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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:  09/13/2016
 
Trade Name:  CUVITRU
 
Generic Name or Proper Name (*):  Immune Globulin Subcutaneous (Human), 20% Liquid*
 
Indications Studied:  Indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older
 
Label Changes Summary:  See Package Insert for new information on biologics
 
PREA(P):  P
 
Sponsor:  Baxalta US, Inc.
 
NNPS:  FALSE
 
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