| 商品名称 | Dasatinib Accord |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| 通用名/非专利名称 | dasatinib (anhydrous) |
| 活性成分 | dasatinib |
| 产品号 | EMEA/H/C/005446 |
| 患者安全信息 | no |
| 授权状态 | Withdrawn |
| ATC编码 | L01EA02 |
| 是否额外监管 | no |
| 是否仿制药 | yes |
| 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 | 2022/03/24 |
| 上市许可持有人/公司名称 | Accord Healthcare S.L.U. |
| 人用药物治疗分组 | Antineoplastic agents |
| 审评意见发布日期 | 2022/01/27 |
| 决定日期 | 2022/06/08 |
| 修订号 | 1 |
| 适应症 | Dasatinib Accord is indicated for the treatment of adult patients with:• Ph+ acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy.Dasatinib Accord is indicated for the treatment of paediatric patients with:• newly diagnosed Ph+ ALL in combination with chemotherapy. |
| 首次发布日期 | 2022/01/24 |
| 修订日期 | 2023/03/30 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/dasatinib-accord-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/dasatinib-accord |