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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  02/09/2012
 
Trade Name:  Famvir
 
Generic or Proper Name (*):  famciclovir
 
Indications Studied:  Recurrent herpes labialis
 
Therapeutic Category:  Antiviral
 
Ages Studied:  12 - < 18 years
 
Study #:  1
 
Study Type:  Efficacy/Safety/Pharmacokinetic
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  53
 
No Centers:  10
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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