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
Hemlibra Human emicizumab emicizumab EMEA/H/C/004406 Roche Registration Limited 2018/02/23 Authorised
Crysvita Human burosumab burosumab EMEA/H/C/004275 Kyowa Kirin Holdings B.V. 2018/02/19 Authorised
Anagrelide Viatris (previously Anagrelide Mylan) Human anagrelide anagrelide hydrochloride EMEA/H/C/004585 Viatris Limited 2018/02/15 Authorised
Herzuma Human trastuzumab trastuzumab EMEA/H/C/002575 Celltrion Healthcare Hungary Kft. 2018/02/09 Authorised
Alkindi Human hydrocortisone hydrocortisone EMEA/H/C/004416 Neurocrine Netherlands B.V. 2018/02/09 Authorised
Ozempic Human semaglutide semaglutide EMEA/H/C/004174 Novo Nordisk A/S 2018/02/08 Authorised
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Human efavirenz;emtricitabine;tenofovir disoproxil efavirenz;emtricitabine;tenofovir disoproxil succinate EMEA/H/C/004274 KRKA, d.d., Novo mesto 2018/02/08 Authorised
Darunavir Krka Human darunavir darunavir EMEA/H/C/004273 KRKA, d.d., Novo mesto 2018/01/26 Authorised
Darunavir Krka d.d. Human darunavir darunavir EMEA/H/C/004891 KRKA, d.d., Novo mesto 2018/01/18 Expired
Mvasi Human bevacizumab bevacizumab EMEA/H/C/004728 Amgen Technology (Ireland) UC 2018/01/15 Authorised
Ocrevus Human ocrelizumab EMEA/H/C/004043 Roche Registration GmbH 2018/01/08 Authorised
Prevymis Human letermovir Letermovir EMEA/H/C/004536 Merck Sharp & Dohme B.V. 2018/01/08 Authorised
Adynovi Human rurioctocog alfa pegol rurioctocog alfa pegol EMEA/H/C/004195 Baxalta Innovations GmbH 2018/01/08 Authorised
Fulvestrant Mylan Human fulvestrant fulvestrant EMEA/H/C/004649 Mylan Pharmaceuticals Limited 2018/01/08 Authorised
Fasenra Human benralizumab Benralizumab EMEA/H/C/004433 AstraZeneca AB 2018/01/08 Authorised
Intrarosa Human prasterone prasterone EMEA/H/C/004138 Endoceutics S.A. 2018/01/08 Authorised
Jorveza Human budesonide Budesonide EMEA/H/C/004655 Dr. Falk Pharma GmbH 2018/01/08 Authorised
Tacforius Human tacrolimus tacrolimus monohydrate EMEA/H/C/004435 Teva B.V. 2017/12/08 Authorised
Zejula Human niraparib niraparib (tosilate monohydrate) EMEA/H/C/004249 GlaxoSmithKline Trading Services Limited 2017/11/16 Authorised
Ontruzant Human trastuzumab trastuzumab EMEA/H/C/004323 Samsung Bioepis NL B.V. 2017/11/15 Authorised

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