欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Stribild
适用类别Human
治疗领域HIV Infections
通用名/非专利名称elvitegravir;cobicistat;emtricitabine;tenofovir disoproxil
活性成分elvitegravir;cobicistat;emtricitabine;tenofovir disoproxil fumarate
产品号EMEA/H/C/002574
患者安全信息No
许可状态Authorised
ATC编码J05AR09
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2013/05/24
上市许可开发者/申请人/持有人Gilead Sciences Ireland UC
人用药物治疗学分组Antivirals for treatment of HIV infections, combinations;Antivirals for systemic use
兽用药物治疗学分组
欧盟委员会决定日期2024/06/27
修订号26
治疗适应症Treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV 1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild.
适用物种
兽用药物ATC编码
首次发布日期2018/07/19
最后更新日期2024/07/23
产品说明书https://www.ema.europa.eu/en/documents/product-information/stribild-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/stribild
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