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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:  10/10/2003
 
Trade Name:  Denavir Cream
 
Generic Name or Proper Name (*):  penciclovir
 
Indications Studied:  Treatment of recurrent herpes labialis (cold sores) in children 12 years of age and older
 
Label Changes Summary:  * Extended indication down from 18 years of age to 12 years of age * Effectiveness extrapolated from adult studies * Safety study in patients 12-17 years of age * Pediatric submission
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Novartis
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral, topical
 
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