| 商品名称 | Deferasirox Accord |
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| 适用类别 | Human |
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| 治疗领域 | Iron Overload;beta-Thalassemia |
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| 通用名/非专利名称 | deferasirox |
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| 活性成分 | deferasirox |
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| 产品号 | EMEA/H/C/005156 |
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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 | V03AC03 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | Yes |
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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 | 2020/01/09 |
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| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
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| 人用药物治疗学分组 | All other therapeutic products;Iron chelating agents |
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| 兽用药物治疗学分组 | |
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| 欧盟委员会决定日期 | 2025/09/30 |
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| 修订号 | 8 |
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| 治疗适应症 | Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older. Deferasirox Accord is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) aged 2 to 5 years, in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, in adult and paediatric patients with other anaemias aged 2 years and older. Deferasirox Accord is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older. |
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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 | 2020/03/04 |
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| 最后更新日期 | 2025/09/30 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/deferasirox-accord-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/deferasirox-accord |
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