通用名称

sofosbuvir/velpatasvir

儿科标签批准日期

2020/3/19 0:00:00

特定指示/秒

Treatment of chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection in pediatric patients 6 years of age and older or weighing at least 17 kg

标签更改摘要

- The pharmacokinetics, safety, and effectiveness have been established in an open-label, multicenter clinical trial. - Safety and effectiveness for treatment of HCV genotype 5 in pediatric patients 6 years and older or weighing at least 17 kg without cirrhosis or with compensated cirrhosis are supported by sofosbuvir, GS-331007, and velpatasvir exposures in adults and pediatric patients. - In patients with severe renal impairment, including those requiring dialysis, exposures of GS-331007, the inactive metabolite of sofosbuvir, are increased. - No data are available regarding the safety in pediatric patients with renal impairment. - Safety and effectiveness have not been established in pediatric patients less than 6 years. - Information on dosing, adverse reactions, PK parameters, and clinical trials. - New 200 mg/50 mg strength tablet.

治疗类别

Antivirals

立法类型

PREA Only

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