申请企业

GILEAD SCIENCES INC

药品名称

VEKLURY (remdesivir)

状态

未解决

承诺描述

Conduct a clinical trial to evaluate the pharmacokinetics and safety of remdesivir in subjects with moderate and severe hepatic impairment to inform appropriate dosage recommendations in patients with COVID-19 with impaired hepatic function. If clinically significant increased exposures are observed in this trial, a subsequent evaluation in subjects with mild hepatic impairment may be required.

承诺状态描述

报告接收日期

批准日期

2020/10/22 0:00:00

截止日期

2022/7/31 0:00:00

CDER/CBER

CD

子类型标记

F