欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Augtyro
适用类别Human
治疗领域Carcinoma, Non-Small-Cell Lung;Cancer
通用名/非专利名称repotrectinib
活性成分repotrectinib
产品号EMEA/H/C/006005
患者安全信息No
许可状态Authorised
ATC编码L01EX28
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2025/01/13
上市许可开发者/申请人/持有人Bristol-Myers Squibb Pharma EEIG
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2024/11/14
修订号
治疗适应症Augtyro as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). Augtyro as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and - who have received a prior NTRK inhibitor, or - have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)
适用物种
兽用药物ATC编码
首次发布日期2024/11/15
最后更新日期2025/01/28
产品说明书https://www.ema.europa.eu/en/documents/product-information/augtyro-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/augtyro
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