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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:  12/04/2015
 
Trade Name:  Gamunex-C
 
Generic Name or Proper Name (*):  Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified*
 
Indications Studied:  Primary Humoral Immunodeficiency in patients two years of age and older
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM069968.pdf  Opens a new window
 
PREA(P):  P
 
Sponsor:  Grifols Therapeutics Inc.
 
NNPS:  FALSE
 
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