Review of Container and Package Labeling Memo, October 20, 2009 - MenHibrix

Date:	October 20, 2009
From:	Maryann Gallagher, Consumer Safety Officer OCBQ/DCM/APLB, HFM-602
Through:	Ele Ibarra-Pratt, RN, MPH, Branch Chief OCBQ/DCM/APLB, HFM-602
To:	Joseph Temenak, Primary Reviewer, OVRR/DVRPA Jennifer Bridgewater, RPM, OVRR/DVRPA/VCTB Meghan Ferris, MD, OVRR/DVRPA/VCTB
Subject:	Review of Proposed Container and Package Labeling
Product:	MENHIBRIX Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine BLA STN 125363
Sponsor:	GSK

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The Advertising and Promotional Labeling Branch (APLB) reviewed the proposed container and package labeling for MENHIBRIX Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine submitted on August 12, 2009, to BLA STN 125363.
APLB has the following comments:

We recommend including the indicated age group i.e., “For 6 weeks through 15 months of age” and the route of administration, with sufficient prominence to help reduce confusion with Menomune and Menactra.

If you have any questions, please contact Maryann Gallagher at 301-827-6330.