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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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

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.