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
Supemtek	Human	trivalent influenza vaccine (recombinant, prepared in cell culture)	A/California/07/2009 (H1N1)pdm09-like strain (A/California/07/2009);A/Texas/50/2012 (H3N2)-like strain (A/Texas/50/2012);B/Brisbane/60/2008-like strain (B/Brisbane/60/2008)	EMEA/H/C/006674	Sanofi Winthrop Industrie	2026/03/30	Authorised
Kayshild	Human	semaglutide	semaglutide	EMEA/H/C/006426	Novo Nordisk A/S	2026/03/26	Authorised
Fylrevy	Human	estetrol	estetrol monohydrate	EMEA/H/C/006213	Gedeon Richter Plc.	2026/03/26	Authorised
Ilumira	Human	lutetium (177Lu) chloride	lutetium (177Lu) chloride	EMEA/H/C/006596	Shine Europe B.V.	2026/03/26	Authorised
Rezurock	Human	belumosudil	belumosudil mesilate	EMEA/H/C/006421	Sanofi Winthrop Industrie	2026/03/24	Authorised
Xevudy	Human	sotrovimab	sotrovimab	EMEA/H/C/005676	GlaxoSmithKline Trading Services Limited	2026/02/18	Withdrawn
Anktiva	Human	nogapendekin alfa inbakicept	nogapendekin alfa inbakicept	EMEA/H/C/006622	Immunitybio Ireland Limited	2026/02/16	Authorised
Exdensur	Human	depemokimab	depemokimab	EMEA/H/C/006446	GlaxoSmithKline Trading Services Limited	2026/02/12	Authorised
mNexspike	Human	COVID-19 mRNA vaccine	single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA template, encoding the N-terminal domain and receptor-binding domain of the viral spike (S) protein of SARS-CoV-2	EMEA/H/C/006428	Moderna Biotech Spain, S.L.	2026/02/12	Authorised
Myqorzo	Human	aficamten	aficamten	EMEA/H/C/006228	Cytokinetics (Ireland) Limited	2026/02/12	Authorised
Aumseqa	Human	Aumolertinib	Aumolertinib mesilate	EMEA/H/C/006069	SFL Pharmaceuticals Deutschland GmbH	2026/02/12	Authorised
Gotenfia	Human	golimumab	golimumab	EMEA/H/C/006621	Stada Arzneimittel AG	2026/02/10	Authorised
Ranluspec	Human	ranibizumab	ranibizumab	EMEA/H/C/006502	Lupin Europe GmbH	2026/02/10	Authorised
Aqneursa	Human	L-acetylleucine	L-acetylleucine	EMEA/H/C/006327	Intrabio Ireland Limited	2026/01/19	Authorised
Dawnzera	Human	donidalorsen	donidalorsen	EMEA/H/C/006554	Otsuka Pharmaceutical Netherlands B.V.	2026/01/19	Authorised
Ondibta	Human	insulin glargine	insulin glargine	EMEA/H/C/006136	Gan & Lee Pharmaceuticals Europe GmbH	2026/01/09	Authorised
Waskyra	Human	etuvetidigene autotemcel	genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human Wiskott-Aldrich Syndrome (WAS) gene	EMEA/H/C/006525	Fondazione Telethon ETS	2026/01/09	Authorised
VacPertagen	Human	pertussis vaccine (recombinant, acellular, component, adsorbed)	recombinant pertussis toxin;filamentous haemagglutinin	EMEA/H/C/006304	BioNet Europe	2026/01/09	Authorised
Inluriyo	Human	imlunestrant	imlunestrant tosilate	EMEA/H/C/006184	Eli Lilly Nederland B.V.	2026/01/09	Authorised
Teduglutide Viatris	Human	teduglutide	teduglutide	EMEA/H/C/006564	Viatris Limited	2026/01/08	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	-