通用名称

cobicistat

儿科标签批准日期

2019/10/3 0:00:00

特定指示/秒

Co-administered with darunavir for treatment of HIV-1 infection in pediatric patients weighing at least 35 kg

标签更改摘要

- 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 aged 12 years and older. - The safety in these patients through 48 weeks was similar to that in antiretroviral treatment-naïve adults. - Safety and effectiveness in combination with darunavir in pediatric patients weighing less than 40 kg have not been established. - Adverse reactions were similar to those observed in adults. - Information on dosing, PK parameters, clinical trial. - Postmarketing study.

治疗类别

Antivirals

立法类型

PREA + BPCA

产品说明书链接

书号

1.0

研究年龄

12 YEARS - 17 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic

研究设计

Multicenter,Open-Label,Phase 2,Phase 3,Multicohort; Multicohort, Switch Study

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西班牙裔拉美裔/拉丁裔总计

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