| 商品名称 | Epoetin Alfa Hexal |
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| 适用类别 | Human |
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| 治疗领域 | Anemia;Kidney Failure, Chronic;Blood Transfusion, Autologous;Myelodysplastic Syndromes |
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| 通用名/非专利名称 | epoetin alfa |
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| 活性成分 | epoetin alfa |
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| 产品号 | EMEA/H/C/000726 |
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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 | B03XA01 |
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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 | Yes |
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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 | 2007/08/27 |
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| 上市许可开发者/申请人/持有人 | Hexal AG |
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| 人用药物治疗学分组 | Antianemic preparations |
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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 | 2025/07/11 |
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| 修订号 | 27 |
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| 治疗适应症 | Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis; Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). |
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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 | 2017/10/04 |
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| 最后更新日期 | 2025/07/11 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/epoetin-alfa-hexal-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/epoetin-alfa-hexal |
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