| 商品名称 | Deferasirox Mylan |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Iron Overload;beta-Thalassemia |
| 通用名/非专利名称 | deferasirox |
| 活性成分 | deferasirox |
| 产品号 | EMEA/H/C/005014 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | V03AC03 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 是否生物类似药 | No |
| 是否附条件批准 | No |
| 是否特殊情形 | No |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2019/09/26 |
| 上市许可开发者/申请人/持有人 | Mylan Pharmaceuticals Limited |
| 人用药物治疗学分组 | Iron chelating agents |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2019/07/25 |
| 欧盟委员会决定日期 | 2025/04/30 |
| 修订号 | 11 |
| 治疗适应症 | Deferasirox Mylan 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 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. 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. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2019/10/10 |
| 最后更新日期 | 2025/09/29 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/deferasirox-mylan-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/deferasirox-mylan |