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
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
Neparvis Human sacubitril;valsartan sacubitril;valsartan EMEA/H/C/004343 Novartis Europharm Limited 2016/05/26 Authorised
Galafold Human migalastat migalastat hydrochloride EMEA/H/C/004059 Amicus Therapeutics Europe Limited 2016/05/25 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
Darzalex Human daratumumab daratumumab EMEA/H/C/004077 Janssen-Cilag International N.V. 2016/05/20 Authorised
Uptravi Human selexipag selexipag EMEA/H/C/003774 Janssen Cilag International NV 2016/05/12 Authorised
Alprolix Human eftrenonacog alfa eftrenonacog alfa EMEA/H/C/004142 Swedish Orphan Biovitrum AB (publ) 2016/05/12 Authorised
Empliciti Human elotuzumab Elotuzumab EMEA/H/C/003967 Bristol-Myers Squibb Pharma EEIG 2016/05/11 Authorised
Idelvion Human albutrepenonacog alfa albutrepenonacog alfa EMEA/H/C/003955 CSL Behring GmbH 2016/05/11 Authorised
Taltz Human ixekizumab ixekizumab EMEA/H/C/003943 Eli Lilly and Company (Ireland) Limited 2016/04/25 Authorised
Lonsurf Human trifluridine;tipiracil trifluridine;tipiracil hydrochloride EMEA/H/C/003897 Les Laboratoires Servier 2016/04/25 Authorised
Descovy Human emtricitabine;tenofovir alafenamide emtricitabine;tenofovir alafenamide EMEA/H/C/004094 Gilead Sciences Ireland UC 2016/04/21 Authorised
Palonosetron Hospira Human palonosetron palonosetron hydrochloride EMEA/H/C/004069 Pfizer Europe MA EEIG 2016/04/08 Withdrawn
Rasagiline Viatris (previously Rasagiline Mylan) Human rasagiline rasagiline tartrate EMEA/H/C/004064 Viatris Limited 2016/04/04 Authorised
Zonisamide Viatris (previously Zonisamide Mylan) Human zonisamide zonisamide EMEA/H/C/004127 Viatris Limited 2016/03/31 Authorised
Wakix Human pitolisant pitolisant EMEA/H/C/002616 Bioprojet Pharma 2016/03/31 Authorised
Amlodipine / Valsartan Mylan Human amlodipine;valsartan amlodipine besilate;valsartan EMEA/H/C/004037 Mylan Pharmaceuticals Limited 2016/03/22 Authorised
Coagadex Human human coagulation factor X human coagulation factor X EMEA/H/C/003855 Kedrion S.p.A. 2016/03/16 Authorised

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