| 商品名称 | Dasatinib Accord Healthcare |
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| 适用类别 | Human |
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| 治疗领域 | Precursor Cell Lymphoblastic Leukemia-Lymphoma;Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
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| 通用名/非专利名称 | dasatinib |
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| 活性成分 | Dasatinib monohydrate |
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| 产品号 | EMEA/H/C/006251 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | L01EA02 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | Yes |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2024/07/26 |
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| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
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| 人用药物治疗学分组 | Antineoplastic agents |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2024/05/30 |
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| 欧盟委员会决定日期 | 2025/08/19 |
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| 修订号 | 2 |
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| 治疗适应症 | Dasatinib Accord Healthcare is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Dasatinib Accord Healthcare is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ ALL in combination with chemotherapy. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2024/05/31 |
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| 最后更新日期 | 2025/11/13 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/dasatinib-accord-healthcare-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/dasatinib-accord-healthcare |
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