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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
Scenesse Clinuvel UK Limited Centralised - Authorisation 22 Dec 2014 EMEA/H/C/2548
Zonegran Eisai Limited Corrigendum 19 Dec 2014
Ristfor Merck Sharp & Dohme Limited Centralised - Renewal 16 Dec 2014 EMEA/H/C/1235/R/47
Ristaben Merck Sharp & Dohme Limited Centralised - Renewal 16 Dec 2014 EMEA/H/C/1234/R/33
Ultibro Breezhaler Novartis Europharm Limited Centralised - Modification 16 Dec 2014
Afinitor Novartis Europharm Limited Centralised - Modification 16 Dec 2014 EMEA/H/C/1038/PSUV/39
DUAVIVE Pfizer Limited Centralised - Authorisation 16 Dec 2014 EMEA/H/C/2314
Ulunar Breezhaler Novartis Europharm Limited Centralised - Modification 16 Dec 2014 EMEA/H/C/3875/PSUV/2
Incivo Janssen-Cilag International NV Centralised - Modification 16 Dec 2014 EMEA/H/C/2313/PSUV/28
Fasturtec Sanofi-Aventis groupe Centralised - Modification 16 Dec 2014 EMEA/H/C/331/PSUV/41
Brintellix H. Lundbeck A/S Centralised - Modification 16 Dec 2014 EMEA/H/C/2717/PSUV/3
Xoterna Breezhaler Novartis Europharm Limited Centralised - Modification 16 Dec 2014
Stivarga Bayer Pharma AG Centralised - Modification 16 Dec 2014 EMEA/H/C/2573/PSUV/4
Votubia Novartis Europharm Limited Centralised - Modification 16 Dec 2014 EMEA/H/C/2311/PSUV/25
Naglazyme BioMarin Europe Ltd Centralised - Yearly update 15 Dec 2014
Xeloda Roche Registration Limited Centralised - Yearly update 15 Dec 2014
Mircera Roche Registration Limited Centralised - Yearly update 15 Dec 2014
Levetiracetam Actavis Group Actavis Group PTC ehf. Centralised - Yearly update 15 Dec 2014
Bronchitol Pharmaxis Pharmaceuticals Limited Centralised - Yearly update 11 Dec 2014
Levetiracetam ratiopharm ratiopharm GmbH Centralised - Yearly update 11 Dec 2014
Eviplera Gilead Sciences International Limited Centralised - Yearly update 11 Dec 2014
Duloxetine Lilly Eli Lilly Nederland B.V. Centralised - Authorisation 8 Dec 2014 EMEA/H/C/4000
Moventig AstraZeneca AB Centralised - Authorisation 8 Dec 2014 EMEA/H/C/2810
Vectibix Amgen Europe B.V. Centralised - Yearly update 5 Dec 2014
Cystagon Orphan Europe S.A.R.L. Centralised - Yearly update 5 Dec 2014
Paliperidone Janssen Janssen-Cilag International NV Centralised - Authorisation 5 Dec 2014
Tevagrastim Teva GmbH Centralised - Yearly update 4 Dec 2014
Ratiograstim ratiopharm GmbH Centralised - Yearly update 4 Dec 2014
Menveo Novartis Vaccines and Diagnostics S.r.l. Centralised - Renewal 4 Dec 2014 EMEA/H/C/1095/R/46
Optimark Mallinckrodt Deutschland GmbH Centralised - Yearly update 1 Dec 2014
Irbesartan Teva Teva Pharma B.V. Centralised - Transfer Marketing Authorisation Holder 1 Dec 2014 EMEA/H/C/1093/T/22
Ibandronic Acid Teva Teva Pharma B.V. Centralised - Transfer Marketing Authorisation Holder 1 Dec 2014 EMEA/H/C/1195/T/11
Desloratadine Teva Teva Pharma B.V. Centralised - Transfer Marketing Authorisation Holder 1 Dec 2014 EMEA/H/C/2419/T/7
Topotecan Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 28 Nov 2014 EMEA/H/C/1071/T/8
Cetrotide Merck Serono Europe Limited Centralised - Yearly update 28 Nov 2014
Brinavess Cardiome UK Limited Centralised - Yearly update 28 Nov 2014
Xtandi Astellas Pharma Europe B.V. Centralised - 2-Monthly update 28 Nov 2014 EMEA/H/C/2639/II/8
Firdapse BioMarin Europe Ltd Centralised - Renewal 28 Nov 2014 EMEA/H/C/1032/R/29
Capecitabine Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 21 Nov 2014
Docetaxel Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 21 Nov 2014
Repaglinide Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 21 Nov 2014
Cervarix GlaxoSmithKline Biologicals S.A. Centralised - 2-Monthly update 21 Nov 2014 EMEA/H/C/721/II/58
Stelara Janssen-Cilag International NV Centralised - 2-Monthly update 21 Nov 2014 EMEA/H/C/958/II/41
Leganto UCB Manufacturing Ireland Ltd Centralised - Modification 21 Nov 2014 EMEA/H/C/2380/PSUV/13
Nexavar Bayer Pharma AG Centralised - Modification 21 Nov 2014 EMEA/H/C/690/PSUV/37
Tafinlar GlaxoSmithKline Trading Services Limited Centralised - Modification 21 Nov 2014 EMEA/H/C/2604/PSUV/5
Trulicity Eli Lilly Nederland B.V. Centralised - Authorisation 21 Nov 2014 EMEA/H/C/2825
Firmagon Ferring Pharmaceuticals A/S Centralised - Modification 21 Nov 2014 EMEA/H/C/986/PSUV/23
Vargatef Boehringer Ingelheim International GmbH Centralised - Authorisation 21 Nov 2014 EMEA/H/C/2569
Tadalafil Mylan Generics [UK] Limited Centralised - Authorisation 21 Nov 2014 EMEA/H/C/3787
Signifor Novartis Europharm Limited Centralised - Variation 19 Nov 2014 EMEA/H/C/2052/X/10
Humira AbbVie Ltd Centralised - Modification 19 Nov 2014 EMEA/H/C/481/PSUV/131
Eklira Genuair Almirall, S.A. Centralised - Modification 19 Nov 2014 EMEA/H/C/2211/PSUV/15
DuoCover Sanofi-Aventis groupe Centralised - Renewal 19 Nov 2014 EMEA/H/C/1144/R/33
Betmiga Astellas Pharma Europe B.V. Centralised - Modification 19 Nov 2014 EMEA/H/C/2388/PSUV/13
Kalydeco Vertex Pharmaceuticals (U.K.) Limited Centralised - Modification 19 Nov 2014 EMEA/H/C/2494/PSUV/21
Thymanax Servier (Ireland) Industries Limited Centralised - Modification 19 Nov 2014 EMEA/H/C/916/PSUV/21
DuoPlavin Sanofi Clir SNC Centralised - Renewal 19 Nov 2014 EMEA/H/C/1143/R/33
Lojuxta Aegerion Pharmaceuticals Limited Centralised - Modification 19 Nov 2014 EMEA/H/C/2578/PSUV/8
AUBAGIO Sanofi-Aventis groupe Centralised - Modification 19 Nov 2014 EMEA/H/C/2514/II/3, EMEA/H/C/2514/PSUV/5
Bretaris Genuair Almirall, S.A. Centralised - Modification 19 Nov 2014 EMEA/H/C/2706/PSUV/14
Duaklir Genuair Almirall, S.A. Centralised - Authorisation 19 Nov 2014 EMEA/H/C/3745
Brimica Genuair Almirall, S.A. Centralised - Authorisation 19 Nov 2014 EMEA/H/C/3969
ZALTRAP Sanofi-Aventis groupe Centralised - Modification 19 Nov 2014 EMEA/H/C/2532/PSUV/9
Aldurazyme Genzyme Europe B.V. Centralised - Annual reassessment 19 Nov 2014 EMEA/H/C/477/S/51
Ketoconazole HRA Laboratoire HRA Pharma Centralised - Authorisation 19 Nov 2014 EMEA/H/C/3906
Budesonide/Formoterol Teva Pharma B.V. Teva Pharma B.V. Centralised - Authorisation 19 Nov 2014 EMEA/H/C/3953
Budesonide/Formoterol Teva Teva Pharma B.V. Centralised - Authorisation 19 Nov 2014 EMEA/H/C/3951
Xaluprine Nova Laboratories Limited Centralised - Modification 19 Nov 2014 EMEA/H/C/2022/PSUV/8
Valdoxan Les Laboratoires Servier Centralised - Modification 19 Nov 2014 EMEA/H/C/915/PSUV/23
Evoltra Genzyme Europe B.V. Centralised - Modification 19 Nov 2014 EMEA/H/C/613/PSUV/44
Vylaer Spiromax Teva Pharma B.V. Centralised - Authorisation 19 Nov 2014 EMEA/H/C/3952
Imnovid Celgene Europe Limited Centralised - Modification 19 Nov 2014 EMEA/H/C/2682/PSUV/6
Lymphoseek Navidea Biopharmaceuticals Limited Centralised - Authorisation 19 Nov 2014 EMEA/H/C/2085
REZOLSTA Janssen-Cilag International NV Centralised - Authorisation 19 Nov 2014 EMEA/H/C/2819
Neupro UCB Manufacturing Ireland Ltd Centralised - Modification 19 Nov 2014 EMEA/H/C/626/PSUV/63
Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH Centralised - Renewal 19 Nov 2014 EMEA/H/C/1129/R/18
Renagel Genzyme Europe B.V. Centralised - Renewal 19 Nov 2014 EMEA/H/C/254/R/100
Temozolomide Sandoz Sandoz Pharmaceuticals GmbH Centralised - Renewal 19 Nov 2014 EMEA/H/C/1128/R/20
Temozolomide HEXAL Hexal AG Centralised - Renewal 19 Nov 2014 EMEA/H/C/1127/R/22
MACI Aastrom Biosciences DK ApS Referral 19 Nov 2014 EMEA/H/C/2522
Tygacil Pfizer Limited Centralised - Yearly update 17 Nov 2014
Zometa Novartis Europharm Limited Centralised - Yearly update 17 Nov 2014
Lamivudine Teva Pharma B.V. Teva B.V. Centralised - Transfer Marketing Authorisation Holder 17 Nov 2014 EMEA/H/C/1111/T/11
Revatio Pfizer Limited Centralised - Yearly update 17 Nov 2014
Tepadina ADIENNE S.r.l. Centralised - Renewal 17 Nov 2014 EMEA/H/C/1046/R/17
Harvoni Gilead Sciences International Limited Centralised - Authorisation 17 Nov 2014 EMEA/H/C/3850
Kivexa ViiV Healthcare UK Limited Centralised - Renewal 17 Nov 2014 EMEA/H/C/581/R/51
Avastin Roche Registration Limited Centralised - Renewal 17 Nov 2014 EMEA/H/C/582/R/68
Fendrix GlaxoSmithKline Biologicals S.A. Centralised - Renewal 17 Nov 2014 EMEA/H/C/550/R/34
Tysabri Biogen Idec Limited Centralised - Yearly update 13 Nov 2014
NovoMix Novo Nordisk A/S Centralised - Yearly update 13 Nov 2014
Neulasta Amgen Europe B.V. Centralised - Yearly update 13 Nov 2014
Ribavirin Teva Pharma BV Teva B.V. Centralised - Transfer Marketing Authorisation Holder 13 Nov 2014 EMEA/H/C/1064/T/15
Ribavirin Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 13 Nov 2014 EMEA/H/C/1018/T/16
Trisenox Teva Pharma B.V. Centralised - Yearly update 13 Nov 2014
Pioglitazone Actavis Actavis Group PTC ehf. Centralised - Yearly update 11 Nov 2014
Nemdatine Actavis Group PTC ehf. Centralised - Yearly update 11 Nov 2014
Glidipion Actavis Group PTC ehf. Centralised - Yearly update 11 Nov 2014
Lamivudine / Zidovudine Teva Teva Pharma B.V. Centralised - Transfer Marketing Authorisation Holder 11 Nov 2014 EMEA/H/C/1236/T/9
Imatinib Teva Teva Pharma B.V. Centralised - Transfer Marketing Authorisation Holder 11 Nov 2014 EMEA/H/C/2585/T/7
Irbesartan / Hydrochlorothiazide Teva Teva Pharma B.V. Centralised - Renewal 11 Nov 2014 EMEA/H/C/1112/R/24
Inlyta Pfizer Limited Centralised - Yearly update 7 Nov 2014
Arava Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 7 Nov 2014
Prometax Novartis Europharm Limited Centralised - Yearly update 7 Nov 2014
Biograstim AbZ-Pharma GmbH Centralised - Yearly update 7 Nov 2014
Repso Teva B.V. Centralised - Transfer Marketing Authorisation Holder 7 Nov 2014 EMEA/H/C/1222/T/14
Pioglitazone Accord Accord Healthcare Limited Centralised - 2-Monthly update 7 Nov 2014 EMEA/H/C/2277/IB/7
Xagrid Shire Pharmaceutical Contracts Ltd Centralised - 2-Monthly update 7 Nov 2014
JETREA ThromboGenics NV Centralised - Yearly update 30 Oct 2014
NexoBrid MediWound Germany GmbH Centralised - Yearly update 30 Oct 2014
Zinforo AstraZeneca AB Centralised - 2-Monthly update 30 Oct 2014 EMEA/H/C/2252/II/16
Hexacima Sanofi Pasteur SA Centralised - Yearly update 30 Oct 2014
Myfenax Teva Pharma B.V. Centralised - Yearly update 30 Oct 2014
Mycophenolate mofetil Teva Teva Pharma B.V. Centralised - Yearly update 30 Oct 2014
PREZISTA Janssen-Cilag International NV Centralised - 2-Monthly update 30 Oct 2014 EMEA/H/C/707/II/63, 64
Elonva Merck Sharp & Dohme Limited Centralised - 2-Monthly update 30 Oct 2014 EMEA/H/C/1106/II/15
Myclausen Herbert J. Passauer GmbH & Co. KG Centralised - Yearly update 27 Oct 2014
Zavesca Actelion Registration Ltd Centralised - Yearly update 27 Oct 2014
Entacapone Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 27 Oct 2014 EMEA/H/C/2075/T/9
Hexyon Sanofi Pasteur MSD, SNC Centralised - Yearly update 27 Oct 2014
Fasturtec Sanofi-Aventis groupe Centralised - Yearly update 27 Oct 2014
BindRen Mitsubishi Tanabe Pharma Europe Ltd. Centralised - Yearly update 27 Oct 2014
Ipreziv Takeda Pharma A/S Centralised - Withdrawal 27 Oct 2014
Invanz Merck Sharp & Dohme Limited Centralised - Yearly update 27 Oct 2014
Synflorix GlaxoSmithKline Biologicals S.A. Centralised - 2-Monthly update 27 Oct 2014 EMEA/H/C/973/II/78
Abraxane Celgene Europe Limited Centralised - 2-Monthly update 27 Oct 2014 EMEA/H/C/778/II/65
Vidaza Celgene Europe Limited Centralised - 2-Monthly update 27 Oct 2014 EMEA/H/C/978/II/28
Zarzio Sandoz GmbH Corrigendum 27 Oct 2014
Nevirapine Teva Teva B.V. Centralised - Transfer Marketing Authorisation Holder 22 Oct 2014 EMEA/H/C/1119/T/11
Privigen CSL Behring GmbH Centralised - Yearly update 22 Oct 2014
Lyxumia Sanofi-Aventis groupe Centralised - Yearly update 22 Oct 2014
Clopidogrel Teva Pharma Teva B.V. Centralised - Transfer Marketing Authorisation Holder 21 Oct 2014 EMEA/H/C/1133/T/24
Clopidogrel Teva Pharma B.V. Teva Pharma B.V. Centralised - Withdrawal 21 Oct 2014
IMBRUVICA Janssen-Cilag International NV Centralised - Authorisation 21 Oct 2014 EMEA/H/C/3791
Cymbalta Eli Lilly Nederland B.V. Centralised - Yearly update 20 Oct 2014
Onglyza AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 15 Oct 2014 EMEA/H/C/1039/T/26
Komboglyze AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 15 Oct 2014 EMEA/H/C/2059/T/18
Atosiban SUN Sun Pharmaceutical Industries Europe BV Centralised - Yearly update 15 Oct 2014
Xeristar Eli Lilly Nederland B.V. Centralised - Yearly update 15 Oct 2014
Advagraf Astellas Pharma Europe B.V. Centralised - Yearly update 15 Oct 2014
Evoltra Genzyme Europe B.V. Centralised - Yearly update 10 Oct 2014
Ariclaim Eli Lilly Nederland B.V. Centralised - Yearly update 10 Oct 2014
Keppra UCB Pharma S.A. 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
Insuman Sanofi-Aventis Deutschland GmbH Centralised - Yearly update 3 Oct 2014
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
FLUENZ MedImmune, LLC Centralised - Withdrawal 1 Oct 2014
BYDUREON AstraZeneca AB Centralised - Transfer Marketing Authorisation Holder 1 Oct 2014 EMEA/H/C/2020/T/26
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 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 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 EMA/H/C/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 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 - Variation 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 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 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
DuoResp Spiromax Teva Pharma B.V. Corrigendum 28 Apr 2014
Orencia Bristol-Myers Squibb Pharma EEIG Corrigendum 28 Apr 2014
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/3/12/998 GlaxoSmithKline Trading Services Limited Centralised Orphan - Transfer of orphan designation 5 Dec 2014 EMA/OD/014/12/T/01
EU/3/11/933 Baxter Innovations GmbH Centralised Orphan - Transfer of orphan designation 3 Dec 2014 EMA/OD/051/11/T/01
EU/3/13/1221 Roche Registration Limited Centralised Orphan - Transfer of orphan designation 3 Dec 2014 EMA/OD/144/13/T/01
EU/3/13/1174 Roche Registration Limited Centralised Orphan - Transfer of orphan designation 3 Dec 2014 EMA/OD/064/13/T/01
EU/3/13/1142 HORAMA SAS Centralised Orphan - Transfer of orphan designation 3 Dec 2014 EMA/OD/031/13/T/01
EU/3/14/1381 Généthon Centralised Orphan - Designation 19 Nov 2014 EMA/OD/166/14
EU/3/14/1380 PTC Therapeutics, Limited Centralised Orphan - Designation 19 Nov 2014 EMA/OD/165/14
EU/3/14/1379 Eagle Laboratories Limited Centralised Orphan - Designation 19 Nov 2014 EMA/OD/162/14
EU/3/14/1378 New B Innovation (UK) Limited Centralised Orphan - Designation 19 Nov 2014 EMA/OD/160/14
EU/3/14/1377 DualTpharma B.V. Centralised Orphan - Designation 19 Nov 2014 EMA/OD/159/14
EU/3/14/1376 Orphazyme ApS Centralised Orphan - Designation 19 Nov 2014 EMA/OD/158/14
EU/3/14/1375 Prof Alain Taieb Centralised Orphan - Designation 19 Nov 2014 EMA/OD/155/14
EU/3/14/1374 Genzyme Europe B.V. Centralised Orphan - Designation 19 Nov 2014 EMA/OD/152/14
EU/3/14/1373 ChemoCentryx Limited Centralised Orphan - Designation 19 Nov 2014 EMA/OD/150/14
EU/3/14/1372 ChemoCentryx Limited Centralised Orphan - Designation 19 Nov 2014 EMA/OD/149/14
EU/3/14/1371 CBR Biotech Strategies GmbH Centralised Orphan - Designation 19 Nov 2014 EMA/OD/148/14
EU/3/14/1370 Novartis Europharm Limited Centralised Orphan - Designation 19 Nov 2014 EMA/OD/147/14
EU/3/14/1369 Novartis Europharm Limited Centralised Orphan - Designation 19 Nov 2014 EMA/OD/146/14
EU/3/14/1368 Medpace Germany GmbH Centralised Orphan - Designation 19 Nov 2014 EMA/OD/145/14
EU/3/14/1367 Consejo Superior de Investigaciones Cientificas (CSIC) Centralised Orphan - Designation 19 Nov 2014 EMA/OD/144/14
EU/3/14/1366 FGK Representative Service GmbH Centralised Orphan - Designation 19 Nov 2014 EMA/OD/140/14
EU/3/14/1365 FGK Representative Service GmbH Centralised Orphan - Designation 19 Nov 2014 EMA/OD/139/14
EU/3/14/1364 Noxxon Pharma AG Centralised Orphan - Designation 19 Nov 2014 EMA/OD/132/14
EU/3/14/1363 Coté Orphan Consulting UK Limited Centralised Orphan - Designation 19 Nov 2014 EMA/OD/131/14
EU/3/14/1362 Inventiva Centralised Orphan - Designation 19 Nov 2014 EMA/OD/130/14
EU/3/14/1361 Inventiva Centralised Orphan - Designation 19 Nov 2014 EMA/OD/129/14
EU/3/14/1360 Apitope International NV Centralised Orphan - Designation 19 Nov 2014 EMA/OD/123/14
EU/3/14/1359 Plexcera Therapeutics EU Limited Centralised Orphan - Designation 19 Nov 2014 EMA/OD/121/14
EU/3/14/1358 FGK Representative Service GmbH Centralised Orphan - Designation 19 Nov 2014 EMA/OD/116/14
EU/3/14/1357 Numedicus Limited Centralised Orphan - Designation 19 Nov 2014 EMA/OD/110/14
EU/3/14/1356 Kiadis Pharma Netherlands B.V. Centralised Orphan - Designation 19 Nov 2014 EMA/OD/103/14
EU/3/14/1355 Clinipace GmbH Centralised Orphan - Designation 19 Nov 2014 EMA/OD/087/14
EU/3/14/1354 Clinipace GmbH Centralised Orphan - Designation 19 Nov 2014 EMA/OD/078/14
EU/3/14/1353 Temmler Pharma GmbH & Co. KG Centralised Orphan - Designation 19 Nov 2014 EMA/OD/074/14
EU/3/11/857 Alnylam UK Limited Centralised Orphan - Transfer of orphan designation 11 Nov 2014 EMA/OD/142/10/T/01
EU/3/14/1267 Alnylam UK Limited Centralised Orphan - Transfer of orphan designation 11 Nov 2014 EMA/OD/194/13/T/01
EU/3/09/683 ASK Pharmaceuticals GmbH Centralised Orphan - Transfer of orphan designation 11 Nov 2014 EMA/OD/080/09/T/02
EU/3/14/1352 GlaxoSmithKline Trading Services Limited Centralised Orphan - Designation 15 Oct 2014 EMA/OD/134/14
EU/3/14/1351 NDA Group AB Centralised Orphan - Designation 15 Oct 2014 EMA/OD/133/14
EU/3/14/1350 Novartis Europharm Limited Centralised Orphan - Designation 15 Oct 2014 EMA/OD/107/14
EU/3/14/1349 Voisin Consulting S.A.R.L. Centralised Orphan - Designation 15 Oct 2014 EMA/OD/138/14
EU/3/14/1348 STEMGEN S.p.A Centralised Orphan - Designation 15 Oct 2014 EMA/OD/111/14
EU/3/14/1347 Great Ormond Street Hospital for Children, NHS Foundation Trust Centralised Orphan - Designation 15 Oct 2014 EMA/OD/104/14
EU/3/14/1346 OxThera AB Centralised Orphan - Designation 15 Oct 2014 EMA/OD/080/14
EU/3/14/1345 Novartis Europharm Limited Centralised Orphan - Designation 15 Oct 2014 EMA/OD/099/14
EU/3/14/1344 PD Dr.med. Joachim Riethmüller Centralised Orphan - Designation 15 Oct 2014 EMA/OD/036/14
EU/3/14/1343 Immunomedics GmbH Centralised Orphan - Designation 15 Oct 2014 EMA/OD/081/14
EU/3/14/1342 S-cubed Ltd Centralised Orphan - Designation 15 Oct 2014 EMA/OD/128/14
EU/3/14/1341 Lucane Pharma SA Centralised Orphan - Designation 15 Oct 2014 EMA/OD/106/14
EU/3/14/1340 NHS National Services Scotland Trading as Scottish National Blood Transfusion Service Centralised Orphan - Designation 15 Oct 2014 EMA/OD/109/14
EU/3/14/1339 GW Pharma Ltd Centralised Orphan - Designation 15 Oct 2014 EMA/OD/083/14
EU/3/14/1338 Généthon Centralised Orphan - Designation 15 Oct 2014 EMA/OD/122/14
EU/3/14/1337 Real Regulatory Limited Centralised Orphan - Designation 15 Oct 2014 EMA/OD/137/14
EU/3/14/1336 Khondrion BV Centralised Orphan - Designation 15 Oct 2014 EMA/OD/068/14
EU/3/14/1335 Almirall, S.A. Centralised Orphan - Designation 15 Oct 2014 EMA/OD/091/14
EU/3/14/1334 Centre National de la Recherche Scientifique (CNRS) Centralised Orphan - Designation 15 Oct 2014 EMA/OD/105/14
EU/3/13/1148 Brainstorm Cell Therapeutics UK Ltd Corrigendum 6 Oct 2014
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/3/14/1263 bluebird bio France Centralised Orphan - Designation 29 Apr 2014 EMA/OD/184/13
Centralised procedures of veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Bovela Boehringer Ingelheim International GmbH Centralised - Authorisation 22 Dec 2014 EMEA/V/C/3703
Comfortis Eli Lilly and Company Ltd, Elanco Animal Health Centralised - Yearly update 11 Dec 2014
Porcilis AR-T DF Intervet International B.V. Centralised - Yearly update 4 Dec 2014
Gripovac 3 Merial Centralised - Renewal 4 Dec 2014 EMEA/V/C/157/R/5
Respiporc Flu3 IDT Biologika GmbH Centralised - Renewal 4 Dec 2014 EMEA/V/C/153/R/6
Semintra Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 28 Nov 2014
ProZinc Boehringer Ingelheim Vetmedica GmbH Centralised - Yearly update 28 Nov 2014
Zolvix Novartis Healthcare A/S Centralised - Renewal 7 Nov 2014 EMEA/V/C/154/R/13
Zulvac 8 Ovis Zoetis Belgium S.A. Centralised - Renewal 7 Nov 2014 EMEA/V/C/147/R/16
Zulvac 8 Bovis Zoetis Belgium S.A. Centralised - Renewal 7 Nov 2014 EMEA/V/C/145/R/16
Porcilis PCV M Hyo Intervet International B.V. Centralised - Authorisation 7 Nov 2014 EMEA/V/C/3796
Apoquel Zoetis Belgium S.A. Centralised - Yearly update 27 Oct 2014
Loxicom Norbrook Laboratories Ltd Centralised - 2-Monthly update 21 Oct 2014 EMEA/V/C/141/IB/21
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
Vectra 3D CEVA SANTE ANIMALE Corrigendum 4 Dec 2013
Community referrals for human medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Oxynal-Targin and associated names Referral 22 Dec 2014 EMEA/H/A-13/1402
Docetaxel (with alcohol in formulation) Referral 22 Dec 2014 EMEA/H/C/PSUSA/1152/201311
Plendil and associated names Referral 16 Dec 2014 EMEA/H/A-30/1385
EMLA cream and associated names Referral 28 Nov 2014 EMEA/H/A-30/1388
Bromocriptine Referral 30 Oct 2014 EMEA/H/A-31/1379
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/A-30/1354
Nerventra Teva Pharma GmbH Centralised - Refusal of marketing authorisation 19 Aug 2014 EMEA/H/C/2546
Estradiol Referral 19 Aug 2014 EMEA/H/A-31/1336
Dexamed and associated names Referral 6 Aug 2014 EMEA/H/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
Community referrals for veterinary medicinal products
Product Marketing Authorisation Holder Decision Type Decision date EMEA Nr
Suanovil 20 and associated names, Captalin and associated names and generic products thereof Referral 11 Dec 2014 EMEA/V/A/86
Resflor solution injectable and associated names Intervet International B.V. Referral 5 Dec 2014 EMEA/V/A/101
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-35/100
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-34/88