Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

Cervarix Final Label Email - Cervarix, October 14, 2009

From: Gemignani, Helen S
Sent: Wednesday, October 14, 2009 10:56 AM
To: 'Matt.Whitman@gsk.com'; 'Cynthia.A.D'Ambrosio@gsk.com'; 'nicholas.perombelon@gsk.com'
Subject: Cervarix Final Label (Package Insert) 10.14.2009

Cynthia D'Ambrosio and I spoke this morning about the 10.13.2009 version of the CBER label sent to GSK last night. Over the phone, she and I made minor edits and those edits have been incorporated. 

 

This is considered the final label for the Cervarix BLA.

 

Helen Sullivan Gemignani
Regulatory Project Manager
FDA/CBER/OVRR
Division of Vaccines and Related Products Applications/Viral Vaccine Branch
(301) 827-3070

Page Last Updated: 04/13/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.