| 商品名称 | Venclyxto |
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| 适用类别 | Human |
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| 治疗领域 | Leukemia, Lymphocytic, Chronic, B-Cell |
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| 通用名/非专利名称 | venetoclax |
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| 活性成分 | venetoclax |
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| 产品号 | EMEA/H/C/004106 |
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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 | L01XX52 |
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| 是否额外监管 | Yes |
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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 | 2016/12/04 |
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| 上市许可开发者/申请人/持有人 | AbbVie Deutschland GmbH & Co. KG |
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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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| 欧盟委员会决定日期 | 2025/10/21 |
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| 修订号 | 21 |
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| 治疗适应症 | Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1). Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. Venclyxto monotherapy is indicated for the treatment of CLL: in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor. Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive 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 | 2018/05/31 |
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| 最后更新日期 | 2025/10/24 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/venclyxto |
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