法规知识库 · EMA 集中审评
Budesonide/Formoterol Teva
budesonide;formoterol fumarate dihydrate · EMEA/H/C/003951 · 已撤市
获批上市许可
2014-11-19
欧委会决定日
2016-12-16
持有人 / 申请人
Teva Pharma B.V.
终止日期字段
2016-12-16
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:R03AK07
治疗领域:Pulmonary Disease, Chronic Obstructive;Asthma
药理分类:Drugs for obstructive airway diseases
修订号:2 · 最新影响 PI 的程序:A31/0002
适应症(原文):Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only. AsthmaBudesonide/Formoterol Teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?2 adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?2 adrenoceptor agonists.or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?2 adrenoceptor agonists. COPDSymptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) 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。
2016-12-16 · 欧委会决定
2016-12-16 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
2014-11-19 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
- 打开官方文件 ↗
Budesonide/Formoterol Teva : EPAR - Scientific Conclusion
scientific-conclusion · 2017-01-31
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Budesonide/Formoterol Teva : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2017-01-31
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Budesonide/Formoterol Teva : EPAR - Public assessment report
assessment-report · 2017-01-31 · EMA/CHMP/707207/2014
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Budesonide/Formoterol Teva : EPAR - Risk-management-plan summary
rmp-summary · 2017-01-31 · EMA/639304/2014
- 打开官方文件 ↗
Budesonide/Formoterol Teva : EPAR - Summary for the public
overview · 2017-01-31 · EMA/601019/2014
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Budesonide/Formoterol Teva-H-C-3951-A31-14165: EPAR - Assessment Report - Article 31
variation-report · 2016-07-15 · EMA/330021/2016
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。