| 商品名称 | Tibsovo |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Leukemia, Myeloid, Acute;Cholangiocarcinoma |
| 通用名/非专利名称 | ivosidenib |
| 活性成分 | Ivosidenib |
| 产品号 | EMEA/H/C/005936 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L01XX62 |
| 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 | 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 | 2023/05/04 |
| 上市许可开发者/申请人/持有人 | Les Laboratoires Servier |
| 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 | 2023/02/23 |
| 欧盟委员会决定日期 | 2024/08/02 |
| 修订号 | 4 |
| 治疗适应症 | Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1). Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2023/04/12 |
| 最后更新日期 | 2025/09/03 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tibsovo-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tibsovo |