| 商品名称 | Temodal |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Glioma |
| 通用名/非专利名称 | temozolomide |
| 活性成分 | temozolomide |
| 产品号 | EMEA/H/C/000229 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01AX03 |
| 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 | No |
| 上市许可日期 | 1999/01/26 |
| 上市许可开发者/申请人/持有人 | Merck Sharp & Dohme B.V. |
| 人用药物治疗学分组 | Antineoplastic agents |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/11/06 |
| 修订号 | 40 |
| 治疗适应症 | Temodal hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/08/23 |
| 最后更新日期 | 2025/11/06 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/temodal-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/temodal |