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
Yesafili Human aflibercept aflibercept EMEA/H/C/006022 Biosimilar Collaborations Ireland Limited 2023/09/15 Authorised
Inaqovi Human cedazuridine;decitabine cedazuridine;decitabine EMEA/H/C/005823 Otsuka Pharmaceutical Netherlands B.V. 2023/09/15 Authorised
Litfulo Human ritlecitinib ritlecitinib tosilate EMEA/H/C/006025 Pfizer Europe MA EEIG 2023/09/15 Authorised
Apretude Human cabotegravir cabotegravir EMEA/H/C/005756 ViiV Healthcare B.V. 2023/09/15 Authorised
Enrylaze Human crisantaspase crisantaspase EMEA/H/C/005917 Jazz Pharmaceuticals Ireland Limited 2023/09/15 Authorised
Abrysvo Human respiratory syncytial virus vaccine (bivalent, recombinant) respiratory Syncytial Virus, subgroup A, stabilized prefusion F protein 847A;respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B EMEA/H/C/006027 Pfizer Europe MA EEIG 2023/08/23 Authorised
Talvey Human talquetamab talquetamab EMEA/H/C/005864 Janssen-Cilag International N.V. 2023/08/21 Authorised
Aquipta Human atogepant atogepant EMEA/H/C/005871 AbbVie Deutschland GmbH & Co. KG 2023/08/11 Authorised
Ztalmy Human ganaxolone ganaxolone EMEA/H/C/005825 Marinus Pharmaceuticals Emerald Limited 2023/07/26 Authorised
Columvi Human glofitamab Glofitamab EMEA/H/C/005751 Roche Registration GmbH  2023/07/07 Authorised
Lytgobi Human futibatinib Futibatinib EMEA/H/C/005627 Taiho Pharma Netherlands B.V. 2023/07/04 Authorised
Camzyos Human mavacamten Mavacamten EMEA/H/C/005457 Bristol-Myers Squibb Pharma EEIG 2023/06/26 Authorised
Opfolda Human miglustat miglustat EMEA/H/C/005695 Amicus Therapeutics Europe Limited 2023/06/26 Authorised
Sugammadex Piramal Human sugammadex sugammadex sodium EMEA/H/C/006083 Piramal Critical Care B.V. 2023/06/23 Authorised
Arexvy Human recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E Respiratory Syncytial Virus recombinant glycoprotein F stabilised in the pre-fusion conformation (RSVPreF3) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology EMEA/H/C/006054 GlaxoSmithKline Biologicals S.A. 2023/06/06 Authorised
Briumvi Human ublituximab ublituximab EMEA/H/C/005914 Neuraxpharm Pharmaceuticals S.L. 2023/05/31 Authorised
Lacosamide Adroiq Human lacosamide lacosamide EMEA/H/C/006047 Extrovis EU Ltd 2023/05/31 Authorised
Sugammadex Adroiq Human sugammadex sugammadex sodium EMEA/H/C/006046 Extrovis EU Ltd 2023/05/26 Authorised
Epysqli Human Eculizumab EMEA/H/C/006036 Samsung Bioepis NL B.V. 2023/05/26 Authorised
Omvoh Human mirikizumab Mirikizumab EMEA/H/C/005122 Eli Lilly Nederland B.V. 2023/05/26 Authorised

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