法规知识库 · EMA 集中审评
Trovan IV
alatrofloxacin mesilate · EMEA/H/C/000161 · 已撤市
获批上市许可
1998-07-03
欧委会决定日
2009-12-31
持有人 / 申请人
Pfizer Limited
终止日期字段
2001-03-20
从产品到官方文件
文件记录
0
官方索引 0
EPAR / 审评
0
assessment / overview 等
产品信息
0
PI / presentations
其他
0
RMP / PIP 等
ATC:J01MA13
治疗领域:Bacterial Infections
药理分类:Antibacterials for systemic use
修订号:— · 最新影响 PI 的程序:—
适应症(原文):Trovafloxacin is a synthetic broad spectrum quinolone antibacterial agent indicated for the treatment of the following infections in adults: Pneumonia: Community Acquired Pneumonia and Nosocomial Pneumonia (mild, moderate, and severe). Note: Efficacy in patients with very severe nosocomial pneumonia and in particular infections due to less susceptible pathogens e.g. P. aeruginosa, has not been established. See also section 4.2. Acute Exacerbations of Chronic Bronchitis Acute Sinusitis Complicated Intra-abdominal Infections and Acute Pelvic Infections Salpingitis Uncomplicated Gonococcal Urethritis and Cervicitis Chlamydial Cervicitis Complicated Skin and Soft Tissue Infections Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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。
2009-12-31 · 欧委会决定
2001-03-20 · 上市许可终止(撤市/失效/撤销等)
Withdrawn
1998-07-03 · 获批上市许可
说明书、EPAR 与其他文件
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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。