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Labeling Meeting Summary - May 5 2009 and May 8, 2009
MEETING DATES: May 5, 2009 and May 8, 2009.
FROM: Debbie Cordaro
RE: Labeling Meeting Summary for STN: 125329/0
ATTENDEES: Hon-Sum Ko, Dorothy Scott, Michael Kennedy, Malgorzata Mikoajczyk, Ann Gaines, Craig Zinderman, Xue Lin, Lisa Stockbridge and Debbie Cordaro
PRODUCT: Immune Globulin Intravenous (Human)
During the meetings held on May 5 and 8, 2009, the committee revised the package insert that resulted in the first revision submitted to the firm on July 16, 2009.