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Pharmaceuticals - Community Register

  

Newly adopted Marketing Authorisation Decisions (last six months)

Centralised procedures of medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Evoltra Genzyme Europe B.V. Centralised - Yearly update 10 Oct 2014
Translarna PTC Therapeutics International Limited Centralised - Transfer Marketing Authorisation Holder 10 Oct 2014 EMEA/H/C/2720/T/1
Tarceva Roche Registration Limited Centralised - Yearly update 8 Oct 2014
Krystexxa Crealta Pharmaceuticals Ireland Limited Centralised - Transfer Marketing Authorisation Holder 8 Oct 2014 EMEA/H/C/2208/T/5
Yentreve Eli Lilly Nederland B.V. Centralised - Yearly update 8 Oct 2014
Xigduo AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 3 Oct 2014 EMEA/H/C/2672/T/5
Forxiga AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 3 Oct 2014 EMEA/H/C/2322/T/15
Jakavi Novartis Europharm Limited Centralised - Variation 3 Oct 2014 EMEA/H/C/2464/X/13
Voriconazole Accord Accord Healthcare Limited Centralised - Yearly update 1 Oct 2014
Bexsero Novartis Vaccines and Diagnostics S.r.l. Centralised - Yearly update 1 Oct 2014
Topotecan Eagle Eagle Laboratories Limited Centralised - Withdrawal 1 Oct 2014
Apidra Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 1 Oct 2014
Iscover Sanofi-Aventis groupe Centralised - Yearly update 1 Oct 2014
Plavix Sanofi Clir SNC Centralised - Yearly update 1 Oct 2014
Liprolog Eli Lilly Nederland B.V. Centralised - Variation 1 Oct 2014 EMEA/H/C/393/X/92
ellaOne Laboratoire HRA Pharma Referral 1 Oct 2014 EMEA/H/C/1027/A-31/28
Zoledronic acid Teva Teva Pharma B.V. Centralised - Variation 1 Oct 2014 EMEA/H/C/2439/X/8
Inflectra Hospira UK Limited Centralised - Yearly update 30 Sep 2014
Infanrix hexa GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 30 Sep 2014
Translarna PTC Therapeutics International Limited Corrigendum 30 Sep 2014
Januvia Merck Sharp & Dohme Limited Centralised - Yearly update 30 Sep 2014
Nuwiq Octapharma AB Corrigendum 30 Sep 2014
Revlimid Celgene Europe Limited Centralised - Modification 30 Sep 2014 EMEA/H/C/717/II/70, EMEA/H/C/717/PSUV/74
Humalog Eli Lilly Nederland B.V. Centralised - Variation 30 Sep 2014 EMEA/H/C/88/X/125
Cinryze ViroPharma SPRL-BVBA Centralised - Modification 30 Sep 2014 EMEA/H/C/1207/PSUV/23
Procoralan Les Laboratoires Servier Corrigendum 22 Sep 2014
Corlentor Les Laboratoires Servier Corrigendum 22 Sep 2014
Multaq Sanofi-Aventis groupe Centralised - Renewal 22 Sep 2014 EMEA/H/C/1043/R/30
Busulfan Fresenius Kabi Fresenius Kabi Oncology Plc. Centralised - Authorisation 22 Sep 2014 EMEA/H/C/2806
Mozobil Genzyme Europe B.V. Centralised - Modification 22 Sep 2014 EMEA/H/C/1030/PSUV/21
Trajenta Boehringer Ingelheim International GmbH Centralised - Yearly update 18 Sep 2014
DuoPlavin Sanofi Clir SNC Centralised - Yearly update 18 Sep 2014
Clopidogrel Zentiva Sanofi-Aventis groupe Centralised - Yearly update 18 Sep 2014
Accofil Accord Healthcare Limited Centralised - Authorisation 18 Sep 2014 EMEA/H/C/3956
Prialt Eisai Limited Centralised - Renewal 18 Sep 2014 EMEA/H/C/551/R/45
Vantavo Merck Sharp & Dohme Limited Centralised - Renewal 18 Sep 2014 EMEA/H/C/1180/R/19
Clopidogrel Apotex Apotex Europe B.V. Centralised - Renewal 18 Sep 2014 EMEA/H/C/1189/R/17
Zydelig Gilead Sciences International Limited Centralised - Authorisation 18 Sep 2014 EMEA/H/C/3843
Oslif Breezhaler Novartis Europharm Limited Centralised - Renewal 18 Sep 2014 EMEA/H/C/1210/R/29
Ilaris Novartis Europharm Limited Centralised - Modification 18 Sep 2014 EMEA/H/C/1109/PSUV/32
Noxafil Merck Sharp & Dohme Limited Centralised - Variation 18 Sep 2014 EMEA/H/C/610/X/33
JEVTANA Sanofi-Aventis groupe Centralised - Modification 18 Sep 2014 EMEA/H/C/2018/PSUV/23
Iclusig ARIAD Pharma Ltd Centralised - Modification 18 Sep 2014 EMEA/H/C/2695/PSUV/9
Onbrez Breezhaler Novartis Europharm Limited Centralised - Renewal 18 Sep 2014 EMEA/H/C/1114/R/29
Xultophy Novo Nordisk A/S Centralised - Authorisation 18 Sep 2014 EMEA/H/C/2647
Hirobriz Breezhaler Novartis Europharm Limited Centralised - Renewal 18 Sep 2014 EMEA/H/C/1211/R/30
Rienso Takeda Pharma A/S Centralised - Modification 18 Sep 2014 EMEA/H/C/2215/PSUV/14
Prevenar 13 Pfizer Limited Centralised - Renewal 18 Sep 2014 EMEA/H/C/1104/R/104
Silodyx Recordati Ireland Ltd Centralised - Renewal 18 Sep 2014 EMEA/H/C/1209/R/16
Urorec Recordati Ireland Ltd Centralised - Renewal 18 Sep 2014 EMEA/H/C/1092/R/16
Pioglitazone Krka Krka, d. d., Novo Mesto Centralised - Withdrawal 16 Sep 2014
Aranesp Amgen Europe B.V. Centralised - Yearly update 16 Sep 2014
Ovaleap Teva B.V. Centralised - Transfer Marketing Authorisation Holder 16 Sep 2014 EMEA/H/C/2608/T/5
Zutectra Biotest Pharma GmbH Centralised - Renewal 16 Sep 2014 EMEA/H/C/1089/R/15
Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 11 Sep 2014
Kolbam ASK Pharmaceuticals GmbH Centralised - Transfer Marketing Authorisation Holder 11 Sep 2014 EMEA/H/C/2081/T/4
Relistor TMC Pharma Services Ltd Centralised - Yearly update 11 Sep 2014
Caelyx Janssen-Cilag International NV Centralised - Yearly update 11 Sep 2014
Eporatio ratiopharm GmbH Centralised - Renewal 11 Sep 2014 EMEA/H/C/1033/R/19
Lamivudine Teva Pharma B.V. Teva Pharma B.V. Centralised - Renewal 11 Sep 2014 EMEA/H/C/1111/R/9
Stribild Gilead Sciences International Limited Centralised - Yearly update 9 Sep 2014
Sildenafil Teva Teva Pharma B.V. Centralised - Renewal 9 Sep 2014 EMEA/H/C/1073/R/25
Lamivudine Teva Teva Pharma B.V. Centralised - Renewal 9 Sep 2014 EMEA/H/C/1113/R/9
Sildenafil ratiopharm ratiopharm GmbH Centralised - Renewal 9 Sep 2014 EMEA/H/C/1080/R/35
ABASRIA Eli Lilly Regional Operations GmbH. Centralised - Authorisation 9 Sep 2014 EMEA/H/C/2835
Rasilamlo Novartis Europharm Limited Referral 9 Sep 2014 EMEA/H/C/2073/A-31/1370
Ipreziv Takeda Pharma A/S Referral 9 Sep 2014 EMEA/H/C/2517/A-31/1370
Edarbi Takeda Pharma A/S Referral 9 Sep 2014 EMEA/H/C/2293/A-31/1370
Sildenafil Actavis Actavis Group PTC ehf. Centralised - Renewal 4 Sep 2014 EMEA/H/C/1090/R/10
Extavia Novartis Europharm Limited Centralised - 2-Monthly update 4 Sep 2014 EMEA/H/C/933/II/64
Simulect Novartis Europharm Limited Centralised - 2-Monthly update 4 Sep 2014 EMEA/H/C/207/II/78
Lucentis Novartis Europharm Limited Centralised - 2-Monthly update 4 Sep 2014 EMEA/H/C/715/II/47
Aprovel Sanofi Clir SNC Referral 4 Sep 2014 EMEA/H/C/141/A-31
Exjade Novartis Europharm Limited Centralised - Modification 4 Sep 2014 EMEA/H/C/670/PSUV/37
Rasilez HCT Novartis Europharm Limited Referral 4 Sep 2014 EMEA/H/C/964/A-31/1370
Copalia HCT Novartis Europharm Limited Referral 4 Sep 2014 EMEA/H/C/1159/A-31/1370
Dafiro HCT Novartis Europharm Limited Referral 4 Sep 2014 EMEA/H/C/1160/A-31/1370
Tolucombi Krka, d. d., Novo Mesto Referral 4 Sep 2014 EMEA/H/C/2549/A-31/1370
Irbesartan HCT Zentiva Sanofi-Aventis groupe Referral 4 Sep 2014 EMEA/H/C/783/A-31/1370
CoAprovel Sanofi Clir SNC Referral 4 Sep 2014 EMEA/H/C/222/A-31/1370
Ifirmasta Krka, d. d., Novo Mesto Referral 4 Sep 2014 EMEA/H/C/962/A-31/1370
Tolura Krka, d. d., Novo Mesto Referral 4 Sep 2014 EMEA/H/C/1196/A-31/1370
Imprida Novartis Europharm Limited Referral 4 Sep 2014 EMEA/H/C/775/A-31/1370
Ifirmacombi Krka, d. d., Novo Mesto Referral 4 Sep 2014 EMEA/H/C/2302/A-31/1370
Irbesartan Teva Teva Pharma B.V. Referral 4 Sep 2014 EMEA/H/C/1093/A-31/1370
PritorPlus Bayer Pharma AG Referral 4 Sep 2014 EMEA/H/A-31/1370/C/414/93
Rasilez Novartis Europharm Limited Referral 4 Sep 2014 EMEA/H/C/780/A-31/1370
Telmisartan Actavis Actavis Group PTC ehf. Referral 4 Sep 2014 EMEA/H/C/1168/A-31/1370
Telmisartan Teva Pharma Teva Pharma B.V. Referral 4 Sep 2014 EMEA/H/C/2511/A-31/1370
Telmisartan Teva Teva Pharma B.V. Referral 4 Sep 2014 EMEA/H/C/1146/A-31/1370
Pritor Bayer Pharma AG Referral 4 Sep 2014 EMEA/H/A-31/1370/C/210/106
Irbesartan Zentiva Sanofi-Aventis groupe Referral 4 Sep 2014 EMEA/H/C/A-31/31/1370/C/785/63
Twynsta Boehringer Ingelheim International GmbH Referral 4 Sep 2014 EMEA/H/C/1224/A-31/1370
Sabervel Pharmathen S.A. Referral 4 Sep 2014 EMEA/H/C/2510/A-31/1370
Exforge Novartis Europharm Limited Referral 4 Sep 2014 EMEA/H/C/716/A-31/1370
Irbesartan / Hydrochlorothiazide Teva Teva Pharma B.V. Referral 4 Sep 2014 EMEA/H/C/1112/A-31/1370
MicardisPlus Boehringer Ingelheim International GmbH Referral 4 Sep 2014 EMEA/H/C/413/A-31/1370
Micardis Boehringer Ingelheim International GmbH Referral 4 Sep 2014
Exforge HCT Novartis Europharm Limited Referral 4 Sep 2014 EMEA/H/A-31/1370/C/1068/29
Copalia Novartis Europharm Limited Referral 4 Sep 2014 EMEA/H/A-31/1370/C/774/69
Dafiro Novartis Europharm Limited Referral 4 Sep 2014 EMEA/H/A-31/1370/C/716/67
Actelsar HCT Actavis Group PTC ehf. Referral 4 Sep 2014 EMEA/H/1370/A-31//2676/3
Karvezide Sanofi-Aventis groupe Referral 4 Sep 2014 EMEA/H/A-31/1370/C/221/165
Kinzalkomb Bayer Pharma AG Referral 4 Sep 2014 EMEA/H/C/415/A-31
Kinzalmono Bayer Pharma AG Referral 4 Sep 2014 EMEA/H/A-31/1370/C/211/94
Karvea Sanofi-Aventis groupe Referral 4 Sep 2014 EMEA/H/A-31/1370/C/142/159
Zoely Teva B.V. Centralised - Transfer Marketing Authorisation Holder 1 Sep 2014 EMEA/H/C/1213/T/23
RoActemra Roche Registration Limited Centralised - 2-Monthly update 1 Sep 2014 EMEA/H/C/955/II/32
DuoCover Sanofi-Aventis groupe Centralised - Yearly update 1 Sep 2014
PHEBURANE Lucane Pharma Centralised - Yearly update 1 Sep 2014
Imatinib Accord Accord Healthcare Limited Centralised - Yearly update 1 Sep 2014
EDURANT Janssen-Cilag International NV Centralised - Yearly update 1 Sep 2014
Libertek Takeda GmbH Centralised - Yearly update 1 Sep 2014
Daliresp Takeda GmbH Centralised - Yearly update 1 Sep 2014
Daxas Takeda GmbH Centralised - Yearly update 1 Sep 2014
Desloratadine ratiopharm ratiopharm GmbH Centralised - Yearly update 1 Sep 2014
Clopidogrel Qualimed Qualimed Centralised - Withdrawal 1 Sep 2014
Xgeva Amgen Europe B.V. Centralised - 2-Monthly update 1 Sep 2014 EMEA/H/C/2173/II/16, 27, 28
Humira AbbVie Ltd Centralised - 2-Monthly update 1 Sep 2014 EMEA/H/C/481/II/127
Macugen PharmaSwiss Ceská republika s.r.o. Centralised - Transfer Marketing Authorisation Holder 1 Sep 2014 EMEA/H/C/620/T/60
Pixuvri CTI Life Sciences Ltd Centralised - Modification 1 Sep 2014 EMEA/H/C/2055/PSUV/15
Clopidogrel / Acetylsalicylic acid Teva Teva Pharma B.V. Centralised - Authorisation 1 Sep 2014 EMEA/H/C/2272
Triumeq ViiV Healthcare UK Limited Centralised - Authorisation 1 Sep 2014 EMEA/H/C/2754
Clopidogrel BGR Laboratoires BIOGARAN Centralised - Transfer Marketing Authorisation Holder 27 Aug 2014 EMEA/H/C/1138/T/20
MACI Aastrom Biosciences DK ApS Centralised - Transfer Marketing Authorisation Holder 26 Aug 2014 EMEA/H/C/2522/T/3
Zalasta Krka, d. d., Novo Mesto Centralised - Yearly update 26 Aug 2014
Xenical Roche Registration Limited Centralised - Yearly update 26 Aug 2014
Aerinaze Merck Sharp & Dohme Limited Centralised - Yearly update 26 Aug 2014
Imnovid Celgene Europe Limited Centralised - Yearly update 26 Aug 2014
Marixino Consilient Health Ltd Centralised - Yearly update 26 Aug 2014
Arixtra Aspen Pharma Trading Limited Centralised - Transfer Marketing Authorisation Holder 26 Aug 2014 EMEA/H/C/403/T/63
Avonex Biogen Idec Limited Centralised - 2-Monthly update 26 Aug 2014 EMEA/H/C/102/II/143
Rebif Merck Serono Europe Limited Centralised - 2-Monthly update 26 Aug 2014 EMEA/H/C/136/II/106
Busilvex Pierre Fabre Médicament Centralised - 2-Monthly update 26 Aug 2014 EMEA/H/C/472/II/19
BeneFIX Pfizer Limited Centralised - Yearly update 26 Aug 2014
Prolia Amgen Europe B.V. Centralised - 2-Monthly update 26 Aug 2014 EMEA/H/C/1120/II/36, 37, 39
Ozurdex Allergan Pharmaceuticals Ireland Centralised - 2-Monthly update 26 Aug 2014 EMEA/H/C/1140/II/15
Betaferon Bayer Pharma AG Centralised - 2-Monthly update 26 Aug 2014 EMEA/H/C/81/II/95
Ecalta Pfizer Limited Centralised - 2-Monthly update 26 Aug 2014 EMEA/H/C/788/II/26
Fareston Orion Corporation Centralised - Modification 26 Aug 2014 EMEA/H/C/91/PSUSA/2999/201309
Temozolomide Teva Teva Pharma B.V. Centralised - Renewal 26 Aug 2014 EMEA/H/C/1126/R/19
Scintimun CIS bio international Centralised - Renewal 26 Aug 2014 EMEA/H/C/1045/R/5
Nevirapine Teva Teva Pharma B.V. Centralised - Renewal 26 Aug 2014 EMEA/H/C/1119/R/10
Velphoro Vifor Fresenius Medical Care Renal Pharma France Centralised - Authorisation 26 Aug 2014 EMEA/H/C/2705
Eylea Bayer Pharma AG Centralised - Modification 26 Aug 2014 EMEA/H/C/2392/PSUV/11
Biopoin Teva GmbH Centralised - Renewal 26 Aug 2014 EMEA/H/C/1036/R/20
Baraclude Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 22 Aug 2014 EMEA/H/C/623/II/41
Vistide Gilead Sciences International Limited Centralised - Withdrawal 22 Aug 2014
Dasselta Krka, d. d., Novo Mesto Centralised - Yearly update 22 Aug 2014
Teysuno Nordic Group B.V. Centralised - Yearly update 22 Aug 2014
Clopidogrel HCS HCS bvba Centralised - Yearly update 22 Aug 2014
Olazax Glenmark Pharmaceuticals s.r.o. Centralised - Renewal 22 Aug 2014 EMEA/H/C/1087/R/14
Repaglinide Krka Krka, d. d., Novo Mesto Centralised - Renewal 22 Aug 2014 EMEA/H/C/1066/R/7
Victrelis Merck Sharp & Dohme Limited Centralised - Modification 22 Aug 2014 EMEA/H/C/2332/PSUV/28
Imvanex Bavarian Nordic A/S Centralised - Modification 22 Aug 2014 EMEA/H/C/2596/PSUV/7
XALKORI Pfizer Limited Centralised - Annual renewal 22 Aug 2014 EMEA/H/C/2489/R/15
Procoralan Les Laboratoires Servier Centralised - Modification 22 Aug 2014 EMEA/H/C/597/PSUR/31
Corlentor Les Laboratoires Servier Centralised - Modification 22 Aug 2014 EMEA/H/C/598/PSUR/30
Vizamyl GE Healthcare Ltd Centralised - Authorisation 22 Aug 2014 EMEA/H/C/2557
ChondroCelect TiGenix NV Centralised - Renewal 22 Aug 2014 EMEA/H/C/878/R/9
Synagis AbbVie Ltd Centralised - Variation 22 Aug 2014 EMEA/H/C/257/X/95
Daklinza Bristol-Myers Squibb Pharma EEIG Centralised - Authorisation 22 Aug 2014 EMEA/H/C/3768
Isentress Merck Sharp & Dohme Limited Centralised - Variation 22 Aug 2014 EMEA/H/C/860/X/44/G
Elonva Merck Sharp & Dohme Limited Centralised - Renewal 22 Aug 2014 EMEA/H/C/1106/R/18
ADCETRIS Takeda Pharma A/S Centralised - Annual renewal 22 Aug 2014 EMEA/H/C/2455/R/17
Enyglid Krka, d. d., Novo Mesto Centralised - Renewal 22 Aug 2014 EMEA/H/C/1065/R/10
Neoclarityn Merck Sharp & Dohme Limited Centralised - Yearly update 19 Aug 2014
Azomyr Merck Sharp & Dohme Limited Centralised - Yearly update 19 Aug 2014
Aerius Merck Sharp & Dohme Limited Centralised - Yearly update 19 Aug 2014
Ristaben Merck Sharp & Dohme Limited Centralised - Yearly update 19 Aug 2014
Olanzapine Mylan Generics [UK] Limited Centralised - Yearly update 19 Aug 2014
Panretin Eisai Limited Centralised - Yearly update 19 Aug 2014
Rivastigmine 3M Health Care Ltd. 3M Health Care Limited Centralised - Withdrawal 19 Aug 2014
Capecitabine SUN Sun Pharmaceutical Industries Europe BV Centralised - Yearly update 19 Aug 2014
Retacrit Hospira UK Limited Centralised - 2-Monthly update 19 Aug 2014 EMEA/H/C/872/IB/55
Olanzapine Glenmark Glenmark Pharmaceuticals Europe Limited Centralised - Renewal 19 Aug 2014 EMEA/H/C/1085/R/19
Olanzapine Glenmark Europe Glenmark Pharmaceuticals Europe Limited Centralised - Renewal 19 Aug 2014 EMEA/H/C/1086/R/18
Rivastigmine 1 A Pharma 1 A Pharma GmbH Centralised - Renewal 19 Aug 2014 EMEA/H/C/1181/R/16
Fluenz Tetra MedImmune, LLC Centralised - Variation 6 Aug 2014 EMEA/H/C/2617/II/20
Optaflu Novartis Vaccines and Diagnostics GmbH Centralised - Variation 6 Aug 2014 EMEA/H/C/758/II/69
Intanza Sanofi Pasteur MSD, SNC Centralised - Variation 6 Aug 2014 EMEA/H/C/957/II/29
IDflu Sanofi Pasteur SA Centralised - Variation 6 Aug 2014 EMEA/H/C/966/II/26
Sprycel Bristol-Myers Squibb Pharma EEIG Centralised - Yearly update 6 Aug 2014
APTIVUS Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 6 Aug 2014 EMEA/H/C/631/II/62/G
Eylea Bayer Pharma AG Centralised - 2-Monthly update 6 Aug 2014 EMEA/H/C/2392/II/9
Olazax Disperzi Glenmark Pharmaceuticals s.r.o. Centralised - Renewal 6 Aug 2014 EMEA/H/C/1088/R/14
IOA Merck Sharp & Dohme Limited Centralised - Withdrawal 31 Jul 2014
Doribax Janssen-Cilag International NV Centralised - Withdrawal 31 Jul 2014
Avastin Roche Registration Limited Centralised - 2-Monthly update 31 Jul 2014 EMEA/H/C/582/II/63
Colobreathe Forest Laboratories UK Ltd Centralised - Yearly update 31 Jul 2014
Xarelto Bayer Pharma AG Centralised - 2-Monthly update 31 Jul 2014 EMEA/H/C/944/II/30
Translarna PTC Therapeutics International Limited Centralised - Authorisation 31 Jul 2014 EMEA/H/C/2720
BYDUREON AstraZeneca AB Centralised - Modification 31 Jul 2014 EMEA/H/C/2020/PSUV/18
Xelevia Merck Sharp & Dohme Limited Centralised - Yearly update 28 Jul 2014
Olanzapine Apotex Apotex Europe B.V. Centralised - Yearly update 28 Jul 2014
Kalydeco Vertex Pharmaceuticals (U.K.) Limited Centralised - 2-Monthly update 28 Jul 2014 EMEA/H/C/2494/II/9
Arzerra Glaxo Group Ltd Centralised - 2-Monthly update 28 Jul 2014 EMEA/H/C/1131/II/27
Byetta AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 28 Jul 2014 EMEA/H/C/698/T/44
Stivarga Bayer Pharma AG Centralised - 2-Monthly update 28 Jul 2014 EMEA/H/C/2573/II/1
Menveo Novartis Vaccines and Diagnostics S.r.l. Centralised - 2-Monthly update 28 Jul 2014 EMEA/H/C/1095/II/42
Enbrel Pfizer Limited Centralised - 2-Monthly update 28 Jul 2014 EMEA/H/C/262/II/167
Eliquis Bristol-Myers Squibb/Pfizer EEIG Centralised - 2-Monthly update 28 Jul 2014 EMEA/H/C/2148/II/14/G
Pandemrix GlaxoSmithKline Biologicals S.A. Centralised - 2-Monthly update 28 Jul 2014 EMEA/H/C/832/II/68, 69
Fabrazyme Genzyme Europe B.V. Centralised - Yearly update 23 Jul 2014
Gazyvaro Roche Registration Limited Centralised - Authorisation 23 Jul 2014 EMEA/H/C/2799
Nuwiq Octapharma AB Centralised - Authorisation 22 Jul 2014 EMEA/H/C/2813
Rapiscan Rapidscan Pharma Solutions EU Ltd Centralised - Modification 22 Jul 2014 EMEA/H/C/1176/PSUV/14
Tesavel Merck Sharp & Dohme Limited Centralised - Yearly update 18 Jul 2014
Revasc Canyon Pharmaceuticals Ltd Centralised - Withdrawal 18 Jul 2014
Omnitrope Sandoz GmbH Centralised - Yearly update 18 Jul 2014
CellCept Roche Registration Limited Centralised - Yearly update 18 Jul 2014
Glivec Novartis Europharm Limited Centralised - Yearly update 18 Jul 2014
Savene Clinigen Healthcare Limited Centralised - Transfer Marketing Authorisation Holder 18 Jul 2014 EMEA/H/C/682/T/17
Onglyza AstraZeneca AB Centralised - Renewal 18 Jul 2014 EMEA/H/C/1039/R/23
Ventavis Bayer Pharma AG Centralised - Variation 18 Jul 2014 EMEA/H/C/474/X/43
Zytiga Janssen-Cilag International NV Centralised - Modification 18 Jul 2014 EMEA/H/C/2321/PSUV/19
Tasmar Meda AB Centralised - Renewal 18 Jul 2014 EMEA/H/C/132/R/47
Irbesartan Teva Teva Pharma B.V. Centralised - Renewal 18 Jul 2014 EMEA/H/C/1093/R/19
Simbrinza Alcon Laboratories (UK) Ltd Centralised - Authorisation 18 Jul 2014 EMEA/H/C/3698
Envarsus Chiesi Farmaceutici S.P.A. Centralised - Authorisation 18 Jul 2014 EMEA/H/C/2655
Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Centralised - Renewal 18 Jul 2014 EMEA/H/C/1124/R/18
Xagrid Shire Pharmaceutical Contracts Ltd Centralised - Renewal 18 Jul 2014 EMEA/H/C/480/R/60
Votubia Novartis Europharm Limited Centralised - Annual renewal 18 Jul 2014 EMEA/H/C/2311/R/24
SANCUSO ProStrakan Limited Centralised - Modification 18 Jul 2014 EMEA/H/C/2296/PSUV/30
Plegridy Biogen Idec Limited Centralised - Authorisation 18 Jul 2014 EMEA/H/C/2827
Dacogen Janssen-Cilag International NV Centralised - Modification 18 Jul 2014 EMEA/H/C/2221/PSUV/11
Adjupanrix GlaxoSmithKline Biologicals S.A. Centralised - Renewal 18 Jul 2014 EMEA/H/C/1206/R/36
Nimenrix GlaxoSmithKline Biologicals S.A. Centralised - Modification 18 Jul 2014 EMEA/H/C/2226/PSUV/20
Viagra Pfizer Limited Centralised - Yearly update 14 Jul 2014
Docetaxel Teva Teva Pharma B.V. Centralised - Renewal 14 Jul 2014 EMEA/H/C/1107/R/13
Riluzole Zentiva Aventis Pharma S.A. Centralised - Yearly update 11 Jul 2014
Rivastigmine HEXAL Hexal AG Centralised - Renewal 11 Jul 2014
Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Centralised - Renewal 11 Jul 2014 EMEA/H/C/1183/R/16
Aclasta Novartis Europharm Limited Centralised - Modification 11 Jul 2014 EMEA/H/C/595/PSUV/47
Olanzapine Cipla Cipla (EU) Limited Centralised - Withdrawal 8 Jul 2014
Flebogamma DIF Instituto Grifols, S.A. Centralised - Yearly update 4 Jul 2014
Optison GE Healthcare AS Centralised - Yearly update 4 Jul 2014
Efavirenz Teva Teva Pharma B.V. Centralised - Yearly update 4 Jul 2014
Fuzeon Roche Registration Limited Centralised - Yearly update 4 Jul 2014
Suboxone RB Pharmaceuticals Limited Corrigendum 4 Jul 2014
Copalia HCT Novartis Europharm Limited Centralised - Renewal 4 Jul 2014 EMEA/H/C/1159/R/38
Dafiro HCT Novartis Europharm Limited Centralised - Renewal 4 Jul 2014 EMEA/H/C/1160
Avastin Roche Registration Limited Centralised - Yearly update 30 Jun 2014
Perjeta Roche Registration Limited Centralised - Yearly update 30 Jun 2014
Arzerra Glaxo Group Ltd Centralised - 2-Monthly update 30 Jun 2014 EMEA/H/C/1131/II/23
Mekinist Glaxo Group Ltd Centralised - Authorisation 30 Jun 2014 EMEA/H/C/2643
Exforge HCT Novartis Europharm Limited Centralised - Renewal 30 Jun 2014 EMEA/H/C/1068/R/37
Topotecan Hospira Hospira UK Limited Centralised - Yearly update 27 Jun 2014
ZALTRAP Sanofi-Aventis groupe Centralised - Yearly update 27 Jun 2014
Zoledronic acid Teva Teva Pharma B.V. Centralised - Yearly update 27 Jun 2014
Orfadin Swedish Orphan Biovitrum International AB Centralised - Yearly update 27 Jun 2014
Ibandronic Acid Teva Teva Pharma B.V. Centralised - Yearly update 27 Jun 2014
Amyvid Eli Lilly Nederland B.V. Centralised - Yearly update 27 Jun 2014
Circadin RAD Neurim Pharmaceuticals EEC Limited Centralised - Yearly update 27 Jun 2014
HALAVEN Eisai Europe Limited Centralised - 2-Monthly update 27 Jun 2014 EMEA/H/C/2084/II/11
Xyrem UCB Pharma Ltd Centralised - 2-Monthly update 27 Jun 2014 EMEA/H/C/593/II/50
Esbriet InterMune UK Limited Centralised - 2-Monthly update 27 Jun 2014 EMEA/H/C/2154/II/16
Kineret Swedish Orphan Biovitrum AB (publ) Centralised - 2-Monthly update 27 Jun 2014 EMEA/H/C/363/IB/49
Foclivia Novartis Vaccines and Diagnostics S.r.l. Centralised - Renewal 27 Jun 2014 EMEA/H/C/1208/R/12
Rasilez Novartis Europharm Limited Centralised - Modification 27 Jun 2014 EMEA/H/C/780/PSUV/90
Cayston Gilead Sciences International Limited Centralised - Modification 27 Jun 2014 EMEA/H/C/996/PSUSA/283
Rasilez HCT Novartis Europharm Limited Centralised - Modification 27 Jun 2014 EMEA/H/C/964/PSUV/60
Rasilamlo Novartis Europharm Limited Centralised - Modification 27 Jun 2014 EMEA/H/C/2073/PSUV/90
Brilique AstraZeneca AB Centralised - Yearly update 23 Jun 2014
Bosulif Pfizer Limited Centralised - 2-Monthly update 23 Jun 2014 EMEA/H/C/2373/II/1
Thymanax Servier (Ireland) Industries Limited Centralised - 2-Monthly update 23 Jun 2014 EMEA/H/C/916/II/19
Diacomit Biocodex Centralised - 2-Monthly update 23 Jun 2014 EMEA/H/C/664/II/16
Vfend Pfizer Limited Centralised - 2-Monthly update 23 Jun 2014 EMEA/H/C/387/II/97
Prevenar 13 Pfizer Limited Centralised - 2-Monthly update 23 Jun 2014 EMEA/H/C/1104/II/98
Zeffix Glaxo Group Ltd Centralised - Renewal 23 Jun 2014 EMEA/H/C/242/R/62
Angiox The Medicines Company UK Ltd Centralised - Renewal 23 Jun 2014 EMEA/H/C/562/R/52
Yondelis Pharma Mar S.A. Centralised - Modification 23 Jun 2014 EMEA/H/C/773/PSUV/38
Ozurdex Allergan Pharmaceuticals Ireland Centralised - Yearly update 19 Jun 2014
Celvapan Baxter AG Centralised - Yearly update 19 Jun 2014
Valdoxan Les Laboratoires Servier Centralised - 2-Monthly update 19 Jun 2014 EMEA/H/C/915/II/21
Topotecan Teva Teva Pharma B.V. Centralised - Renewal 19 Jun 2014 EMEA/H/C/1071/R/7
Ilaris Novartis Europharm Limited Centralised - Renewal 19 Jun 2014 EMEA/H/C/1109/R/31
Javlor Pierre Fabre Médicament Centralised - Modification 19 Jun 2014 EMEA/H/C/983/PSUV/15
Samsca Otsuka Pharmaceutical Europe Ltd. Centralised - Renewal 19 Jun 2014 EMEA/H/C/980/R/16
Osseor Les Laboratoires Servier Centralised - Modification 19 Jun 2014 EMEA/H/C/561/PSUV/37
GILENYA Novartis Europharm Limited Centralised - Modification 19 Jun 2014 EMEA/H/C/2202/PSUV/27
Protelos Les Laboratoires Servier Centralised - Modification 19 Jun 2014 EMEA/H/C/560/PSUV/42
Erivedge Roche Registration Limited Centralised - Annual renewal 19 Jun 2014 EMEA/H/C/2602/R/6
Votubia Novartis Europharm Limited Centralised - Modification 19 Jun 2014 EMEA/H/C/2311/PSUV/22
Simponi Janssen Biologics B.V. Centralised - Renewal 19 Jun 2014 EMEA/H/C/992/R/56
Repaglinide Teva Teva Pharma B.V. Centralised - Renewal 19 Jun 2014 EMEA/H/C/1067/R/8
Tovanor Breezhaler Novartis Europharm Limited Centralised - Modification 19 Jun 2014 EMEA/H/C/2690/PSUV/4
Seebri Breezhaler Novartis Europharm Limited Centralised - Modification 19 Jun 2014 EMEA/H/C/2430/PSUV/4
Enurev Breezhaler Novartis Europharm Limited Centralised - Modification 19 Jun 2014 EMEA/H/C/2691/PSUV/4
Remicade Janssen Biologics B.V. Centralised - Modification 19 Jun 2014 EMEA/H/C/240/PSUV/180
Incivo Janssen-Cilag International NV Centralised - Modification 19 Jun 2014 EMEA/H/C/2313/PSUV/24
Imatinib Actavis Actavis Group PTC ehf. Centralised - Variation 12 Jun 2014 EMEA/H/C/2594/IB/4, EMEA/H/C/2594/X/3
Zutectra Biotest Pharma GmbH Centralised - Yearly update 6 Jun 2014
Champix Pfizer Limited Centralised - Yearly update 6 Jun 2014
Telmisartan Teva Pharma Teva Pharma B.V. Centralised - Yearly update 6 Jun 2014
Silgard Merck Sharp & Dohme Limited Centralised - 2-Monthly update 6 Jun 2014 EMEA/H/C/732/WS/523
Gardasil Sanofi Pasteur MSD, SNC Centralised - 2-Monthly update 6 Jun 2014 EMEA/H/C/703/WS/523
Resolor Shire Pharmaceuticals Ireland Limited Centralised - Renewal 6 Jun 2014 EMEA/H/C/1012/R/32
Edarbi Takeda Pharma A/S Centralised - Transfer Marketing Authorisation Holder 6 Jun 2014 EMEA/H/C/2293/T/12
Topotecan Actavis Actavis Group PTC ehf. Centralised - Renewal 6 Jun 2014 EMEA/H/C/1031/R/11
Velmetia Merck Sharp & Dohme Limited Centralised - Yearly update 3 Jun 2014
Ristfor Merck Sharp & Dohme Limited Centralised - Yearly update 3 Jun 2014
Efficib Merck Sharp & Dohme Limited Centralised - Yearly update 3 Jun 2014
Janumet Merck Sharp & Dohme Limited Centralised - Yearly update 3 Jun 2014
Kepivance Swedish Orphan Biovitrum AB (publ) Centralised - Yearly update 3 Jun 2014
Prolia Amgen Europe B.V. Centralised - 2-Monthly update 3 Jun 2014 EMEA/H/C/1120/II/30
Kiovig Baxter AG Centralised - Yearly update 3 Jun 2014
Macugen PharmaSwiss Ceská republika s.r.o. Centralised - Yearly update 3 Jun 2014
Nevanac Alcon Laboratories (UK) Ltd Centralised - Yearly update 3 Jun 2014
Ibandronic acid Sandoz Sandoz Pharmaceuticals GmbH Centralised - Yearly update 3 Jun 2014
Adasuve Alexza UK Ltd Centralised - Yearly update 3 Jun 2014
Pradaxa Boehringer Ingelheim International GmbH Centralised - 2-Monthly update 3 Jun 2014 EMEA/H/C/829/II/48
Docetaxel Teva Teva Pharma B.V. Centralised - Yearly update 3 Jun 2014
Docetaxel Mylan Mylan S.A.S Centralised - Yearly update 3 Jun 2014
Lysodren Laboratoire HRA Pharma Centralised - Yearly update 3 Jun 2014
Memantine LEK Pharmathen S.A. Centralised - Yearly update 3 Jun 2014
Yondelis Pharma Mar S.A. Centralised - Annual reassessment 3 Jun 2014 EMEA/H/C/773/S/37
Clopidogrel Krka d.d. Krka, d. d., Novo Mesto Centralised - Renewal 3 Jun 2014 EMEA/H/C/1137/R/18
Suboxone RB Pharmaceuticals Limited Centralised - Yearly update 23 May 2014
GILENYA Novartis Europharm Limited Centralised - 2-Monthly update 23 May 2014 EMEA/H/C/2202/II/21
Nexavar Bayer Pharma AG Centralised - 2-Monthly update 23 May 2014 EMEA/H/C/690/II/35
Invega Janssen-Cilag International NV Centralised - 2-Monthly update 23 May 2014 EMEA/H/C/746/II/37
Mabthera Roche Registration Limited Centralised - 2-Monthly update 23 May 2014 EMEA/H/C/165/II/89
Clopidogrel Acino Acino AG Centralised - Transfer Marketing Authorisation Holder 23 May 2014 EMEA/H/C/1166/T/8
Docetaxel Kabi Fresenius Kabi Oncology Plc. Centralised - Yearly update 22 May 2014
Iasibon Pharmathen S.A. Centralised - Yearly update 22 May 2014
Selincro H. Lundbeck A/S Centralised - Yearly update 22 May 2014
Vaniqa Almirall, S.A. Centralised - Yearly update 22 May 2014
Grastofil Apotex Europe B.V. Centralised - 2-Monthly update 22 May 2014 EMEA/H/C/2150/II/3/G
Ipreziv Takeda Pharma A/S Centralised - Transfer Marketing Authorisation Holder 22 May 2014 EMEA/H/C/2517/T/12
Adjupanrix GlaxoSmithKline Biologicals S.A. Centralised - 2-Monthly update 22 May 2014 EMEA/H/C/1206/II/35
Prepandrix GlaxoSmithKline Biologicals S.A. Centralised - 2-Monthly update 22 May 2014 EMEA/H/C/822/II/52/G
Busilvex Pierre Fabre Médicament Centralised - Modification 22 May 2014 EMEA/H/C/472/PSUSA/464
Protelos Les Laboratoires Servier Centralised - Renewal 22 May 2014 EMEA/H/C/560/R/41
PegIntron Merck Sharp & Dohme Limited Centralised - Modification 22 May 2014 EMEA/H/C/280/PSUV/117
ViraferonPeg Merck Sharp & Dohme Limited Centralised - Modification 22 May 2014 EMEA/H/C/329/PSUV/110
Sylvant Janssen-Cilag International NV Centralised - Authorisation 22 May 2014 EMEA/H/C/3708
Clopidogrel TAD TAD Pharma GmbH Centralised - Renewal 22 May 2014
Ebilfumin Actavis Group PTC ehf. Centralised - Authorisation 22 May 2014 EMEA/H/C/3717
Osseor Les Laboratoires Servier Centralised - Renewal 22 May 2014 EMEA/H/C/561/R/36
Jardiance Boehringer Ingelheim International GmbH Centralised - Authorisation 22 May 2014 EMEA/H/C/2677
Clopidogrel Mylan Mylan S.A.S Centralised - Renewal 22 May 2014 EMEA/H/C/1134/R/27
Entyvio Takeda Pharma A/S Centralised - Authorisation 22 May 2014 EMEA/H/C/2782
Fampyra Biogen Idec Limited Centralised - Annual renewal 22 May 2014 EMEA/H/C/2097/R/14
Clopidogrel DURA Mylan dura GmbH Centralised - Renewal 22 May 2014 EMEA/H/C/1132/R/17
Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Centralised - Renewal 22 May 2014 EMEA/H/C/1165/R/27
Preotact NPS Pharma Holdings Limited Centralised - Withdrawal 16 May 2014
Docetaxel Accord Accord Healthcare Limited Centralised - Yearly update 16 May 2014
Clopidogrel Teva Pharma B.V. Teva Pharma B.V. Centralised - Yearly update 16 May 2014
Relvar Ellipta Glaxo Group Ltd Corrigendum 16 May 2014
Vizarsin Krka, d. d., Novo Mesto Centralised - Renewal 16 May 2014 EMEA/H/C/1076/R/18
Javlor Pierre Fabre Médicament Centralised - Renewal 16 May 2014
Afinitor Novartis Europharm Limited Centralised - Renewal 16 May 2014 EMEA/H/C/1038/R/36
Cimzia UCB Pharma S.A. Centralised - Renewal 16 May 2014 EMEA/H/C/1037/R/40
Clopidogrel Teva Teva Pharma B.V. Centralised - Renewal 16 May 2014 EMEA/H/C/1053/R/29
InductOs Medtronic BioPharma B.V. Centralised - Yearly update 14 May 2014
Isentress Merck Sharp & Dohme Limited Centralised - Renewal 14 May 2014 EMEA/H/C/860/R/45
Zyllt Krka, d. d., Novo Mesto Centralised - Renewal 14 May 2014 EMEA/H/C/1058/R/16
XALKORI Pfizer Limited Centralised - Modification 14 May 2014 EMEA/H/C/2489/PSUV/12
OLYSIO Janssen-Cilag International NV Centralised - Authorisation 14 May 2014 EMEA/H/C/2777
Pandemic influenza vaccine H5N1 BAXTER Baxter AG Centralised - Renewal 14 May 2014 EMEA/H/C/1200/R/16
Clopidogrel Krka Krka, d. d., Novo Mesto Centralised - Renewal 14 May 2014 EMEA/H/C/1056/R/22
Clopidogrel BGR Laboratoires BIOGARAN Centralised - Renewal 8 May 2014 EMEA/H/C/1138/R/13
Clopidogrel Teva Pharma Teva Pharma B.V. Centralised - Renewal 8 May 2014 EMEA/H/C/1133/R/19
Laventair Glaxo Group Ltd Centralised - Authorisation 8 May 2014 EMEA/H/C/3754
Anoro Glaxo Group Ltd Centralised - Authorisation 8 May 2014 EMEA/H/C/2751
Carbaglu Orphan Europe S.A.R.L. Centralised - Yearly update 7 May 2014
Trobalt Glaxo Group Ltd Centralised - 2-Monthly update 7 May 2014 EMEA/H/C/1245/II/23
Tresiba Novo Nordisk A/S Centralised - 2-Monthly update 7 May 2014 EMEA/H/C/2498/II/6
NutropinAq Ipsen Pharma Centralised - Yearly update 6 May 2014
Rivastigmine 1 A Pharma 1 A Pharma GmbH Centralised - Yearly update 6 May 2014
Vyndaqel Pfizer Limited Centralised - Yearly update 6 May 2014
Invirase Roche Registration Limited Centralised - 2-Monthly update 2 May 2014 EMEA/H/C/113/II/104
Revinty Ellipta Glaxo Group Ltd Centralised - Authorisation 2 May 2014 EMEA/H/C/2745
DuoResp Spiromax Teva Pharma B.V. Corrigendum 28 Apr 2014
Orencia Bristol-Myers Squibb Pharma EEIG Corrigendum 28 Apr 2014
Victoza Novo Nordisk A/S Centralised - 2-Monthly update 28 Apr 2014 EMEA/H/C/1026/II/23, 24
Avamys Glaxo Group Ltd Centralised - Yearly update 28 Apr 2014
alli Glaxo Group Ltd Centralised - Yearly update 28 Apr 2014
Orencia Bristol-Myers Squibb Pharma EEIG Centralised - 2-Monthly update 28 Apr 2014 EMEA/H/C/701/II/77
Exjade Novartis Europharm Limited Centralised - Yearly update 28 Apr 2014
Tepadina ADIENNE S.r.l. Centralised - Yearly update 28 Apr 2014
Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Centralised - Yearly update 28 Apr 2014
Pegasys Roche Registration Limited Centralised - 2-Monthly update 28 Apr 2014 EMEA/H/C/395/II/73
Vimizim BioMarin Europe Ltd Centralised - Authorisation 28 Apr 2014 EMEA/H/C/2779
Rebetol Merck Sharp & Dohme Limited Centralised - Modification 28 Apr 2014 EMEA/H/C/246/10007/201307
Ribavirin Teva Pharma BV Teva Pharma B.V. Centralised - Modification 28 Apr 2014 EMEA/H/C/1064/PSUSA/10007
Ribavirin Teva Teva Pharma B.V. Centralised - Modification 28 Apr 2014 EMEA/H/C/1018/PSUSA/10007
Incruse Glaxo Group Ltd Centralised - Authorisation 28 Apr 2014 EMEA/H/C/2809
BiResp Spiromax Teva Pharma B.V. Centralised - Authorisation 28 Apr 2014 EMEA/H/C/3890
DuoResp Spiromax Teva Pharma B.V. Centralised - Authorisation 28 Apr 2014 EMEA/H/C/2348
Glybera uniQure biopharma B.V. Centralised - Annual reassessment 28 Apr 2014 EMEA/H/C/2145/S/27
Ribavirin Mylan Generics [UK] Limited Centralised - Modification 28 Apr 2014 EMEA/H/C/1185/PSU/10007
Deltyba Otsuka Novel Products GmbH Centralised - Authorisation 28 Apr 2014 EMEA/H/C/2552
Nimenrix GlaxoSmithKline Biologicals S.A. Centralised - Yearly update 23 Apr 2014
Integrilin Glaxo Group Ltd Centralised - Yearly update 23 Apr 2014
Volibris Glaxo Group Ltd Centralised - Yearly update 23 Apr 2014
Rivastigmine HEXAL Hexal AG Centralised - Yearly update 23 Apr 2014
Vfend Pfizer Limited Centralised - Yearly update 23 Apr 2014
Ferriprox Apotex Europe B.V. Centralised - Yearly update 23 Apr 2014
Ryzodeg Novo Nordisk A/S Centralised - Yearly update 23 Apr 2014
CANCIDAS Merck Sharp & Dohme Limited Centralised - Yearly update 23 Apr 2014
Noxafil Merck Sharp & Dohme Limited Centralised - Variation 23 Apr 2014 EMEA/H/C/610/X/28
Elaprase Shire Human Genetic Therapies AB Centralised - Modification 23 Apr 2014 EMEA/H/C/700/PSU/34
Ketek Aventis Pharma S.A. Centralised - Modification 23 Apr 2014 EMEA/H/C/354/PSUV/60
Bretaris Genuair Almirall, S.A. Centralised - Modification 23 Apr 2014 EMEA/H/C/2706/PSUR/8
Eklira Genuair Almirall, S.A. Centralised - Modification 23 Apr 2014 EMEA/H/C/2211/PSUR/8
Instanyl Takeda Pharma A/S Centralised - Renewal 23 Apr 2014 EMEA/H/C/959/R/22
Stocrin Merck Sharp & Dohme Limited Centralised - Renewal 23 Apr 2014 EMEA/H/C/250/R/96
Sustiva Bristol-Myers Squibb Pharma EEIG Centralised - Renewal 23 Apr 2014 EMEA/H/C/249/R/120
Vokanamet Janssen-Cilag International NV Centralised - Authorisation 23 Apr 2014 EMEA/H/C/2656
Onglyza AstraZeneca AB Centralised - Modification 23 Apr 2014 EMEA/H/C/1039/PSU/30
Iressa AstraZeneca AB Centralised - Renewal 23 Apr 2014 EMEA/H/C/1016/1016/R/12
Hemangiol Pierre Fabre Dermatologie Centralised - Authorisation 23 Apr 2014 EMEA/H/C/2621
Ulunar Breezhaler Novartis Europharm Limited Centralised - Authorisation 23 Apr 2014 EMEA/H/C/3875
Pegasys Roche Registration Limited Centralised - Modification 23 Apr 2014 EMEA/H/C/395/PSUV/72
Aloxi Helsinn Birex Pharmaceuticals Ltd Centralised - Modification 23 Apr 2014 EMEA/H/C/563/PSUV/33
Betmiga Astellas Pharma Europe B.V. Centralised - Modification 23 Apr 2014 EMEA/H/C/2388/PSUV/7
Qutenza Astellas Pharma Europe B.V. Centralised - Renewal 23 Apr 2014 EMEA/H/C/909/R/31
Siklos Addmedica Centralised - Modification 23 Apr 2014 EMEA/H/C/689/PSUV/20
Vedrop Orphan Europe S.A.R.L. Centralised - Renewal 23 Apr 2014 EMEA/H/C/920/R/7
RoActemra Roche Registration Limited Centralised - Variation 23 Apr 2014 EMEA/H/C/955/X/30
Tamiflu Roche Registration Limited Corrigendum 4 Dec 2013
Centralised procedures of orphan medicinal products for human use
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
EU/3/05/278 PTC Therapeutics International Limited Centralised Orphan - Transfer of orphan designation 6 Oct 2014 EMA/OD/106/04/T/03
EU/3/11/897 RLM Consulting Centralised Orphan - Transfer of orphan designation 6 Oct 2014 EMA/OD/029/11/T/01
EU/3/13/1232 Scioderm Limited Centralised Orphan - Transfer of orphan designation 6 Oct 2014 EMA/OD/145/13/T/01
EU/3/10/747 AVEO Pharma Ltd. Centralised Orphan - Transfer of orphan designation 24 Sep 2014 EMA/OD/148/09/T/02
EU/3/06/381 Envestia Limited Centralised Orphan - Transfer of orphan designation 24 Sep 2014 EMA/OD/007/06/T/02
EU/3/11/945 Voisin Consulting S.A.R.L. Centralised Orphan - Transfer of orphan designation 24 Sep 2014 EMA/OD/105/11/T/01
EU/3/14/1276 Basilea Medical Ltd Corrigendum 4 Sep 2014
EU/3/14/1333 Vertex Pharmaceuticals (U.K.) Limited Centralised Orphan - Designation 22 Aug 2014 EMA/OD/032/14
EU/3/14/1332 Corline Systems AB Centralised Orphan - Designation 22 Aug 2014 EMA/OD/090/14
EU/3/14/1331 IDEA Innovative Drug European Associates Limited Centralised Orphan - Designation 22 Aug 2014 EMA/OD/048/14
EU/3/14/1330 Centro de Investigación Biomédica en Red (CIBER) Centralised Orphan - Designation 22 Aug 2014 EMA/OD/102/14
EU/3/14/1329 Diamond BioPharm Limited Centralised Orphan - Designation 22 Aug 2014 EMA/OD/101/14
EU/3/14/1328 Roche Registration Limited Centralised Orphan - Designation 22 Aug 2014 EMA/OD/100/14
EU/3/14/1327 Amyndas Pharmaceuticals S.A. Centralised Orphan - Designation 22 Aug 2014 EMA/OD/098/14
EU/3/14/1326 Vall d'Hebron Institute of Research Centralised Orphan - Designation 22 Aug 2014 EMA/OD/093/14
EU/3/14/1325 Roche Registration Limited Centralised Orphan - Designation 22 Aug 2014 EMA/OD/092/14
EU/3/14/1324 DualTpharma B.V. Centralised Orphan - Designation 22 Aug 2014 EMA/OD/086/14
EU/3/14/1323 Synovo GmbH Centralised Orphan - Designation 22 Aug 2014 EMA/OD/085/14
EU/3/14/1322 Innate Pharma S.A. Centralised Orphan - Designation 22 Aug 2014 EMA/OD/084/14
EU/3/14/1321 Fondazione Telethon Centralised Orphan - Designation 22 Aug 2014 EMA/OD/082/14
EU/3/14/1320 Medical University of Vienna Centralised Orphan - Designation 22 Aug 2014 EMA/OD/075/14
EU/3/14/1319 Richardson Associates Regulatory Affairs Ltd Centralised Orphan - Designation 22 Aug 2014 EMA/OD/073/14
EU/3/14/1318 BSV BioScience GmbH Centralised Orphan - Designation 22 Aug 2014 EMA/OD/072/14
EU/3/14/1317 Clinipace GmbH Centralised Orphan - Designation 22 Aug 2014 EMA/OD/071/14
EU/3/14/1316 Richardson Associates Regulatory Affairs Ltd Centralised Orphan - Designation 22 Aug 2014 EMA/OD/069/14
EU/3/14/1315 Cerenis Therapeutics Holding SA Centralised Orphan - Designation 22 Aug 2014 EMA/OD/064/14
EU/3/14/1314 Cerenis Therapeutics Holding SA Centralised Orphan - Designation 22 Aug 2014 EMA/OD/063/14
EU/3/14/1313 Clinipace GmbH Centralised Orphan - Designation 22 Aug 2014 EMA/OD/061/14
EU/3/14/1312 Richardson Associates Regulatory Affairs Ltd Centralised Orphan - Designation 22 Aug 2014 EMA/OD/057/14
EU/3/14/1311 Les Laboratoires Servier Centralised Orphan - Designation 22 Aug 2014 EMA/OD/053/14
EU/3/14/1310 Genzyme Europe B.V. Centralised Orphan - Designation 22 Aug 2014 EMA/OD/052/14
EU/3/14/1309 NDA Group AB Centralised Orphan - Designation 22 Aug 2014 EMA/OD/049/14
EU/3/14/1308 JJGConsultancy Ltd Centralised Orphan - Designation 22 Aug 2014 EMA/OD/043/14
EU/3/14/1307 Dr. Philipp Heinrich Novak Centralised Orphan - Designation 22 Aug 2014 EMA/OD/018/14
EU/3/07/485 Theorem Clinical Research GmbH Centralised Orphan - Transfer of orphan designation 12 Aug 2014 EMA/OD/059/07/T/0
EU/3/12/1089 Wilson Therapeutics AB Centralised Orphan - Transfer of orphan designation 30 Jul 2014 EMA/OD/142/12/T/01
EU/3/13/1156 inVentiv Health Germany GmbH Centralised Orphan - Transfer of orphan designation 30 Jul 2014 EMA/OD/045/13/T/01
EU/3/07/446 GlaxoSmithKline Trading Services Limited Centralised Orphan - Transfer of orphan designation 30 Jul 2014 EMA/OD/102/06/T/01
EU/3/05/313 GlaxoSmithKline Trading Services Limited Centralised Orphan - Transfer of orphan designation 30 Jul 2014 EMA/OD/053/05/T/02
EU/3/14/1293 GlaxoSmithKline Trading Services Limited Centralised Orphan - Designation 30 Jul 2014 EMA/OD/021/14
EU/3/14/1292 GlaxoSmithKline Trading Services Limited Centralised Orphan - Designation 30 Jul 2014 EMA/OD/020/14
EU/3/14/1306 Raptor Pharmaceuticals Europe BV Centralised Orphan - Designation 29 Jul 2014 EMA/OD/070/14
EU/3/14/1305 AbbVie Ltd Centralised Orphan - Designation 29 Jul 2014 EMA/OD/065/14
EU/3/14/1304 Alexion Europe SAS Centralised Orphan - Designation 29 Jul 2014 EMA/OD/062/14
EU/3/14/1303 AstraZeneca AB Centralised Orphan - Designation 29 Jul 2014 EMA/OD/059/14
EU/3/14/1302 Maďthé Tauber Centralised Orphan - Designation 29 Jul 2014 EMA/OD/054/14
EU/3/14/1301 Biogen Idec Limited Centralised Orphan - Designation 29 Jul 2014 EMA/OD/051/14
EU/3/14/1300 IDEA Innovative Drug European Associates Limited Centralised Orphan - Designation 29 Jul 2014 EMA/OD/047/14
EU/3/14/1299 Bayer Pharma AG Centralised Orphan - Designation 29 Jul 2014 EMA/OD/044/14
EU/3/14/1298 Alnylam UK Limited Centralised Orphan - Designation 29 Jul 2014 EMA/OD/041/14
EU/3/14/1297 Alnylam UK Limited Centralised Orphan - Designation 29 Jul 2014 EMA/OD/039/14
EU/3/14/1296 Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione Centralised Orphan - Designation 29 Jul 2014 EMA/OD/037/14
EU/3/14/1295 Richardson Associates Regulatory Affairs Ltd Centralised Orphan - Designation 29 Jul 2014 EMA/OD/035/14
EU/3/14/1294 Dr Ulrich Granzer Centralised Orphan - Designation 29 Jul 2014 EMA/OD/028/14
EU/3/14/1291 Amgen Europe B.V. Centralised Orphan - Designation 29 Jul 2014 EMA/OD/012/14
EU/3/01/059 Clinigen Healthcare Limited Centralised Orphan - Transfer of orphan designation 29 Jul 2014 EMA/OD/021/01/T/03
EU/3/14/1290 NightstaRx Ltd. Centralised Orphan - Designation 4 Jul 2014 EMA/OD/033/14
EU/3/14/1289 A1M Pharma AB Centralised Orphan - Designation 4 Jul 2014 EMA/OD/027/14
EU/3/14/1288 Dr Falk Pharma GmbH Centralised Orphan - Designation 4 Jul 2014 EMA/OD/026/14
EU/3/14/1287 Dr Ulrich Granzer Centralised Orphan - Designation 4 Jul 2014 EMA/OD/023/14
EU/3/14/1286 MorphoSys AG Centralised Orphan - Designation 4 Jul 2014 EMA/OD/022/14
EU/3/14/1285 Clinuvel (UK) Limited Centralised Orphan - Designation 4 Jul 2014 EMA/OD/019/14
EU/3/14/1284 Basilea Medical Ltd Centralised Orphan - Designation 4 Jul 2014 EMA/OD/009/14
EU/3/14/1283 Fondazione Telethon Centralised Orphan - Designation 4 Jul 2014 EMA/OD/005/14
EU/3/14/1282 Fondazione Telethon Centralised Orphan - Designation 4 Jul 2014 EMA/OD/004/14
EU/3/14/1281 Vertex Pharmaceuticals (U.K.) Limited Centralised Orphan - Designation 4 Jul 2014 EMA/OD/002/14
EU/3/08/548 Amgen Europe B.V. Centralised Orphan - Transfer of orphan designation 19 Jun 2014 EMA/OD/120/07/T/03
EU/3/10/727 Sanofi-Aventis Recherche & Développement Centralised Orphan - Transfer of orphan designation 19 Jun 2014 EMA/OD/137/09/T/01
EU/3/09/720 Sanofi-Aventis Recherche & Développement Centralised Orphan - Transfer of orphan designation 19 Jun 2014 EMA/OD/127/09/T/01
EU/3/14/1280 Cochamo Systems Ltd Centralised Orphan - Designation 10 Jun 2014 EMA/OD/006/14
EU/3/14/1275 Gene Signal SAS Centralised Orphan - Designation 10 Jun 2014 EMA/OD/008/14
EU/3/14/1279 Clanotech AB Centralised Orphan - Designation 4 Jun 2014 EMA/OD/016/14
EU/3/14/1278 Alan Boyd Consultants Ltd Centralised Orphan - Designation 4 Jun 2014 EMA/OD/015/14
EU/3/14/1277 Imperial Innovations Limited Centralised Orphan - Designation 4 Jun 2014 EMA/OD/013/14
EU/3/14/1276 Basilea Medical Ltd Centralised Orphan - Designation 4 Jun 2014 EMA/OD/010/14
EU/3/14/1274 CLL Pharma Centralised Orphan - Designation 4 Jun 2014 EMA/OD/003/14
EU/3/14/1273 Epitarget AS Centralised Orphan - Designation 4 Jun 2014 EMA/OD/001/14
EU/3/14/1272 Shire Pharmaceuticals Ireland Limited Centralised Orphan - Designation 4 Jun 2014 EMA/OD/201/13
EU/3/14/1271 Nordic Nanovector AS Centralised Orphan - Designation 4 Jun 2014 EMA/OD/200/13
EU/3/14/1270 CellAct Pharma GmbH Centralised Orphan - Designation 4 Jun 2014 EMA/OD/199/13
EU/3/14/1269 ITG Isotope Technologies Garching GmbH Centralised Orphan - Designation 4 Jun 2014 EMA/OD/196/13
EU/3/03/183 Eumedica N.V. Centralised Orphan - Transfer of orphan designation 20 May 2014 EMEA/OD/028/03/T/01
EU/3/12/1013 Inserm-ANRS (Agence Nationale de Recherches sur le Sida et les Hépatites Virales) Centralised Orphan - Transfer of orphan designation 15 May 2014 EMA/OD/011/12/T/01
EU/3/07/495 Orbona Pharma Ltd Centralised Orphan - Transfer of orphan designation 15 May 2014 EMA/OD/064/07/T/01
EU/3/10/753 Intercept s.r.l. Corrigendum 5 May 2014
EU/3/14/1268 Sanofi-Aventis groupe Centralised Orphan - Designation 29 Apr 2014 EMA/OD/198/13
EU/3/14/1267 Voisin Consulting S.A.R.L. Centralised Orphan - Designation 29 Apr 2014 EMA/OD/194/13
EU/3/14/1266 Novartis Europharm Limited Centralised Orphan - Designation 29 Apr 2014 EMA/OD/187/13
EU/3/14/1265 Oncos Therapeutics Oy Centralised Orphan - Designation 29 Apr 2014 EMA/OD/186/13
EU/3/14/1264 Janssen-Cilag International NV Centralised Orphan - Designation 29 Apr 2014 EMA/OD/185/13
EU/3/14/1263 bluebird bio France Centralised Orphan - Designation 29 Apr 2014 EMA/OD/184/13
EU/3/12/963 Actelion Registration Ltd Centralised Orphan - Transfer of orphan designation 28 Apr 2014 EMA/OD/112/11/T/01
EU/3/09/645 Novartis Europharm Limited Centralised Orphan - Transfer of orphan designation 28 Apr 2014 EMEA/OD/010/09/T/01
EU/3/08/580 Dr. Ulrich Bogdahn Centralised Orphan - Transfer of orphan designation 28 Apr 2014 EMEA/OD/042/08/T/01
EU/3/08/532 Dr. Ulrich Bogdahn Centralised Orphan - Transfer of orphan designation 28 Apr 2014 EMEA/OD/102/07/T/01
Centralised procedures of veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 30 Sep 2014
Meloxoral Le Vet B.V. Centralised - Yearly update 30 Sep 2014
Zulvac 1+8 Ovis Zoetis Belgium S.A. Centralised - Yearly update 16 Sep 2014
Zulvac 1 Bovis Zoetis Belgium S.A. Centralised - Yearly update 9 Sep 2014
Zulvac 1 Ovis Zoetis Belgium S.A. Centralised - Yearly update 9 Sep 2014
Pirsue Zoetis Belgium S.A. Centralised - Yearly update 9 Sep 2014
Fevaxyn Pentofel Zoetis Belgium S.A. Centralised - Yearly update 9 Sep 2014
Aivlosin ECO Animal Health Ltd Centralised - Renewal 9 Sep 2014 EMEA/V/C/83/R/59
Nobilis IB Primo QX Intervet International B.V. Centralised - Authorisation 4 Sep 2014 EMEA/V/C/2802
Inflacam Chanelle Pharmaceuticals Manufacturing Limited Centralised - Yearly update 1 Sep 2014
Suvaxyn Aujeszky 783 + O/W Zoetis Belgium S.A. Centralised - Yearly update 1 Sep 2014
Convenia Zoetis Belgium S.A. Centralised - Yearly update 27 Aug 2014
Stronghold Zoetis Belgium S.A. Centralised - Yearly update 26 Aug 2014
Procox Bayer Animal Health GmbH Centralised - Yearly update 26 Aug 2014
Naxcel Zoetis Belgium S.A. Centralised - Yearly update 26 Aug 2014
Cortavance VIRBAC S.A. Centralised - Yearly update 26 Aug 2014
Slentrol Zoetis Belgium S.A. Centralised - Yearly update 26 Aug 2014
Zolvix Novartis Healthcare A/S Centralised - Yearly update 19 Aug 2014
Cardalis CEVA SANTE ANIMALE Corrigendum 19 Aug 2014
Activyl Tick Plus Intervet International B.V. Centralised - Yearly update 5 Aug 2014
Versican Plus L4 Zoetis Belgium S.A. Centralised - Authorisation 31 Jul 2014 EMEA/V/C/3680
Versican Plus Pi/L4R Zoetis Belgium S.A. Centralised - Authorisation 31 Jul 2014 EMEA/V/C/3682/
Palladia Zoetis Belgium S.A. Centralised - Renewal 31 Jul 2014 EMEA/V/C/150/R/7
Versican Plus Pi/L4 Zoetis Belgium S.A. Centralised - Authorisation 31 Jul 2014 EMEA/V/C/3683
Osurnia Novartis Santé Animale S.A.S. Centralised - Authorisation 31 Jul 2014 EMEA/V/C/3753
Poulvac E. coli Zoetis Belgium S.A. Centralised - Yearly update 28 Jul 2014
ProteqFlu-Te Merial Centralised - 2-Monthly update 11 Jul 2014 EMEA/V/C/74/II/17
ProteqFlu Merial Centralised - 2-Monthly update 11 Jul 2014 EMEA/V/C/73/II/14
ERYSENG PARVO Laboratorios Hipra, S.A. Centralised - Authorisation 8 Jul 2014 EMEA/V/C/2762
Draxxin Zoetis Belgium S.A. Centralised - Variation 8 Jul 2014 EMEA/V/C/77/X/26
SevoFlo Abbott Laboratories Ltd Centralised - Yearly update 8 Jul 2014
Versican Plus DHPPi Zoetis Belgium S.A. Centralised - Authorisation 4 Jul 2014 EMEA/V/C/3679
Versican Plus Pi Zoetis Belgium S.A. Centralised - Authorisation 4 Jul 2014 EMEA/V/C/3681
ERYSENG Laboratorios Hipra, S.A. Centralised - Authorisation 4 Jul 2014 EMEA/V/C/2761
TruScient Zoetis Belgium S.A. Centralised - Yearly update 30 Jun 2014
Hiprabovis IBR Marker Live Laboratorios Hipra, S.A. Centralised - Yearly update 27 Jun 2014
Zulvac 8 Ovis Zoetis Belgium S.A. Centralised - Yearly update 27 Jun 2014
Zulvac 8 Bovis Zoetis Belgium S.A. Centralised - Yearly update 27 Jun 2014
Econor Novartis Tiergesundheit GmbH Centralised - Transfer Marketing Authorisation Holder 23 Jun 2014 EMEA/V/C/42/T/47
Locatim Biokema Anstalt Centralised - Yearly update 19 Jun 2014
Previcox Merial Centralised - Yearly update 19 Jun 2014
Leucogen Virbac Centralised - Renewal 12 Jun 2014 EMEA/V/C/144/R/2
Metacam Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 6 Jun 2014
Cerenia Zoetis Belgium S.A. Centralised - 2-Monthly update 6 Jun 2014 EMEA/V/C/106/II/22
Melovem Dopharma Research B.V. Centralised - Renewal 6 Jun 2014 EMEA/V/C/152/R/8
Leucofeligen FeLV/RCP Virbac Centralised - Renewal 6 Jun 2014 EMEA/V/C/143/R/3
Suvaxyn PCV Zoetis Belgium S.A. Centralised - Renewal 6 Jun 2014 EMEA/V/C/149/R/16
Vectra Felis CEVA SANTE ANIMALE Centralised - Authorisation 6 Jun 2014 EMEA/V/C/2746
Activyl Intervet International B.V. Centralised - Yearly update 3 Jun 2014
Circovac Merial Centralised - Yearly update 16 May 2014
Recocam Cross Vetpharm Group, Ltd Centralised - Yearly update 7 May 2014
Cardalis CEVA SANTE ANIMALE Centralised - Yearly update 7 May 2014
Versican Plus DHPPi/L4R Zoetis Belgium S.A. Centralised - Authorisation 7 May 2014 EMEA/V/C/2759
Versican Plus DHPPi/L4 Zoetis Belgium S.A. Centralised - Authorisation 7 May 2014 EMEA/V/C/3678
Flexicam Dechra Veterinary Products A/S Centralised - Withdrawal 6 May 2014
Community referrals for human medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Hydroxyethyl starch Corrigendum 8 Oct 2014
Emergency contraceptives medicinal products containing levonorgestrel Referral 30 Sep 2014 EMEA/H/A-31/1391
Anagrelide Centralised - Modification 18 Sep 2014 EMEA/H/C/PSUSA/208/201309
Renin-angiotensin system (RAS)-acting agents Referral 4 Sep 2014 EMEA/H/A-31/1370
Diacerein Referral 4 Sep 2014 EMEA/H/A-31/1349
Domperidone Art 31 Rectificative Decision 1 Sep 2014
Sandostatin LAR and associated names Referral 26 Aug 2014 EMEA/H/A-30/1355
Sandostatin and associated names Referral 26 Aug 2014 EMEA/H/R/A30/1354
Nerventra Teva Pharma GmbH Centralised - Refusal of marketing authorisation 19 Aug 2014 EMEA/H/C/2546
Estradiol Referral 19 Aug 2014 EMEA/H/R/A-31/1336
Dexamed and associated names Referral 6 Aug 2014 EMEA/A-29/1375
Seroquel/Seroquel XR and associated names AstraZeneca UK Limited Referral 6 Aug 2014 EMEA/H/A-30/1362
Domperidone Art 31 Corrigendum 5 Aug 2014
Neocepri Endocyte Europe B.V. Centralised - Refusal of marketing authorisation 5 Aug 2014 EMEA/H/C/2773
Folcepri Endocyte Europe B.V. Centralised - Refusal of marketing authorisation 5 Aug 2014 EMEA/H/C/2570
Vynfinit Endocyte Europe B.V. Centralised - Refusal of marketing authorisation 5 Aug 2014 EMEA/H/C/2571
Reasanz Novartis Europharm Limited Centralised - Refusal of marketing authorisation 5 Aug 2014 EMEA/H/C/2817
Masiviera AB Science S.A. Centralised - Refusal of marketing authorisation 23 Jul 2014 EMEA/H/C/2659
Domperidone Art 31 Referral 14 Jul 2014 EMEA/H/A-31/1365
Caustinerf arsenical, Yranicid arsenical and other associated names for topical use Referral 11 Jul 2014
Masican AB Science S.A. Centralised - Refusal of marketing authorisation 4 Jul 2014 EMEA/H/C/2670
Crestor and associated names AstraZeneca UK Limited Referral 30 Jun 2014 EMEA/H/A-29-PAE/1378
Zolpidem Referral 23 Jun 2014 EMEA/H/A-31/1377
Ribavirin Centralised - Modification 28 Apr 2014 EMEA/H/C/PSUSA/10007/201307
methysergide Referral 28 Apr 2014 EMEA/H/A-31/1335
Community referrals for veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Baytril Referral 1 Sep 2014 EMEA/V/A/97
Baytril Referral 1 Sep 2014 EMEA/V/A/91
Veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs Referral 31 Jul 2014 EMEA/V/A/100
Enrofloxacin to be administered via the drinking water to chickens and/or turkeys Corrigendum 22 Jul 2014
Fiprex CAT 52.5 mg spot-on solution for cats, Fiprex S 75 mg spot-on solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for dogs, Fiprex XL 412.5 mg spot-on solution for dogs Vet-Agro Trading Sp. z o.o. Referral 14 Jul 2014 EMEA/V/A/99
Linco-Spectin 100 and its associated names Referral 11 Jul 2014 EMEA/V/A/88/Art.34