通用名称

baloxavir marboxil

儿科标签批准日期

2018/10/24 0:00:00

特定指示/秒

Treatment of acute uncomplicated influenza in patients 12 years and older who have been symptomatic for no more than 48 hours

标签更改摘要

- Safety and effectiveness for the treatment of influenza have been established in adults and pediatric patients 12 years and older weighing at least 40 kg. - Safety and effectiveness have not been established in pediatric patients less than 12 years. - Use in pediatric patients 12 years and older weighing at least 40 kg is supported by one randomized, double-blind, controlled trial in which 118 adolescents were randomized to receive either Xofluza (N=80) or placebo (N=38). The median time to alleviation of symptoms in adolescent subjects was 54 hours compared to 93 hours for subjects who received placebo. - Adverse reactions reported in adolescents were similar to those reported in adults. - Information on dosing, adverse reactions, clinical trial and PK parameters in adults and pediatric patients 12 years and older. - New drug.

治疗类别

Antivirals

立法类型

PREA Only

产品说明书链接

书号

2.0 1.0

研究年龄

6 MONTHS - 11 YEARS 12 YEARS - 19 YEARS

学习类型

Efficacy,Safety,Pharmacokinetic Efficacy,Safety,Pharmacokinetic

研究设计

Open-Label,Trad PK Placebo,Single-Blind,Trad PK

登记的患者

107 144

患者分析

N/A N/A

中心的数量

41 297

国家数量

1 3

西班牙裔拉美裔/拉丁裔总计

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非西班牙裔/非拉丁裔总人数

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总数#种族不明

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亚裔学生总数

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黑人总数

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白人总数

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夏威夷或太平洋岛民总数

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美洲印第安人/阿拉斯加本地人总数

N/A N/A

其他种族总计

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未知种族总数

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国家

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