申请企业

Sanofi Pasteur Inc.

药品名称

Fluzone; Fluzone High Dose; Fluzone Intradermal; Fluzone Quadrivalent; Fluzone HD Quadrivalent, Influenza Virus Vaccine

状态

提交

承诺描述

To establish a pregnancy registry that will enroll women exposed to Fluzone Intradermal Quadrivalent during pregnancy and collect data on their outcomes and newborn health status. Annual reports for this registry will be submitted with the Periodic Benefit-Risk Evaluation Report that includes all other Fluzone® influenza vaccines. When the registry has collected data on the outcomes specified in the protocol for 4 years, Sanofi will submit a final study report including information for both Fluzone Intradermal Quadrivalent and Fluzone Quadrivalent vaccine (administered intramuscularly). After submission of the registry report, Sanofi will continue enrolling in the registry pending CBER review of the report and determination that the registry can be discontinued.

承诺状态描述

报告接收日期

2020/11/24 0:00:00

批准日期

1999/12/9 0:00:00

截止日期

2020/12/31 0:00:00

CDER/CBER

CB

子类型标记