法规知识库 · EMA 集中审评
Exjade
deferasirox · EMEA/H/C/000670 · 已授权
获批上市许可
2006-08-28
欧委会决定日
2026-09-03
持有人 / 申请人
Novartis Europharm Limited
终止日期字段
无
从产品到官方文件
文件记录
32
官方索引 32
EPAR / 审评
29
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：V03AC03
治疗领域：beta-Thalassemia;Iron Overload
药理分类：All other therapeutic products
修订号：58 · 最新影响 PI 的程序：VR/0000333352
适应症（原文）：Exjade 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 six years and older. Exjade 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 patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged two to five years; in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged two years and older; in patients with other anaemias aged two years and older. Exjade 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。
2026-09-03 · 欧委会决定
2006-08-28 · 获批上市许可
2006-06-28 · 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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Exjade : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-20
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Exjade : EPAR - Risk management plan
rmp · 2026-10-20
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Exjade-PAM-0000247779 : EPAR - Assessment report
variation-report · 2025-11-25 · EMADOC-1700519818-2297201
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Exjade : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-08-21
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Exjade-H-C-PSUSA-00000939-201910 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-08-26 · EMA/CHMP/273774/2020
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Exjade-H-C-670-P46-0078 : EPAR - Assessment Report
variation-report · 2020-07-20 · EMA/371160/2020
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Exjade-H-C-PSUSA-00000939-201810 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-10-04 · EMA/529960/2019
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Exjade-H-C-670-P46-0076 : EPAR - Assessment Report
variation-report · 2018-10-30 · EMA/612425/2018
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Exjade : EPAR - Medicine overview
overview · 2018-08-13 · EMA/81812/2013
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Exjade-H-C-PSUSA-00000939-201710 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2018-08-02 · EMA/523750/2018
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Exjade-H-C-670-P46-074 : EPAR - Assessment Report
variation-report · 2018-01-11 · EMA/CHMP/816134/2017
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Exjade : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2017-11-24 · EMA/610304/2017
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Exjade-H-C-670-X-0054 : EPAR - Assessment Report - Extension
variation-report · 2017-11-24 · EMA/639290/2017
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Exjade-H-C-PSUSA-00000939-201610 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-09-18 · EMA/465552/2017
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Exjade-H-C-670-P46-070 : EPAR - Assessment Report
variation-report · 2017-06-02 · EMA/244743/2017
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Exjade-H-C-670-P46-073 : EPAR - Assessment Report
variation-report · 2017-03-10 · EMA/167292/2017
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Exjade-H-C-670-P46-072 : EPAR - Assessment Report
variation-report · 2017-03-09 · EMA/166371/2017
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Exjade-H-C-670-P46-060.1 : EPAR - Assessment Report
variation-report · 2016-11-22 · EMA/CHMP/763315/2016
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Exjade-H-C-670-P46-0069 : EPAR - Assessment Report
variation-report · 2016-08-18 · EMA/551185/2016
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Exjade-H-C-PSUSA-00000939-201510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-08-12 · EMA/533978/2016
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Exjade-H-C-670-P46-0066 : EPAR - Assessment Report
variation-report · 2016-06-03 · EMA/331072/2016
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Exjade-H-C-670-P46-0065 : EPAR - Assessment Report
variation-report · 2016-06-03 · EMA/331067/2016
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Exjade-H-C-670-X-0043 : EPAR - Assessment Report - Extension
variation-report · 2016-04-22 · EMA/CHMP/107225/2016
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Exjade-H-C-PSUSA-00000939-201410 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-09-07 · EMA/410711/2015
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Exjade-H-C-670-PSUV-0037 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-10-06 · EMA/CHMP/610925/2014
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Exjade-H-C-670-II-0025 : EPAR - Assessment Report - Variation
variation-report · 2013-07-18 · EMA/CHMP/294499/2013
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Exjade-H-C-670-II-0026 : EPAR - Assessment Report - Variation
variation-report · 2013-02-19 · EMA/44672/2013
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Exjade : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2007-04-17
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Exjade : EPAR - Scientific Discussion
scientific-discussion · 2007-04-17
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。