法规知识库 · EMA 集中审评
Revinty Ellipta
fluticasone furoate;vilanterol trifenatate · EMEA/H/C/002745 · 已授权
获批上市许可
2014-05-02
欧委会决定日
2025-03-12
持有人 / 申请人
GlaxoSmithKline Trading Services Limited
终止日期字段
无
从产品到官方文件
文件记录
15
官方索引 15
EPAR / 审评
13
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：R03AK10
治疗领域：Asthma
药理分类：Adrenergics and other drugs for obstructive airway diseases
修订号：25 · 最新影响 PI 的程序：T/0000247760
适应症（原文）：Asthma Indication Revinty Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists. COPD Indication Revinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite bronchodilator therapy.
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。
2025-03-12 · 欧委会决定
2014-05-02 · 获批上市许可
2014-03-20 · 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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Revinty Ellipta : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-03-14
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Revinty Ellipta-H-C-002745-P46-010 : EPAR - Assessment Report
variation-report · 2025-02-24 · EMA/67549/2025
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Revinty Ellipta : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2024-09-03
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Revinty Ellipta-H-C-2745-P46-0009 : EPAR - Assessment Report
variation-report · 2023-02-02 · EMA/49502/2023
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Revinty Ellipta : EPAR - Risk-management-plan summary
rmp-summary · 2022-10-06
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Revinty Ellipta-H-C-2745-WS-0708 : EPAR - Assessment Report - Variation
variation-report · 2020-01-28 · EMA/499766/2015
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Revinty Ellipta-H-C-2745-WS-1208 : EPAR - Assessment Report - Variation
variation-report · 2018-05-17 · EMA/CHMP/187802/2018
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Revinty Ellipta : EPAR - Medicine overview
overview · 2018-05-17 · EMA/176766/2014
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Revinty Ellipta-H-C-2745-P46-0005 : EPAR - Assessment Report
variation-report · 2018-01-30 · EMA/60364/2018
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Revinty Ellipta-H-C-2745-P46-0006 : EPAR - Assessment Report
variation-report · 2018-01-30 · EMA/61080/2018
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Revinty Ellipta-H-C-2745-A31-14165: EPAR - Assessment Report - Article 31
variation-report · 2016-07-15 · EMA/330021/2016
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Revinty Ellipta : EPAR - Scientific Conclusion
scientific-conclusion · 2016-07-15
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Revinty Ellipta : EPAR - Public assessment report
assessment-report · 2014-06-17 · EMA/CHMP/175905/2014
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。