| 商品名称 | Reblozyl |
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| 适用类别 | Human |
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| 治疗领域 | Anemia;Myelodysplastic Syndromes;beta-Thalassemia |
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| 通用名/非专利名称 | luspatercept |
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| 活性成分 | Luspatercept |
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| 产品号 | EMEA/H/C/004444 |
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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 | B03XA06 |
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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 | 2020/06/25 |
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| 上市许可开发者/申请人/持有人 | Bristol Myers Squibb Pharma EEIG |
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| 人用药物治疗学分组 | Other antianemic preparations |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2020/04/30 |
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| 欧盟委员会决定日期 | 2025/09/18 |
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| 修订号 | 10 |
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| 治疗适应症 | Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia. Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia. |
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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 | 2020/07/08 |
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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/reblozyl-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/reblozyl |
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