| 商品名称 | Iclusig |
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| 适用类别 | Human |
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| 治疗领域 | Leukemia, Myeloid;Leukemia, Lymphoid |
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| 通用名/非专利名称 | ponatinib |
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| 活性成分 | ponatinib |
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| 产品号 | EMEA/H/C/002695 |
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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 | L01EA05 |
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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 | Yes |
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| 是否罕用药 | No |
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| 上市许可日期 | 2013/07/01 |
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| 上市许可开发者/申请人/持有人 | Incyte Biosciences Distribution B.V. |
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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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| 欧盟委员会决定日期 | 2025/10/16 |
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| 修订号 | 27 |
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| 治疗适应症 | Iclusig is indicated in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. See sections 4.2 Assessment of cardiovascular status prior to start of therapy and 4.4 situations where an alternative treatment may be considered. |
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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 | 2018/06/04 |
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| 最后更新日期 | 2025/11/12 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/iclusig |
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