法规知识库 · EMA 集中审评
Riltrava Aerosphere
budesonide;formoterol fumarate dihydrate;glycopyrronium bromide · EMEA/H/C/005311 · 已授权
获批上市许可
2022-01-06
欧委会决定日
2026-09-18
持有人 / 申请人
AstraZeneca AB
终止日期字段
无
从产品到官方文件
文件记录
8
官方索引 8
EPAR / 审评
6
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：R03AL11
治疗领域：Pulmonary Disease, Chronic Obstructive
药理分类：Drugs for obstructive airway diseases
修订号：7 · 最新影响 PI 的程序：X/0000287672
适应症（原文）：Riltrava Aerosphere is indicated as a maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid and a long acting beta2 agonist. Riltrava Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.
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。
2026-09-18 · 欧委会决定
2022-01-06 · 获批上市许可
2021-11-11 · 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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Riltrava Aerosphere-X-0000287672 : EPAR - Assessment report - variation
variation-report · 2026-10-02 · EMADOC-1700519818-3392940
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Riltrava Aerosphere : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-02
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Riltrava Aerosphere : EPAR - Medicine Overview
overview · 2026-10-02 · EMADOC-1829012207-63035
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Riltrava Aerosphere : EPAR - Risk management plan
rmp · 2026-10-02
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Riltrava Aerosphere : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-09-30
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Riltrava Aerosphere : EPAR - Public Assessment Report
assessment-report · 2022-02-04 · EMA/622167/2021
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。