| 商品名称 | Crysvita |
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| 适用类别 | Human |
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| 治疗领域 | Hypophosphatemia, Familial;Hypophosphatemic Rickets, X-Linked Dominant;Osteomalacia |
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| 通用名/非专利名称 | burosumab |
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| 活性成分 | burosumab |
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| 产品号 | EMEA/H/C/004275 |
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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 | M05BX05 |
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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 | 2018/02/19 |
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| 上市许可开发者/申请人/持有人 | Kyowa Kirin Holdings B.V. |
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| 人用药物治疗学分组 | Drugs for treatment of bone diseases |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2017/12/14 |
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| 欧盟委员会决定日期 | 2025/11/21 |
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| 修订号 | 16 |
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| 治疗适应症 | Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. Crysvita is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults. |
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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 | 2018/02/19 |
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| 最后更新日期 | 2025/11/24 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/crysvita-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/crysvita |
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