| 商品名称 | Sprycel |
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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 (anhydrous) |
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| 活性成分 | dasatinib |
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| 产品号 | EMEA/H/C/000709 |
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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 | No |
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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 | 2006/11/20 |
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| 上市许可开发者/申请人/持有人 | Bristol-Myers Squibb Pharma EEIG |
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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 | 2006/09/21 |
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| 欧盟委员会决定日期 | 2025/05/14 |
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| 修订号 | 45 |
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| 治疗适应症 | Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML CP) or Ph+ CML CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy. Sprycel 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 mesilate; Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Sprycel 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. |
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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 | 2018/08/03 |
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| 最后更新日期 | 2025/06/18 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/sprycel |
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