| 商品名称 | Bosulif |
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| 适用类别 | Human |
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| 治疗领域 | Leukemia, Myeloid |
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| 通用名/非专利名称 | bosutinib |
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| 活性成分 | bosutinib (as monohydrate) |
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| 产品号 | EMEA/H/C/002373 |
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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 | L01EA04 |
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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 | 2013/03/27 |
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| 上市许可开发者/申请人/持有人 | Pfizer Europe MA EEIG |
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| 人用药物治疗学分组 | Antineoplastic agents;Protein kinase inhibitors |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2013/01/17 |
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| 欧盟委员会决定日期 | 2025/09/30 |
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| 修订号 | 28 |
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| 治疗适应症 | Bosulif is indicated for the treatment of:• Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).• Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.• Adult patients with accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. |
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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 | 2018/08/02 |
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| 最后更新日期 | 2025/09/30 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/bosulif-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/bosulif |
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