| 商品名称 | Strimvelis |
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| 适用类别 | Human |
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| 治疗领域 | Severe Combined Immunodeficiency |
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| 通用名/非专利名称 | autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence |
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| 活性成分 | autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells |
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| 产品号 | EMEA/H/C/003854 |
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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 | L03 |
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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 | Yes |
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| 上市许可日期 | 2016/05/26 |
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| 上市许可开发者/申请人/持有人 | Fondazione Telethon ETS |
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| 人用药物治疗学分组 | Immunostimulants |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2016/03/31 |
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| 欧盟委员会决定日期 | 2025/07/04 |
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| 修订号 | 12 |
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| 治疗适应症 | Strimvelis is indicated for the treatment of patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID), for whom no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available (see section 4.2 and section 4.4). |
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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 | 2018/08/23 |
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| 最后更新日期 | 2025/12/18 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/strimvelis-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/strimvelis |
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