| 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 |
| 授权状态 | Authorised |
| ATC编码 | L01XX62 |
| 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 | yes |
| 批准上市日期 | 2023/05/04 |
| 上市许可持有人/公司名称 | Les Laboratoires Servier |
| 人用药物治疗分组 | Antineoplastic agents |
| 审评意见发布日期 | 2023/02/23 |
| 修订号 | |
| 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. |
| 首次发布日期 | 2023/04/12 |
| 修订日期 | 2023/05/12 |
| 产品信息 | 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-0 |