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法规知识库 · EMA 集中审评

Silapo

epoetin zeta · EMEA/H/C/000760 · 已授权

生物类似药

获批上市许可

2007-12-18

欧委会决定日

2026-10-23

持有人 / 申请人

Stada Arzneimittel AG

终止日期字段

无

从产品到官方文件

文件记录

7

官方索引 7

EPAR / 审评

5

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:B03XA01

治疗领域:Anemia;Blood Transfusion, Autologous;Cancer;Kidney Failure, Chronic

药理分类:Antianemic preparations

修订号:19 · 最新影响 PI 的程序:VR/0000371595

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 adult and paediatric 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). Silapo can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood saving 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). Silapo is indicated for non-iron deficient adults prior to major elective orthopaedic surgery having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 ml). Silapo can be used to increase haemoglobin concentration in symptomatic anaemia (haemoglobin concentration of ?10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/ml).

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。

  1. 2026-10-23 · 欧委会决定

  2. 2007-12-18 · 获批上市许可

  3. 2007-10-18 · 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 5产品信息 2其他 0

EPAR / 审评资料

  • Silapo : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2026-10-23

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  • Silapo : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2026-08-04

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  • Silapo : EPAR - Medicine overview

    overview · 2019-03-21 · EMA/448577/2012

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  • Silapo : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2008-01-15

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  • Silapo : EPAR - Scientific Discussion

    scientific-discussion · 2008-01-15

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产品信息

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。