欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Turvel
适用类别Human
治疗领域Bacterial Infections
通用名/非专利名称trovafloxacin
活性成分trovafloxacin
产品号EMEA/H/C/000158
患者安全信息No
许可状态Withdrawn
ATC编码J01MA13
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期1998/07/08
上市许可开发者/申请人/持有人Pfizer Limited
人用药物治疗学分组Antibacterials for systemic use
兽用药物治疗学分组
欧盟委员会决定日期2010/01/11
修订号
治疗适应症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.
适用物种
兽用药物ATC编码
首次发布日期2010/01/11
最后更新日期2010/01/11
产品说明书
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/turvel
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