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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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