法规知识库 · EMA 集中审评
Epoetin Alfa Hexal
epoetin alfa · EMEA/H/C/000726 · 已授权
获批上市许可
2007-08-27
欧委会决定日
2025-07-11
持有人 / 申请人
Hexal AG
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
10
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：B03XA01
治疗领域：Anemia;Kidney Failure, Chronic;Blood Transfusion, Autologous;Myelodysplastic Syndromes
药理分类：Antianemic preparations
修订号：27 · 最新影响 PI 的程序：VR/0000278097
适应症（原文）：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).
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2025-07-11 · 欧委会决定
2007-08-27 · 获批上市许可
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
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Epoetin Alfa Hexal : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-07-11
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Epoetin Alfa Hexal : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-07-11
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Epoetin alfa Hexal : EPAR - Risk management plan
rmp-summary · 2024-07-24
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Epoetin Alfa Hexal-H-C-726-WS-1406-0069 : EPAR - Assessment report - Variation
variation-report · 2018-10-02 · EMA/CHMP/549796/2018
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Epoetin Alfa Hexal : EPAR Risk-management-plan summary
rmp-summary · 2018-10-02
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Epoetin Alfa Hexal : EPAR - Summary for the public
overview · 2018-10-02
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Epoetin Alfa Hexal : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2011-04-18
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Epoetin Alfa Hexal-H-C-726-X-10 : EPAR - Assessment Report - Variation
variation-report · 2008-12-16
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Epoetin Alfa Hexal : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2007-09-17
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Epoetin Alfa Hexal : EPAR - Scientific Discussion
scientific-discussion · 2007-09-13
产品信息
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Epoetin Alfa Hexal : EPAR - Product information - tracked changes
product-information-tracked-changes · 2025-07-11
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Epoetin Alfa Hexal : EPAR - Product information
product-information · 2025-07-11
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Epoetin Alfa Hexal : EPAR - All Authorised presentations
all-authorised-presentations · 2018-10-02
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。