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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  11/14/2008
 
Trade Name:  Neulasta
 
Generic or Proper Name (*):  Pefilgrastim
 
Indications Studied:  Decrease the incidence of infection in pediatric patients with sarcoma
 
Therapeutic Category:  Hematopoietic
 
Ages Studied:  0 - 21 years
 
Study #:  1
 
Study Type:  Safety/Pharmacokinetic
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  44
 
No Centers:  10
 
No Countries:  2
 
BPCA(B), PREA(P):  P
 
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