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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:
08/16/2001
Trade Name:
Epivir-HBV
Generic Name or Proper Name (*):
lamivudine
Indications Studied:
Treatment of Chronic Hepatitis B
Label Changes Summary:
Safety and effectiveness established down to 2 years Established a dose of 3mg/kg/day up to a maximum of 100mg/day (adult dose)
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
GlaxoSmithKline
Pediatric Exclusivity Granted Date:
07/25/2001
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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