法规知识库 · EMA 集中审评
GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.)
budesonide;formoterol fumarate dihydrate · EMEA/H/C/004882 · 已授权
获批上市许可
2020-04-03
欧委会决定日
2025-02-10
持有人 / 申请人
Teva Pharma B.V.
终止日期字段
无
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:R03AK07
治疗领域:Asthma;Pulmonary Disease, Chronic Obstructive
药理分类:Drugs for obstructive airway diseases
修订号:6 · 最新影响 PI 的程序:R/0016
适应症(原文):Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only. Asthma Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. or -in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. COPD Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
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。
2025-02-10 · 欧委会决定
2020-04-03 · 获批上市许可
2020-01-30 · 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 ↗
GoResp Digihaler : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-02-18
- 打开官方文件 ↗
GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) : EPAR - Risk management plan
rmp · 2024-04-16
- 打开官方文件 ↗
Budesonide/Formoterol Teva Pharma B.V. : EPAR - Medicine overview
overview · 2020-04-07 · EMA/118969/2020
- 打开官方文件 ↗
Budesonide/Formoterol Teva Pharma B.V. : EPAR - Public assessment report
assessment-report · 2020-04-07 · EMA/83618/2020
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。