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New Pediatric Labeling Information Database - Detail
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Pediatrics
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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