欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Atazanavir Viatris (previously Atazanavir Mylan)
适用类别Human
治疗领域HIV Infections
通用名/非专利名称atazanavir
活性成分atazanavir (as sulfate)
产品号EMEA/H/C/004048
患者安全信息No
许可状态Authorised
ATC编码J05AE08
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2016/08/22
上市许可开发者/申请人/持有人Viatris Limited
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2016/06/23
欧盟委员会决定日期2025/05/14
修订号19
治疗适应症Atazanavir Viatris, co-administered with low dose ritonavir, is indicated for the treatment of HIV 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations). There are very limited data available from children aged 6 to less than 18 years. The choice of Atazanavir  Viatrisin treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.
适用物种
兽用药物ATC编码
首次发布日期2018/05/03
最后更新日期2025/06/18
产品说明书https://www.ema.europa.eu/en/documents/product-information/atazanavir-viatris-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/atazanavir-mylan
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