法规知识库 · EMA 集中审评
Relvar Ellipta
fluticasone furoate;vilanterol · EMEA/H/C/002673 · 已授权
获批上市许可
2013-11-13
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
17
官方索引 17
EPAR / 审评
15
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：R03AK10
治疗领域：Pulmonary Disease, Chronic Obstructive
药理分类：Adrenergics and other drugs for obstructive airway diseases
修订号：28 · 最新影响 PI 的程序：T/0000247757
适应症（原文）：Asthma indication: Relvar 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. patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist. COPD indication: Relvar 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
2013-11-13 · 获批上市许可
2013-09-19 · 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 ↗
Relvar Ellipta : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-04-10
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Relvar Ellipta : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-04-10
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Relvar Ellipta-H-C-002673-P46-017 : EPAR - Assessment Report
variation-report · 2025-02-24 · EMA/67428/2025
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Relvar Ellipta-H-C-2673-WS-2438-G : EPAR - Assessment Report
variation-report · 2023-11-08 · EMA/499751/2023
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Relvar Ellipta-H-C-2673-P46-016 : EPAR - Assessment Report
variation-report · 2023-02-02 · EMA/30446/2023
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Relvar Ellipta : EPAR - Risk-management-plan summary
rmp-summary · 2022-10-06
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Relvar Ellipta-H-C-2673-P46-015 : EPAR - Assessment Report
variation-report · 2022-03-18 · EMA/168280/2022
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Relvar Ellipta-H-C-2673-WS-0708 : EPAR - Assessment Report - Variation
variation-report · 2020-01-28 · EMA/499766/2015
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Relvar Ellipta-H-C-2673-WS-1208 : EPAR - Assessment Report - Variation
variation-report · 2018-04-25 · EMA/CHMP/187802/2018
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Relvar Ellipta : EPAR - Medicine overview
overview · 2018-04-25 · EMA/731724/2013
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Relvar Ellipta-H-C-2673-P46-0011 : EPAR - Assessment Report
variation-report · 2018-01-30 · EMA/60086/2018
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Relvar Ellipta-H-C-2673-P46-0012 : EPAR - Assessment Report
variation-report · 2018-01-30 · EMA/61047/2018
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Relvar Ellipta : EPAR - Scientific Conclusion
scientific-conclusion · 2016-07-15
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Relvar Ellipta-H-C-2673-A31-14165: EPAR - Assessment Report - Article 31
variation-report · 2016-07-15 · EMA/330021/2016
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Relvar Ellipta : EPAR - Public assessment report
assessment-report · 2013-12-10 · EMA/282960/2013
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。