申请企业

GENENTECH INC

药品名称

Xofluza (baloxavir marboxil)

状态

未间断

承诺描述

Submit the clinical study report including the datasets and pharmacokinetic/pharmacodynamic modeling data for the Phase 3 Study 1719T0834 conducted in pediatric subjects from 12 months to less than 12 years of age to evaluate the pharmacokinetics, safety, and efficacy of baloxavir marboxil for the prevention of influenza as post-exposure prophylaxis in household contacts of an index case. Include characterization of baloxavir resistance-associated substitutions including supporting datasets.

承诺状态描述

The trial is underway.

报告接收日期

批准日期

2020/11/23 0:00:00

截止日期

2021/12/31 0:00:00

CDER/CBER

CD

子类型标记

P