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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:
12/30/2002
Trade Name:
Zovirax Cream
Generic Name or Proper Name (*):
acyclovir
Indications Studied:
Treatment of herpes labialis (cold sores) in children 12 years and older
Label Changes Summary:
Adolescents 12-17 years of age included in clinical safety studies. dosing regimen established waived in children < 12 years of age because rarely seen in that population New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
GlaxoSmithKline
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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