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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  02/09/2012
 
Trade Name:  Famvir
 
Generic Name or Proper Name (*):  famciclovir
 
Indications Studied:  Recurrent herpes labialis
 
Label Changes Summary:  Efficacy has not been established in pediatric patients for the treatment of recurrent herpes labialis Information on an open label PK, safety and efficacy study in children 12 to <18 years with recurrent herpes labialis added to Pediatric Use subsection of labelingPostmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Novartis
 
Therapeutic Category:  Antiviral
 
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