通用名称

baloxavir marboxil

儿科标签批准日期

2020/11/23 0:00:00

特定指示/秒

Treatment and post-exposure prophylaxis of influenza in adults and pediatric patients 12 years and older

标签更改摘要

Treatment - Safety and effectiveness for the treatment of acute uncomplicated influenza in pediatric patients 12 years and older weighing at least 40 kg is supported by one randomized, double-blind, controlled trial in otherwise healthy patients (Trial 2) and one trial in patients at high risk of developing influenza-related complications (Trial 3). A total of 117 otherwise healthy adolescents 12-17 years old were randomized and received either XOFLUZA (N=76) or placebo (N=41) in Trial 2; 38 adolescents aged 12 to 17 years at high risk for influenza complications were randomized and received either Xofluza (N=21) or placebo (N=17) in Trial 3. - Adverse events reported in adolescents in both trials were similar to those reported in adults. - Safety and efficacy in pediatric patients less than 12 years have not been established for the treatment of acute uncomplicated influenza. Prophylaxis - Safety and effectiveness for post-exposure prophylaxis in adolescents (12 years to < 18 years) is supported by one randomized, double-blind, controlled trial conducted in Japan (Trial 4). A total of 12 patients from ≥ 12 to < 18 years received Xofluza. - Adverse events reported in adolescent subjects were similar to those reported in adults in the same trial. - Safety and efficacy for post-exposure prophylaxis of influenza in pediatric patients less than 12 years of age have not been established.

治疗类别

Antivirals

立法类型

PREA Only

产品说明书链接