法规知识库 · EMA 集中审评
Revolade
eltrombopag · EMEA/H/C/001110 · 已授权
获批上市许可
2010-03-11
欧委会决定日
2026-01-15
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
21
官方索引 21
EPAR / 审评
18
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：B02BX05
治疗领域：Purpura, Thrombocytopenic, Idiopathic;Anemia, Aplastic
药理分类：Other systemic hemostatics;Antihemorrhagics
修订号：39 · 最新影响 PI 的程序：VR/0000288153
适应症（原文）：Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.4 and 5.1). Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).
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。
2026-01-15 · 欧委会决定
2010-03-11 · 获批上市许可
2009-12-17 · 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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Revolade : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-02-26
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Revolade : EPAR - Risk Management Plan
rmp · 2026-02-26
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Revolade-PAM-0000274861 : EPAR - Assessment Report
variation-report · 2025-09-25 · EMADOC-1700519818-2460734
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Revolade : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2024-11-28
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Revolade-H-C-001110-II-0068 : EPAR - Assessment Report - Variation
variation-report · 2022-11-04 · EMA/850880/2022
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Revolade : EPAR - Medicine overview
overview · 2022-11-04 · EMA/142918/2019
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Revolade-H-C-001110-P46-032 : EPAR - Assessment Report
variation-report · 2021-07-21 · EMA/345551/2021
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Revolade-H-C-1110-II-0049 : EPAR - Assessment Report - Variation
variation-report · 2020-02-12 · EMA/CHMP/620491/2019
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Revolade-H-C-1110-II-0050 : EPAR - Assessment Report - Variation
variation-report · 2019-05-28 · EMA/293205/2019
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Revolade-H-C-PSUSA-00001205-201709 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-07-20 · EMA/496004/2018
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Revolade-H-C-1110-P46-028 : EPAR - Assessment Report
variation-report · 2018-04-26 · EMA/125720/2018
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Revolade-H-C-PSUSA-00001205-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-08-23 · EMA/481010/2017
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Revolade-H-C-1110-X-0022-G : EPAR - Assessment Report - Extension
variation-report · 2016-04-20 · EMA/CHMP/722220/2015
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Revolade-H-C-1110-II-0023 : EPAR - Assessment Report - Variation
variation-report · 2016-04-07 · EMA/CHMP/38474/2016
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Revolade-H-C-1110-II-0020 : EPAR - Assessment Report - Variation
variation-report · 2015-11-05 · EMA/CHMP/598426/2015
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Revolade-H-C-1110-X-0012-G : EPAR - Assessment Report - Extension
variation-report · 2013-10-15 · EMA/491212/2013
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Revolade : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2011-06-07
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Revolade : EPAR - Public assessment report
assessment-report · 2010-05-18
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。