|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.