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
Atazanavir Krka	Human	atazanavir	atazanavir (as sulfate)	EMEA/H/C/004859	Krka, d.d., Novo mesto	2019/03/25	Authorised
Rizmoic	Human	naldemedine	naldemedine tosilate	EMEA/H/C/004256	Shionogi B.V.	2019/02/18	Authorised
Miglustat Dipharma	Human	miglustat	miglustat	EMEA/H/C/004904	Dipharma Arzneimittel GmbH	2019/02/18	Authorised
Mulpleo (previously Lusutrombopag Shionogi)	Human	lusutrombopag	Lusutrombopag	EMEA/H/C/004720	Shionogi B.V.	2019/02/18	Authorised
Vantobra (previously Tobramycin PARI)	Human	tobramycin	tobramycin	EMEA/H/C/005086	Pari Pharma GmbH	2019/02/18	Authorised
Besremi	Human	ropeginterferon alfa-2b	ropeginterferon alfa-2b	EMEA/H/C/004128	AOP Orphan Pharmaceuticals GmbH	2019/02/15	Authorised
Zirabev	Human	bevacizumab	bevacizumab	EMEA/H/C/004697	Pfizer Europe MA EEIG	2019/02/14	Authorised
Erleada	Human	apalutamide	apalutamide	EMEA/H/C/004452	Janssen-Cilag International NV	2019/01/14	Authorised
Ghryvelin (previously Macimorelin Aeterna Zentaris)	Human	macimorelin	macimorelin acetate	EMEA/H/C/004660	Atnahs Pharma Netherlands B.V.	2019/01/11	Authorised
Silodosin Recordati	Human	silodosin	silodosin	EMEA/H/C/004964	Recordati Ireland Ltd	2019/01/07	Authorised
Namuscla	Human	mexiletine hcl	Mexiletine hydrochloride	EMEA/H/C/004584	Lupin Europe GmbH	2018/12/18	Authorised
Bevespi Aerosphere	Human	glycopyrronium;formoterol fumarate dihydrate	glycopyrronium;formoterol fumarate dihydrate	EMEA/H/C/004245	AstraZeneca AB	2018/12/18	Authorised
Dengvaxia	Human	dengue tetravalent vaccine (live, attenuated)	chimeric yellow fever dengue virus serotype 1 (live, attenuated);chimeric yellow fever dengue virus serotype 2 (live, attenuated);chimeric yellow fever dengue virus serotype 3 (live, attenuated);chimeric yellow fever dengue virus serotype 4 (live, attenuated)	EMEA/H/C/004171	Sanofi Winthrop Industrie	2018/12/12	Withdrawn
Flucelvax Tetra	Human	influenza vaccine (surface antigen, inactivated, prepared in cell cultures)	A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022, CVR-167) A/Massachusetts/18/2022 (H3N2)-like strain (A/Sydney/1304/2022, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type)	EMEA/H/C/004814	Seqirus Netherlands B.V.	2018/12/12	Authorised
Ogivri	Human	trastuzumab	trastuzumab	EMEA/H/C/004916	Biosimilar Collaborations Ireland Limited	2018/12/12	Authorised
Pifeltro	Human	doravirine	doravirine	EMEA/H/C/004747	Merck Sharp & Dohme B.V.	2018/11/22	Authorised
Jivi	Human	damoctocog alfa pegol	Damoctocog alfa pegol	EMEA/H/C/004054	Bayer AG	2018/11/22	Authorised
Delstrigo	Human	doravirine;lamivudine;tenofovir disoproxil	doravirine;lamivudine;tenofovir disoproxil fumarate	EMEA/H/C/004746	Merck Sharp & Dohme B.V.	2018/11/22	Authorised
Luxturna	Human	voretigene neparvovec	voretigene neparvovec	EMEA/H/C/004451	Novartis Europharm Limited	2018/11/22	Authorised
Takhzyro	Human	lanadelumab	lanadelumab	EMEA/H/C/004806	Takeda Pharmaceuticals International AG Ireland Branch	2018/11/22	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	-