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
Dasatinib Accordpharma	Human	dasatinib (anhydrous)	dasatinib	EMEA/H/C/005317	Accord Healthcare S.L.U.	2022/03/24	Withdrawn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
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
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
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

商品名称Name of medicine	*示例：Zokinvy（英文）
药品通用名或非专利名称International non-proprietary name (INN) / common name	*示例：lonafarnib（英文）
活性成分Active substance	*示例：lonafarnib（英文）
产品号EMA product number	*示例：EMEA/H/C/005271
ATC编号ATC code	*示例：L01EA06
上市许可开发者/申请人/持有人Marketing authorisation developer / applicant / holder	*示例：Janssen
药物治疗学分组Pharmacotherapeutic group	*示例：Antineoplastic
适应症Therapeutic indication	*示例：leukaemia
许可状态Medicine status
上市许可日期Marketing authorisation date	-