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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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


 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