欧盟EMA药品数据库-欧盟集中审批药品
(European Medicines Agency Authorisation of Medicines DataBase)
商品名称 适用类别 通用名称 活性成分 产品号 上市许可开发者/申请人/持有人 上市许可日期 许可状态
Cinqaero Human reslizumab reslizumab EMEA/H/C/003912 Teva B.V. 2016/08/15 Authorised
Zepatier Human elbasvir;grazoprevir elbasvir;grazoprevir EMEA/H/C/004126 Merck Sharp & Dohme B.V. 2016/07/22 Authorised
Bortezomib Sun Human bortezomib bortezomib EMEA/H/C/004076 SUN Pharmaceutical Industries (Europe) B.V. 2016/07/22 Authorised
Bortezomib Hospira Human bortezomib bortezomib EMEA/H/C/004207 Pfizer Europe MA EEIG 2016/07/22 Authorised
Pemetrexed Fresenius Kabi Human pemetrexed pemetrexed EMEA/H/C/003895 Fresenius Kabi Deutschland GmbH 2016/07/22 Authorised
Qtern Human saxagliptin;dapagliflozin saxagliptin;dapagliflozin propanediol monohydrate EMEA/H/C/004057 Astra Zeneca AB 2016/07/15 Authorised
EndolucinBeta Human lutetium (177Lu) chloride lutetium (177Lu) chloride EMEA/H/C/003999 ITM Medical Isotopes GmbH 2016/07/06 Authorised
Epclusa Human sofosbuvir;velpatasvir sofosbuvir;velpatasvir EMEA/H/C/004210 Gilead Sciences Ireland UC 2016/07/06 Authorised
Zinbryta Human daclizumab daclizumab EMEA/H/C/003862 Biogen Idec Ltd 2016/07/01 Withdrawn
Enzepi Human pancreas powder pancreas powder EMEA/H/C/002070 Allergan Pharmaceuticals International Limited 2016/06/29 Withdrawn
Ongentys Human opicapone opicapone EMEA/H/C/002790 Bial - Portela Cª, S.A. 2016/06/24 Authorised
Zavicefta Human ceftazidime;avibactam avibactam sodium;ceftazidime pentahydrate EMEA/H/C/004027 Pfizer Ireland Pharmaceuticals Unlimited Company 2016/06/23 Authorised
Odefsey Human emtricitabine;rilpivirine;tenofovir alafenamide emtricitabine;rilpivirine hydrochloride;tenofovir alafenamide EMEA/H/C/004156 Gilead Sciences Ireland UC 2016/06/21 Authorised
Neparvis Human sacubitril;valsartan sacubitril;valsartan EMEA/H/C/004343 Novartis Europharm Limited 2016/05/26 Authorised
Strimvelis Human autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells EMEA/H/C/003854 Fondazione Telethon ETS 2016/05/26 Authorised
Flixabi Human infliximab infliximab EMEA/H/C/004020 Samsung Bioepis NL B.V. 2016/05/26 Authorised
Palonosetron Accord Human palonosetron palonosetron EMEA/H/C/004129 Accord Healthcare S.L.U. 2016/05/26 Authorised
Galafold Human migalastat migalastat hydrochloride EMEA/H/C/004059 Amicus Therapeutics Europe Limited 2016/05/25 Authorised
Darzalex Human daratumumab daratumumab EMEA/H/C/004077 Janssen-Cilag International N.V. 2016/05/20 Authorised
Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) Human pandemic influenza vaccine (H5N1) (live attenuated, nasal) reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain EMEA/H/C/003963 AstraZeneca AB 2016/05/20 Authorised

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