Yearly update 13 May 2015
Trizivir ViiV Healthcare UK Limited Centralised - Yearly update 13 May 2015
Leflunomide ratiopharm ratiopharm GmbH Centralised - 2-Monthly update 13 May 2015 EMEA/H/C/2035/IB/17
Memantine Merz Merz Pharmaceuticals GmbH Centralised - Yearly update 13 May 2015
Arzerra Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 6 May 2015 EMEA/H/C/1131/T/38
Provenge Dendreon UK Limited Centralised - Withdrawal 6 May 2015
Clopidogrel Krka Krka, d. d., Novo Mesto Centralised - Yearly update 6 May 2015
Celsentri ViiV Healthcare UK Limited Centralised - Yearly update 6 May 2015
Tafinlar Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 6 May 2015
Optaflu Novartis Influenza Vaccines Marburg GmbH Centralised - Transfer Marketing Authorisation Holder 6 May 2015
Imatinib Teva Teva B.V. Centralised - 2-Monthly update 6 May 2015 EMEA/H/C/2585/IB/9/G
Revolade Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 6 May 2015
Celvapan Baxter AG Centralised - Renewal 6 May 2015 EMEA/H/C/982/R/29
Zykadia Novartis Europharm Limited Centralised - Authorisation 6 May 2015 EMEA/H/C/3819
Dafiro HCT Novartis Europharm Limited Centralised - 2-Monthly update 5 May 2015 EMEA/H/C/1160/WS/710
Telzir ViiV Healthcare UK Limited Centralised - Yearly update 5 May 2015
Zypadhera Eli Lilly Nederland B.V. Centralised - Yearly update 5 May 2015
Voncento CSL Behring GmbH Centralised - Yearly update 5 May 2015
Copalia HCT Novartis Europharm Limited Centralised - 2-Monthly update 5 May 2015 EMEA/H/C/1159/WS/710
Imprida Novartis Europharm Limited Centralised - 2-Monthly update 5 May 2015 EMEA/H/C/775/WS/709
Exforge Novartis Europharm Limited Centralised - 2-Monthly update 5 May 2015 EMEA/H/C/716/WS/709
Clopidogrel DURA Mylan dura GmbH Centralised - Withdrawal 5 May 2015
Tyverb Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 5 May 2015 EMEA/H/C/795/T/43
Tamiflu Roche Registration Limited Centralised - 2-Monthly update 5 May 2015 EMEA/H/C/402/H/C/110/G
Dafiro Novartis Europharm Limited Centralised - 2-Monthly update 5 May 2015 EMEA/H/C/776/IG/514
Zoledronic acid Teva Pharma Teva B.V. Centralised - 2-Monthly update 5 May 2015 EMEA/H/C/2437/IB/10
Copalia Novartis Europharm Limited Centralised - 2-Monthly update 5 May 2015 EMEA/H/C/774/WS/709
Irbesartan / Hydrochlorothiazide Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 5 May 2015
Votrient Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 5 May 2015 EMEA/H/C/1141/T/30
Erivedge Roche Registration Limited Centralised - 2-Monthly update 5 May 2015 EMEA/H/C/2602/II/15/G
Exforge HCT Novartis Europharm Limited Centralised - 2-Monthly update 5 May 2015 EMEA/H/C/1068/WS/710
Orfadin Swedish Orphan Biovitrum International AB Centralised - Variation 5 May 2015 EMEA/H/C/555/X/42
Sycrest Organon N.V. Centralised - Renewal 5 May 2015 EMEA/H/C/1177/R/19
INCRELEX Ipsen Pharma Centralised - Annual reassessment 5 May 2015 EMEA/H/C/704/S/32
Hycamtin Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 24 Apr 2015 EMEA/H/C/123/T/68
Atriance Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 24 Apr 2015 EMEA/H/C/752T/28
Xiliarx Novartis Europharm Limited Centralised - Yearly update 24 Apr 2015
Jalra Novartis Europharm Limited Centralised - Yearly update 24 Apr 2015
Galvus Novartis Europharm Limited Centralised - Yearly update 24 Apr 2015
Benlysta Glaxo Group Ltd Centralised - Yearly update 24 Apr 2015
Trobalt Glaxo Group Ltd Centralised - Yearly update 24 Apr 2015
Luveris Merck Serono Europe Limited Centralised - Yearly update 24 Apr 2015
Docetaxel Winthrop Aventis Pharma S.A. Centralised - Yearly update 24 Apr 2015
Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - 2-Monthly update 24 Apr 2015 EMEA/H/C/2692/IB/1/G
Daxas Takeda GmbH, (HRB 701257) Centralised - Renewal 24 Apr 2015 EMEA/H/C/1179/R/24
Xiapex Swedish Orphan Biovitrum AB (publ) PSUSA - Modification 24 Apr 2015 EMEA/H/C/2048/PSUSA/871/201402
Eklira Genuair AstraZeneca AB PSUSA - Modification 24 Apr 2015 EMEA/H/C/2211/PSUSA/9005/201407
Bretaris Genuair AstraZeneca AB PSUSA - Modification 24 Apr 2015 EMEA/H/C/2706/PSUSA/9005/201407
Arzerra Novartis Europharm Limited Centralised - Authorisation - Switch to non-conditional 24 Apr 2015 EMEA/H/C/1131/II/35
Tivicay ViiV Healthcare UK Limited PSUSA - Modification 24 Apr 2015 EMEA/H/C/2753/PSUSA 10075
Onglyza AstraZeneca AB PSUSA - Modification 24 Apr 2015 EMEA/H/C/1039/PSUSA/2685
ABILIFY MAINTENA Otsuka Pharmaceutical Europe Ltd. PSUSA - Modification 24 Apr 2015 EMEA/H/C/2755/PSUSA/234
Toujeo Sanofi-Aventis Deutschland GmbH Centralised - Variation 24 Apr 2015 EMEA/H/C/309/X/79/G
JETREA ThromboGenics NV Centralised - Variation 24 Apr 2015 EMEA/H/C/2381/X/13
Libertek Takeda GmbH, (HRB 701257) Centralised - Renewal 24 Apr 2015 EMEA/H/C/2399R/20
Daliresp Takeda GmbH, (HRB 701257) Centralised - Renewal 24 Apr 2015 EMEA/H/C/2398/R/20
Deltyba Otsuka Novel Products GmbH Centralised - Annual renewal 24 Apr 2015 EMEA/H/C/2552/R/4
Abilify Otsuka Pharmaceutical Europe Ltd. PSUSA - Modification 24 Apr 2015
Rapiscan Rapidscan Pharma Solutions EU Ltd Centralised - Renewal 24 Apr 2015 EMEA/H/C/1176/R/17
Fosavance Merck Sharp & Dohme Limited Centralised - Renewal 24 Apr 2015 EMEA/H/C/619/R/32
Mekinist Novartis Europharm Limited Centralised - Transfer Marketing Authorisation Holder 20 Apr 2015 EMEA/H/C/2643/T/5
Combivir ViiV Healthcare UK Limited Centralised - Yearly update 20 Apr 2015
Zevalin Spectrum Pharmaceuticals B.V. Centralised - Yearly update 15 Apr 2015
Zyprexa Velotab Eli Lilly Nederland B.V. Centralised - Yearly update 13 Apr 2015
Zyprexa Eli Lilly Nederland B.V. Centralised - Yearly update 13 Apr 2015
SonoVue Bracco International B.V. Centralised - Yearly update 13 Apr 2015
Taxotere Aventis Pharma S.A. Centralised - Yearly update 13 Apr 2015
Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Centralised - Yearly update 13 Apr 2015
Zyllt Krka, d. d., Novo Mesto Centralised - Yearly update 13 Apr 2015
Tecfidera Biogen Idec Limited Centralised - Yearly update 13 Apr 2015
Targretin Eisai Limited Centralised - Yearly update 13 Apr 2015
Zomarist Novartis Europharm Limited Centralised - Yearly update 13 Apr 2015
Axura Merz Pharmaceuticals GmbH Centralised - Yearly update 13 Apr 2015
Azopt Alcon Laboratories (UK) Ltd Centralised - Yearly update 13 Apr 2015
Capecitabine Accord Accord Healthcare Limited Centralised - Yearly update 13 Apr 2015
Ecansya Krka, d. d., Novo Mesto Centralised - Yearly update 13 Apr 2015
Icandra Novartis Europharm Limited Centralised - Yearly update 13 Apr 2015
Ristempa Amgen Europe B.V. Centralised - Authorisation 13 Apr 2015 EMEA/H/C/3910
Rienso Takeda Pharma A/S Centralised - Withdrawal 13 Apr 2015
Clopidogrel Mylan Mylan S.A.S Centralised - Yearly update 9 Apr 2015
Clopidogrel DURA Mylan dura GmbH Centralised - Yearly update 9 Apr 2015
M-M-RVAXPRO Sanofi Pasteur MSD SNC Centralised - Yearly update 9 Apr 2015
Eucreas Novartis Europharm Limited Centralised - Yearly update 9 Apr 2015
Forsteo Eli Lilly Nederland B.V. Centralised - Yearly update 9 Apr 2015
Clopidogrel Acino Acino AG Centralised - Yearly update 9 Apr 2015
Levitra Bayer Pharma AG Centralised - Yearly update 9 Apr 2015
GONAL-f Merck Serono Europe Limited Centralised - Yearly update 9 Apr 2015
Cubicin Novartis Europharm Limited Centralised - Yearly update 9 Apr 2015
Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 9 Apr 2015
Olanzapine Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 9 Apr 2015 EMEA/H/C/810/T/59
Glybera uniQure biopharma B.V. Centralised - Annual reassessment 9 Apr 2015 EMEA/H/C/2145/S/39
Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Centralised - Transfer Marketing Authorisation Holder 8 Apr 2015 EMEA/H/C/1183/T/19
Rotarix GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 8 Apr 2015
ReFacto AF Pfizer Limited Centralised - Yearly update 8 Apr 2015
Invokana Janssen-Cilag International NV Centralised - Yearly update 8 Apr 2015
Dukoral Valneva Sweden AB Centralised - Yearly update 8 Apr 2015
Ammonaps Swedish Orphan International AB Centralised - Yearly update 8 Apr 2015
Adenuric Menarini International Operations Luxembourg S.A. Centralised - 2-Monthly update 8 Apr 2015 EMEA/H/C/777/II/37
Sustiva Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 8 Apr 2015 EMEA/H/C/249/II/126/G
Daxas Takeda GmbH, (HRB 701257) PSUSA - Modification 8 Apr 2015 EMEA/H/C/PSUSA/0002658/201407
Emtriva Gilead Sciences International Limited Centralised - Yearly update 30 Mar 2015
Avastin Roche Registration Limited Centralised - 2-Monthly update 30 Mar 2015 EMEA/H/C/582/II/72
Suboxone RB Pharmaceuticals Limited Centralised - 2-Monthly update 30 Mar 2015 EMEA/H/C/697/II/30/G
Vectibix Amgen Europe B.V. Centralised - 2-Monthly update 30 Mar 2015 EMEA/H/C/741/II/65
Soliris Alexion Europe SAS Centralised - 2-Monthly update 30 Mar 2015 EMEA/H/C/791/II/66, EMEA/H/C/791/II/71/G
Lojuxta Aegerion Pharmaceuticals Limited Centralised - 2-Monthly update 30 Mar 2015 EMEA/H/C/2578/II/14/G
Kaletra AbbVie Ltd Centralised - 2-Monthly update 30 Mar 2015 EMEA/H/C/368/II/148
Nevanac Alcon Laboratories (UK) Ltd PSUSA - Modification 30 Mar 2015 EMEA/H/C/818/PSUV/29
PecFent Archimedes Development Ltd PSUSA - Modification 30 Mar 2015 EMEA/H/C/1164/PSUSA/1369/201404
BindRen Mitsubishi Tanabe Pharma Europe Ltd. Rectificative Decision 26 Mar 2015
Intelence Janssen-Cilag International NV Centralised - Yearly update 26 Mar 2015
Humira AbbVie Ltd Centralised - 2-Monthly update 26 Mar 2015 EMEA/H/C/481/II/134
Bondronat Roche Registration Limited Centralised - Yearly update 26 Mar 2015
DUTREBIS Merck Sharp & Dohme Limited Centralised - Authorisation 26 Mar 2015 EMEA/H/C/3823
Mysimba Orexigen Therapeutics Ireland Limited Centralised - Authorisation 26 Mar 2015 EMEA/H/C/3687
Quinsair Aptalis Pharma SAS Centralised - Authorisation 26 Mar 2015 EMEA/H/C/2789
Actraphane Novo Nordisk A/S Centralised - Yearly update 23 Mar 2015
Stocrin Merck Sharp & Dohme Limited Centralised - Yearly update 23 Mar 2015
Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Renewal 23 Mar 2015 EMEA/H/C/1227/R/19
Ozurdex Allergan Pharmaceuticals Ireland Centralised - Renewal 23 Mar 2015 EMEA/H/C/1140/R/18
Ibandronic acid Accord Accord Healthcare Limited Centralised - Variation 23 Mar 2015 EMEA/H/C/2638/X/6
Xeplion Janssen-Cilag International NV PSUSA - Modification 23 Mar 2015 EMEA/H/C/2105/PSUV/16
Libertek Takeda GmbH, (HRB 701257) PSUSA - Modification 23 Mar 2015 EMEA/H/C/PSUSA/2658/201407
Daliresp Takeda GmbH, (HRB 701257) PSUSA - Modification 23 Mar 2015 EMEA/H/C/PSUSA/2658/201407
Saxenda Novo Nordisk A/S Centralised - Authorisation 23 Mar 2015 EMEA/H/C/3780
Kengrexal The Medicines Company UK Ltd Centralised - Authorisation 23 Mar 2015 EMEA/H/C/3773
Pixuvri CTI Life Sciences Ltd Centralised - Annual renewal 23 Mar 2015 EMEA/H/C/2055/R/20
Sivextro Cubist (UK) Ltd Centralised - Authorisation 23 Mar 2015 EMEA/H/C/2846/
Azarga Alcon Laboratories (UK) Ltd Centralised - Yearly update 19 Mar 2015
Mycophenolate mofetil Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 19 Mar 2015 EMEA/H/C/882/T/22
Viread Gilead Sciences International Limited Centralised - Yearly update 19 Mar 2015
Ibandronic acid Sandoz Sandoz Pharmaceuticals GmbH Centralised - Transfer Marketing Authorisation Holder 19 Mar 2015 EMEA/H/C/2367/T/13
Effentora Teva B.V. Centralised - Transfer Marketing Authorisation Holder 19 Mar 2015 EMEA/H/C/833/T/36
Victoza Novo Nordisk A/S PSUSA - Modification 19 Mar 2015 EMEA/H/C/1026/PSUV/29
Orbactiv The Medicines Company UK Ltd Centralised - Authorisation 19 Mar 2015 EMEA/H/C/3785/
IKERVIS Santen Oy Centralised - Authorisation 19 Mar 2015 EMEA/H/C/2066
Sprycel Bristol-Myers Squibb Pharma EEIG PSUSA - Modification 19 Mar 2015 EMEA/H/C/709/PSUV/41
Rienso Takeda Pharma A/S PSUSA - Modification 19 Mar 2015 EMEA/H/C/2215/PSUV/15
Raplixa ProFibrix BV Centralised - Authorisation 19 Mar 2015 EMEA/H/C/2807/
Orphacol Laboratoires CTRS Centralised - Annual reassessment 19 Mar 2015 EMEA/H/C/1250/S/8
Tolura Krka, d. d., Novo Mesto Centralised - Renewal 19 Mar 2015 EMEA/H/C/1196/R/22
Vantobra PARI Pharma GmbH Centralised - Authorisation 18 Mar 2015 EMEA/H/C/2633
Omnitrope Sandoz GmbH Centralised - 2-Monthly update 16 Mar 2015 EMEA/H/C/607/IB/40
Esmya Gedeon Richter Plc. Centralised - Yearly update 16 Mar 2015
Desloratadine Actavis Actavis Group PTC ehf. Centralised - Yearly update 16 Mar 2015
Temozolomide Sandoz Sandoz GmbH Centralised - Transfer Marketing Authorisation Holder 16 Mar 2015
Constella Almirall, S.A. Centralised - Yearly update 16 Mar 2015
Zerit Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 16 Mar 2015
Emadine Alcon Laboratories (UK) Ltd Centralised - Yearly update 16 Mar 2015
Evoltra Genzyme Europe B.V. Centralised - Annual reassessment 16 Mar 2015 EMEA/H/C/613/S/45
Betmiga Astellas Pharma Europe B.V. PSUSA - Modification 16 Mar 2015 EMEA/H/C/2388/PSUV/15
Busulfan Fresenius Kabi Fresenius Kabi Oncology Plc. Centralised - 2-Monthly update 11 Mar 2015 EMEA/H/C/2806/IB/1
Levetiracetam Hospira Hospira UK Limited Centralised - Yearly update 11 Mar 2015
Glybera uniQure biopharma B.V. Centralised - Yearly update 11 Mar 2015
Crixivan Merck Sharp & Dohme Limited Centralised - Yearly update 11 Mar 2015
Colobreathe Forest Laboratories UK Ltd Referral 11 Mar 2015 EMEA/H/C/1225/A-31
Jakavi Novartis Europharm Limited Centralised - 2-Monthly update 11 Mar 2015 EMEA/H/C/2464/II/16
Eurartesim Sigma-Tau Industrie Farmaceutiche Riunite S.p.A Centralised - Yearly update 10 Mar 2015
Truvada Gilead Sciences International Limited Centralised - Yearly update 10 Mar 2015
Sildenafil Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 10 Mar 2015 EMEA/H/C/1073/T/28
Cholib Abbott Healthcare Products Ltd Centralised - Transfer Marketing Authorisation Holder 10 Mar 2015 EMEA/H/C/2559/T/9
BindRen Mitsubishi Tanabe Pharma Europe Ltd. Centralised - Withdrawal 5 Mar 2015
Norvir AbbVie Ltd Centralised - Yearly update 5 Mar 2015
Invirase Roche Registration Limited Centralised - Yearly update 5 Mar 2015
Eklira Genuair AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 5 Mar 2015 EMEA/H/C/2211/T/21
Bretaris Genuair AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 5 Mar 2015 EMEA/H/C/2706/T/20
Ketoconazole HRA Laboratoire HRA Pharma Rectificative Decision 5 Mar 2015 EMEA/H/C/3906
Buccolam ViroPharma SPRL-BVBA Centralised - Yearly update 5 Mar 2015
Instanyl Takeda Pharma A/S PSUSA - Modification 5 Mar 2015 EMEA/H/C/959/PSUSA-1369-201404
Effentora Teva B.V. PSUSA - Modification 5 Mar 2015 EMEA/H/C/833/PSUSA/1369/201404
Duaklir Genuair AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 26 Feb 2015 EMEA/H/C/3745/T/3
Brimica Genuair AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 26 Feb 2015 EMEA/H/C/3969/T/3
Epivir ViiV Healthcare UK Limited Centralised - 2-Monthly update 26 Feb 2015 EMEA/H/C/107/WS/578
Prevenar 13 Pfizer Limited Centralised - 2-Monthly update 26 Feb 2015 EMEA/H/C/1104/II/111
Abraxane Celgene Europe Limited Centralised - 2-Monthly update 26 Feb 2015 EMEA/H/C/778/II/67
Ziagen ViiV Healthcare UK Limited Centralised - 2-Monthly update 26 Feb 2015 EMEA/H/C/252/WS/578
Tasermity Genzyme Europe B.V. Centralised - Authorisation 26 Feb 2015 EMEA/H/C/3968
Bosulif Pfizer Limited Centralised - Annual renewal 26 Feb 2015 EMEA/H/C/2373/R/10
Yellox PharmaSwiss Ceská republika s.r.o. PSUSA - Modification 26 Feb 2015 EMEA/H/C/1198/PSUV/10
Lysodren Laboratoire HRA Pharma PSUSA - Modification 26 Feb 2015 EMEA/H/C/521/PSUV/16
Hexyon Sanofi Pasteur MSD SNC Centralised - 2-Monthly update 24 Feb 2015 EMEA/H/C/2796/WS/676
Hexacima Sanofi Pasteur SA Centralised - 2-Monthly update 24 Feb 2015 EMEA/H/C/2702/WS/676
Aloxi Helsinn Birex Pharmaceuticals Ltd Centralised - 2-Monthly update 24 Feb 2015 EMEA/H/C/563/II/38
Eylea Bayer Pharma AG Centralised - 2-Monthly update 24 Feb 2015 EMEA/H/C/2392/II/13
Xadago Zambon S.p.A. Centralised - Authorisation 24 Feb 2015 EMEA/H/C/2396
RotaTeq Sanofi Pasteur MSD SNC Centralised - Yearly update 19 Feb 2015
Reyataz Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 19 Feb 2015
Memantine Accord Accord Healthcare Limited Centralised - Yearly update 19 Feb 2015
Abilify Otsuka Pharmaceutical Europe Ltd. Centralised - Yearly update 19 Feb 2015
Mixtard Novo Nordisk A/S Centralised - Yearly update 19 Feb 2015
NeuroBloc Eisai Limited Centralised - Yearly update 19 Feb 2015
Fertavid Merck Sharp & Dohme Limited Centralised - Yearly update 19 Feb 2015
EVARREST Omrix Biopharmaceuticals N.V. Centralised - Yearly update 19 Feb 2015
Victrelis Merck Sharp & Dohme Limited PSUSA - Modification 19 Feb 2015 EMEA/H/C/2332/PSUV/31
Clopidogrel ratiopharm Teva Pharma B.V. Centralised - Authorisation 19 Feb 2015 EMEA/H/C/4006
Xydalba Durata Therapeutics International B.V. Centralised - Authorisation 19 Feb 2015 EMEA/H/C/2840
Revlimid Celgene Europe Limited Centralised - Variation 19 Feb 2015 EMEA/H/C/717/X/73/G
Toujeo Sanofi-Aventis Deutschland GmbH Centralised - Renewal 17 Feb 2015 EMEA/H/C/309/R/86
Lantus Sanofi-Aventis Deutschland GmbH Centralised - Renewal 17 Feb 2015 EMEA/H/C/284/R/96
Vidaza Celgene Europe Limited PSUSA - Modification 17 Feb 2015 EMEA/H/C/978/PSUV/29
Arzerra Novartis Europharm Limited Centralised - Annual renewal 17 Feb 2015 EMEA/H/C/1131/R/33
Oprymea Krka, d. d., Novo Mesto Centralised - Variation 17 Feb 2015 EMEA/H/C/941/X/17
Renagel Genzyme Europe B.V. PSUSA - Modification 17 Feb 2015 EMEA/H/C/254/PSUV/101
Holoclar Chiesi Farmaceutici S.P.A. Centralised - Authorisation 17 Feb 2015 EMEA/H/C/2450
Sutent Pfizer Limited PSUSA - Modification 17 Feb 2015 EMEA/H/C/687/PSUV/52
Tyverb Novartis Europharm Limited Centralised - Authorisation - Switch to non-conditional 17 Feb 2015 EMEA/H/C/795/II/37
Esbriet Roche Registration Limited Centralised - Transfer Marketing Authorisation Holder 12 Feb 2015 EMEA/H/C/2154/T/27
Hepsera Gilead Sciences International Limited Centralised - Yearly update 11 Feb 2015
Pumarix GlaxoSmithKline Biologicals S.A. Centralised - Withdrawal 11 Feb 2015
Champix Pfizer Limited Centralised - Yearly update 11 Feb 2015
Somavert Pfizer Limited Centralised - Yearly update 11 Feb 2015
Vitekta Gilead Sciences International Limited Centralised - Yearly update 11 Feb 2015
HBVAXPRO Sanofi Pasteur MSD SNC Centralised - Yearly update 11 Feb 2015
Zoledronic acid Hospira Hospira UK Limited Centralised - Yearly update 11 Feb 2015
TOBI Podhaler Novartis Europharm Limited Rectificative Decision 11 Feb 2015
Tyverb Novartis Europharm Limited Centralised - Yearly update 11 Feb 2015
Ribavirin Mylan Generics [UK] Limited Centralised - Renewal 11 Feb 2015 EMEA/H/C/1185/R/21
Olanzapine Apotex Apotex Europe B.V. Centralised - Renewal 11 Feb 2015 EMEA/H/C/1178/R/22
Telmisartan Teva Pharma Teva B.V. Centralised - Transfer Marketing Authorisation Holder 10 Feb 2015 EMEA/H/C/2511/T/12
Telmisartan Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 10 Feb 2015 EMEA/H/C/1146/T/17
Tybost Gilead Sciences International Limited Centralised - Yearly update 10 Feb 2015
Replagal Shire Human Genetic Therapies AB Centralised - Yearly update 10 Feb 2015
Busilvex Pierre Fabre Médicament Corrigendum 8 Feb 2015
Levetiracetam SUN Sun Pharmaceutical Industries Europe BV Centralised - Yearly update 6 Feb 2015
Leflunomide ratiopharm ratiopharm GmbH Centralised - Yearly update 6 Feb 2015
Zarzio Sandoz GmbH Centralised - Yearly update 6 Feb 2015
Filgrastim Hexal Hexal AG Centralised - Yearly update 6 Feb 2015
Bridion Merck Sharp & Dohme Limited Centralised - Yearly update 6 Feb 2015
Opgenra Olympus Biotech International Limited Centralised - Yearly update 6 Feb 2015
Firazyr Shire Orphan Therapies GmbH Centralised - Yearly update 6 Feb 2015
Ceplene Meda AB Centralised - Yearly update 6 Feb 2015
Adenuric Menarini International Operations Luxembourg S.A. Centralised - Yearly update 6 Feb 2015
Vimpat UCB Pharma S.A. Centralised - Yearly update 6 Feb 2015
Herceptin Roche Registration Limited Centralised - Yearly update 6 Feb 2015
Tracleer Actelion Registration Ltd Corrigendum 6 Feb 2015
Raloxifene Teva Teva B.V. Centralised - Renewal 6 Feb 2015 EMEA/H/C/1075/R/13
Pergoveris Merck Serono Europe Limited Centralised - Yearly update 3 Feb 2015
Levetiracetam Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 3 Feb 2015 EMEA/H/C/2316/T/18
Xiapex Swedish Orphan Biovitrum AB (publ) Centralised - 2-Monthly update 30 Jan 2015 EMEA/H/C/2048/II/44
Clopidogrel Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 30 Jan 2015 EMEA/H/C/1053/T/34
VELCADE Janssen-Cilag International NV Centralised - 2-Monthly update 30 Jan 2015 EMEA/H/C/539/II/72
Tresiba Novo Nordisk A/S Centralised - 2-Monthly update 30 Jan 2015 EMEA/H/C/2498/II/11
Pioglitazone Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 30 Jan 2015 EMEA/H/C/2297/T/11
Pioglitazone Teva Pharma Teva B.V. Centralised - Transfer Marketing Authorisation Holder 30 Jan 2015 EMEA/H/C/2410/T/8
Trisenox Teva B.V. Centralised - Transfer Marketing Authorisation Holder 30 Jan 2015 EMEA/H/C/388/T/52
Evicel Omrix Biopharmaceuticals N.V. Centralised - Yearly update 27 Jan 2015
VPRIV Shire Pharmaceuticals Ireland Limited Centralised - Yearly update 27 Jan 2015
Pramipexole Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 27 Jan 2015
Myocet Teva B.V. Centralised - Transfer Marketing Authorisation Holder 27 Jan 2015 EMEA/H/C/297/T/54
Myfenax Teva B.V. Centralised - Transfer Marketing Authorisation Holder 27 Jan 2015 EMEA/H/C/884/T/22
Levetiracetam Teva Teva B.V. Centralised - Yearly update 27 Jan 2015
Yellox PharmaSwiss Ceská republika s.r.o. Centralised - Transfer Marketing Authorisation Holder 27 Jan 2015 EMEA/H/C/1198/T/11
Lyrica Pfizer Limited Centralised - Yearly update 22 Jan 2015
Atripla Bristol-Myers Squibb and Gilead Sciences Limited Centralised - Yearly update 22 Jan 2015
Spedra Menarini International Operations Luxembourg S.A. Centralised - 2-Monthly update 22 Jan 2015 EMEA/H/C/2581/II/7
Incivo Janssen-Cilag International NV Centralised - 2-Monthly update 22 Jan 2015 EMEA/H/C/2313/II/34
Gliolan medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 19 Jan 2015
Cerdelga Genzyme Europe B.V. Centralised - Authorisation 19 Jan 2015 EMEA/H/C/3724
Cometriq TMC Pharma Services Ltd Centralised - Annual renewal 19 Jan 2015 EMEA/H/C/2640/R/9
Aclasta Novartis Europharm Limited Centralised - Renewal 19 Jan 2015 EMEA/H/C/595/R/51
BYDUREON AstraZeneca AB PSUSA - Modification 19 Jan 2015 EMEA/H/C/2020/PSUV/24
Zontivity Merck Sharp & Dohme Limited Centralised - Authorisation 19 Jan 2015 EMEA/H/C/2814/
Sirturo Janssen-Cilag International NV Centralised - Annual renewal 19 Jan 2015 EMEA/H/C/2614/R/3
Optaflu Novartis Influenza Vaccines Marburg GmbH PSUSA - Modification 19 Jan 2015 EMEA/H/C/758/PSUV/70
Picato Leo Pharma A/S Centralised - Yearly update 15 Jan 2015
Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 15 Jan 2015
Advate Baxter AG Centralised - Yearly update 15 Jan 2015
TOBI Podhaler Novartis Europharm Limited Centralised - Yearly update 15 Jan 2015
Nivestim Hospira UK Limited Centralised - Yearly update 15 Jan 2015
Memantine ratiopharm ratiopharm GmbH Centralised - Yearly update 15 Jan 2015
Votrient Novartis Europharm Limited Centralised - Yearly update 15 Jan 2015
Cholib Abbott Healthcare Products Ltd Centralised - Yearly update 15 Jan 2015
Matever Pharmathen S.A. Centralised - Yearly update 15 Jan 2015
Sevelamer carbonate Zentiva Genzyme Europe B.V. Centralised - Authorisation 15 Jan 2015 EMEA/H/C/3971
Exviera AbbVie Ltd Centralised - Authorisation 15 Jan 2015 EMEA/H/C/3837
Cosentyx Novartis Europharm Limited Centralised - Authorisation 15 Jan 2015 EMEA/H/C/3729/
Ofev Boehringer Ingelheim International GmbH Centralised - Authorisation 15 Jan 2015 EMEA/H/C/3821
Vectibix Amgen Europe B.V. Centralised - Authorisation - Switch to non-conditional 15 Jan 2015 EMEA/H/C/741/R/64
Procoralan Les Laboratoires Servier Referral 15 Jan 2015 EMEA/H/A20/1404/C/597/32
Corlentor Les Laboratoires Servier Referral 15 Jan 2015 EMEA/H/A20/1404/C/598/31
Senshio Shionogi Limited Centralised - Authorisation 15 Jan 2015 EMEA/H/C/2780
Viekirax AbbVie Ltd Centralised - Authorisation 15 Jan 2015 EMEA/H/C/3839
Prolia Amgen Europe B.V. Centralised - Renewal 15 Jan 2015 EMEA/H/C/1120/R/43
Vipidia Takeda Pharma A/S PSUSA - Modification 15 Jan 2015 EMEA/H/C/2182/PSUV/7
Vipdomet Takeda Pharma A/S PSUSA - Modification 15 Jan 2015 EMEA/H/C/2654/PSUV/8
Incresync Takeda Pharma A/S PSUSA - Modification 15 Jan 2015 EMEA/H/C/2178/PSUV/8
Otezla Celgene Europe Limited Centralised - Authorisation 15 Jan 2015 EMEA/H/C/3746
Revolade Novartis Europharm Limited Centralised - Renewal 15 Jan 2015 EMEA/H/C/1110/R/18
Byetta AstraZeneca AB PSUSA - Modification 15 Jan 2015 EMEA/H/C/698/PSUV/45
SANCUSO ProStrakan Limited PSUSA - Modification 15 Jan 2015 EMEA/H/C/2296/PSUV/34
Latuda Takeda Pharma A/S PSUSA - Modification 15 Jan 2015 EMEA/H/C/2713/PSUV/2
Opsumit Actelion Registration Ltd PSUSA - Modification 15 Jan 2015 EMEA/H/C/2697/PSUV/3
Simponi Janssen Biologics B.V. PSUSA - Modification 15 Jan 2015 EMEA/H/C/992/PSUR/58
Caprelsa AstraZeneca AB Centralised - Annual renewal 15 Jan 2015 EMEA/H/C/2315/R/9
Iclusig ARIAD Pharma Ltd Referral 15 Jan 2015 EMEA/H/C/2695/A-20/3
Focetria Novartis Vaccines and Diagnostics S.r.l. PSUSA - Modification 15 Jan 2015 EMEA/H/C/710/PSUV/33
ProQuad Sanofi Pasteur MSD SNC Centralised - Yearly update 12 Jan 2015
Zostavax Sanofi Pasteur MSD SNC Centralised - Yearly update 12 Jan 2015
Emselex Merus Labs Luxco S.à R.L. Centralised - Yearly update 12 Jan 2015
Defitelio Gentium S.p.A. Centralised - Yearly update 12 Jan 2015
Glybera uniQure biopharma B.V. Corrigendum 12 Jan 2015
Nuwiq Octapharma AB Corrigendum 12 Jan 2015
Temozolomide Accord Accord Healthcare Limited Centralised - Renewal 12 Jan 2015 EMEA/H/C/1125/R/26
Tracleer Actelion Registration Ltd Centralised - 2-Monthly update 12 Jan 2015 EMEA/H/C/401/II/66
Rasagiline ratiopharm Teva B.V. Centralised - Authorisation 12 Jan 2015 EMEA/H/C/3957
Savene Clinigen Healthcare Limited PSUSA - Modification 12 Jan 2015 EMEA/H/C/682/PSUSA/1001
ellaOne Laboratoire HRA Pharma Centralised - 2-Monthly update 7 Jan 2015 EMEA/H/C/1027/II/21
Stayveer Marklas Nederland B.V. Centralised - Yearly update 19 Dec 2014
Micardis Boehringer Ingelheim International GmbH Corrigendum 4 Sep 2014
Irbesartan / Hydrochlorothiazide Teva Teva B.V. Corrigendum 4 Sep 2014
Pravafenix LABORATOIRES SMB SA Corrigendum 30 Aug 2012
Procedures for centrally authorised orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
EU/3/15/1487 Sigma-Tau Rare Disease Limited Transfer of orphan designation 25 Jun 2015 EMA/OD/277/14/T/01
EU/3/13/1151 Onxeo DK, Filial af Onxeo S.A., Frankrig Transfer of orphan designation 25 Jun 2015 EMA/OD/036/13/T/01
EU/3/05/269 TMC Pharma Services Ltd Transfer of orphan designation 25 Jun 2015 EMA/OD/098/04/T/01
EU/3/12/1055 Onxeo DK, Filial af Onxeo S.A., Frankrig Transfer of orphan designation 25 Jun 2015 EMA/OD/103/12/T/01
EU/3/07/513 FGK Representative Service GmbH Transfer of orphan designation 19 Jun 2015 EMA/OD/074/07/T/01
EU/3/02/119 Clinical Network Services (UK) Ltd Transfer of orphan designation 19 Jun 2015 EMA/OD/037/02/T/01
EU/3/15/1510 Mitsubishi Tanabe Pharma Europe Ltd. Orphan Designation 19 Jun 2015 EMA/OD/032/15
EU/3/15/1509 AveXis EU, Ltd Orphan Designation 19 Jun 2015 EMA/OD/028/15
EU/3/15/1508 Ultragenyx UK Limited Orphan Designation 19 Jun 2015 EMA/OD/026/15
EU/3/15/1507 Panoptes Pharma Ges.m.b.H Orphan Designation 19 Jun 2015 EMA/OD/024/15
EU/3/15/1506 Isarna Therapeutics GmbH Orphan Designation 19 Jun 2015 EMA/OD/021/15
EU/3/15/1505 Roche Registration Limited Orphan Designation 19 Jun 2015 EMA/OD/014/15
EU/3/15/1504 Roche Registration Limited Orphan Designation 19 Jun 2015 EMA/OD/013/15
EU/3/15/1503 PSR Group B.V. Orphan Designation 19 Jun 2015 EMA/OD/010/15
EU/3/15/1502 Dr Ulrich Granzer Orphan Designation 19 Jun 2015 EMA/OD/009/15
EU/3/15/1501 Baxalta Innovations GmbH Orphan Designation 19 Jun 2015 EMA/OD/003/15
EU/3/15/1500 MYR GmbH Orphan Designation 19 Jun 2015 EMA/OD/329/14
EU/3/14/1331 Celgene Europe Limited Transfer of orphan designation 19 Jun 2015 EMA/OD/048/14/T/01
EU/3/10/727 Sanofi-Aventis groupe Transfer of orphan designation 5 Jun 2015 EMA/OD/137/09/T/02
EU/3/09/720 Sanofi-Aventis groupe Transfer of orphan designation 5 Jun 2015 EMA/OD/127/09/T/02
EU/3/12/1010 PTC Therapeutics International Limited Transfer of orphan designation 5 Jun 2015 EMA/OD/032/12/T/01
EU/3/05/277 PTC Therapeutics International Limited Transfer of orphan designation 5 Jun 2015 EMA/OD/107/04/T/03
EU/3/14/1380 PTC Therapeutics International Limited Transfer of orphan designation 5 Jun 2015 EMA/OD/165/14/T/01
EU/3/15/1432 BioMarin International Limited Transfer of orphan designation 5 Jun 2015 EMA/OD/192/14/T/01
EU/3/12/1078 BioMarin International Limited Transfer of orphan designation 5 Jun 2015 EMA/OD/122/12/T/01
EU/3/12/1077 BioMarin International Limited Transfer of orphan designation 5 Jun 2015 EMA/OD/121/12/T/01
EU/3/12/992 BioMarin International Limited Transfer of orphan designation 5 Jun 2015 EMA/OD/143/11/T/01
EU/3/12/991 BioMarin International Limited Transfer of orphan designation 5 Jun 2015 EMA/OD/142/11/T/01
EU/3/08/598 BioMarin International Limited Transfer of orphan designation 5 Jun 2015 EMA/OD/081/08/T/01
EU/3/15/1499 Regulatory Resources Group Ltd Orphan Designation 21 May 2015 EMA/OD/019/15
EU/3/15/1498 Clinical Network Services (UK) Ltd Orphan Designation 21 May 2015 EMA/OD/018/15
EU/3/15/1497 Prana Biotechnology UK Limited Orphan Designation 21 May 2015 EMA/OD/017/15
EU/3/15/1496 Dr Ulrich Granzer Orphan Designation 21 May 2015 EMA/OD/008/15
EU/3/15/1495 Pharma Gateway AB Orphan Designation 21 May 2015 EMA/OD/007/15
EU/3/15/1494 ImmunoGen Europe Limited Orphan Designation 21 May 2015 EMA/OD/005/15
EU/3/15/1493 ACE Pharmaceuticals BV Orphan Designation 21 May 2015 EMA/OD/004/15
EU/3/15/1492 Centre National de la Recherche Scientifique (CNRS) Orphan Designation 21 May 2015 EMA/OD/325/14
EU/3/15/1491 Cochamo Systems Ltd Orphan Designation 21 May 2015 EMA/OD/322/14
EU/3/15/1490 S-cubed Ltd Orphan Designation 21 May 2015 EMA/OD/320/14
EU/3/15/1489 Toleranzia AB Orphan Designation 21 May 2015 EMA/OD/318/14
EU/3/15/1488 Right Track Regulatory Limited Orphan Designation 21 May 2015 EMA/OD/314/14
EU/3/15/1487 Sigma-Tau Rare Disease Limited Orphan Designation 21 May 2015 EMA/OD/277/14
EU/3/09/636 IDEA Innovative Drug European Associates Limited Transfer of orphan designation 21 May 2015 EMA/OD/110/08/T/03
EU/3/14/1356 Kiadis Pharma Netherlands B.V. Corrigendum 13 May 2015
EU/3/13/1113 CTI Clinical Trial and Consulting Services Europe GmbH Corrigendum 13 May 2015
EU/3/14/1363 Coté Orphan Consulting UK Limited Corrigendum 13 May 2015
EU/3/09/683 Retrophin Europe Limited Transfer of orphan designation 13 May 2015 EMA/OD/080/09/T/03
EU/3/08/581 Novartis Europharm Limited Transfer of orphan designation 13 May 2015 EMA/OD/051/08/T/01
EU/3/12/989 AstraZeneca UK Limited Transfer of orphan designation 13 May 2015 EMA/OD/151/11/T/01
EU/3/14/1309 ReveraGen BioPharma Limited Transfer of orphan designation 13 May 2015 EMA/OD/049/14/T/01
EU/3/14/1274 Orphit Transfer of orphan designation 7 May 2015 EMA/OD/003/14/T/01
EU/3/14/1406 sigma-tau Arzneimittel GmbH Transfer of orphan designation 7 May 2015 EMA/OD/196/14/T/01
EU/3/07/486 HORAMA SAS Transfer of orphan designation 7 May 2015 EMA/OD/043/07/T/01
EU/3/07/484 HORAMA SAS Transfer of orphan designation 7 May 2015 EMA/OD/072/07/T/01
EU/3/12/973 Ultragenyx UK Limited Transfer of orphan designation 7 May 2015 EMA/OD/127/11/T/02
EU/3/09/659 Voisin Consulting S.A.R.L. Transfer of orphan designation 7 May 2015 EMA/OD/028/09/T/01
EU/3/08/599 BioMarin International Limited Transfer of orphan designation 24 Apr 2015 EMA/OD/082/08/T/03
EU/3/14/1296 Voisin Consulting S.A.R.L. Transfer of orphan designation 24 Apr 2015 EMA/OD/037/14/T/01
EU/3/05/293 Novartis Europharm Limited Transfer of orphan designation 24 Apr 2015 EMA/OD/015/05/T/02
EU/3/12/972 Ultragenyx UK Limited Transfer of orphan designation 24 Apr 2015 EMA/OD/126/11/T/02
EU/3/15/1486 Clinipace GmbH Orphan Designation 24 Apr 2015 EMA/OD/327/14
EU/3/15/1485 Ability Pharmaceuticals SL Orphan Designation 24 Apr 2015 EMA/OD/326/14
EU/3/15/1484 Biological Consulting Europe Ltd Orphan Designation 24 Apr 2015 EMA/OD/319/14
EU/3/15/1483 Neuroprotexeon Ltd Orphan Designation 24 Apr 2015 EMA/OD/315/14
EU/3/15/1482 HORAMA SAS Orphan Designation 24 Apr 2015 EMA/OD/312/14
EU/3/15/1481 Ipsen Pharma Orphan Designation 24 Apr 2015 EMA/OD/311/14
EU/3/15/1480 NV Hemipsherx BioPharma Europe Orphan Designation 24 Apr 2015 EMA/OD/310/14
EU/3/15/1479 Nekonal S.a.r.l. Orphan Designation 24 Apr 2015 EMA/OD/308/14
EU/3/15/1478 EUDRAC Limited Orphan Designation 24 Apr 2015 EMA/OD/307/14
EU/3/15/1477 Oncolytics Biotech (UK) Limited Orphan Designation 24 Apr 2015 EMA/OD/302/14
EU/3/15/1476 Arno Therapeutics UK, Limited Orphan Designation 24 Apr 2015 EMA/OD/301/14
EU/3/15/1475 Arno Therapeutics UK, Limited Orphan Designation 24 Apr 2015 EMA/OD/300/14
EU/3/15/1474 JJGConsultancy Ltd Orphan Designation 24 Apr 2015 EMA/OD/295/14
EU/3/15/1473 Celgene Europe Limited Orphan Designation 24 Apr 2015 EMA/OD/284/14
EU/3/15/1472 Blue Earth Diagnostics Ltd Orphan Designation 24 Apr 2015 EMA/OD/280/14
EU/3/10/732 Syndax Limited Transfer of orphan designation 24 Apr 2015 EMA/OD/150/09/T/01
EU/3/14/1389 LYSOGENE Corrigendum 1 Apr 2015
EU/3/14/1322 Innate Pharma S.A. Corrigendum 1 Apr 2015
EU/3/13/1210 NPS Pharma UK Ltd Corrigendum 1 Apr 2015
EU/3/09/661 Ipsen Pharma Transfer of orphan designation 1 Apr 2015 EMA/OD/047/09/T/01
EU/3/14/1243 Plexcera Therapeutics EU Limited Transfer of orphan designation 1 Apr 2015 EMA/OD/167/13/T/01
EU/3/14/1258 Pharma Gateway AB Transfer of orphan designation 25 Mar 2015 EMA/OD/190/13/T/01
EU/3/14/1294 FGK Representative Service GmbH Transfer of orphan designation 25 Mar 2015 EMA/OD/028/14/T/01
EU/3/12/1025 Aegerion Pharmaceuticals Limited Transfer of orphan designation 25 Mar 2015 EMA/OD/036/12/T/03
EU/3/12/1024 Aegerion Pharmaceuticals Limited Transfer of orphan designation 25 Mar 2015 EMA/OD/035/12/T/03
EU/3/12/1023 Aegerion Pharmaceuticals Limited Transfer of orphan designation 25 Mar 2015 EMA/OD/033/12/T/03
EU/3/12/1022 Aegerion Pharmaceuticals Limited Transfer of orphan designation 25 Mar 2015 EMA/OD/033/12/T/03
EU/3/12/1060 Takeda Pharma A/S Transfer of orphan designation 19 Mar 2015 EMA/OD/110/12/T/01
EU/3/11/899 Takeda Pharma A/S Transfer of orphan designation 19 Mar 2015 EMA/OD/048/11/T/01
EU/3/10/769 Baxalta Innovations GmbH Transfer of orphan designation 19 Mar 2015 EMA/OD/057/10/T/01
EU/3/10/768 Baxalta Innovations GmbH Transfer of orphan designation 19 Mar 2015 EMA/OD/019/10/T/01
EU/3/10/767 Baxalta Innovations GmbH Transfer of orphan designation 19 Mar 2015 EMA/OD/058/10/T/01
EU/3/01/058 Dompé farmaceutici s.p.a. Transfer of orphan designation 19 Mar 2015 EMA/OD/012/01/T/03
EU/3/11/912 Dompé farmaceutici s.p.a. Transfer of orphan designation 19 Mar 2015 EMA/OD/049/11/T/01
EU/3/13/1135 Dompé farmaceutici s.p.a. Transfer of orphan designation 19 Mar 2015 EMA/OD/015/13/T/01
EU/3/15/1471 GMP-Orphan SAS Orphan Designation 19 Mar 2015 EMA/OD/001/15
EU/3/15/1470 Luzitin S.A Orphan Designation 19 Mar 2015 EMA/OD/305/14
EU/3/15/1469 Oncolytics Biotech (UK) Limited Orphan Designation 19 Mar 2015 EMA/OD/304/14
EU/3/15/1468 Gauchers Association Orphan Designation 19 Mar 2015 EMA/OD/303/14
EU/3/15/1467 Chiesi Farmaceutici S.P.A. Orphan Designation 19 Mar 2015 EMA/OD/299/14
EU/3/15/1466 Chiesi Farmaceutici S.P.A. Orphan Designation 19 Mar 2015 EMA/OD/298/14
EU/3/15/1465 Chiesi Farmaceutici S.P.A. Orphan Designation 19 Mar 2015 EMA/OD/297/14
EU/3/15/1464 Assistance Publique Hôpitaux de Marseille Orphan Designation 19 Mar 2015 EMA/OD/296/14
EU/3/15/1463 Oncopeptides AB Orphan Designation 19 Mar 2015 EMA/OD/293/14
EU/3/15/1462 Universitätsklinikum Tübingen (UKT) Orphan Designation 19 Mar 2015 EMA/OD/289/14
EU/3/15/1461 Biotie Therapies Corp Orphan Designation 19 Mar 2015 EMA/OD/288/14
EU/3/15/1460 Eisai Europe Limited Orphan Designation 19 Mar 2015 EMA/OD/287/14
EU/3/15/1459 Impasara Ltd Orphan Designation 19 Mar 2015 EMA/OD/283/14
EU/3/15/1458 ImmunoGen Europe Limited Orphan Designation 19 Mar 2015 EMA/OD/281/14
EU/3/15/1457 Daiichi Sankyo Development Ltd Orphan Designation 19 Mar 2015 EMA/OD/279/14
EU/3/15/1456 RLM Consulting Orphan Designation 19 Mar 2015 EMA/OD/270/14
EU/3/15/1455 Richardson Associates Regulatory Affairs Ltd Orphan Designation 19 Mar 2015 EMA/OD/267/14
EU/3/15/1454 Sixera Pharma AB Orphan Designation 19 Mar 2015 EMA/OD/264/14
EU/3/15/1453 Isis USA Ltd Orphan Designation 19 Mar 2015 EMA/OD/256/14
EU/3/15/1452 QRC Consultants Ltd Orphan Designation 19 Mar 2015 EMA/OD/253/14
EU/3/15/1451 CTI Clinical Trial and Consulting Services Europe GmbH Orphan Designation 19 Mar 2015 EMA/OD/238/14
EU/3/15/1450 Advanced Accelerator Applications SA Orphan Designation 19 Mar 2015 EMA/OD/219/14
EU/3/15/1440 Miltenyi Biotec GmbH Orphan Designation 19 Mar 2015 EMA/OD/247/14
EU/3/15/1438 Miltenyi Biotec GmbH Orphan Designation 19 Mar 2015 EMA/OD/245/14
EU/3/12/966 Merck KGaA Transfer of orphan designation 5 Mar 2015 EMA/OD/110/11/T/01
EU/3/11/895 Medical Need Europe AB Transfer of orphan designation 5 Mar 2015 EMA/OD/033/11/T01
EU/3/10/823 Aegerion Pharmaceuticals Limited Transfer of orphan designation 26 Feb 2015 EMA/OD/089/10/T/02
EU/3/14/1300 Celgene Europe Limited Transfer of orphan designation 26 Feb 2015 EMA/OD/047/14/T/01
EU/3/04/241 Roche Registration Limited Transfer of orphan designation 26 Feb 2015 EMA/OD/052/04/T/02
EU/3/15/1432 BioMarin International Limited Orphan Designation 18 Feb 2015 EMA/OD/192/14
EU/3/15/1448 Voisin Consulting S.A.R.L. Orphan Designation 12 Feb 2015 EMA/OD/268/14
EU/3/15/1447 Eli Lilly Nederland B.V. Orphan Designation 12 Feb 2015 EMA/OD/266/14
EU/3/15/1446 AlzProtect sas Orphan Designation 12 Feb 2015 EMA/OD/261/14
EU/3/15/1445 Bristol-Myers Squibb Pharma EEIG Orphan Designation 12 Feb 2015 EMA/OD/258/14
EU/3/15/1444 HAC Pharma Orphan Designation 12 Feb 2015 EMA/OD/254/14
EU/3/15/1443 Impasara Ltd Orphan Designation 12 Feb 2015 EMA/OD/251/14
EU/3/15/1442 Fibreu Limited Orphan Designation 12 Feb 2015 EMA/OD/250/14
EU/3/15/1441 Baxalta Innovations GmbH Orphan Designation 12 Feb 2015 EMA/OD/249/14
EU/3/15/1439 Miltenyi Biotec GmbH Orphan Designation 12 Feb 2015 EMA/OD/246/14
EU/3/15/1437 Theorem Clinical Research GmbH Orphan Designation 12 Feb 2015 EMA/OD/240/14
EU/3/15/1436 Infant Bacterial Therapeutics AB Orphan Designation 12 Feb 2015 EMA/OD/237/14
EU/3/15/1435 Covis Pharma S.à.r.l. Orphan Designation 12 Feb 2015 EMA/OD/225/14
EU/3/15/1434 PsiOxus Therapeutics Ltd Orphan Designation 12 Feb 2015 EMA/OD/211/14
EU/3/15/1433 Dilaforette AB Orphan Designation 12 Feb 2015 EMA/OD/210/14
EU/3/15/1431 BioCryst UK Ltd. Orphan Designation 12 Feb 2015 EMA/OD/170/14
EU/3/12/970 Pharma Gateway AB Transfer of orphan designation 2 Feb 2015 EMA/OD/138/11/T/01
EU/3/13/1124 Vtesse Europe Limited Transfer of orphan designation 2 Feb 2015 EMA/OD/191/12/T/01
EU/3/04/222 TRX Services Limited Transfer of orphan designation 2 Feb 2015 EMA/OD/044/02/T/03
EU/3/08/532 NeuroVision Pharma GmbH Transfer of orphan designation 2 Feb 2015 EMEA/OD/102/07/T/02
EU/3/08/580 NeuroVision Pharma GmbH Transfer of orphan designation 2 Feb 2015 EMEA/OD/042/08/T/02
EU/3/08/563 Vertex Pharmaceuticals (U.K.) Limited Transfer of orphan designation 23 Jan 2015 EMA/OD/012/08/T/01
EU/3/04/260 Chiesi Farmaceutici S.P.A. Transfer of orphan designation 22 Jan 2015 EMA/OD/074/04/T/01
EU/3/14/1430 Professor Edward G. Tuddenham Orphan Designation 15 Jan 2015 EMA/OD/224/14
EU/3/14/1429 TMC Pharma Services Ltd Orphan Designation 15 Jan 2015 EMA/OD/223/14
EU/3/14/1428 Alan Boyd Consultants Ltd Orphan Designation 15 Jan 2015 EMA/OD/222/14
EU/3/14/1427 AM-Pharma BV Orphan Designation 15 Jan 2015 EMA/OD/218/14
EU/3/14/1426 Richardson Associates Regulatory Affairs Ltd Orphan Designation 15 Jan 2015 EMA/OD/217/14
EU/3/14/1425 Ospedale San Raffaele s.r.l. Orphan Designation 15 Jan 2015 EMA/OD/216/14
EU/3/14/1424 MorphoSys AG Orphan Designation 15 Jan 2015 EMA/OD/215/14
EU/3/14/1423 Richardson Associates Regulatory Affairs Ltd Orphan Designation 15 Jan 2015 EMA/OD/214/14
EU/3/14/1422 BioMarin Europe Ltd Orphan Designation 15 Jan 2015 EMA/OD/213/14
EU/3/14/1421 ARIAD Pharma Ltd Orphan Designation 15 Jan 2015 EMA/OD/212/14
EU/3/14/1420 Dr Yanick Crow Orphan Designation 15 Jan 2015 EMA/OD/206/14
EU/3/14/1419 Dr Yanick Crow Orphan Designation 15 Jan 2015 EMA/OD/205/14
EU/3/14/1418 THERAVECTYS Orphan Designation 15 Jan 2015 EMA/OD/204/14
EU/3/14/1417 THERAVECTYS Orphan Designation 15 Jan 2015 EMA/OD/203/14
EU/3/14/1416 Atlab Pharma SAS Orphan Designation 15 Jan 2015 EMA/OD/199/14
EU/3/14/1415 Magnus Invention Management Ltd Orphan Designation 15 Jan 2015 EMA/OD/198/14
EU/3/14/1414 Hope Pharmaceuticals, Ltd Orphan Designation 15 Jan 2015 EMA/OD/191/14
EU/3/14/1413 Regulatory Resources Group Ltd Orphan Designation 15 Jan 2015 EMA/OD/188/14
EU/3/14/1412 Karcinolys S.A.S Orphan Designation 15 Jan 2015 EMA/OD/187/14
EU/3/14/1411 Dr Ulrich Granzer Orphan Designation 15 Jan 2015 EMA/OD/179/14
EU/3/14/1410 ACE BioSciences A/S Orphan Designation 15 Jan 2015 EMA/OD/172/14
EU/3/14/1409 Designerx Europe Limited Orphan Designation 15 Jan 2015 EMA/OD/076/14
EU/3/13/1220 Coté Orphan Consulting UK Limited Corrigendum 18 Dec 2013
Procedures for centrally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Profender Bayer Animal Health GmbH Centralised - Yearly update 19 Jun 2015
Previcox Merial Centralised - Yearly update 10 Jun 2015
Kexxtone Eli Lilly and Company Limited Centralised - Yearly update 10 Jun 2015
Cerenia Zoetis Belgium S.A. Centralised - Variation 10 Jun 2015 EMEA/V/C/106/X/23
Sileo Orion Corporation Centralised - Authorisation 10 Jun 2015 EMEA/V/C/3764/
Equilis Te Intervet International B.V. Centralised - Renewal 10 Jun 2015 EMEA/V/C/93/R/6
Equisolon Le Vet B.V. Centralised - Yearly update 5 Jun 2015
Recuvyra Eli Lilly and Company Limited Centralised - Yearly update 5 Jun 2015
Bovilis BTV8 Intervet International B.V. Centralised - Renewal 5 Jun 2015 EMEA/V/C/148/R/7
Meloxivet Eli Lilly and Company Limited Centralised - Yearly update 27 May 2015
Purevax RCPCh Merial Centralised - Yearly update 27 May 2015
Purevax FeLV Merial Centralised - Yearly update 27 May 2015
Suprelorin VIRBAC S.A. Centralised - Yearly update 27 May 2015
Nobilis IB 4-91 Intervet International B.V. Centralised - Yearly update 13 May 2015
Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Centralised - Variation 13 May 2015 EMEA/V/C/121/X/15
Purevax RCP Merial Centralised - Yearly update 5 May 2015
MS-H vaccine Pharmsure International Ltd Centralised - Yearly update 5 May 2015
Porcilis ColiClos Intervet International B.V. Centralised - Yearly update 24 Apr 2015
Draxxin Zoetis Belgium S.A. Centralised - 2-Monthly update 13 Apr 2015 EMEA/V/C/77/II/34
BROADLINE Merial Centralised - 2-Monthly update 13 Apr 2015 EMEA/V/C/2700/II/1
Porcilis Porcoli Intervet International B.V. Centralised - Yearly update 13 Apr 2015
Metacam Boehringer Ingelheim Vetmedica GmbH Centralised - Variation 9 Apr 2015 EMEA/V/C/33/X/107
Nobivac Myxo-RHD Intervet International B.V. Centralised - 2-Monthly update 26 Mar 2015 EMEA/V/C/2004/IB/4
Zuprevo Intervet International B.V. Centralised - 2-Monthly update 16 Mar 2015 EMEA/V/C/2009/II/6
Coliprotec F4 Prevtec Microbia GmbH Centralised - Authorisation 16 Mar 2015 EMEA/V/C/3797
Stronghold Zoetis Belgium S.A. Centralised - Variation 11 Mar 2015 EMEA/V/C/50/X/51/G
Dexdomitor Orion Corporation Centralised - Yearly update 5 Mar 2015
Advocate Bayer Animal Health GmbH Centralised - Yearly update 5 Mar 2015
CERTIFECT Merial Centralised - Yearly update 26 Feb 2015
ECOPORC SHIGA IDT Biologika GmbH Centralised - Yearly update 26 Feb 2015
Nobivac Myxo-RHD Intervet International B.V. Centralised - Yearly update 19 Feb 2015
BTVPUR AlSap 1-8 Merial Centralised - Yearly update 17 Feb 2015
BTVPUR AlSap 1 Merial Centralised - Yearly update 17 Feb 2015
Suvaxyn CSF Marker Zoetis Belgium S.A. Centralised - Authorisation 10 Feb 2015 EMEA/V/C/2757
Zulvac SBV Zoetis Belgium S.A. Centralised - Authorisation 6 Feb 2015 EMEA/V/C/2781
Emdocam Emdoka bvba Centralised - 2-Monthly update 30 Jan 2015 EMEA/V/C/2283/IB/6
TruScient Zoetis Belgium S.A. Centralised - Withdrawal 15 Jan 2015
Slentrol Zoetis Belgium S.A. Centralised - Withdrawal 15 Jan 2015
BLUEVAC BTV8 CZ Veterinaria, S.A. Centralised - Annual reassessment 15 Jan 2015 EMEA/V/C/156/S/3
NEXGARD SPECTRA Merial Centralised - Authorisation 15 Jan 2015 EMEA/V/C/3842
Coxevac CEVA SANTE ANIMALE Centralised - Variation 12 Jan 2015 EMEA/V/C/155/S/7
Melovem Dopharma Research B.V. Corrigendum 25 Sep 2013
Procedures for nationally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Myoson and associated names Meditop Pharmaceutical Ltd Referral 25 Jun 2015 EMEA/H/A-29/1412
Merisone and associated names Meditop Pharmaceutical Ltd Referral 25 Jun 2015 EMEA/H/A-29/1411
Ikorel and associated names and Dancor and associated names Referral 5 Jun 2015 EMEA/H/A-30//1380
fentanyl PSUSA - Modification 15 Apr 2015
Nasonex and associated names Referral 19 Jan 2015 EMEA/H/A-30/1374
Seasonique Referral 12 Jan 2015 EMEA/H/A-29/1392
Dexrazoxane PSUSA - Modification 12 Jan 2015 EMEA/H/C/PSUSA/1001/201402
Procedures for nationally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Baytril Corrigendum 8 Apr 2015
Veterinary medicinal products containing colistin to be administered orally Referral 16 Mar 2015 EMEA/V/A/106
Gentamicin - Veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses Referral 11 Feb 2015 EMEA/V/A/104