法规知识库 · EMA 集中审评
Deferasirox Accord
deferasirox · EMEA/H/C/005156 · 已授权
获批上市许可
2020-01-09
欧委会决定日
2026-10-20
持有人 / 申请人
Accord Healthcare S.L.U.
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:V03AC03
治疗领域:Iron Overload;beta-Thalassemia
药理分类:All other therapeutic products;Iron chelating agents
修订号:9 · 最新影响 PI 的程序:VR/0000378089
适应症(原文):Deferasirox Accord 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. Deferasirox Accord is also indicated for 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. Deferasirox Accord is also indicated for 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。
2026-10-20 · 欧委会决定
2020-01-09 · 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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Deferasirox Accord : EPAR - Procedural steps taken and scientific information after the authorisation
procedural-steps-after · 2026-10-20
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Deferasirox Accord : EPAR - Procedural steps taken and scientific information after the authorisation (archived)
procedural-steps-after · 2025-01-06
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Deferasirox Accord : EPAR - Risk-management-plan summary
rmp-summary · 2025-01-06
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Deferasirox Accord : EPAR - Medicine overview
overview · 2020-03-04 · EMA/626874/2019
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Deferasirox Accord : EPAR - Public assessment report
assessment-report · 2020-03-04 · EMA/659255/2019
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。