商品名称 | Tepmetko |
---|---|
适用类别 | Human |
治疗领域 | Carcinoma, Non-Small-Cell Lung |
通用名/非专利名称 | tepotinib |
活性成分 | Tepotinib hydrochloride monohydrate |
产品号 | EMEA/H/C/005524 |
患者安全信息 | no |
授权状态 | Authorised |
ATC编码 | L01EX21 |
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 | 2022/02/16 |
上市许可持有人/公司名称 | Merck Europe B.V. |
人用药物治疗分组 | Antineoplastic agents |
审评意见发布日期 | 2021/12/16 |
决定日期 | 2023/08/31 |
修订号 | 2 |
适应症 | Tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. |
首次发布日期 | 2022/05/05 |
修订日期 | 2023/11/20 |
产品信息 | https://www.ema.europa.eu/en/documents/product-information/tepmetko-epar-product-information_en.pdf |
公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tepmetko |