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
Fabhalta	Human	iptacopan	iptacopan hydrochloride monohydrate	EMEA/H/C/005764	Novartis Europharm Limited	2024/05/17	Authorised
Wyost	Human	denosumab	denosumab	EMEA/H/C/006378	Sandoz GmbH	2024/05/17	Authorised
Jubbonti	Human	denosumab	denosumab	EMEA/H/C/005964	Sandoz GmbH	2024/05/16	Authorised
Omlyclo	Human	omalizumab	omalizumab	EMEA/H/C/005958	Celltrion Healthcare Hungary Kft.	2024/05/16	Authorised
Emblaveo	Human	aztreonam;avibactam	avibactam;aztreonam	EMEA/H/C/006113	Pfizer Europe MA EEIG	2024/04/22	Authorised
Dimethyl fumarate Accord	Human	dimethyl fumarate	dimethyl fumarate	EMEA/H/C/006471	Accord Healthcare Ltd	2024/04/22	Authorised
Dimethyl fumarate Mylan	Human	dimethyl fumarate	dimethyl fumarate	EMEA/H/C/006397	Mylan Ireland Limited	2024/04/22	Authorised
Dimethyl fumarate Neuraxpharm	Human	dimethyl fumarate	dimethyl fumarate	EMEA/H/C/006500	Neuraxpharm Pharmaceuticals S.L.	2024/04/22	Authorised
Incellipan	Human	pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)	Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen	EMEA/H/C/006051	Seqirus Netherlands B.V.	2024/04/19	Authorised
Pyzchiva	Human	ustekinumab	ustekinumab	EMEA/H/C/006183	Samsung Bioepis NL B.V.	2024/04/19	Authorised
Nintedanib Accord	Human	nintedanib	nintedanib	EMEA/H/C/006179	Accord Healthcare S.L.U.	2024/04/19	Authorised
Apremilast Accord	Human	apremilast	apremilast	EMEA/H/C/006208	Accord Healthcare S.L.U.	2024/04/19	Authorised
Voydeya	Human	danicopan	Danicopan	EMEA/H/C/005517	Alexion Europe SAS	2024/04/19	Authorised
Filspari	Human	sparsentan	sparsentan	EMEA/H/C/005783	Vifor France	2024/04/19	Authorised
Celldemic	Human	zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)	Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen	EMEA/H/C/006052	Seqirus Netherlands B.V.	2024/04/19	Authorised
Tizveni	Human	tislelizumab	tislelizumab	EMEA/H/C/005542	BeiGene Ireland Ltd	2024/04/19	Withdrawn
Zynyz	Human	retifanlimab	retifanlimab	EMEA/H/C/006194	Incyte Biosciences Distribution B.V.	2024/04/19	Authorised
Niapelf	Human	paliperidone	paliperidone palmitate	EMEA/H/C/006185	Neuraxpharm Pharmaceuticals S.L.	2024/03/31	Authorised
Ryzneuta	Human	efbemalenograstim alfa	efbemalenograstim alfa	EMEA/H/C/005828	Evive Biotechnology Ireland Limited	2024/03/21	Authorised
Exblifep	Human	cefepime;enmetazobactam	cefepime dihydrochloride monohydrate;Enmetazobactam	EMEA/H/C/005431	Advanz Pharma Limited	2024/03/21	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	-