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
Dimethyl fumarate Polpharma Human dimethyl fumarate dimethyl fumarate EMEA/H/C/005955 Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. 2022/05/13 Revoked
Dimethyl fumarate Mylan Human dimethyl fumarate dimethyl fumarate EMEA/H/C/005956 Mylan Ireland Limited 2022/05/13 Revoked
Amversio Human betaine anhydrous betaine EMEA/H/C/005637 SERB SA 2022/05/05 Authorised
Orgovyx Human relugolix relugolix EMEA/H/C/005353 Accord Healthcare S.L.U. 2022/04/29 Authorised
Quviviq Human daridorexant daridorexant hydrochloride EMEA/H/C/005634 Idorsia Pharmaceuticals Deutschland GmbH 2022/04/29 Authorised
Kapruvia Human difelikefalin difelikefalin EMEA/H/C/005612 Vifor Fresenius Medical Care Renal Pharma France 2022/04/25 Authorised
Uplizna Human inebilizumab inebilizumab EMEA/H/C/005818 Amgen Europe B.V. 2022/04/25 Authorised
Vydura Human rimegepant rimegepant EMEA/H/C/005725 Pfizer Europe MA EEIG  2022/04/25 Authorised
Sitagliptin Accord Human sitagliptin sitagliptin hydrochloride EMEA/H/C/005598 Accord Healthcare S.L.U. 2022/04/25 Authorised
PreHevbri Human hepatitis B surface antigen hepatitis B surface antigen EMEA/H/C/005466 VBI Vaccines B.V. 2022/04/25 Withdrawn
Truvelog Mix 30 Human insulin aspart insulin aspart EMEA/H/C/005635 Sanofi Winthrop Industrie 2022/04/25 Authorised
Inpremzia Human insulin human (rDNA) insulin human (rDNA) EMEA/H/C/005331 Baxter Holding B.V. 2022/04/25 Withdrawn
Padcev Human enfortumab vedotin Enfortumab vedotin EMEA/H/C/005392 Astellas Pharma Europe B.V. 2022/04/13 Authorised
Breyanzi Human lisocabtagene maraleucel lisocabtagene maraleucel EMEA/H/C/004731 Bristol-Myers Squibb Pharma EEIG 2022/04/04 Authorised
Kimmtrak Human tebentafusp tebentafusp EMEA/H/C/004929 Immunocore Ireland Limited 2022/04/01 Authorised
Stimufend Human pegfilgrastim pegfilgrastim EMEA/H/C/004780 Fresenius Kabi Deutschland GmbH 2022/03/28 Authorised
Evusheld Human tixagevimab;cilgavimab tixagevimab;cilgavimab EMEA/H/C/005788 AstraZeneca AB 2022/03/25 Withdrawn
Vildagliptin / Metformin hydrochloride Accord Human vildagliptin;metformin hydrochloride metformin hydrochloride;vildagliptin EMEA/H/C/005738 Accord Healthcare S.L.U. 2022/03/24 Authorised
Sondelbay Human teriparatide teriparatide EMEA/H/C/005827 Accord Healthcare S.L.U. 2022/03/24 Authorised
Dasatinib Accord Human dasatinib (anhydrous) dasatinib EMEA/H/C/005446 Accord Healthcare S.L.U. 2022/03/24 Withdrawn

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