Fluzone; Fluzone High Dose; Fluzone Intradermal; Fluzone Quadrivalent; Fluzone HD Quadrivalent, Influenza Virus Vaccine_美国药品上市后承诺数据库

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

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

发布

承诺描述

Deferred pediatric study QHD00015 under PREA to evaluate the safety and immunogenicity of Fluzone High Dose Quadrivalent, for the prevention of influenza disease caused by influenza subtype A viruses and type B viruses contained in the vaccine in pediatric patients ages 3 to less than 5 years.

承诺状态描述

Per FDA letter dated July 1, 2020, this PMR has been Released.

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

2024/1/31 0:00:00

CDER/CBER

CB

子类型标记

P