法规知识库 · EMA 集中审评
Ketek
telithromycin · EMEA/H/C/000354 · 已撤市
获批上市许可
2001-07-09
欧委会决定日
2017-02-07
持有人 / 申请人
Aventis Pharma S.A.
终止日期字段
2019-06-07
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:J01FA15
治疗领域:Sinusitis;Tonsillitis;Bronchitis, Chronic;Pharyngitis;Community-Acquired Infections;Pneumonia, Bacterial
药理分类:Antibacterials for systemic use
修订号:25 · 最新影响 PI 的程序:N/0068
适应症(原文):When prescribing Ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agents and the local prevalence of resistance. Ketek is indicated for the treatment of the following infections: In patients of 18 years and older community-acquired pneumonia, mild or moderate. when treating infections caused by known or suspected beta-lactam- and / or macrolide-resistant strains (according to history of patients or national and / or regional resistance data) covered by the antibacterial spectrum of telithromycin: acute exacerbation of chronic bronchitis; acute sinusitis; In patients of 12 years and older tonsillitis / pharyngitis caused by Streptococcus pyogenes, as an alternative when beta-lactam antibiotics are not appropriate in countries / regions with a significant prevalence of macrolide-resistant S. pyogenes, when mediated by ermTR or mefA.
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。
2019-06-07 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
2017-02-07 · 欧委会决定
2001-07-09 · 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
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Ketek-H-C-379-P46-0060 : EPAR - Assessment Report
variation-report · 2019-06-19 · EMA/743325/2014
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Ketek-H-C-354-PSUV-0060 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-06-19 · EMA/294682/2014
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Ketek-H-C-354-A45-0039 : EPAR - Assessment Report
variation-report · 2019-06-19 · EMA/531185/2012
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Ketek : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2019-06-19
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Ketek : EPAR - Summary for the public
overview · 2019-06-19
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Ketek : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2019-06-19
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Ketek-H-C-354-A22-41: EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2019-06-19
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Ketek : EPAR - Scientific Discussion
scientific-discussion · 2019-06-19
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。