| 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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| 授权状态 | 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 | 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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| 批准上市日期 | 2006/11/20 |
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| 上市许可持有人/公司名称 | Bristol-Myers Squibb Pharma EEIG |
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| 人用药物治疗分组 | Antineoplastic agents |
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| 审评意见发布日期 | 2006/09/21 |
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| 决定日期 | 2022/06/16 |
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| 修订号 | 41 |
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| 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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| 首次发布日期 | 2018/08/03 |
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| 修订日期 | 2023/10/30 |
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| 产品信息 | 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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