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Vaccines, Blood & Biologics

Proper Name Review Memorandum, September 2, 2009 - MenHibrix

DATE:September 2, 2009
FROM:Joseph J. Temenak, Ph.D.Chair, Biologics License Application STN 125363
SUBJECT: Proper name review for GlaxoSmithKline Biologicals’ Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine (proposed proprietary name: MenHibrix)   

        


The proper name proposed by GSK, “Meningococcal Groups C and Y and
Haemophilus b Tetanus Toxoid Conjugate Vaccine”, is consistent with other licensed vaccines that contain similar components and with the OVRR memorandum, “Guideline for Non-proprietary Vaccine Names” dated December 19, 2007.  The OVRR memorandum was provided by Dr. Marion Gruber (IOD-OVRR) to assist in the review of the proposed proper name.

In my view, the proper name proposed by GSK is acceptable.

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