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
Kirsty (previously Kixelle) Human insulin aspart insulin aspart EMEA/H/C/004965 Biosimilar Collaborations Ireland Limited 2021/02/05 Authorised
Rukobia Human fostemsavir fostemsavir trometamol EMEA/H/C/005011 ViiV Healthcare B.V. 2021/02/04 Authorised
Vaxzevria (previously COVID-19 Vaccine AstraZeneca) Human COVID-19 Vaccine (ChAdOx1-S [recombinant]) ChAdOx1-SARS-COV-2 EMEA/H/C/005675 AstraZeneca AB 2021/01/29 Withdrawn
Enhertu Human trastuzumab deruxtecan trastuzumab deruxtecan EMEA/H/C/005124 Daiichi Sankyo Europe GmbH 2021/01/18 Authorised
Onbevzi Human bevacizumab bevacizumab EMEA/H/C/005640 Samsung Bioepis NL B.V. 2021/01/11 Withdrawn
Roclanda Human latanoprost / netarsudil Latanoprost;netarsudil mesilate EMEA/H/C/005107 Santen Oy 2021/01/07 Authorised
Xofluza Human baloxavir marboxil Baloxavir marboxil EMEA/H/C/004974 Roche Registration GmbH 2021/01/07 Authorised
Elzonris Human tagraxofusp tagraxofusp EMEA/H/C/005031 Stemline Therapeutics B.V. 2021/01/07 Authorised
Spikevax (previously COVID-19 Vaccine Moderna) Human COVID-19 mRNA vaccine single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 EMEA/H/C/005791 Moderna Biotech Spain, S.L. 2021/01/06 Authorised
Comirnaty Human COVID-19 mRNA vaccine single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 EMEA/H/C/005735 BioNTech Manufacturing GmbH 2020/12/21 Authorised
Phesgo Human pertuzumab;trastuzumab pertuzumab;trastuzumab EMEA/H/C/005386 Roche Registration GmbH 2020/12/21 Authorised
Fintepla Human fenfluramine fenfluramine hydrochloride EMEA/H/C/003933 UCB Pharma S.A.   2020/12/18 Authorised
Lenalidomide Mylan Human lenalidomide lenalidomide EMEA/H/C/005306 Mylan Ireland Limited 2020/12/18 Authorised
Libmeldy Human autologous CD34+ cells encoding ARSA gene atidarsagene autotemcel EMEA/H/C/005321 Orchard Therapeutics (Netherlands) B.V. 2020/12/17 Authorised
Palforzia Human defatted powder of Arachis hypogaea L., semen (peanuts) defatted powder of Arachis hypogaea L., semen (peanuts) EMEA/H/C/004917 Stallergenes 2020/12/17 Authorised
Rekambys Human rilpivirine rilpivirine EMEA/H/C/005060 Janssen-Cilag International NV 2020/12/17 Authorised
Vocabria Human cabotegravir cabotegavir sodium;cabotegravir EMEA/H/C/004976 ViiV Healthcare B.V. 2020/12/17 Authorised
Tecartus Human brexucabtagene autoleucel autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) EMEA/H/C/005102 Kite Pharma EU B.V. 2020/12/14 Authorised
Leqvio Human inclisiran inclisiran EMEA/H/C/005333 Novartis Europharm Limited 2020/12/09 Authorised
Trixeo Aerosphere Human formoterol;glycopyrronium bromide;budesonide formoterol fumarate dihydrate;glycopyrronium bromide;Budesonide EMEA/H/C/004983 AstraZeneca AB 2020/12/09 Authorised

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