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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation - Cervarix, October 20, 2009

Submission Type: Original Application   Submission ID:  125259/0    Office: OVRR  

Product:

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Applicant:                                                                        

GlaxoSmithKline Biologicals          

Telecon Date/Time:  02-OCT-2009 07:17 PM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  HELEN GEMIGNANI

Telecon Summary:

Revised CERVARIX Packaging

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No    

Related STNs:  None

Related PMCs:  None

Telecon Body:


From: Gemignani, Helen S
Sent: Friday, October 02, 2009 7:17 PM
To: 'Matt.Whitman@gsk.com'
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; 'nicholas.perombelon@gskbio.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.