| 商品名称 | Zydelig |
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| 适用类别 | Human |
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| 治疗领域 | Lymphoma, Non-Hodgkin;Leukemia, Lymphocytic, Chronic, B-Cell |
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| 通用名/非专利名称 | idelalisib |
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| 活性成分 | Idelalisib |
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| 产品号 | EMEA/H/C/003843 |
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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 | L01XX47 |
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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 | 2014/09/18 |
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| 上市许可开发者/申请人/持有人 | Gilead Sciences Ireland UC |
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| 人用药物治疗学分组 | Antineoplastic agents;Other 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 | 2014/07/25 |
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| 欧盟委员会决定日期 | 2024/06/20 |
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| 修订号 | 21 |
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| 治疗适应症 | Zydelig is indicated in combination with an anti?CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies. Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment. |
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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 | 2018/06/07 |
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| 最后更新日期 | 2024/10/21 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/zydelig-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/zydelig |
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