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	上市许可持有人/公司名称	上市批准日期	授权状态
Bekemv	Human	eculizumab	Eculizumab	EMEA/H/C/005652	Amgen Technology (Ireland) UC	2023/04/19	Authorised
Opzelura	Human	ruxolitinib	ruxolitinib phosphate	EMEA/H/C/005843	Incyte Biosciences Distribution B.V.	2023/04/19	Authorised
Akeega	Human	niraparib, abiraterone acetate	abiraterone acetate, Niraparib tosilate monohydrate	EMEA/H/C/005932	Janssen-Cilag International N.V.	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 heterodimer – B.1.351-B.1.1.7 strains	EMEA/H/C/006058	Hipra Human Health S.L.	2023/03/30	Authorised
Dapagliflozin Viatris	Human	dapagliflozin	dapagliflozin	EMEA/H/C/006006	Viatris Limited	2023/03/24	Authorised
Sotyktu	Human	deucravacitinib	Deucravacitinib	EMEA/H/C/005755	Bristol-Myers Squibb Pharma EEIG	2023/03/24	Authorised
Pombiliti	Human	cipaglucosidase alfa	Cipaglucosidase alfa	EMEA/H/C/005703	Amicus Therapeutics Europe Limited	2023/03/20	Authorised
Imjudo	Human	tremelimumab	Tremelimumab	EMEA/H/C/006016	AstraZeneca AB	2023/02/20	Authorised
Tremelimumab AstraZeneca	Human	tremelimumab	Tremelimumab	EMEA/H/C/004650	AstraZeneca AB	2023/02/20	Authorised
Hemgenix	Human	etranacogene dezaparvovec	Etranacogene dezaparvovec	EMEA/H/C/004827	CSL Behring GmbH	2023/02/20	Authorised
Dimethyl fumarate Accord	Human	dimethyl fumarate	dimethyl fumarate	EMEA/H/C/005950	Accord Healthcare S.L.U.	2023/02/15	Authorised
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
Ebvallo	Human	tabelecleucel	Tabelecleucel	EMEA/H/C/004577	Pierre Fabre Medicament	2022/12/16	Authorised
Plerixafor Accord	Human	plerixafor	Plerixafor	EMEA/H/C/005943	Accord Healthcare S.L.U.	2022/12/16	Authorised
Dimethyl fumarate Teva	Human	dimethyl fumarate	dimethyl fumarate	EMEA/H/C/005963	Teva GmbH	2022/12/12	Authorised
Eladynos	Human	abaloparatide	abaloparatide	EMEA/H/C/005928	Theramex Ireland Limited	2022/12/12	Authorised

药品名称Medicine name	*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Product number	*示例：EMEA/H/C/005271
ATC编号ATC code	*示例：L01EA06
上市许可持有人/公司名称Marketing authorisation holder/company name	*示例：Janssen
人用药物治疗分组Human pharmacotherapeutic group	*示例：Antineoplastic
适应症Condition / indication	*示例：leukaemia
授权状态Authorisation status
上市批准日期Marketing authorisation date	-