Vaccines, Blood & Biologics
Submission of Report to BLA - Cervarix, August 2, 2007
Record of Telephone Conversation
STN Number: 125259/0
Manufacturer: GlaxoSmithKline Biologicals
Product: Human Papillomavirus Vaccine, ASO4 Adjuvant-Adsorbed
To: File
From: Helen S. Gemignani, Regulatory Project Manager
Subject: Submission of Report to BLA
Telecon Date: 02-Aug-2007 Telecon Time: 08:33am
Telecon Initiated by: Helen S. Gemignani
Contact Phone: 610 787-3726
Signature:
Summary of Telecon
I advised Mr. Whitman to send a copy of the Preliminary Safety Assessment of Adverse Events report to the BLA.
End of Teleconference
FDA Participants
- Helen S. Gemignani
GSK Participants
- Matt Whitman







