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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Novartis
Therapeutic Category:
Antiviral
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