欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Telzir
适用类别Human
治疗领域HIV Infections
通用名/非专利名称fosamprenavir
活性成分fosamprenavir calcium
产品号EMEA/H/C/000534
患者安全信息No
许可状态Authorised
ATC编码J05AE07
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2004/07/12
上市许可开发者/申请人/持有人ViiV Healthcare BV
人用药物治疗学分组Antivirals for systemic use
兽用药物治疗学分组
欧盟委员会决定日期2022/08/19
修订号48
治疗适应症Telzir in combination with low-dose ritonavir is indicated for the treatment of human-immunodeficiency-virus-type-1-infected adults, adolescents and children of six years and above in combination with other antiretroviral medicinal products. In moderately antiretroviral-experienced adults, Telzir in combination with low-dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. No comparative studies have been undertaken in children or adolescents. In heavily pretreated patients, the use of Telzir in combination with low-dose ritonavir has not been sufficiently studied. In protease-inhibitor-experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history.
适用物种
兽用药物ATC编码
首次发布日期2017/03/10
最后更新日期2022/08/23
产品说明书https://www.ema.europa.eu/en/documents/product-information/telzir-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/telzir
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