欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Epoetin Alfa Hexal
适用类别Human
治疗领域Anemia; Kidney Failure, Chronic; Cancer
通用名/非专利名称epoetin alfa
活性成分epoetin alfa
产品号EMEA/H/C/000726
患者安全信息no
授权状态Authorised
ATC编码B03XA01
是否额外监管no
是否仿制药no
是否生物类似药yes
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
批准上市日期2007/08/27
上市许可持有人/公司名称Hexal AG
人用药物治疗分组Antianemic preparations
决定日期2023/11/20
修订号24
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).,
首次发布日期2017/10/04
修订日期2023/11/21
产品信息https://www.ema.europa.eu/en/documents/product-information/epoetin-alfa-hexal-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/epoetin-alfa-hexal
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