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	许可状态
Tuzodi	Human	midazolam	Midazolam Hydrochloride	EMEA/H/C/005658	Regulatory Pharma Net S.r.l.	Application withdrawn
Hemosyvet	Veterinary	etamsylate	Etamsylate	EMEA/V/C/006461		Authorised
Atropine sulfate FGK	Human	atropine	atropine sulfate	EMEA/H/C/006385	FGK Representative Service GmbH	Refused
Librela	Veterinary	bedinvetmab	bedinvetmab	EMEA/V/C/005180		Authorised
Lenivia	Veterinary	izenivetmab	izenivetmab	EMEA/V/C/006455		Authorised
Hydrocortisone Aguettant	Human		hydrocortisone	EMEA/H/C005201	Laboratoire Aguettant	Application withdrawn
Vaxxitek HVT+IBD+H5	Veterinary	avian influenza vaccine (live recombinant)	Turkey herpesvirus, strain rHVT-IBD-H5 (cell-associated), expressing the VP2 protein gene of Infectious bursal disease virus and haemagglutinin gene of Avian influenza virus subtype H5, live	EMEA/V/C/006751		Authorised
Teizeild	Human	teplizumab	teplizumab	EMEA/H/C/005496	Sanofi Winthrop Industrie	Opinion
Kizfizo	Human	temozolomide	temozolomide	EMEA/H/C/006169	ORPHELIA Pharma	Refused
Enflonsia	Human	clesrovimab	clesrovimab	EMEA/H/C/006497	Merck Sharp Dohme Limited	Opinion
Ohtuvayre	Human	ensifentrine	ensifentrine	EMEA/H/C/006742	Verona Pharma Ireland Limited	Application withdrawn
Insulin Aspart Injection	Human	insulin aspart	insulin aspart	EMEA/H/C/006720	Masuu Pharma Europe Limited	Application withdrawn
Nurzigma	Human	pridopidine	pridopidine hydrochloride	EMEA/H/C/006261	Prilenia Therapeutics B.V.	Application withdrawn
Aqneursa	Human	L-acetylleucine	L-acetylleucine	EMEA/H/C/006327	Intrabio Ireland Limited	Opinion
Enzalutamide Accordpharma	Human	enzalutamide	enzalutamide	EMEA/H/C/006612	Accord Healthcare	Opinion
Rezurock	Human	Belumosudil	Belumosudil mesilate	EMEA/H/C/006421	Sanofi Winthrop Industrie	Opinion
Dawnzera	Human	donidalorsen	donidalorsen sodium	EMEA/H/C/006554	Otsuka Pharmaceutical Netherlands B.V.	Opinion
GalenVita	Human	germanium (68Ge) chloride;gallium (68Ga) chloride	germanium (68Ge) chloride;gallium (68Ga) chloride	EMEA/H/C/006639	Curium Romania S.R.L.	Opinion
Ondibta	Human	insulin glargine	insulin glargine	EMEA/H/C/006136	Gan & Lee Pharmaceuticals Europe GmbH	Opinion
Osqay	Human	denosumab	denosumab	EMEA/H/C/006492	Theramex Ireland Limited	Opinion

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	-