| 商品名称 | Spexotras |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Glioma |
| 通用名/非专利名称 | trametinib |
| 活性成分 | trametinib dimethyl sulfoxide |
| 产品号 | EMEA/H/C/005886 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01EE01 |
| 是否额外监管 | No |
| 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 | No |
| 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 | 2024/01/05 |
| 上市许可开发者/申请人/持有人 | Novartis Europharm Limited |
| 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 | 2023/11/09 |
| 欧盟委员会决定日期 | 2025/11/03 |
| 修订号 | 9 |
| 治疗适应症 | Low-grade glioma Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. High-grade glioma Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2023/11/10 |
| 最后更新日期 | 2025/11/03 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/spexotras-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/spexotras |