| 商品名称 | Casgevy |
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| 适用类别 | Human |
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| 治疗领域 | beta-Thalassemia;Anemia, Sickle Cell |
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| 通用名/非专利名称 | exagamglogene autotemcel |
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| 活性成分 | Exagamglogene autotemcel |
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| 产品号 | EMEA/H/C/005763 |
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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 | B06AX05 |
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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 | Yes |
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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 | Yes |
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| 上市许可日期 | 2024/02/09 |
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| 上市许可开发者/申请人/持有人 | Vertex Pharmaceuticals (Ireland) Limited |
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| 人用药物治疗学分组 | Other hematological agents |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2023/12/14 |
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| 欧盟委员会决定日期 | 2025/07/24 |
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| 修订号 | 5 |
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| 治疗适应症 | β thalassemia Casgevy is indicated for the treatment of transfusion dependent β thalassemia (TDT) in patients 12 years of age and older for whom haematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen (HLA) matched related HSC donor is not available. Sickle cell disease Casgevy is indicated for the treatment of severe sickle cell disease (SCD) in patients 12 years of age and older with recurrent vaso occlusive crises (VOCs) for whom haematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen (HLA) matched related HSC donor is not available. |
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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 | 2023/12/15 |
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| 最后更新日期 | 2025/09/03 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/casgevy-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/casgevy |
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