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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  02/17/2011
 
Trade Name:  Hizentra
 
Generic or Proper Name (*):  Globulin Subcutaneous (Human), 20% Liquid *
 
Indications Studied:  Postmarketing study
 
Therapeutic Category:  Immune Serum
 
Ages Studied:  2 - < 18 years
 
Study #:  1
 
Study Type:  Efficacy/Safety/Pharmacokinetic/Tolerability
 
Study Design:  Multicenter, Open-label, Single arm
 
No Patients:  51
 
No Centers:  15
 
No Countries:  8
 
BPCA(B), PREA(P):  P
 
Unknown:  0
 
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