欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Talvey
适用类别Human
治疗领域Multiple Myeloma
通用名/非专利名称talquetamab
活性成分talquetamab
产品号EMEA/H/C/005864
患者安全信息No
许可状态Authorised
ATC编码L01FX29
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Yes
上市许可日期2023/08/21
上市许可开发者/申请人/持有人Janssen-Cilag International N.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2023/07/20
欧盟委员会决定日期2024/06/24
修订号5
治疗适应症Talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti CD38 antibody and have demonstrated disease progression on the last therapy.
适用物种
兽用药物ATC编码
首次发布日期2023/07/17
最后更新日期2024/06/28
产品说明书https://www.ema.europa.eu/en/documents/product-information/talvey-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/talvey
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