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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。

  1. 2016-12-16 · 欧委会决定

  2. 2016-12-16 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  3. 2014-11-19 · 获批上市许可

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 6产品信息 2其他 0

EPAR / 审评资料

  • 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

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  • 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

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产品信息

  • Budesonide/Formoterol Teva : EPAR - All Authorised presentations

    all-authorised-presentations · 2017-01-31

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  • Budesonide/Formoterol Teva : EPAR - Product Information

    product-information · 2017-01-31

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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。