欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Reyataz
适用类别Human
治疗领域HIV Infections
通用名/非专利名称atazanavir sulfate
活性成分atazanavir (as sulfate)
产品号EMEA/H/C/000494
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2004/03/01
上市许可开发者/申请人/持有人Bristol-Myers Squibb Pharma EEIG
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2024/09/05
修订号57
治疗适应症Reyataz capsules, co-administered with low dose ritonavir, are 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 (see section 4.2). 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). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1). Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2). 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). The choice of Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).
适用物种
兽用药物ATC编码
首次发布日期2018/02/22
最后更新日期2024/10/16
产品说明书https://www.ema.europa.eu/en/documents/product-information/reyataz-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/reyataz
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