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
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
Zynyz Human retifanlimab retifanlimab EMEA/H/C/006194 Incyte Biosciences Distribution B.V. 2024/04/19 Authorised
Voydeya Human danicopan Danicopan EMEA/H/C/005517 Alexion Europe SAS 2024/04/19 Authorised
Apremilast Accord Human apremilast apremilast EMEA/H/C/006208 Accord Healthcare S.L.U. 2024/04/19 Authorised
Filspari Human sparsentan sparsentan EMEA/H/C/005783 Vifor France 2024/04/19 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
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Tizveni Human tislelizumab tislelizumab EMEA/H/C/005542 BeiGene Ireland Ltd 2024/04/19 Withdrawn
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
Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma) Human dabigatran etexilate dabigatran etexilate mesilate EMEA/H/C/005922 Teva GmbH 2024/02/19 Authorised
Velsipity Human etrasimod Etrasimod arginine EMEA/H/C/006007 Pfizer Europe MA EEIG  2024/02/16 Authorised
Ibuprofen Gen.Orph Human ibuprofen Ibuprofen EMEA/H/C/006129 Gen.Orph 2024/02/16 Authorised
Pomalidomide Viatris Human pomalidomide Pomalidomide EMEA/H/C/006195 Viatris Limited 2024/02/16 Authorised
Skyclarys Human omaveloxolone omaveloxolone EMEA/H/C/006084 Biogen Netherlands B.V. 2024/02/09 Authorised

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