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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  12/24/2009
 
Trade Name:  Famvir
 
Generic or Proper Name (*):  famciclovir
 
Indications Studied:  Treatment of children 1 month  12 years of age w/ herpes simplex (HSV) & 1  12 years w/ varicella zoster (VSV)
 
Therapeutic Category:  Antiviral
 
Ages Studied:  1 month - 12 years
 
Study #:  1
 
Study Type:  Safety/Pharmacokinetic
 
Study Design:  Open label/Population Pharmacokinetic
 
No Patients:  47
 
No Centers:  6
 
No Countries:  6
 
BPCA(B), PREA(P):  B, P
 
Asian:  2
 
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