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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  07/22/2011
 
Trade Name:  GAMMAGARD LIQUID
 
Generic or Proper Name (*):  Immune Globulin Infusion (Human)*
 
Indications Studied:  Treatment of patients with primary immunodeficiency associated with defects in humoral immunity in adults and pediatric patients two years of age or older
 
Therapeutic Category:  Immunomodulator
 
Ages Studied:  2 - < 16 years
 
Study #:  1
 
Study Type:  Pharmacokinetic/Tolerability
 
Study Design:  Open-label, Uncontrolled, Randomized, Phase III, Multi-center
 
No Patients:  61
 
No Centers:  9
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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