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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
Zoledronic acid Teva Pharma Teva B.V. Centralised - Yearly update 15 Jul 2016
Opsumit Actelion Registration Ltd Centralised - Yearly update 15 Jul 2016
Stelara Janssen-Cilag International NV Centralised - Yearly update 15 Jul 2016
NeoRecormon Roche Registration Limited Centralised - Yearly update 15 Jul 2016
Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 15 Jul 2016
Levetiracetam Teva Teva B.V. Centralised - Renewal 15 Jul 2016 EMEA/H/C/2316/R/21
Jardiance Boehringer Ingelheim International GmbH PSUSA - Modification 15 Jul 2016 EMEA/H/C/PSUSA/10388/201510
Qtern AstraZeneca AB Centralised - Authorisation 15 Jul 2016 EMEA/H/C/4057
ATryn GTC Biotherapeutics UK Limited Centralised - Renewal 15 Jul 2016 EMEA/H/C/587/R/24
Komboglyze AstraZeneca AB Centralised - Renewal 15 Jul 2016 EMEA/H/C/2059/R/32
Pramipexole Accord Accord Healthcare Limited Centralised - Renewal 15 Jul 2016 EMEA/H/C/2291/R/10
Sprycel Bristol-Myers Squibb Pharma EEIG Centralised - Renewal 15 Jul 2016 EMEA/H/C/709/R/50
Thalidomide Celgene Celgene Europe Limited PSUSA - Modification 15 Jul 2016 EMEA/H/C/PSUSA/2919/201510
Exjade Novartis Europharm Limited PSUSA - Modification 15 Jul 2016 EMEA/H/C/PSUSA/939/201510
Luminity Lantheus MI UK Limited Centralised - Renewal 15 Jul 2016 EMEA/H/C/654/R/21
Votrient Novartis Europharm Limited Centralised - Yearly update 14 Jul 2016
Ariclaim Eli Lilly Nederland B.V. Centralised - Yearly update 14 Jul 2016
Darzalex Janssen-Cilag International NV Rectificative Decision 14 Jul 2016
Otezla Celgene Europe Limited PSUSA - Modification 8 Jul 2016 EMEA/H/C/PSUSA/10338/201509
Revlimid Celgene Europe Limited Centralised - 2-Monthly update 8 Jul 2016 EMEA/H/C/717/II/79
Nivestim Hospira UK Limited Centralised - Yearly update 6 Jul 2016
Mircera Roche Registration Limited Centralised - Yearly update 6 Jul 2016
Olanzapine Mylan Generics [UK] Limited Centralised - Yearly update 6 Jul 2016
Xarelto Bayer Pharma AG Centralised - Yearly update 6 Jul 2016
Arzerra Novartis Europharm Limited Centralised - Yearly update 6 Jul 2016
Rapilysin Actavis Group PTC ehf. Centralised - Yearly update 6 Jul 2016
Oprymea Krka, d. d., Novo Mesto Centralised - Yearly update 6 Jul 2016
Vylaer Spiromax Teva Pharma B.V. Referral 6 Jul 2016 EMEA/H/A-31/1415/C/3952/03
Budesonide/Formoterol Teva Teva Pharma B.V. Referral 6 Jul 2016 EMEA/H/C/3951/A-31
Epclusa Gilead Sciences International Ltd. Centralised - Authorisation 6 Jul 2016 EMEA/H/C/004210/0000
EndolucinBeta ITG Isotope Technologies Garching GmbH Centralised - Authorisation 6 Jul 2016 EMEA/H/C/3999
Duloxetine Lilly Eli Lilly Nederland B.V. Centralised - Yearly update 4 Jul 2016
Clopidogrel Apotex Apotex Europe B.V. Centralised - Yearly update 4 Jul 2016
DuoResp Spiromax Teva Pharma B.V. Referral 4 Jul 2016 EMEA/H/A-31/1415
BiResp Spiromax Teva Pharma B.V. Referral 4 Jul 2016 EMEA/H/A-31/415
Zinbryta Biogen Idec Limited Centralised - Authorisation 1 Jul 2016 EMEA/H/C/3862
Krystexxa Crealta Pharmaceuticals Ireland Limited Centralised - Withdrawal 30 Jun 2016
Yentreve Eli Lilly Nederland B.V. Centralised - Yearly update 30 Jun 2016
Hycamtin Novartis Europharm Limited Centralised - Yearly update 30 Jun 2016
Zarzio Sandoz GmbH Centralised - Yearly update 30 Jun 2016
Filgrastim Hexal Hexal AG Centralised - Yearly update 30 Jun 2016
Velmetia Merck Sharp & Dohme Limited Centralised - Yearly update 30 Jun 2016
Ristaben Merck Sharp & Dohme Limited Centralised - Yearly update 30 Jun 2016
Janumet Merck Sharp & Dohme Limited Centralised - Yearly update 30 Jun 2016
Toujeo Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 30 Jun 2016
Ceplene Meda AB Centralised - Yearly update 30 Jun 2016
Efficib Merck Sharp & Dohme Limited Centralised - Yearly update 30 Jun 2016
Opgenra Olympus Biotech International Limited Centralised - Withdrawal 30 Jun 2016
Eylea Bayer Pharma AG Centralised - 2-Monthly update 30 Jun 2016 EMEA/H/C/2392/II/27/G
OLYSIO Janssen-Cilag International NV Centralised - 2-Monthly update 30 Jun 2016 EMEA/H/C/2777/II/15
Dacogen Janssen-Cilag International NV Centralised - 2-Monthly update 30 Jun 2016 EMEA/H/C/2221/IB/26
Kivexa ViiV Healthcare UK Limited Centralised - Yearly update 29 Jun 2016
Tyverb Novartis Europharm Limited Centralised - Yearly update 29 Jun 2016
Vidaza Celgene Europe Limited Centralised - 2-Monthly update 29 Jun 2016 EMEA/H/C/978/IB/36
Revestive NPS Pharma Holdings Limited Centralised - 2-Monthly update 29 Jun 2016 EMEA/H/C/2345/II/20
ViraferonPeg Merck Sharp & Dohme Limited Centralised - Yearly update 29 Jun 2016
Memantine Mylan Generics [UK] Limited Centralised - Yearly update 29 Jun 2016
PegIntron Merck Sharp & Dohme Limited Centralised - Yearly update 29 Jun 2016
Incivo Janssen-Cilag International NV Centralised - Yearly update 29 Jun 2016
Mycamine Astellas Pharma Europe B.V. Centralised - 2-Monthly update 29 Jun 2016 EMEA/H/C/734/II/31
Kyprolis Amgen Europe B.V. Centralised - 2-Monthly update 29 Jun 2016 EMEA/H/C/003790/II/01/G
Champix Pfizer Limited Centralised - Renewal 29 Jun 2016 EMEA/H/C/699/R/61
Enzepi APTALIS PHARMA SAS Centralised - Authorisation 29 Jun 2016 EMEA/H/C/2070
Yondelis Pharma Mar S.A. PSUSA - Modification 29 Jun 2016 EMEA/H/C/PSUSA/3001/201509
Matever Pharmathen S.A. Centralised - Renewal 29 Jun 2016 EMEA/H/C/2024/R/23
Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH PSUSA - Modification 29 Jun 2016 EMEA/H/C/PSUSA/3149/201508
Januvia Merck Sharp & Dohme Limited Centralised - Yearly update 24 Jun 2016
ADCETRIS Takeda Pharma A/S Centralised - 2-Monthly update 24 Jun 2016 EMEA/H/C/2455/II/25
Zoledronic acid Hospira Hospira UK Limited Centralised - Yearly update 24 Jun 2016
Advate Baxter AG Centralised - Yearly update 24 Jun 2016
Grepid Pharmathen S.A. Centralised - Yearly update 24 Jun 2016
Tolura Krka, d. d., Novo Mesto Centralised - Yearly update 24 Jun 2016
Emtriva Gilead Sciences International Limited Centralised - Yearly update 24 Jun 2016
Rasilez HCT Novartis Europharm Limited Centralised - 2-Monthly update 24 Jun 2016 EMEA/H/C/964/WS/0849
Imnovid Celgene Europe Limited Centralised - 2-Monthly update 24 Jun 2016 EMEA/H/C/2682/II/0016/G
Tysabri Biogen Idec Limited Centralised - 2-Monthly update 24 Jun 2016 EMEA/H/C/603/II/77
Simponi Janssen Biologics B.V. Centralised - 2-Monthly update 24 Jun 2016 EMEA/H/C/992/II/63
Humira AbbVie Ltd Centralised - 2-Monthly update 24 Jun 2016 EMEA/H/C/481/II/146
Rasilez Novartis Europharm Limited Centralised - 2-Monthly update 24 Jun 2016 EMEA/H/C/780/WS/849
Zavicefta AstraZeneca AB Centralised - Authorisation 24 Jun 2016 EMEA/H/C/4027
Aprovel Sanofi Clir SNC PSUSA - Modification 24 Jun 2016 EMEA/H/C/141/PSUSA/1782/201508
Relvar Ellipta Glaxo Group Ltd Referral 24 Jun 2016 EMEA/H/A-31/1415/C/2673/14
Revinty Ellipta Glaxo Group Ltd Referral 24 Jun 2016 EMEA/H/A-31/1415/C/2745/10
Cubicin Merck Sharp & Dohme Limited PSUSA - Modification 24 Jun 2016 EMEA/H/C/637/931/201509
Ongentys Bial - Portela & Cª, SA Centralised - Authorisation 24 Jun 2016 EMEA/H/C/2790
Daklinza Bristol-Myers Squibb Pharma EEIG Centralised - Variation 24 Jun 2016 EMEA/H/C/3768/X/13
Dropcys Lucane Pharma Centralised - Refusal of marketing authorisation 24 Jun 2016 EMEA/H/C/4038
Modigraf Astellas Pharma Europe B.V. Centralised - Yearly update 21 Jun 2016
Eurartesim Sigma-Tau Industrie Farmaceutiche Riunite S.p.A Centralised - Yearly update 21 Jun 2016
Capecitabine SUN Sun Pharmaceutical Industries Europe BV Centralised - Withdrawal 21 Jun 2016
Zometa Novartis Europharm Limited PSUSA - Modification 21 Jun 2016 EMEA/H/C/336/PSUSA-3149/201508
Irbesartan Zentiva Sanofi-Aventis groupe PSUSA - Modification 21 Jun 2016 EMEA/H/C/785/1782/201508
Odefsey Gilead Sciences International Limited Centralised - Authorisation 21 Jun 2016 EMEA/H/C/4156
Lemtrada Genzyme Therapeutics Ltd PSUSA - Modification 21 Jun 2016 EMEA/H/C/3718/PSUSA/10055/201509
Karvea Sanofi-Aventis groupe PSUSA - Modification 21 Jun 2016 EMEA/H/C/PSUSA/1782/201508
Reyataz Bristol-Myers Squibb Pharma EEIG Centralised - Variation 21 Jun 2016 EMEA/H/C/494/X/94/G
Tesavel Merck Sharp & Dohme Limited Centralised - Yearly update 16 Jun 2016
Advagraf Astellas Pharma Europe B.V. Centralised - Yearly update 16 Jun 2016
Avonex Biogen Idec Limited Centralised - Yearly update 16 Jun 2016
Protopic Leo Pharma A/S Centralised - Transfer Marketing Authorisation Holder 16 Jun 2016 EMEA/H/C/374/T/64
Xelevia Merck Sharp & Dohme Limited Centralised - Yearly update 16 Jun 2016
Gazyvaro Roche Registration Limited Centralised - 2-Monthly update 13 Jun 2016 EMEA/H/C/2799/II/7
Zyllt Krka, d. d., Novo Mesto Centralised - Yearly update 9 Jun 2016
Cubicin Merck Sharp & Dohme Limited Centralised - Rectificative 9 Jun 2016
VPRIV Shire Pharmaceuticals Ireland Limited Centralised - 2-Monthly update 9 Jun 2016 EMEA/H/C/1249/II/29
Telmisartan Teva Pharma Teva B.V. Centralised - Renewal 9 Jun 2016 EMEA/H/C/2511/R/14
Clopidogrel Krka Krka, d. d., Novo Mesto Centralised - Yearly update 2 Jun 2016
Kiovig Baxter AG Centralised - Yearly update 2 Jun 2016
Kineret Swedish Orphan Biovitrum AB (publ) Centralised - Yearly update 2 Jun 2016
Lonquex UAB "Sicor Biotech" Centralised - Yearly update 2 Jun 2016
Clopidogrel BGR Laboratoires BIOGARAN Centralised - Yearly update 2 Jun 2016
Capecitabine Accord Accord Healthcare Limited Centralised - Yearly update 2 Jun 2016
Vimpat UCB Pharma S.A. Centralised - Yearly update 2 Jun 2016
Altargo Glaxo Group Ltd Centralised - Yearly update 2 Jun 2016
Adrovance Merck Sharp & Dohme Limited Centralised - Yearly update 2 Jun 2016
Temozolomide Accord Accord Healthcare Limited Centralised - Yearly update 2 Jun 2016
Tasigna Novartis Europharm Limited Centralised - Yearly update 2 Jun 2016
Imatinib Actavis Actavis Group PTC ehf. Centralised - Yearly update 2 Jun 2016
Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Centralised - Yearly update 2 Jun 2016
Avastin Roche Registration Limited Centralised - 2-Monthly update 2 Jun 2016 EMEA/H/C/582/II/86
Neuraceq Piramal Imaging Limited PSUSA - Modification 2 Jun 2016 EMEA/H/C/2553/PSUSA/10094/201508
Revlimid Celgene Europe Limited Centralised - Yearly update 1 Jun 2016
Cotellic Roche Registration Limited Centralised - 2-Monthly update 1 Jun 2016 EMEA/H/C/3960/II/1/G
Zinforo AstraZeneca AB Centralised - 2-Monthly update 1 Jun 2016 EMEA/H/C/2252/II/22
HyQvia Baxalta Innovations GmbH Centralised - 2-Monthly update 1 Jun 2016 EMEA/H/C/2491/II/21
Clopidogrel / Acetylsalicylic acid Teva Teva Pharma B.V. Centralised - Withdrawal 1 Jun 2016
Clopidogrel TAD TAD Pharma GmbH Centralised - Yearly update 27 May 2016
Clopidogrel HCS HCS bvba Centralised - Yearly update 26 May 2016
Ytracis CIS bio international Centralised - Yearly update 26 May 2016
Conbriza Pfizer Limited Centralised - Yearly update 26 May 2016
Neulasta Amgen Europe B.V. Centralised - Yearly update 26 May 2016
Rixubis Baxalta Innovations GmbH Centralised - Yearly update 26 May 2016
Taxotere Aventis Pharma S.A. Centralised - Yearly update 26 May 2016
Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 26 May 2016
Clopidogrel / Acetylsalicylic acid Teva Teva Pharma B.V. Centralised - Yearly update 26 May 2016
Liprolog Eli Lilly Nederland B.V. Centralised - Yearly update 26 May 2016
Nexium Control Pfizer Consumer Healthcare Limited Centralised - Yearly update 26 May 2016
Duaklir Genuair AstraZeneca AB Centralised - Yearly update 26 May 2016
Firazyr Shire Orphan Therapies GmbH Centralised - Yearly update 26 May 2016
Clopidogrel Teva Teva B.V. Centralised - Yearly update 26 May 2016
Victoza Novo Nordisk A/S Centralised - 2-Monthly update 26 May 2016 EMEA/H/C/1026/II/38
Afinitor Novartis Europharm Limited Centralised - 2-Monthly update 26 May 2016 EMEA/H/C/1038/II/48
Ferriprox Apotex Europe B.V. Centralised - 2-Monthly update 26 May 2016 EMEA/H/C/236/II/103
IMBRUVICA Janssen-Cilag International NV Centralised - 2-Monthly update 26 May 2016 EMEA/H/C/3791/II/16
HyQvia Baxalta Innovations GmbH Centralised - Yearly update 26 May 2016
DepoCyte Pacira Limited Centralised - Yearly update 26 May 2016
Glubrava Takeda Pharma A/S PSUSA - Modification 26 May 2016 EMEA/H/C/893/2417/201507
Glustin Takeda Pharma A/S PSUSA - Modification 26 May 2016 EMEA/H/C/286/PSUSA/2417/201507
Actos Takeda Pharma A/S PSUSA - Modification 26 May 2016 EMEA/H/C/285/PSUSA/2417/201507
Cayston Gilead Sciences International Limited Centralised - Renewal 26 May 2016 EMEA/H/C/996/R/58
Zytiga Janssen-Cilag International NV Centralised - Renewal 26 May 2016 EMEA/H/C/2321/R/38
Palonosetron Accord Accord Healthcare Limited Centralised - Authorisation 26 May 2016 EMEA/H/C/4129
Cinryze Shire Services BVBA Centralised - Renewal 26 May 2016 EMEA/H/C/1207/R/40
Competact Takeda Pharma A/S PSUSA - Modification 26 May 2016 EMEA/H/C/655/PSUSA/2417/201507
XALKORI Pfizer Limited PSUSA - Modification 26 May 2016 EMEA/H/C/2489/PSUSA/10042/201508
Strimvelis GlaxoSmithKline Trading Services Limited Centralised - Authorisation (orphan status) 26 May 2016 EMEA/H/C/3854
Trevicta Janssen-Cilag International NV Centralised - Variation 26 May 2016 EMEA/H/C/4066/X/7/G
Erivedge Roche Registration Limited Centralised - Annual renewal 26 May 2016 EMEA/H/C/2602/R/23
Galafold Amicus Therapeutics UK Ltd Centralised - Authorisation 26 May 2016 EMEA/H/C/4059
Dexdor Orion Corporation Centralised - Renewal 26 May 2016 EMEA/H/C/2268/R/19
Fampyra Biogen Idec Limited Centralised - Annual renewal 26 May 2016 EMEA/H/C/2097/R/29
Zeffix Glaxo Group Ltd PSUSA - Modification 26 May 2016 EMEA/H/C/PSUSA/1824/201507
Flixabi Samsung Bioepis UK Limited Centralised - Authorisation 26 May 2016 EMEA/H/C/4020
Mabthera Roche Registration Limited Centralised - Variation 26 May 2016 EMEA/H/C/165/X/101/G
Vibativ Clinigen Healthcare Limited Centralised - Renewal 26 May 2016 EMEA/H/C/1240/R/25
Neparvis Novartis Europharm Limited Centralised - Authorisation 26 May 2016 EMEA/H/C/4343
Buccolam Shire Services BVBA Centralised - Renewal 26 May 2016 EMEA/H/C/2267:/R/32
Levodopa/Carbidopa/Entacapone Orion Orion Corporation Centralised - Renewal 26 May 2016 EMEA/H/C/2441/R/19
Imnovid Celgene Europe Limited PSUSA - Modification 26 May 2016 EMEA/H/C/2682/PSUSA/10127/201508
Tandemact Takeda Pharma A/S PSUSA - Modification 26 May 2016 EMEA/H/C/680/PSUSA/2417/201507
Constella Allergan Pharmaceuticals International Ltd. PSUSA - Modification 26 May 2016 EMEA/H/C/PSUSA/10025/201508
Clopidogrel Krka d.d. Krka, d. d., Novo Mesto Centralised - Yearly update 20 May 2016
Gazyvaro Roche Registration Limited Centralised - Yearly update 20 May 2016
Hexyon Sanofi Pasteur MSD SNC Centralised - Yearly update 20 May 2016
Darzalex Janssen-Cilag International NV Centralised - Authorisation 20 May 2016 EMEA/H/C/4077
Ceprotin Baxter AG Centralised - Yearly update 20 May 2016
Pandemic influenza vaccine H5N1 MedImmune MedImmune, LLC Centralised - Authorisation 20 May 2016 EMEA/H/C/3963
Wilzin Orphan Europe S.A.R.L. Centralised - Yearly update 17 May 2016
Champix Pfizer Limited Centralised - Yearly update 17 May 2016
Epivir ViiV Healthcare UK Limited Centralised - Yearly update 17 May 2016
Imatinib Teva Teva B.V. Centralised - Yearly update 17 May 2016
Capecitabine SUN Sun Pharmaceutical Industries Europe BV Centralised - Yearly update 17 May 2016
Hexacima Sanofi Pasteur SA Centralised - Yearly update 13 May 2016
ALPROLIX Biogen Idec Limited Corrigendum 12 May 2016
Clopidogrel Mylan Mylan S.A.S Centralised - Yearly update 12 May 2016
Integrilin Glaxo Group Ltd Centralised - Yearly update 12 May 2016
Enurev Breezhaler Novartis Europharm Limited Centralised - Yearly update 12 May 2016
Brimica Genuair AstraZeneca AB Centralised - Yearly update 12 May 2016
Desloratadine Teva Teva B.V. Centralised - Yearly update 12 May 2016
Tepadina ADIENNE S.r.l. Centralised - Yearly update 12 May 2016
Glybera uniQure biopharma B.V. Centralised - Yearly update 12 May 2016
Docetaxel Winthrop Aventis Pharma S.A. Centralised - Yearly update 12 May 2016
Seebri Breezhaler Novartis Europharm Limited Centralised - Yearly update 12 May 2016
Tovanor Breezhaler Novartis Europharm Limited Centralised - Yearly update 12 May 2016
ALPROLIX Biogen Idec Limited Centralised - Authorisation 12 May 2016 EMEA/H/C/4142
NovoEight Novo Nordisk A/S Centralised - Yearly update 12 May 2016
Uptravi Actelion Registration Ltd Centralised - Authorisation 12 May 2016 EMEA/H/C/3774
Inlyta Pfizer Limited Centralised - Yearly update 11 May 2016
Humalog Eli Lilly Nederland B.V. Centralised - Yearly update 11 May 2016
Desloratadine Actavis Actavis Group PTC ehf. Centralised - Yearly update 11 May 2016
Plenadren Shire Services BVBA Centralised - Yearly update 11 May 2016
Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Yearly update 11 May 2016
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 11 May 2016 EMEA/H/C/3985/II/3
Humira AbbVie Ltd Centralised - 2-Monthly update 11 May 2016 EMEA/H/C/481/II/147
Zerit Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 11 May 2016 EMEA/H/C/110/II/99
IDELVION CSL Behring GmbH Centralised - Authorisation 11 May 2016 EMEA/H/C/3955
Empliciti Bristol-Myers Squibb Pharma EEIG Centralised - Authorisation 11 May 2016 EMEA/H/C/3967
Combivir ViiV Healthcare UK Limited Centralised - Yearly update 2 May 2016
ellaOne Laboratoire HRA Pharma Centralised - Yearly update 2 May 2016
Synflorix GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 2 May 2016
Bortezomib Accord Accord Healthcare Limited Centralised - 2-Monthly update 2 May 2016 EMEA/H/C/3984/IB/6/G
Harvoni Gilead Sciences International Limited Centralised - 2-Monthly update 2 May 2016 EMEA/H/C/3850/IB/28/G
Quadramet CIS bio international Centralised - Yearly update 2 May 2016
Ebilfumin Actavis Group PTC ehf. Centralised - 2-Monthly update 2 May 2016 EMEA/H/C/3717/IB/4
HALAVEN Eisai Europe Limited Centralised - 2-Monthly update 2 May 2016 EMEA/H/C/2084/II/28
Lyxumia Sanofi-Aventis groupe Centralised - 2-Monthly update 2 May 2016 EMEA/H/C/2445/II/14
Norvir AbbVie Ltd Centralised - 2-Monthly update 2 May 2016 EMEA/H/C/127/II/140
Ixiaro Valneva Austria GmbH Centralised - 2-Monthly update 2 May 2016 EMEA/H/C/963/II/75
Tafinlar Novartis Europharm Limited Centralised - 2-Monthly update 2 May 2016 EMEA/H/C/2604/II/18
Xigduo AstraZeneca AB Corrigendum 28 Apr 2016
Forxiga AstraZeneca AB Corrigendum 28 Apr 2016
Xigduo AstraZeneca AB Referral 28 Apr 2016 EMEA/H/A-20/1419/C/2672/12
Forxiga AstraZeneca AB Referral 28 Apr 2016 EMEA/H/C/2322/21
Levetiracetam ratiopharm ratiopharm GmbH Centralised - Renewal 28 Apr 2016 EMEA/H/C/2244/R/14
Synjardy Boehringer Ingelheim International GmbH Referral 28 Apr 2016 EMEA/H/A-20/1419/C/3770/1
Viekirax AbbVie Ltd PSUSA - Modification 28 Apr 2016 EMEA/H/C/3839/PSUSA/10367/201507
Vokanamet Janssen-Cilag International NV Referral 28 Apr 2016 EMEA/H/C/2656/A-20/1419/7
ABILIFY MAINTENA Otsuka Pharmaceutical Europe Ltd. PSUSA - Modification 28 Apr 2016 EMEA/H/C/2755/PSUSA/234/201507
ZALTRAP Sanofi-Aventis groupe PSUSA - Modification 28 Apr 2016 EMEA/H/C/2532/PSUSA/10019/201508
Trizivir ViiV Healthcare UK Limited Centralised - Yearly update 25 Apr 2016
Cubicin Merck Sharp & Dohme Limited Centralised - Transfer Marketing Authorisation Holder 25 Apr 2016 EMEA/H/C/637/T/56
Competact Takeda Pharma A/S Centralised - Renewal 25 Apr 2016 EMEA/H/C/655/R/57
Jardiance Boehringer Ingelheim International GmbH Referral 25 Apr 2016 EMEA/H/A-20/1419/C/2677/7
Invokana Janssen-Cilag International NV Referral 25 Apr 2016 EMEA/H/A-20/1419/C/2649/11
Bondronat Roche Registration Limited PSUSA - Modification 25 Apr 2016 EMEA/H/C/PSUSA/1702/201506
Picato Leo Pharma A/S PSUSA - Modification 25 Apr 2016 EMEA/H/C/2275/PSUSA/10035/201507
Tysabri Biogen Idec Limited Referral 25 Apr 2016 EMEA/H/C/603/A-20/1416/83
Taltz Eli Lilly Nederland B.V. Centralised - Authorisation 25 Apr 2016 EMEA/H/C/3943
Lonsurf Les Laboratoires Servier Centralised - Authorisation 25 Apr 2016 EMEA/H/C/3897
Helicobacter Test INFAI INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Centralised - Yearly update 21 Apr 2016
Dasselta Krka, d. d., Novo Mesto Centralised - Yearly update 21 Apr 2016
Desloratadine ratiopharm ratiopharm GmbH Centralised - Yearly update 21 Apr 2016
Zoely Teva B.V. Centralised - Renewal 21 Apr 2016 EMEA/H/C/1213/R/32
Temozolomide SUN Sun Pharmaceutical Industries Europe BV Centralised - Renewal 21 Apr 2016 EMEA/H/C/2198/R/19
Descovy Gilead Sciences International Limited Centralised - Authorisation 21 Apr 2016 EMEA/H/C/4094
Exviera AbbVie Ltd PSUSA - Modification 21 Apr 2016 EMEA/H/C/3837/PSUSA/10363
Yervoy Bristol-Myers Squibb Pharma EEIG Centralised - Renewal 21 Apr 2016 EMEA/H/C/2213/R/35
Bonviva Roche Registration Limited PSUSA - Modification 21 Apr 2016 EMEA/H/C/501/PSUSA/1702/201506
Abilify Otsuka Pharmaceutical Europe Ltd. PSUSA - Modification 21 Apr 2016 EMEA/H/C/471/234/201507
Nplate Amgen Europe B.V. PSUSA - Modification 21 Apr 2016 EMEA/H/C/942/PSUSA/2660/201507
Exjade Novartis Europharm Limited Centralised - Renewal 18 Apr 2016 EMEA/H/C/670/R/47
Tysabri Biogen Idec Limited Centralised - Renewal 18 Apr 2016 EMEA/H/C/603/R/91
Tresiba Novo Nordisk A/S Centralised - Yearly update 13 Apr 2016
Ryzodeg Novo Nordisk A/S Centralised - Yearly update 13 Apr 2016
Vectibix Amgen Europe B.V. Centralised - Yearly update 13 Apr 2016
Cholib BGP Products Ltd Centralised - Yearly update 13 Apr 2016
Jakavi Novartis Europharm Limited Centralised - Yearly update 13 Apr 2016
Zypadhera Eli Lilly Nederland B.V. Centralised - Yearly update 13 Apr 2016
Tamiflu Roche Registration Limited Centralised - Yearly update 13 Apr 2016
Ixiaro Valneva Austria GmbH Centralised - Yearly update 13 Apr 2016
Nemdatine Actavis Group PTC ehf. Centralised - Yearly update 13 Apr 2016
Trevicta Janssen-Cilag International NV Centralised - Yearly update 13 Apr 2016
Ibandronic acid Sandoz Sandoz GmbH Centralised - Renewal 13 Apr 2016 EMEA/H/C/2367/R/17
Zyprexa Eli Lilly Nederland B.V. Centralised - Yearly update 8 Apr 2016
Entacapone Orion Orion Corporation Centralised - Renewal 8 Apr 2016 EMEA/H/C/2440/R/11
Palonosetron Hospira Hospira UK Limited Centralised - Authorisation 8 Apr 2016 EMEA/H/C/4069
INCRELEX Ipsen Pharma Centralised - Annual reassessment 8 Apr 2016 EMEA/H/C/704/S/35
Ziagen ViiV Healthcare UK Limited Centralised - Yearly update 7 Apr 2016
Imprida Novartis Europharm Limited Centralised - Yearly update 7 Apr 2016
Dafiro HCT Novartis Europharm Limited Centralised - Yearly update 7 Apr 2016
Gardasil 9 Sanofi Pasteur MSD SNC Centralised - 2-Monthly update 4 Apr 2016 EMEA/H/C/3852/II/4
Opdivo Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 4 Apr 2016 EMEA/H/C/3985/II/8
Humira AbbVie Ltd Centralised - 2-Monthly update 4 Apr 2016 EMEA/H/C/481/II/149
Telzir ViiV Healthcare UK Limited Centralised - 2-Monthly update 4 Apr 2016 EMEA/H/C/534/II/82
Revolade Novartis Europharm Limited Centralised - Variation 4 Apr 2016 EMEA/H/C/1110/X/22/G
Rasagiline Mylan Mylan S.A.S Centralised - Authorisation 4 Apr 2016 EMEA/H/C/4064
JEVTANA Sanofi-Aventis groupe PSUSA - Modification 4 Apr 2016 EMEA/H/C/2018/PSUSA/476/201506
Xgeva Amgen Europe B.V. Centralised - Renewal 4 Apr 2016 EMEA/H/C/2173/R/42
Caelyx Janssen-Cilag International NV Centralised - Yearly update 31 Mar 2016
Vargatef Boehringer Ingelheim International GmbH Centralised - Yearly update 31 Mar 2016
Eviplera Gilead Sciences International Limited Centralised - Yearly update 31 Mar 2016
Revatio Pfizer Limited Centralised - Yearly update 31 Mar 2016
Ecansya Krka, d. d., Novo Mesto Centralised - 2-Monthly update 31 Mar 2016 EMEA/H/C/2605/IB/17
Lynparza AstraZeneca AB Centralised - 2-Monthly update 31 Mar 2016 EMEA/H/C/3726/II/1/G
Capecitabine Teva Teva B.V. Centralised - 2-Monthly update 31 Mar 2016 EMEA/H/C/2362/IB/21
Giotrif Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 31 Mar 2016 EMEA/H/C/2280/II/12
Epoetin alfa Hexal Hexal AG Centralised - 2-Monthly update 31 Mar 2016 EMEA/H/C/726/II/WS/877
Binocrit Sandoz GmbH Centralised - 2-Monthly update 31 Mar 2016 EMEA/H/C/725/WS/877
Ruconest Pharming Group N.V. Centralised - 2-Monthly update 31 Mar 2016 EMEA/H/C/1223/II/31
Angiox The Medicines Company UK Ltd Rectificative Decision 31 Mar 2016
Zonisamide Mylan Mylan S.A.S Centralised - Authorisation 31 Mar 2016 EMEA/H/C/4127
Betmiga Astellas Pharma Europe B.V. PSUSA - Modification 31 Mar 2016 EMEA/H/C/PSUSA/10031/201506/
Wakix Bioprojet Pharma Centralised - Authorisation 31 Mar 2016 EMEA/H/C/2616
Evra Janssen-Cilag International NV Centralised - Yearly update 30 Mar 2016
TachoSil Takeda Austria GmbH Centralised - 2-Monthly update 30 Mar 2016 EMEA/H/C/505/II/57
Abseamed Medice Arzneimittel Pütter GmbH & Co KG Centralised - 2-Monthly update 30 Mar 2016 EMEA/H/C/727/WS/877
Vidaza Celgene Europe Limited PSUSA - Modification 30 Mar 2016 EMEA/H/C/978/PSUSA/274/201505
Anoro Glaxo Group Ltd PSUSA - Modification 30 Mar 2016 EMEA/H/C/2751/PSUSA/10264/201506
Zydelig Gilead Sciences International Limited Referral 23 Mar 2016 EMEA/H/C/3843/A-20
Elocta Swedish Orphan Biovitrum AB (publ) Centralised - Transfer Marketing Authorisation Holder 23 Mar 2016 EMEA/H/C/3964/T/2
Kepivance Swedish Orphan Biovitrum AB (publ) Centralised - 2-Monthly update 22 Mar 2016 EMEA/H/C/609/IB/45
Copalia HCT Novartis Europharm Limited Centralised - Yearly update 22 Mar 2016
Exforge Novartis Europharm Limited Centralised - Yearly update 22 Mar 2016
Iclusig ARIAD Pharma Ltd PSUSA - Modification 22 Mar 2016 EMEA/H/C/PSUSA/10128/201506
Trajenta Boehringer Ingelheim International GmbH Centralised - Renewal 22 Mar 2016 EMEA/H/C/2110/R/21
Exjade Novartis Europharm Limited Centralised - Variation 22 Mar 2016 EMEA/H/C/670/X/43
Lumigan Allergan Pharmaceuticals Ireland Rectificative Decision 22 Mar 2016 EMEA/H/C/PSUSA/413/201503
Amlodipine/Valsartan Mylan Mylan S.A.S Centralised - Authorisation 22 Mar 2016 EMEA/H/C/4037
Mekinist Novartis Europharm Limited PSUSA - Modification 22 Mar 2016 EMEA/H/C/PSUSA/10262/201505
Laventair Glaxo Group Ltd PSUSA - Modification 22 Mar 2016 EMEA/H/C/PSUSA/10264/201506
Pixuvri CTI Life Sciences Ltd Centralised - Annual renewal 22 Mar 2016 EMEA/H/C/2055/R/25
Zykadia Novartis Europharm Limited Centralised - Annual renewal 22 Mar 2016 EMEA/H/C/3819/R/4
Cuprymina SPARKLE S.r.l. Centralised - Yearly update 16 Mar 2016
Coagadex Bio Products Laboratory Ltd Centralised - Authorisation 16 Mar 2016 EMEA/H/C/3855
Neofordex Laboratoires CTRS Centralised - Authorisation 16 Mar 2016 EMEA/H/C/4071
Savene Clinigen Healthcare Limited Centralised - Yearly update 11 Mar 2016
Deltyba Otsuka Novel Products GmbH Centralised - Annual renewal 11 Mar 2016 EMEA/H/C/2552/R/10
Topotecan Teva Teva B.V. Centralised - Yearly update 11 Mar 2016
Celsentri ViiV Healthcare UK Limited Centralised - Yearly update 10 Mar 2016
Onglyza AstraZeneca AB Centralised - Yearly update 10 Mar 2016
Triumeq ViiV Healthcare UK Limited Centralised - Yearly update 7 Mar 2016
Signifor Novartis Europharm Limited Centralised - Yearly update 7 Mar 2016
Dacogen Janssen-Cilag International NV Centralised - Yearly update 7 Mar 2016
Avamys Glaxo Group Ltd Centralised - Yearly update 7 Mar 2016
Mozobil Genzyme Europe B.V. Centralised - Yearly update 2 Mar 2016
Exforge HCT Novartis Europharm Limited Centralised - Yearly update 2 Mar 2016
Faslodex AstraZeneca UK Limited Centralised - Yearly update 2 Mar 2016
Efavirenz Teva Teva B.V. Centralised - Yearly update 2 Mar 2016
Nuedexta Jenson Pharmaceutical Services Ltd Centralised - Withdrawal 2 Mar 2016
Dafiro Novartis Europharm Limited Centralised - Yearly update 2 Mar 2016
Copalia Novartis Europharm Limited Centralised - Yearly update 2 Mar 2016
DuoPlavin Sanofi Clir SNC Centralised - Yearly update 2 Mar 2016
Menveo GSK Vaccines S.r.l. Centralised - Yearly update 2 Mar 2016
Xydalba Durata Therapeutics International B.V. Centralised - 2-Monthly update 2 Mar 2016 EMEA/H/C/2840/II/4
Jentadueto Boehringer Ingelheim International GmbH PSUSA - Modification 2 Mar 2016 EMEA/H/C/PSUSA/9214/201505
Jentadueto Boehringer Ingelheim International GmbH Centralised - Yearly update 26 Feb 2016
PREZISTA Janssen-Cilag International NV Centralised - Yearly update 26 Feb 2016
Clopidogrel/Acetylsalicylic acid Zentiva (ex DuoCover) Sanofi-Aventis groupe Centralised - Yearly update 26 Feb 2016
Vibativ Clinigen Healthcare Limited Centralised - 2-Monthly update 26 Feb 2016 EMEA/H/C/1240/II/23
Viread Gilead Sciences International Limited Centralised - Yearly update 26 Feb 2016
Urorec Recordati Ireland Ltd Centralised - Yearly update 26 Feb 2016
Clopidogrel Zentiva Sanofi-Aventis groupe Centralised - Yearly update 26 Feb 2016
Bridion Merck Sharp & Dohme Limited Centralised - Yearly update 26 Feb 2016
Cerdelga Genzyme Europe B.V. Centralised - Yearly update 25 Feb 2016
Firdapse BioMarin Europe Ltd. Corrigendum 24 Feb 2016
Vylaer Spiromax Teva Pharma B.V. Centralised - Yearly update 24 Feb 2016
Silodyx Recordati Ireland Ltd Centralised - Yearly update 24 Feb 2016
Peyona Chiesi Farmaceutici S.P.A. Centralised - Yearly update 24 Feb 2016
Brintellix H. Lundbeck A/S Centralised - Yearly update 24 Feb 2016
Afinitor Novartis Europharm Limited Centralised - Yearly update 24 Feb 2016
Ravicti Horizon Pharma Ireland Limited Centralised - Transfer Marketing Authorisation Holder 24 Feb 2016 EMEA/H/C/3822/T/1
Kepivance Swedish Orphan Biovitrum AB (publ) Centralised - Withdrawal 24 Feb 2016
Xultophy Novo Nordisk A/S Centralised - 2-Monthly update 24 Feb 2016 EMEA/H/C/2647/II/12
Odomzo Novartis Europharm Limited Centralised - 2-Monthly update 24 Feb 2016 EMEA/H/C/2839/II/1/G
Stribild Gilead Sciences International Limited Centralised - Yearly update 24 Feb 2016
Firdapse BioMarin Europe Ltd. Centralised - Yearly update 24 Feb 2016
Vizarsin Krka, d. d., Novo Mesto Centralised - 2-Monthly update 22 Feb 2016 EMEA/H/C/1076/IB/24
Scintimun CIS bio international Centralised - 2-Monthly update 22 Feb 2016 EMEA/H/C/1045/IB/7
Azilect Teva B.V. Centralised - Transfer Marketing Authorisation Holder 22 Feb 2016 EMEA/H/C/574/T/71
Zoledronic acid Mylan Mylan S.A.S Centralised - Yearly update 22 Feb 2016
Herceptin Roche Registration Limited Centralised - Yearly update 22 Feb 2016
Fasturtec Sanofi-Aventis groupe Centralised - Yearly update 22 Feb 2016
Constella Allergan Pharmaceuticals International Ltd. Centralised - Transfer Marketing Authorisation Holder 22 Feb 2016 EMEA/H/C/2490/T/24
Ketoconazole HRA Laboratoire HRA Pharma PSUSA - Modification 22 Feb 2016 EMEA/H/C/3906/PSUSA/10316/201505
Tygacil Pfizer Limited Centralised - Renewal 22 Feb 2016 EMEA/H/C/644/R/95
Eporatio ratiopharm GmbH PSUSA - Modification 22 Feb 2016 EMEA/H/C/PSUSA/1240/201504
Methylthioninium chloride Proveblue Provepharm S.A.S. Corrigendum 18 Feb 2016
Brilique AstraZeneca AB Corrigendum 18 Feb 2016
Myfenax Teva B.V. Centralised - 2-Monthly update 18 Feb 2016 EMEA/H/C/884/IB/26
Mycophenolate mofetil Teva Teva B.V. Centralised - 2-Monthly update 18 Feb 2016 EMEA/H/C/882/IB/25
Lamivudine Teva Pharma B.V. Teva B.V. Centralised - Yearly update 18 Feb 2016
Aldara Meda AB Centralised - Yearly update 18 Feb 2016
Zurampic AstraZeneca AB Centralised - Authorisation 18 Feb 2016 EMEA/H/C/3932
Feraccru Shield TX (UK) Limited Centralised - Authorisation 18 Feb 2016 EMEA/H/C/2733
Biopoin Teva GmbH PSUSA - Modification 18 Feb 2016 EMEA/H/C/1036/PSUSA/1240/201504
Kovaltry Bayer Pharma AG Centralised - Authorisation 18 Feb 2016 EMEA/H/C/3825
BYDUREON AstraZeneca AB Centralised - Renewal 18 Feb 2016 EMEA/H/C/2020/R/31
Methylthioninium chloride Proveblue Provepharm S.A.S. PSUSA - Modification 18 Feb 2016 EMEA/H/C/PSUSA/2029/201505
Trajenta Boehringer Ingelheim International GmbH PSUSA - Modification 18 Feb 2016 EMEA/H/C/PSUSA/1886/201505
Iblias Bayer Pharma AG Centralised - Authorisation 18 Feb 2016 EMEA/H/C/4147
NULOJIX Bristol-Myers Squibb Pharma EEIG Centralised - Renewal 18 Feb 2016 EMEA/H/C/2098/R/31
Victrelis Merck Sharp & Dohme Limited Centralised - Renewal 18 Feb 2016 EMEA/H/C/2332/R/36
Brilique AstraZeneca AB Centralised - Variation 18 Feb 2016 EMEA/H/C/1241/X/29
TOBI Podhaler Novartis Europharm Limited Centralised - Renewal 18 Feb 2016 EMEA/H/C/2155/R/34
Hizentra CSL Behring GmbH Centralised - Renewal 18 Feb 2016 EMEA/H/C/2127/R/54
Benlysta Glaxo Group Ltd Centralised - Renewal 18 Feb 2016 EMEA/H/C/2015/R/36
Lojuxta Aegerion Pharmaceuticals Limited Centralised - Variation 18 Feb 2016 EMEA/H/C/2578/X/16
Latuda Sunovion Pharmaceuticals Europe Ltd Centralised - Transfer Marketing Authorisation Holder 15 Feb 2016 EMEA/H/C/2713/T/13
Vaxelis Sanofi Pasteur MSD SNC Centralised - Authorisation 15 Feb 2016 EMEA/H/C/3982
Rivastigmine Actavis Actavis Group PTC ehf. Centralised - Renewal 15 Feb 2016 EMEA/H/C/2036/R/16
Portrazza Eli Lilly Nederland B.V. Centralised - Authorisation 15 Feb 2016 EMEA/H/C/3886
Simbrinza Alcon Laboratories (UK) Ltd Centralised - Yearly update 11 Feb 2016
Zydelig Gilead Sciences International Limited Centralised - Yearly update 11 Feb 2016
Zoledronic acid Teva Teva B.V. Centralised - Yearly update 11 Feb 2016
Sevelamer carbonate Zentiva Genzyme Europe B.V. Centralised - Yearly update 11 Feb 2016
Sutent Pfizer Limited Centralised - Yearly update 11 Feb 2016
Xigduo AstraZeneca AB Centralised - Yearly update 11 Feb 2016
Truvada Gilead Sciences International Limited Centralised - Yearly update 11 Feb 2016
Tybost Gilead Sciences International Limited Centralised - Yearly update 11 Feb 2016
Vitekta Gilead Sciences International Limited Centralised - Yearly update 11 Feb 2016
Solumarv Marvel Lifesciences Limited Centralised - Refusal of marketing authorisation 11 Feb 2016 EMEA/H/C/3858
Caspofungin Accord Accord Healthcare Limited Centralised - Authorisation 11 Feb 2016 EMEA/H/C/4134
Zostavax Sanofi Pasteur MSD SNC Centralised - Renewal 11 Feb 2016 EMEA/H/C/674/R/96
Cresemba Basilea Medical Ltd Rectificative Decision 11 Feb 2016 EMEA/H/C/2734
Hepsera Gilead Sciences International Limited Centralised - Yearly update 8 Feb 2016
Plavix Sanofi Clir SNC Centralised - Yearly update 8 Feb 2016
Iscover Sanofi-Aventis groupe Centralised - Yearly update 8 Feb 2016
Zoledronic acid Accord Accord Healthcare Limited Centralised - Yearly update 8 Feb 2016
Irbesartan Teva Teva B.V. Centralised - Yearly update 8 Feb 2016
Methylthioninium chloride Proveblue Provepharm S.A.S. Centralised - Renewal 8 Feb 2016 EMEA/H/C/2108/R/27
TAGRISSO AstraZeneca AB Centralised - Authorisation 2 Feb 2016 EMEA/H/C/4124
Daklinza Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 28 Jan 2016 EMEA/H/C/3768/II/10
Ultibro Breezhaler Novartis Europharm Limited Centralised - Yearly update 28 Jan 2016
Comtess Orion Corporation Centralised - Yearly update 28 Jan 2016
Clopidogrel Acino Acino AG Centralised - 2-Monthly update 28 Jan 2016 EMEA/H/C/1166/IB/18/G
Xoterna Breezhaler Novartis Europharm Limited Centralised - Yearly update 28 Jan 2016
Voriconazole Hospira Hospira UK Limited Centralised - 2-Monthly update 28 Jan 2016 EMEA/H/C/3737/IB/1
Relistor PharmaSwiss Ceská republika s.r.o. Centralised - Transfer Marketing Authorisation Holder 28 Jan 2016 EMEA/H/C/870/T/41
Defitelio Gentium S.p.A. Centralised - Yearly update 28 Jan 2016
Revolade Novartis Europharm Limited Centralised - 2-Monthly update 28 Jan 2016 EMEA/H/C/1110/II/23
Sovaldi Gilead Sciences International Limited Centralised - 2-Monthly update 28 Jan 2016 EMEA/H/C/2798/II/18
Nonafact Sanquin Plasma Products B.V. Centralised - Transfer Marketing Authorisation Holder 28 Jan 2016 EMEA/H/C/348/T/55
Bexsero GlaxoSmithKline Vaccines S.r.l. Centralised - Yearly update 28 Jan 2016
Sildenafil ratiopharm ratiopharm GmbH Centralised - 2-Monthly update 25 Jan 2016 EMEA/H/C/1080/IB/37
Armisarte Actavis Group PTC ehf. Corrigendum 18 Jan 2016
Envarsus Chiesi Farmaceutici S.P.A. Corrigendum 14 Dec 2015
Praxbind Boehringer Ingelheim International GmbH Corrigendum 20 Nov 2015
Ozurdex Allergan Pharmaceuticals Ireland Corrigendum 23 Mar 2015
Procedures for centrally authorised orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
EU/3/16/1708 Lucane Pharma SA Orphan designation 14 Jul 2016 EMA/OD/060/16
EU/3/16/1707 Lucane Pharma SA Orphan designation 14 Jul 2016 EMA/OD/058/16
EU/3/16/1706 Lucane Pharma SA Orphan designation 14 Jul 2016 EMA/OD/057/16
EU/3/16/1705 Lucane Pharma SA Orphan designation 14 Jul 2016 EMA/OD/053/16
EU/3/16/1694 Adprotech Limited Orphan designation 14 Jul 2016 EMA/OD/064/16
EU/3/16/1693 GenSight- Biologics Orphan designation 14 Jul 2016 EMA/OD/028/16
EU/3/16/1692 Vicore Pharma AB Orphan designation 14 Jul 2016 EMA/OD/046/16
EU/3/16/1691 Pfizer Limited Orphan designation 14 Jul 2016 EMA/OD/066/16
EU/3/16/1689 Alacrita LLP Orphan designation 27 Jun 2016 EMA/OD/031/16
EU/3/16/1688 TMC Pharma Services Ltd Orphan designation 27 Jun 2016 EMA/OD/033/16
EU/3/16/1687 Akari Therapeutics Plc Orphan designation 27 Jun 2016 EMA/OD/030/16
EU/3/16/1686 Mereo Biopharma Group Limited Orphan designation 27 Jun 2016 EMA/OD/052/16
EU/3/16/1685 Serendex Pharmaceuticals A/S Orphan designation 27 Jun 2016 EMA/OD/005/16
EU/3/16/1684 Alexion Europe SAS Orphan designation 27 Jun 2016 EMA/OD/047/16
EU/3/16/1683 Therapicon Srl Orphan designation 27 Jun 2016 EMA/OD/007/16
EU/3/16/1681 Dr Alain Vicari Orphan designation 27 Jun 2016 EMA/OD/004/16
EU/3/16/1680 Chugai Pharma Europe Ltd Orphan designation 27 Jun 2016 EMA/OD/014/16
EU/3/16/1679 Orbus Therapeutics Limited Orphan designation 27 Jun 2016 EMA/OD/009/16
EU/3/16/1678 Kiadis Pharma Netherlands B.V. Orphan designation 27 Jun 2016 EMA/OD/008/16
EU/3/16/1677 Sun Pharmaceutical Industries Europe BV Orphan designation 27 Jun 2016 EMA/OD/012/16
EU/3/16/1676 Pharma Gateway AB Orphan designation 27 Jun 2016 EMA/OD/032/16
EU/3/16/1675 CATS Consultants GmbH Orphan designation 27 Jun 2016 EMA/OD/022/16
EU/3/16/1674 QRC Consultants Ltd Orphan designation 27 Jun 2016 EMA/OD/020/16
EU/3/16/1673 FGK Representative Service Ltd. Orphan designation 27 Jun 2016 EMA/OD/034/16
EU/3/16/1672 Celgene Europe Limited Orphan designation 27 Jun 2016 EMA/OD/016/16
EU/3/16/1671 Coté Orphan Consulting UK Limited Orphan designation 27 Jun 2016 EMA/OD/023/16
EU/3/15/1582 ICON Clinical Research Limited Transfer of orphan designation 17 Jun 2016 EMA/OD/145/15/T/01
EU/3/15/1530 FGK Representative Service GmbH Transfer of orphan designation 16 Jun 2016 EMA/OD/057/15/T/01
EU/3/14/1308 MCA Regulatory Limited Transfer of orphan designation 16 Jun 2016 EMA/OD/043/14/T/01
EU/3/06/419 SynCore Biotechnology Europe GmbH Transfer of orphan designation 16 Jun 2016 EMA/OD/063/06/T/01
EU/3/14/1287 FGK Representative Service GmbH Transfer of orphan designation 16 Jun 2016 EMA/OD/023/14/T/01
EU/3/13/1228 Intercept Pharma Ltd Transfer of orphan designation 16 Jun 2016 EMA/OD/136/13/T/01
EU/3/10/753 Intercept Pharma Ltd Transfer of orphan designation 16 Jun 2016 EMA/OD/073/09/T/01
EU/3/15/1550 ProMetic Pharma SMT Limited Transfer of orphan designation 16 Jun 2016 EMA/OD/072/15/T/01
EU/3/14/1375 ProGeLife S.A.S. Transfer of orphan designation 16 Jun 2016 EMA/OD/155/14/T/01
EU/3/13/1152 Chiltern International Limited Transfer of orphan designation 16 Jun 2016 EMA/OD/037/13/T/01
EU/3/01/083 Gliotherapy Limited Transfer of orphan designation 16 Jun 2016 EMA/OD/055/01/T/01
EU/3/14/1246 Ipsen Pharma Transfer of orphan designation 16 Jun 2016 EMA/OD/173/13/T/01
EU/3/10/821 Promethera Biosciences Transfer of orphan designation 16 Jun 2016 EMA/OD/108/10/T/01
EU/3/10/820 Promethera Biosciences Transfer of orphan designation 16 Jun 2016 EMA/OD/107/10/T/01
EU/3/10/819 Promethera Biosciences Transfer of orphan designation 16 Jun 2016 EMA/OD/106/10/T/01
EU/3/10/818 Promethera Biosciences Transfer of orphan designation 16 Jun 2016 EMA/OD/105/10/T/01
EU/3/07/470 Promethera Biosciences Transfer of orphan designation 16 Jun 2016 EMA/OD/042/07/T/01
EU/3/06/362 Promethera Biosciences Transfer of orphan designation 16 Jun 2016 EMA/OD/037/05/T/01
EU/3/16/1667 Aceso Biologics Consulting Ltd Corrigendum 30 May 2016
EU/3/09/661 Ipsen Pharma Amendment of orphan designation 30 May 2016 EMEA/OD/047/09
EU/3/16/1670 Groupe d’étude des histiocytoses Orphan designation 30 May 2016 EMA/OD/026/16
EU/3/16/1669 Centro de Investigación Biomédica en Red (CIBER) Orphan designation 30 May 2016 EMA/OD/027/16
EU/3/16/1668 Arch Bio Ireland Ltd Orphan designation 30 May 2016 EMA/OD/013/16
EU/3/16/1667 Aceso Biologics Consulting Ltd Orphan designation 30 May 2016 EMA/OD/015/16
EU/3/16/1666 QRC Consultants Ltd Orphan designation 30 May 2016 EMA/OD/017/16
EU/3/16/1665 TMC Pharma Services Ltd Orphan designation 30 May 2016 EMA/OD/002/16
EU/3/16/1664 Alan Boyd Consultants Ltd Orphan designation 30 May 2016 EMA/OD/025/16
EU/3/16/1663 Nextrasearch di Gasparetto Adolfo & C., Sas Orphan designation 30 May 2016 EMA/OD/003/16
EU/3/16/1662 QRC Consultants Ltd Orphan designation 30 May 2016 EMA/OD/011/16
EU/3/16/1661 Alexion Europe SAS Orphan designation 30 May 2016 EMA/OD/246/15
EU/3/16/1660 Fondazione Telethon Orphan designation 30 May 2016 EMA/OD/024/16
EU/3/16/1659 Orphazyme ApS Orphan designation 30 May 2016 EMA/OD/256/15
EU/3/16/1658 Shire Pharmaceuticals Ireland Limited Orphan designation 30 May 2016 EMA/OD/208/15
EU/3/16/1657 Coté Orphan Consulting UK Limited Orphan designation 30 May 2016 EMA/OD/245/15
EU/3/06/372 Shire Services BVBA Other procedure 12 May 2016
EU/3/15/1452 AMO Pharma Ltd Transfer of orphan designation 28 Apr 2016 EMA/OD/253/14/T/01
EU/3/16/1656 SELLAS Life Sciences Group UK, Limited Orphan designation 28 Apr 2016 EMA/OD/243/15
EU/3/16/1655 SELLAS Life Sciences Group UK, Limited Orphan designation 28 Apr 2016 EMA/OD/233/15
EU/3/16/1654 Acies Bio d.o.o. Orphan designation 28 Apr 2016 EMA/OD/250/15
EU/3/16/1653 Galderma R&D Orphan designation 28 Apr 2016 EMA/OD/254/15
EU/3/16/1652 Herantis Pharma Plc Orphan designation 28 Apr 2016 EMA/OD/241/15
EU/3/16/1651 Voisin Consulting S.A.R.L. Orphan designation 28 Apr 2016 EMA/OD/249/15
EU/3/16/1650 QRC Consultants Ltd Orphan designation 28 Apr 2016 EMA/OD/242/15
EU/3/16/1649 AbbVie Ltd Orphan designation 28 Apr 2016 EMA/OD/239/15
EU/3/16/1648 Tracon Pharma Limited Orphan designation 28 Apr 2016 EMA/OD/215/15
EU/3/16/1647 Campharm Ltd Orphan designation 28 Apr 2016 EMA/OD/219/15
EU/3/16/1646 Dr Regenold GmbH Development·Regulatory·Market Access Orphan designation 28 Apr 2016 EMA/OD/251/15
EU/3/16/1645 Richardson Associates Regulatory Affairs Ltd Orphan designation 28 Apr 2016 EMA/OD/248/15
EU/3/16/1644 Chimerix UK Ltd Orphan designation 28 Apr 2016 EMA/OD/234/15
EU/3/16/1643 Cytori Ltd Orphan designation 28 Apr 2016 EMA/OD/257/15
EU/3/16/1642 Intrexon Actobiotics N.V. Orphan designation 28 Apr 2016 EMA/OD/218/15
EU/3/16/1641 ProQR Therapeutics IV BV Orphan designation 28 Apr 2016 EMA/OD/255/15
EU/3/16/1640 Celgene Europe Limited Orphan designation 28 Apr 2016 EMA/OD/253/15
EU/3/16/1639 Coté Orphan Consulting UK Limited Orphan designation 28 Apr 2016 EMA/OD/252/15
EU/3/12/1027 Sanquin Plasma Products B.V. Transfer of orphan designation 28 Apr 2016 EMA/OD/045/12/T/01
EU/3/15/1603 Aduro Biotech Holdings, Europe B.V. Transfer of orphan designation 13 Apr 2016 EMA/OD/168/15/T/01
EU/3/15/1604 Aduro Biotech Holdings, Europe B.V. Transfer of orphan designation 13 Apr 2016 EMA/OD/169/15/T/01
EU/3/15/1594 Aduro Biotech Holdings, Europe B.V. Transfer of orphan designation 13 Apr 2016 EMA/OD/157/15/T/01
EU/3/01/077 NPS Pharma Holdings Limited Transfer of orphan designation 13 Apr 2016 EMA/OD/045/01/T/04
EU/3/08/588 Baxalta Innovations GmbH Transfer of orphan designation 13 Apr 2016 EMEA/OD/056/08/T/01
EU/3/16/1638 Eiger Biopharmaceuticals Europe Limited Orphan designation 21 Mar 2016 EMA/OD/179/15
EU/3/16/1637 Alnylam UK Limited Orphan designation 21 Mar 2016 EMA/OD/195/15
EU/3/16/1636 Pharm Research Associates (UK) Limited Orphan designation 21 Mar 2016 EMA/OD/238/15
EU/3/16/1635 Escala Therapeutics Ltd Orphan designation 21 Mar 2016 EMA/OD/228/15
EU/3/16/1634 Pharm Research Associates (UK) Limited Orphan designation 21 Mar 2016 EMA/OD/159/15
EU/3/16/1633 Diamond BioPharm Limited Orphan designation 21 Mar 2016 EMA/OD/211/15
EU/3/16/1632 Piramal Imaging GmbH Orphan designation 21 Mar 2016 EMA/OD/200/15
EU/3/16/1631 Piramal Imaging GmbH Orphan designation 21 Mar 2016 EMA/OD/201/15
EU/3/16/1630 Clinipace GmbH Orphan designation 21 Mar 2016 EMA/OD/203/15
EU/3/16/1629 Alan Boyd Consultants Ltd Orphan designation 21 Mar 2016 EMA/OD/187/15
EU/3/16/1628 New B Innovation (UK) Limited Orphan designation 21 Mar 2016 EMA/OD/192/15
EU/3/16/1627 Wainwright Associates Limited Orphan designation 21 Mar 2016 EMA/OD/210/15
EU/3/16/1626 Acerta Pharma, BV Orphan designation 21 Mar 2016 EMA/OD/237/15
EU/3/16/1625 Acerta Pharma, BV Orphan designation 21 Mar 2016 EMA/OD/231/15
EU/3/16/1624 Acerta Pharma, BV Orphan designation 21 Mar 2016 EMA/OD/196/15
EU/3/16/1623 Pharma Gateway AB Orphan designation 21 Mar 2016 EMA/OD/227/15
EU/3/16/1622 BioMarin Europe Ltd Orphan designation 21 Mar 2016 EMA/OD/230/15
EU/3/13/1125 AbbVie Ltd Corrigendum 15 Mar 2016
EU/3/13/1157 AbbVie Ltd Corrigendum 15 Mar 2016
EU/3/14/1371 FGK Representative Service GmbH Transfer of orphan designation 15 Mar 2016 EMA/OD/148/14/T/01
EU/3/16/1612 Retrophin Europe Limited Corrigendum 15 Mar 2016
EU/3/13/1133 Shire Pharmaceuticals Ireland Limited Transfer of orphan designation 15 Mar 2016 EMA/OD/013/13/T/01
EU/3/07/519 Shire Pharmaceuticals Ireland Limited Transfer of orphan designation 15 Mar 2016 EMA/OD/067/07/T/02
EU/3/11/875 Avivia Projects BV Transfer of orphan designation 29 Feb 2016 EMA/OD/167/10/T/01
EU/3/12/1051 AstraZeneca UK Limited Transfer of orphan designation 29 Feb 2016 EMA/OD/091/12/T/01
EU/3/14/1311 XOMA UK Limited Transfer of orphan designation 29 Feb 2016 EMA/OD/053/14/T/01
EU/3/13/1111 XOMA UK Limited Transfer of orphan designation 29 Feb 2016 EMA/OD/161/12/T/01
EU/3/10/796 XOMA UK Limited Transfer of orphan designation 29 Feb 2016 EMA/OD/062/10/T/02
EU/3/07/442 Isabelle Ramirez Transfer of orphan designation 17 Feb 2016 EMEA/OD/097/06/T/01
EU/3/05/343 Isabelle Ramirez Transfer of orphan designation 17 Feb 2016 EMEA/OD/068/05/T/01
EU/3/13/1232 Amicus Therapeutics UK Ltd Transfer of orphan designation 17 Feb 2016 EMA/OD/145/13/T/02
EU/3/04/244 Kamada BioPharma Limited Transfer of orphan designation 17 Feb 2016 EMA/OD/054/04/T/05
EU/3/16/1621 GW Research Ltd Orphan designation 17 Feb 2016 EMA/OD/222/15
EU/3/16/1620 Voisin Consulting S.A.R.L. Orphan designation 17 Feb 2016 EMA/OD/213/15
EU/3/16/1619 Eyevensys SA Orphan designation 17 Feb 2016 EMA/OD/207/15
EU/3/16/1618 FLAG Therapeutics Ltd Orphan designation 17 Feb 2016 EMA/OD/206/15
EU/3/16/1617 AbbVie Ltd Orphan designation 17 Feb 2016 EMA/OD/205/15
EU/3/16/1616 Prof. Michael Hanna Orphan designation 17 Feb 2016 EMA/OD/199/15
EU/3/16/1615 Gilead Sciences International Ltd Orphan designation 17 Feb 2016 EMA/OD/197/15
EU/3/16/1614 RV Developpement Orphan designation 17 Feb 2016 EMA/OD/194/15
EU/3/16/1613 RV Developpement Orphan designation 17 Feb 2016 EMA/OD/193/15
EU/3/16/1612 Retrophin Europe Limited Orphan designation 17 Feb 2016 EMA/OD/189/15
EU/3/16/1611 Dr Waseem Qasim Orphan designation 17 Feb 2016 EMA/OD/188/15
EU/3/16/1610 Orsenix Holdings BV Orphan designation 17 Feb 2016 EMA/OD/180/15
EU/3/16/1609 Assign Group Development UK Ltd Orphan designation 17 Feb 2016 EMA/OD/177/15
EU/3/16/1608 Amyndas Pharmaceuticals S.A. Orphan designation 17 Feb 2016 EMA/OD/104/15
EU/3/10/739 Horizon Pharma Ireland Limited Transfer of orphan designation 29 Jan 2016 EMA/OD/007/10/T/01
EU/3/10/738 Horizon Pharma Ireland Limited Transfer of orphan designation 29 Jan 2016 EMA/OD/006/10/T/01
EU/3/10/737 Horizon Pharma Ireland Limited Transfer of orphan designation 29 Jan 2016 EMA/OD/005/10/T/01
EU/3/10/736 Horizon Therapeutics Limited Transfer of orphan designation 29 Jan 2016 EMA/OD/004/10/T/01
EU/3/10/735 Horizon Pharma Ireland Limited Transfer of orphan designation 29 Jan 2016 EMA/OD/003/10/T/01
EU/3/10/734 Horizon Pharma Ireland Limited Transfer of orphan designation 29 Jan 2016 EMA/OD/002/10/T/01
EU/3/10/733 Horizon Pharma Ireland Limited Transfer of orphan designation 29 Jan 2016 EMEA/OD/124/09/T/01
EU/3/10/747 EUSA Pharma (UK) Limited Transfer of orphan designation 29 Jan 2016 EMA/OD/148/09/T/03
EU/3/14/1416 OGD2 Pharma Transfer of orphan designation 29 Jan 2016 EMA/OD/199/14/T/01
Procedures for centrally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Oxyglobin OPK Biotech Netherlands BV Centralised - Yearly update 8 Jul 2016
Suvaxyn CSF Marker Zoetis Belgium S.A. Centralised - Yearly update 4 Jul 2016
Loxicom Norbrook Laboratories Ltd Centralised - Yearly update 24 Jun 2016
Nobilis Influenza H5N2 Intervet International B.V. Centralised - Renewal 22 Jun 2016 EMEA/V/C/118/R/12
Metacam Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 21 Jun 2016
Emdocam Emdoka bvba Centralised - Renewal 21 Jun 2016 EMEA/V/C/2283/R/7
Sevocalm Chanelle Pharmaceuticals Manufacturing Limited Centralised - Authorisation 21 Jun 2016 EMEA/V/C/4199
Nobivac L4 Intervet International B.V. Centralised - Yearly update 3 Jun 2016
RevitaCAM Zoetis Belgium S.A. Centralised - Withdrawal 26 May 2016
Aivlosin ECO Animal Health Ltd Centralised - 2-Monthly update 26 May 2016 EMEA/V/C/83/II/64
Apoquel Zoetis Belgium S.A. Centralised - Yearly update 17 May 2016
Proteq West Nile Merial Centralised - Renewal 17 May 2016 EMEA/V/C/2005/R/7
MS-H vaccine Pharmsure International Ltd Centralised - Renewal 17 May 2016 EMEA/V/C/161/R/9
Bravecto Intervet International B.V. Centralised - Variation 17 May 2016 EMEA/V/C/2526/X/5
Suvaxyn PCV Zoetis Belgium S.A. Centralised - Yearly update 3 May 2016
Naxcel Zoetis Belgium S.A. Centralised - Yearly update 27 Apr 2016
Draxxin Zoetis Belgium S.A. Centralised - 2-Monthly update 27 Apr 2016 EMEA/V/C/77/II/31
Oncept IL-2 Merial Centralised - Yearly update 20 Apr 2016
Aftovaxpur Doe Merial Centralised - 2-Monthly update 20 Apr 2016 EMEA/V/C/2292/II/6
LETIFEND Laboratorios LETI, S.L.unipersonal Centralised - Authorisation 20 Apr 2016 EMEA/V/C/3865
Evalon Laboratorios Hipra, S.A. Corrigendum 18 Apr 2016
Clomicalm Elanco Europe Ltd. Centralised - Transfer Marketing Authorisation Holder 18 Apr 2016 EMEA/V/C/39/T/20
ECOPORC SHIGA IDT Biologika GmbH Centralised - Yearly update 18 Apr 2016
Profender Bayer Animal Health GmbH Centralised - 2-Monthly update 18 Apr 2016 EMEA/V/C/97/II/32
Pexion Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 18 Apr 2016
Zulvac 1 Bovis Zoetis Belgium S.A. Centralised - Renewal 18 Apr 2016 EMEA/V/C/2334/R/10
Zulvac 1 Ovis Zoetis Belgium S.A. Centralised - Renewal 18 Apr 2016 EMEA/V/C/2335/R/11
Evalon Laboratorios Hipra, S.A. Centralised - Authorisation 18 Apr 2016 EMEA/V/C/4013
CERTIFECT Merial Centralised - Renewal 18 Apr 2016 EMEA/V/C/2002/R/11
BTVPUR Merial Centralised - 2-Monthly update 12 Apr 2016 EMEA/V/C/2231/II/7/G
Poulvac E. coli Zoetis Belgium S.A. Centralised - Variation 12 Apr 2016 EMEA/V/C/2007/X/8
Meloxidolor Le Vet Beheer B.V. Centralised - Yearly update 4 Apr 2016
Zuprevo Intervet International B.V. Centralised - Renewal 22 Mar 2016 EMEA/V/C/2009/R/10
Purevax RCP FeLV Merial Centralised - Yearly update 15 Mar 2016
Versican Plus DHPPi/L4R Zoetis Belgium S.A. Centralised - Yearly update 15 Mar 2016
Versican Plus DHPPi/L4 Zoetis Belgium S.A. Centralised - Yearly update 15 Mar 2016
Versican Plus DHPPi Zoetis Belgium S.A. Centralised - Yearly update 15 Mar 2016
BLUEVAC BTV8 CZ Veterinaria, S.A. Centralised - Variation 15 Mar 2016 EMEA/V/C/156/R/6
Palladia Zoetis Belgium S.A. Centralised - Yearly update 8 Mar 2016
Econor Elanco Europe Ltd. Centralised - Transfer Marketing Authorisation Holder 26 Feb 2016 EMEA/V/C/42/T/48
Trifexis Eli Lilly and Company Ltd, Elanco Animal Health Centralised - Yearly update 26 Feb 2016
Vectra Felis CEVA SANTE ANIMALE Corrigendum 25 Feb 2016
Activyl Tick Plus Intervet International B.V. Centralised - Yearly update 25 Feb 2016
Vectra Felis CEVA SANTE ANIMALE Centralised - Yearly update 25 Feb 2016
Vectra 3D CEVA SANTE ANIMALE Centralised - Yearly update 25 Feb 2016
Zactran Merial Centralised - Variation 10 Feb 2016 EMEA/V/C/129/X/27
Velactis Ceva Santé Animale Corrigendum 9 Dec 2015
Purevax Rabies Merial Corrigendum 2 Dec 2015
Procedures for nationally authorised medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease Referral 29 Jun 2016 EMEA/H/A-31/1415
Zoledronic acid (indicated for cancer and fractures) PSUSA - Modification 29 Jun 2016 EMEA/H/C/PSUSA/3149/201508
Irbesartan PSUSA - Modification 24 Jun 2016 EMEA/H/C/1782/201508
Novantrone and associated names Referral 24 Jun 2016 EMEA/H/A-30/1399
Iron containing intravenous medicinal products Corrigendum 28 Apr 2016
Cymevene intravenous and associated names Referral 28 Apr 2016 EMEA/H/A-30/1406
Aripiprazole PSUSA - Modification 25 Apr 2016 EMEA/H/C/PSUSA/234/201507
Zoledronic acid (indicated for cancer and fractures) Rectificative Decision 7 Apr 2016
Tobramycin VVB Referral 4 Apr 2016 EMEA/H/A-29/1428
bimatoprost PSUSA - Modification 31 Mar 2016 EMEA/H/C/413/201503
Rivastigmine Rectificative Decision 7 Mar 2016
Procedures for nationally authorised veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Colistin combinations Referral 14 Jul 2016 EMEA/V/A-35/111
CattleMarker IBR Inactivated emulsion for injection for cattle Zoetis Belgium S.A. Referral 10 Jun 2016 EMEA/V/A/115
Gutal 1000 g/kg premix for medicated feeding stuff for piglets Corrigendum 4 Apr 2016
Baytril Rectificative Decision 4 Apr 2016
Baytril Rectificative Decision 4 Apr 2016
Closamectin Pour-On Solution and associated names - Art 78 Referral 22 Mar 2016 EMEA/V/A/113