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
Orladeyo Human berotralstat berotralstat dihydrochloride EMEA/H/C/005138 BioCryst Ireland Limited 2021/04/30 Authorised
Abiraterone Accord Human abiraterone abiraterone acetate EMEA/H/C/005408 Accord Healthcare S.L.U. 2021/04/26 Authorised
Jemperli Human dostarlimab dostarlimab EMEA/H/C/005204 GlaxoSmithKline Trading Services Limited 2021/04/21 Authorised
Abevmy Human bevacizumab bevacizumab EMEA/H/C/005327 Biosimilar Collaborations Ireland Limited 2021/04/21 Authorised
Sogroya Human somapacitan somapacitan EMEA/H/C/005030 Novo Nordisk A/S 2021/03/31 Authorised
Seffalair Spiromax Human salmeterol;fluticasone propionate fluticasone propionate;salmeterol xinafoate EMEA/H/C/004881 Teva B.V. 2021/03/26 Authorised
Kesimpta Human ofatumumab ofatumumab EMEA/H/C/005410 Novartis Europharm Limited  2021/03/26 Authorised
Ontozry Human cenobamate cenobamate EMEA/H/C/005377 Angelini Pharma S.p.A 2021/03/26 Authorised
Byfavo Human remimazolam remimazolam besilate EMEA/H/C/005246 Paion Pharma GmbH 2021/03/26 Authorised
Oyavas Human bevacizumab bevacizumab EMEA/H/C/005556 STADA Arzneimittel AG 2021/03/26 Authorised
Evrysdi Human risdiplam risdiplam EMEA/H/C/005145 Roche Registration GmbH  2021/03/26 Authorised
BroPair Spiromax Human salmeterol;fluticasone propionate salmeterol xinafoate;fluticasone propionate EMEA/H/C/005591 Teva B.V. 2021/03/26 Withdrawn
Vazkepa Human icosapent ethyl Icosapent ethyl EMEA/H/C/005398 Amarin Pharmaceuticals Ireland Limited 2021/03/26 Authorised
Alymsys Human bevacizumab bevacizumab EMEA/H/C/005286 Mabxience Research SL 2021/03/26 Authorised
Thiotepa Riemser Human thiotepa thiotepa EMEA/H/C/005434 Esteve Pharmaceuticals GmbH 2021/03/26 Authorised
Pemazyre Human pemigatinib pemigatinib EMEA/H/C/005266 Incyte Biosciences Distribution B.V. 2021/03/26 Authorised
Nexpovio Human selinexor selinexor EMEA/H/C/005127 Stemline Therapeutics B.V. 2021/03/26 Authorised
Jcovden (previously COVID-19 Vaccine Janssen) Human COVID-19 vaccine (Ad26.COV2-S [recombinant]) adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S) EMEA/H/C/005737 Janssen-Cilag International NV 2021/03/11 Withdrawn
Heplisav B Human hepatitis B surface antigen hepatitis B surface antigen EMEA/H/C/005063 Dynavax GmbH 2021/02/18 Authorised
Retsevmo Human selpercatinib selpercatinib EMEA/H/C/005375 Eli Lilly Nederland B.V. 2021/02/11 Authorised

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