REVIEW MEMORANDUM

Date: September 1, 2009

 To: Matt Whitman
 Director, Regulatory Affairs
 GlaxoSmithKline

 Through: Ele Ibarra-Pratt, RN, MPH
 Branch Chief, APLB

From: Lisa Stockbridge, Ph.D.
 Consumer Safety Officer
 OCBQ/DCM/APLB, HFM-602

 Product: CERVARIX (Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
BLA 125259/0/56

Re: Proposed logo and Coming Soon Advertisement


 

The Advertising and Promotional Labeling Branch (APLB) has received GlaxoSmithKline’s (GSK) July 16, 2009, submission of a proposed logo and Coming Soon advertisement for Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant.

APLB has reviewed the proposed material and has no objections to its use at this time.

f you have any further questions or comments, you may contact Dr. Lisa Stockbridge, APLB Consumer Safety Officer, at 301-827-6226.
