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
Azacitidine Celgene Human azacitidine azacitidine EMEA/H/C/005300 Celgene Europe BV 2019/08/02 Withdrawn
LysaKare Human arginine;lysine L-arginine hydrochloride;L-lysine hydrochloride EMEA/H/C/004541 Advanced Accelerator Applications 2019/07/25 Authorised
Cufence Human trientine dihydrochloride trientine dihydrochloride EMEA/H/C/004111 Univar Solutions BV 2019/07/25 Authorised
Posaconazole Accord Human posaconazole posaconazole EMEA/H/C/005005 Accord Healthcare S.L.U. 2019/07/25 Authorised
Posaconazole AHCL Human posaconazole posaconazole EMEA/H/C/005028 Accord Healthcare S.L.U. 2019/07/25 Authorised
Ultomiris Human ravulizumab ravulizumab EMEA/H/C/004954 Alexion Europe SAS 2019/07/02 Authorised
Dovato Human dolutegravir;lamivudine dolutegravir sodium;lamivudine EMEA/H/C/004909 ViiV Healthcare B.V. 2019/07/01 Authorised
Xromi Human hydroxycarbamide hydroxycarbamide EMEA/H/C/004837 Lipomed GmbH 2019/07/01 Authorised
Libtayo Human cemiplimab cemiplimab EMEA/H/C/004844 Regeneron Ireland Designated Activity Company (DAC) 2019/06/28 Authorised
Striascan Human ioflupane (123l) ioflupane (123l) EMEA/H/C/004745 CIS bio international 2019/06/25 Authorised
Ambrisentan Viatris (previously Ambrisentan Mylan) Human ambrisentan ambrisentan EMEA/H/C/004985 Viatris Limited 2019/06/20 Authorised
Grasustek Human pegfilgrastim pegfilgrastim EMEA/H/C/004556 Juta Pharma GmbH 2019/06/20 Authorised
Talzenna Human talazoparib talazoparib EMEA/H/C/004674 Pfizer Europe MA EEIG 2019/06/20 Authorised
Doptelet Human avatrombopag avatrombopag maleate EMEA/H/C/004722 Swedish Orphan Biovitrum AB (publ) 2019/06/20 Authorised
Esperoct Human turoctocog alfa pegol turoctocog alfa pegol EMEA/H/C/004883 Novo Nordisk A/S 2019/06/20 Authorised
Trecondi Human treosulfan treosulfan EMEA/H/C/004751 medac Gesellschaft für klinische Spezialpräparate mbH 2019/06/20 Authorised
Sixmo Human buprenorphine buprenorphine hydrochloride EMEA/H/C/004743 L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A. 2019/06/19 Withdrawn
Temybric Ellipta Human fluticasone furoate;umeclidinium;vilanterol fluticasone furoate;umeclidinium bromide;vilanterol trifenatate EMEA/H/C/005254 GlaxoSmithKline Trading Services Limited 2019/06/12 Lapsed
Zynteglo Human betibeglogene autotemcel autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene EMEA/H/C/003691 bluebird bio (Netherlands) B.V. 2019/05/29 Withdrawn
Frontpro (previously Afoxolaner Merial) Veterinary afoxolaner afoxolaner EMEA/V/C/005126 2019/05/20 Authorised

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