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
Akeega Human niraparib;abiraterone acetate abiraterone acetate;niraparib (tosilate monohydrate) EMEA/H/C/005932 Janssen-Cilag International N.V. 2023/04/19 Authorised
Bekemv Human eculizumab Eculizumab EMEA/H/C/005652 Amgen Technology (Ireland) UC 2023/04/19 Authorised
Sitagliptin / Metformin hydrochloride Sun Human sitagliptin;metformin hydrochloride sitagliptin fumarate;metformin hydrochloride EMEA/H/C/005778 Sun Pharmaceutical Industries Europe B.V. 2023/03/31 Authorised
Bimervax Human COVID-19 Vaccine (recombinant, adjuvanted) SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion dimer produced by recombinant DNA technology EMEA/H/C/006058 Hipra Human Health S.L. 2023/03/30 Authorised
Sotyktu Human deucravacitinib deucravacitinib EMEA/H/C/005755 Bristol-Myers Squibb Pharma EEIG 2023/03/24 Authorised
Dapagliflozin Viatris Human dapagliflozin dapagliflozin EMEA/H/C/006006 Viatris Limited 2023/03/24 Authorised
Pombiliti Human cipaglucosidase alfa Cipaglucosidase alfa EMEA/H/C/005703 Amicus Therapeutics Europe Limited 2023/03/20 Authorised
Tremelimumab AstraZeneca Human tremelimumab tremelimumab EMEA/H/C/004650 AstraZeneca AB 2023/02/20 Withdrawn
Hemgenix Human etranacogene dezaparvovec Etranacogene dezaparvovec EMEA/H/C/004827 CSL Behring GmbH 2023/02/20 Authorised
Imjudo Human tremelimumab tremelimumab EMEA/H/C/006016 AstraZeneca AB 2023/02/20 Authorised
Dimethyl fumarate Accord Human dimethyl fumarate dimethyl fumarate EMEA/H/C/005950 Accord Healthcare S.L.U. 2023/02/15 Revoked
Kauliv Human teriparatide teriparatide EMEA/H/C/004932 Strides Pharma (Cyprus) Limited 2023/01/12 Authorised
Sugammadex Amomed Human sugammadex sugammadex sodium EMEA/H/C/005935 AOP Orphan Pharmaceuticals GmbH 2023/01/10 Authorised
Pirfenidone Viatris Human pirfenidone Pirfenidone EMEA/H/C/005862 Viatris Limited 2023/01/10 Authorised
Zynlonta Human loncastuximab tesirine loncastuximab tesirine EMEA/H/C/005685 Swedish Orphan Biovitrum AB 2022/12/20 Authorised
Plerixafor Accord Human plerixafor Plerixafor EMEA/H/C/005943 Accord Healthcare S.L.U. 2022/12/16 Authorised
Ebvallo Human tabelecleucel tabelecleucel EMEA/H/C/004577 Pierre Fabre Medicament 2022/12/16 Authorised
Eladynos Human abaloparatide abaloparatide EMEA/H/C/005928 Theramex Ireland Limited 2022/12/12 Authorised
Dimethyl fumarate Teva Human dimethyl fumarate dimethyl fumarate EMEA/H/C/005963 Teva GmbH 2022/12/12 Revoked
Pemetrexed Baxter Human pemetrexed pemetrexed disodium heptahydrate EMEA/H/C/005848 Baxter Holding B.V. 2022/12/09 Authorised

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