| 商品名称 | Kaftrio |
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| 适用类别 | Human |
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| 治疗领域 | Cystic Fibrosis |
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| 通用名/非专利名称 | ivacaftor;tezacaftor;elexacaftor |
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| 活性成分 | ivacaftor;tezacaftor;elexacaftor |
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| 产品号 | EMEA/H/C/005269 |
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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 | R07AX32 |
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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 | No |
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| 是否罕用药 | Yes |
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| 上市许可日期 | 2020/08/21 |
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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 respiratory system products |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2020/06/25 |
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| 欧盟委员会决定日期 | 2025/10/16 |
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| 修订号 | 31 |
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| 治疗适应症 | Kaftrio tablets are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Kaftrio granules are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. |
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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 | 2020/08/21 |
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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/kaftrio-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/kaftrio |
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