欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Darunavir Viatris (previously Darunavir Mylan)
适用类别Human
治疗领域HIV Infections
通用名/非专利名称darunavir
活性成分darunavir
产品号EMEA/H/C/004068
患者安全信息No
许可状态Authorised
ATC编码J05AE10
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2017/01/03
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2016/09/14
欧盟委员会决定日期2025/12/04
修订号17
治疗适应症Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection (see section 4.2). Darunavir Viatris 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2): For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated. For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1). Darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.  Darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2).  Darunavir Viatris 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:  antiretroviral therapy (ART)-naïve (see section 4.2).  ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ? 100 cells x 10?/L. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).
适用物种
兽用药物ATC编码
首次发布日期2018/07/12
最后更新日期2025/12/11
产品说明书https://www.ema.europa.eu/en/documents/product-information/darunavir-viatris-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/darunavir-viatris
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