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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  07/30/2015
 
Trade Name:  Gammaplex
 
Generic Name or Proper Name (*):  Immune Globulin Intravenous (Human) 5% Liquid*
 
Indications Studied:  Treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bio Products Laboratory
 
NNPS:  FALSE
 
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