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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Labeling Request Memorandum, May 14, 2012 - MenHibrix

Date: May 14, 2012

To: 125363
From: David Staten, RPM

Subject: Labeling Request

Reference is made to the Hiberix (STN 125347) file to include a 0.9% sodium chloride diluent vial presentation manufactured by –b(4)-------------------. Changes had been made in the PI for this supplement that will pertain equally to the MenHibrix PI. In order to facilitate the review of the MenHibrix labeling, CBER requested a revised PI which contains the changes made to the Hiberix PI. GSK agreed.