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
Reblozyl Human luspatercept Luspatercept EMEA/H/C/004444 Bristol Myers Squibb Pharma EEIG 2020/06/25 Authorised
Fingolimod Accord Human fingolimod fingolimod hydrochloride  EMEA/H/C/005191 Accord Healthcare S.L.U. 2020/06/25 Authorised
Byannli (previously Paliperidone Janssen-Cilag International) Human paliperidone paliperidone palmitate EMEA/H/C/005486 Janssen-Cilag International N.V.   2020/06/18 Authorised
Atectura Breezhaler Human indacaterol;mometasone indacaterol acetate;mometasone furoate EMEA/H/C/005067 Novartis Europharm Limited  2020/05/30 Authorised
Bemrist Breezhaler Human indacaterol;mometasone indacaterol;mometasone furoate EMEA/H/C/005516 Novartis Europharm Limited  2020/05/30 Authorised
Sarclisa Human isatuximab Isatuximab EMEA/H/C/004977 Sanofi Winthrop Industrie 2020/05/30 Authorised
Zeposia Human ozanimod ozanimod hydrochloride EMEA/H/C/004835 Bristol-Myers Squibb Pharma EEIG 2020/05/20 Authorised
Nepexto Human etanercept etanercept EMEA/H/C/004711 Biosimilar Collaborations Ireland Limited 2020/05/20 Authorised
Fluad Tetra Human influenza vaccine (surface antigen, inactivated, adjuvanted) A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) / A/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022 IVR-237) / B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) influenza virus EMEA/H/C/004993 Seqirus Netherlands B.V. 2020/05/20 Authorised
Zolgensma Human onasemnogene abeparvovec onasemnogene abeparvovec EMEA/H/C/004750 Novartis Europharm Limited  2020/05/18 Authorised
Fetcroja Human cefiderocol cefiderocol sulfate tosilate EMEA/H/C/004829 Shionogi B.V. 2020/04/23 Authorised
Tigecycline Accord Human tigecycline tigecycline EMEA/H/C/005114 Accord Healthcare S.L.U. 2020/04/17 Authorised
Rybelsus Human semaglutide semaglutide EMEA/H/C/004953 Novo Nordisk A/S 2020/04/03 Authorised
Trepulmix Human treprostinil treprostinil sodium EMEA/H/C/005207 SciPharm Sàrl 2020/04/03 Authorised
GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) Human budesonide;formoterol fumarate dihydrate Budesonide;formoterol fumarate dihydrate EMEA/H/C/004882 Teva Pharma B.V.  2020/04/03 Authorised
Cinacalcet Accordpharma Human cinacalcet cinacalcet hydrochloride EMEA/H/C/005236 Accord Healthcare S.L.U. 2020/04/03 Authorised
Vaxchora Human cholera vaccine, oral, live vibrio cholerae, strain cvd 103-hgr, live EMEA/H/C/003876 Bavarian Nordic A/S 2020/04/01 Authorised
Ruxience Human rituximab rituximab EMEA/H/C/004696 Pfizer Europe MA EEIG  2020/04/01 Authorised
Nilemdo Human bempedoic acid bempedoic acid EMEA/H/C/004958 Daiichi Sankyo Europe GmbH 2020/04/01 Authorised
Arsenic trioxide Mylan Human arsenic trioxide arsenic trioxide EMEA/H/C/005235 Mylan Ireland Limited 2020/04/01 Withdrawn

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