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Vaccines

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