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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:
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
PREA(P):
P
Sponsor:
Grifols Therapeutics Inc.
NNPS:
FALSE
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