欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Tukysa
适用类别Human
治疗领域Breast Neoplasms; Neoplasm Metastasis
通用名/非专利名称tucatinib
活性成分Tucatinib
产品号EMEA/H/C/005263
患者安全信息no
授权状态Authorised
ATC编码L01EH03
是否额外监管yes
是否仿制药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
批准上市日期2021/02/11
上市许可持有人/公司名称Seagen B.V.
人用药物治疗分组Antineoplastic agents
审评意见发布日期2020/12/10
决定日期2023/07/20
修订号5
适应症Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑HER2 treatment regimens.
首次发布日期2021/02/18
修订日期2023/08/21
产品信息https://www.ema.europa.eu/en/documents/product-information/tukysa-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/tukysa
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