欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Ziagen
适用类别Human
治疗领域HIV Infections
通用名/非专利名称abacavir
活性成分abacavir
产品号EMEA/H/C/000252
患者安全信息No
许可状态Authorised
ATC编码J05AF06
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1999/07/08
上市许可开发者/申请人/持有人ViiV Healthcare B.V.
人用药物治疗学分组Antivirals for systemic use
兽用药物治疗学分组
审评意见日期1999/03/25
欧盟委员会决定日期2024/01/08
修订号49
治疗适应症Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children. The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy. Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
适用物种
兽用药物ATC编码
首次发布日期2018/03/01
最后更新日期2024/01/09
产品说明书https://www.ema.europa.eu/en/documents/product-information/ziagen-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/ziagen
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