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Vaccines

Record of Telephone Conversation - Cervarix, August 28, 2009 PM

System Info - 104079  SHONE, DEANNA   02-Sep-2009 14:48:31  SHONEDE

RECORD OF TELEPHONE CONVERSATION

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:  28-AUG-2009 02:20 PM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Advice

Author:  HELEN GEMIGNANI

Telecon Summary:

Final Product UNII Codes

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


From: Gemignani, Helen S
Sent: Friday, August 28, 2009 2:20 PM
To: 'Matt.Whitman@gsk.com'
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'
Subject: Cervarix - UNII Codes

Here are the final UNII Codes for Cervarix as well as the descriptions for the active substances. FDA no longer assigns active moiety codes. Please let us know if you object to the residue descriptions as they contain actual protein sequences.

 

Active

  •   HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN        UNII    M7H9CF9G0Z
  •   HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN        UNII    7XB76X2V7T 

 

Inactive

  •   3-O-desacyl-4’-monophosphoryl lipid A (MPL)  (preferred term MONOPHOSPHORYL LIPID A)                          UNII MWC0ET1L2P
  •   Sodium dihydrogen phosphate dihydrate  (preferred term SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE)   UNII  5QWK665956
  •   Aluminum Hydroxide   5QB0T2IUN0

 

Helen Sullivan Gemignani
Regulatory Project Manager
FDA/CBER/OVRR
Division of Vaccines and Related Products Applications/Viral Vaccine Branch
(301) 827-3070

HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN

UNII M7H9CF9G0Z

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Two (2) pages determined to be non-releasable:  (b)(4)