法规知识库 · EMA 集中审评
BiResp Spiromax
budesonide;formoterol fumarate dihydrate · EMEA/H/C/003890 · 已授权
获批上市许可
2014-04-28
欧委会决定日
2024-07-18
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
10
官方索引 10
EPAR / 审评
8
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：13 · 最新影响 PI 的程序：IG1765
适应症（原文）：Asthma BiResp Spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?? adrenoceptor agonist) is appropriate: in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?? adrenoceptor agonists. or in patients already adequately controlled on both inhaled corticosteroids and long-acting ?? adrenoceptor agonists. COPDBiResp Spiromax is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV?) <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。
2024-07-18 · 欧委会决定
2014-04-28 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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BiResp Spiromax : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-07-24
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BiResp Spiromax-H-C-3890-II-0033 : EPAR - Assessment Report - Variation
variation-report · 2021-06-09 · EMA/CHMP/310289/2021
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BiResp Spiromax : EPAR - Risk-management-plan summary
rmp-summary · 2021-06-09
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BiResp Spiromax : EPAR - Summary for the public
overview · 2021-06-09 · EMA/265709/2021
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BiResp Spiromax-H-C-PSUSA-00010585-201908 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-07-31 · EMA/271549/2020
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BiResp Spiromax : EPAR - Scientific Conclusion
scientific-conclusion · 2016-07-15
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BiResp Spiromax-H-C-3890-A31-14165: EPAR - Assessment Report - Article 31
variation-report · 2016-07-15 · EMA/330021/2016
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BiResp Spiromax : EPAR - Public assessment report
assessment-report · 2014-05-19 · EMA/CHMP/175684/2014
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。