欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan)
适用类别Human
治疗领域HIV Infections
通用名/非专利名称lopinavir;ritonavir
活性成分lopinavir;ritonavir
产品号EMEA/H/C/004025
患者安全信息No
许可状态Authorised
ATC编码J05AR10
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2016/01/14
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2015/11/19
欧盟委员会决定日期2024/07/29
修订号19
治疗适应症Lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years. The choice of lopinavir/ritonavir to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.
适用物种
兽用药物ATC编码
首次发布日期2018/06/14
最后更新日期2024/09/12
产品说明书https://www.ema.europa.eu/en/documents/product-information/lopinavir/ritonavir-mylan-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/lopinavir-ritonavir-viatris
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