法规知识库 · EMA 集中审评
NeoRecormon
epoetin beta · EMEA/H/C/000116 · 已授权
获批上市许可
1997-07-16
欧委会决定日
2025-05-01
持有人 / 申请人
Roche Registration GmbH
终止日期字段
无
从产品到官方文件
文件记录
10
官方索引 10
EPAR / 审评
8
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：B03XA01
治疗领域：Kidney Failure, Chronic;Anemia;Cancer;Blood Transfusion, Autologous
药理分类：Antianemic preparations
修订号：35 · 最新影响 PI 的程序：VR/0000262770
适应症（原文）：Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients; treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy; increasing the yield of autologous blood from patients in a pre-donation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
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。
2025-05-01 · 欧委会决定
1997-07-16 · 获批上市许可
1996-10-16 · CHMP 意见通过
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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NeoRecormon : EPAR - Medicine overview
overview · 2026-06-12 · EMEA/H/C/000116
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NeoRecormon : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-05-02
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NeoRecormon : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-02
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NeoRecormon : EPAR - Risk management plan
rmp-summary · 2024-07-22
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NeoRecormon-H-C-116-II-0037 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2005-10-21
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NeoRecormon : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-10-21
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NeoRecormon : EPAR - Scientific Discussion
scientific-discussion · 2005-10-21
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NeoRecormon : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2005-10-21
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。