欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Jyseleca
适用类别Human
治疗领域Arthritis, Rheumatoid
通用名/非专利名称filgotinib
活性成分filgotinib maleate
产品号EMEA/H/C/005113
患者安全信息No
许可状态Authorised
ATC编码L04AF04
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2020/09/24
上市许可开发者/申请人/持有人Alfasigma S.p.A.
人用药物治疗学分组Immunosuppressants
兽用药物治疗学分组
审评意见日期2020/07/23
欧盟委员会决定日期2025/06/02
修订号14
治疗适应症Rheumatoid arthritis Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). Ulcerative colitis Jyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.
适用物种
兽用药物ATC编码
首次发布日期2020/05/26
最后更新日期2025/06/10
产品说明书https://www.ema.europa.eu/en/documents/product-information/jyseleca-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/jyseleca
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