欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Altargo
适用类别Human
治疗领域Impetigo;Staphylococcal Skin Infections
通用名/非专利名称retapamulin
活性成分retapamulin
产品号EMEA/H/C/000757
患者安全信息No
许可状态Withdrawn
ATC编码D06AX13
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2007/05/24
上市许可开发者/申请人/持有人Glaxo Group Ltd
人用药物治疗学分组Antibiotics and chemotherapeutics for dermatological use
兽用药物治疗学分组
欧盟委员会决定日期2015/11/09
修订号15
治疗适应症Short term treatment of the following superficial skin infections: impetigo; infected small lacerations, abrasions or sutured wounds. See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus. 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2015/11/09
最后更新日期2019/03/15
产品说明书https://www.ema.europa.eu/en/documents/product-information/altargo-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/altargo
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