Record of Telephone Conversation - Cervarix, October 20, 2009
Submission Type: Original Application Submission ID: 125259/0 Office: OVRR
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Telecon Date/Time: 02-OCT-2009 07:17 PM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Revised CERVARIX Packaging
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Gemignani, Helen S
Sent: Friday, October 02, 2009 7:17 PM
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; 'email@example.com'
Subject: FW: Revised CERVARIX Packaging
We have reviewed your revised carton and container labels attached and concur that the carton and container labeling is acceptable. These labels will be included in the final labeling when final action taken on this file. Please consider that printing before final action will be at your own risk.