欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Stocrin
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/000250
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1999/05/28
上市许可开发者/申请人/持有人Merck Sharp & Dohme 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1999/02/24
欧盟委员会决定日期2023/04/14
修订号49
治疗适应症Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Stocrin 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 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 Stocrin.
适用物种
兽用药物ATC编码
首次发布日期2018/07/30
最后更新日期2023/04/25
产品说明书https://www.ema.europa.eu/en/documents/product-information/stocrin-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/stocrin
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