商品名称 | Augtyro |
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适用类别 | Human |
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治疗领域 | Carcinoma, Non-Small-Cell Lung;Cancer |
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通用名/非专利名称 | repotrectinib |
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活性成分 | repotrectinib |
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产品号 | EMEA/H/C/006005 |
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患者安全信息 | No |
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许可状态 | Authorised |
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ATC编码 | L01EX28 |
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是否额外监管 | Yes |
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是否仿制药或hybrid药物 | No |
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是否生物类似药 | No |
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是否附条件批准 | Yes |
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是否特殊情形 | No |
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是否加速审评 | No |
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是否罕用药 | No |
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上市许可日期 | 2025/01/13 |
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上市许可开发者/申请人/持有人 | Bristol-Myers Squibb Pharma EEIG |
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人用药物治疗学分组 | Antineoplastic agents |
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兽用药物治疗学分组 | |
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审评意见日期 | 2024/11/14 |
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修订号 | |
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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) |
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适用物种 | |
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兽用药物ATC编码 | |
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首次发布日期 | 2024/11/15 |
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最后更新日期 | 2025/01/28 |
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产品说明书 | https://www.ema.europa.eu/en/documents/product-information/augtyro-epar-product-information_en.pdf |
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公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/augtyro |
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