欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Efavirenz Teva
适用类别Human
治疗领域HIV Infections
通用名/非专利名称efavirenz
活性成分efavirenz
产品号EMEA/H/C/002352
患者安全信息No
许可状态Authorised
ATC编码J05AG03
是否额外监管No
是否仿制药或hybrid药物Yes
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2012/01/09
上市许可开发者/申请人/持有人Teva B.V.
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2023/02/27
修订号12
治疗适应症Efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children 3 years of age and older. Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with protease inhibitors (PIs) has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz.
适用物种
兽用药物ATC编码
首次发布日期2016/09/09
最后更新日期2023/03/03
产品说明书https://www.ema.europa.eu/en/documents/product-information/efavirenz-teva-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/efavirenz-teva
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