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
Erleada Human apalutamide apalutamide EMEA/H/C/004452 Janssen-Cilag International NV 2019/01/14 Authorised
Ghryvelin (previously Macimorelin Aeterna Zentaris) Human macimorelin macimorelin acetate EMEA/H/C/004660 Atnahs Pharma Netherlands B.V. 2019/01/11 Authorised
Silodosin Recordati Human silodosin silodosin EMEA/H/C/004964 Recordati Ireland Ltd 2019/01/07 Authorised
Namuscla Human mexiletine hcl Mexiletine hydrochloride EMEA/H/C/004584 Lupin Europe GmbH 2018/12/18 Authorised
Bevespi Aerosphere Human glycopyrronium;formoterol fumarate dihydrate glycopyrronium;formoterol fumarate dihydrate EMEA/H/C/004245 AstraZeneca AB 2018/12/18 Authorised
Dengvaxia Human dengue tetravalent vaccine (live, attenuated) chimeric yellow fever dengue virus serotype 1 (live, attenuated);chimeric yellow fever dengue virus serotype 2 (live, attenuated);chimeric yellow fever dengue virus serotype 3 (live, attenuated);chimeric yellow fever dengue virus serotype 4 (live, attenuated) EMEA/H/C/004171 Sanofi Winthrop Industrie 2018/12/12 Withdrawn
Flucelvax Tetra Human influenza vaccine (surface antigen, inactivated, prepared in cell cultures) A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022, CVR-167) A/Massachusetts/18/2022 (H3N2)-like strain (A/Sydney/1304/2022, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type) EMEA/H/C/004814 Seqirus Netherlands B.V. 2018/12/12 Authorised
Ogivri Human trastuzumab trastuzumab EMEA/H/C/004916 Biosimilar Collaborations Ireland Limited 2018/12/12 Authorised
Poteligeo Human mogamulizumab mogamulizumab EMEA/H/C/004232 Kyowa Kirin Holdings B.V. 2018/11/22 Authorised
Pifeltro Human doravirine doravirine EMEA/H/C/004747 Merck Sharp & Dohme B.V. 2018/11/22 Authorised
Jivi Human damoctocog alfa pegol Damoctocog alfa pegol EMEA/H/C/004054 Bayer AG 2018/11/22 Authorised
Delstrigo Human doravirine;lamivudine;tenofovir disoproxil doravirine;lamivudine;tenofovir disoproxil fumarate EMEA/H/C/004746 Merck Sharp & Dohme B.V. 2018/11/22 Authorised
Luxturna Human voretigene neparvovec voretigene neparvovec EMEA/H/C/004451 Novartis Europharm Limited  2018/11/22 Authorised
Takhzyro Human lanadelumab lanadelumab EMEA/H/C/004806 Takeda Pharmaceuticals International AG Ireland Branch 2018/11/22 Authorised
Alunbrig Human brigatinib brigatinib EMEA/H/C/004248 Takeda Pharma A/S 2018/11/22 Authorised
Ziextenzo Human pegfilgrastim pegfilgrastim EMEA/H/C/004802 Sandoz GmbH 2018/11/22 Authorised
Vaborem Human meropenem;vaborbactam meropenem trihydrate;vaborbactam EMEA/H/C/004669 Menarini International Operations Luxembourg S.A. 2018/11/20 Authorised
Pelmeg Human pegfilgrastim pegfilgrastim EMEA/H/C/004700 Mundipharma Corporation (Ireland) Limited 2018/11/20 Authorised
Buvidal Human buprenorphine buprenorphine EMEA/H/C/004651 Camurus AB 2018/11/20 Authorised
Apealea Human paclitaxel paclitaxel EMEA/H/C/004154 Inceptua AB 2018/11/20 Withdrawn

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