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
Sapropterin Dipharma Human sapropterin sapropterin dihydrochloride EMEA/H/C/005646 Dipharma Arzneimittel GmbH 2022/02/16 Authorised
Kerendia Human finerenone Finerenone EMEA/H/C/005200 Bayer AG 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
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
Paxlovid Human nirmatrelvir;ritonavir nirmatrelvir;ritonavir EMEA/H/C/005973 Pfizer Europe MA EEIG 2022/01/28 Authorised
Vyepti Human eptinezumab Eptinezumab EMEA/H/C/005287 H. Lundbeck A/S 2022/01/24 Authorised
Voraxaze Human glucarpidase glucarpidase EMEA/H/C/005467 SERB SAS 2022/01/11 Authorised
Skytrofa (previously Lonapegsomatropin Ascendis Pharma) Human lonapegsomatropin Lonapegsomatropin EMEA/H/C/005367 Ascendis Pharma Endocrinology Division A/S 2022/01/11 Authorised
Tavneos Human avacopan avacopan EMEA/H/C/005523 Vifor Fresenius Medical Care Renal Pharma France 2022/01/11 Authorised
Wegovy Human semaglutide semaglutide EMEA/H/C/005422 Novo Nordisk A/S 2022/01/06 Authorised
Tecovirimat SIGA Human tecovirimat monohydrate tecovirimat EMEA/H/C/005248 SIGA Technologies Netherlands B.V. 2022/01/06 Authorised
Riltrava Aerosphere Human formoterol fumarate dihydrate;glycopyrronium;budesonide Budesonide;formoterol fumarate dihydrate;glycopyrronium bromide EMEA/H/C/005311 AstraZeneca AB 2022/01/06 Authorised
Lumykras Human sotorasib sotorasib EMEA/H/C/005522 Amgen Europe B.V. 2022/01/06 Authorised
Nuvaxovid Human COVID-19 Vaccine (recombinant, adjuvanted) SARS CoV-2 (Original) recombinant spike protein;SARS-CoV-2 (Omicron XBB.1.5) recombinant spike protein EMEA/H/C/005808 Sanofi Winthrop Industrie 2021/12/20 Authorised
Aspaveli Human pegcetacoplan pegcetacoplan EMEA/H/C/005553 Swedish Orphan Biovitrum AB (publ) 2021/12/13 Authorised
Vaxneuvance Human pneumococcal polysaccharide conjugate vaccine (adsorbed) pneumococcal polysaccharide conjugate vaccine (adsorbed) EMEA/H/C/005477 Merck Sharp & Dohme B.V.  2021/12/13 Authorised

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