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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:
01/22/2014
Trade Name:
Xerese
Generic Name or Proper Name (*):
acyclovir/ hydrocortisone
Indications Studied:
Treatment of recurrent herpes labialis
Label Changes Summary:
Expanded indication to include 6 years to less than 12 years; previously approved for use in 12 years and older Safety and effectiveness in pediatric patients less than 6 years of age have not been established Adverse reactions similar to those observed in adultsInformation on dose, and clinical trial
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Valeant International Bermuda
NNPS:
FALSE'
Therapeutic Category:
Antiviral, topical
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