欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Welireg
适用类别Human
治疗领域Carcinoma, Renal Cell;von Hippel-Lindau Disease
通用名/非专利名称belzutifan
活性成分belzutifan
产品号EMEA/H/C/005636
患者安全信息No
许可状态Authorised
ATC编码L01XX74
是否额外监管Yes
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Yes
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2025/02/12
上市许可开发者/申请人/持有人Merck Sharp & Dohme B.V.
人用药物治疗学分组Antineoplastic agents
兽用药物治疗学分组
审评意见日期2024/12/12
欧盟委员会决定日期2025/02/12
修订号
治疗适应症Renal cell carcinoma (RCC) Welireg is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies. von Hippel-Lindau (VHL) disease-associated tumours Welireg is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.
适用物种
兽用药物ATC编码
首次发布日期2024/12/13
最后更新日期2025/02/27
产品说明书https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/welireg
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