申请企业

Emergent Travel Health, Inc.

药品名称

Vaxchora, Cholera Vaccine Live Oral

状态

未间断

承诺描述

To establish a pregnancy registry for VAXCHORA in the United States to prospectively collect data on spontaneously reported exposures to VAXCHORA occurring within 28 days prior to the last menstrual period or at any time during pregnancy. You will submit annual reports as well as a 5-year summary report, after which you will continue enrolling patients in the registry and submitting annual reports pending CBER review of the reports and determination that the registry can be discontinued.

承诺状态描述

报告接收日期

2020/8/10 0:00:00

批准日期

2016/6/10 0:00:00

截止日期

2022/9/1 0:00:00

CDER/CBER

CB

子类型标记