法规知识库 · EMA 集中审评
Deferasirox Mylan
deferasirox · EMEA/H/C/005014 · 已授权
获批上市许可
2019-09-26
欧委会决定日
2026-10-15
持有人 / 申请人
Mylan Pharmaceuticals Limited
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
5
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC:V03AC03
治疗领域:Iron Overload;beta-Thalassemia
药理分类:Iron chelating agents
修订号:14 · 最新影响 PI 的程序:VR/0000365923
适应症(原文):Deferasirox Mylan is indicated for the treatment of chronic iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) aged 2 to 5 years, in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, in adult and paediatric patients with other anaemias aged 2 years and older. the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion dependent thalassaemia syndromes aged 10 years and older.
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。
2026-10-15 · 欧委会决定
2019-09-26 · 获批上市许可
2019-07-25 · 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
- 打开官方文件 ↗
Deferasirox Mylan : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-16
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Deferasirox Mylan : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-02
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Deferasirox Mylan : EPAR - Risk management plan
rmp-summary · 2024-10-14
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Deferasirox Mylan : EPAR - Medicine overview
overview · 2019-10-10 · EMA/515414/2019
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Deferasirox Mylan : EPAR - Public assessment report
assessment-report · 2019-10-10 · EMA/CHMP/509090/2019
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。