欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Vibativ
适用类别Human
治疗领域Pneumonia, Bacterial;Cross Infection
通用名/非专利名称telavancin
活性成分telavancin
产品号EMEA/H/C/001240
患者安全信息No
许可状态Withdrawn
ATC编码J01XA03
是否额外监管Yes
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2011/09/02
上市许可开发者/申请人/持有人Theravance Biopharma Ireland Umited
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2017/09/08
修订号10
治疗适应症Vibativ is indicated for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA). Vibativ should be used only in situations where it is known or suspected that other alternatives are not suitable. 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2017/09/08
最后更新日期2018/05/16
产品说明书https://www.ema.europa.eu/en/documents/product-information/vibativ-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/vibativ-0
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