通用名称

cobicistat

儿科标签批准日期

2019/8/22 0:00:00

特定指示/秒

HIV-1 infection in pediatric patients weighing ≥ 35 kg

标签更改摘要

- Safety and effectiveness co -administered with atazanavir and two nucleoside reverse transcriptase inhibitors for the treatment of HIV-1 infection have been established in virologically suppressed pediatric patients weighing at least 35 kg. - Use for this indication is supported by evidence from adequate and well-controlled studies in adults, and by pharmacokinetic, safety, and virologic data from an open-label trial in virologically suppressed, HIV-1 infected pediatric patients 12 years and older. - Safety through 48 weeks was similar to that in antiretroviral treatment-naïve adults. - Safety and effectiveness in combination with atazanavir in pediatric patients weighing less than 35 kg have not been established. - Safety and effectiveness in combination with darunavir in pediatric patients have not been established. - Information on dosing, PK parameters, adverse reactions, and clinical trial. - Postmarketing study

治疗类别

Antivirals

立法类型

PREA + BPCA

产品说明书链接