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
Inpremzia Human insulin human (rDNA) insulin human (rDNA) EMEA/H/C/005331 Baxter Holding B.V. 2022/04/25 Withdrawn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Evusheld Human tixagevimab;cilgavimab tixagevimab;cilgavimab EMEA/H/C/005788 AstraZeneca AB 2022/03/25 Withdrawn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Dasatinib Accord Human dasatinib (anhydrous) dasatinib EMEA/H/C/005446 Accord Healthcare S.L.U. 2022/03/24 Withdrawn
Dasatinib Accordpharma Human dasatinib (anhydrous) dasatinib EMEA/H/C/005317 Accord Healthcare S.L.U. 2022/03/24 Withdrawn
Ontilyv Human opicapone opicapone EMEA/H/C/005782 Bial Portela & Companhia S.A. 2022/02/21 Lapsed
Sapropterin Dipharma Human sapropterin sapropterin dihydrochloride EMEA/H/C/005646 Dipharma Arzneimittel GmbH 2022/02/16 Authorised
Sitagliptin / Metformin hydrochloride Mylan Human sitagliptin hydrochloride monohydrate;metformin hydrochloride sitagliptin hydrochloride monohydrate;metformin hydrochloride EMEA/H/C/005678 Mylan Pharmaceuticals Limited 2022/02/16 Authorised
Kerendia Human finerenone Finerenone EMEA/H/C/005200 Bayer AG 2022/02/16 Authorised
Tepmetko Human tepotinib tepotinib hydrochloride monohydrate EMEA/H/C/005524 Merck Europe B.V. 2022/02/16 Authorised
Saphnelo Human anifrolumab anifrolumab EMEA/H/C/004975 AstraZeneca AB 2022/02/14 Authorised
Ngenla Human somatrogon somatrogon EMEA/H/C/005633 Pfizer Europe MA EEIG 2022/02/14 Authorised
Prevenar 20 (previously Apexxnar) Human pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) Pneumococcal polysaccharide serotype 1;Pneumococcal polysaccharide serotype 3;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 5;Pneumococcal polysaccharide serotype 6A;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 7F;Pneumococcal polysaccharide serotype 8;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 10A;Pneumococcal polysaccharide serotype 11A;pneumococcal polysaccharide serotype 12F;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 15b;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19A;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 22F;Pneumococcal polysaccharide serotype 23F;Pneumococcal polysaccharide serotype 33F EMEA/H/C/005451 Pfizer Europe MA EEIG 2022/02/14 Authorised
Okedi Human risperidone risperidone EMEA/H/C/005406 Laboratorios Farmacéuticos Rovi, S.A. 2022/02/14 Authorised
Oxbryta Human voxelotor voxelotor EMEA/H/C/004869 Pfizer Europe MA EEIG  2022/02/14 Suspended

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