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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:  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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  GlaxoSmithKline
 
Pediatric Exclusivity Granted Date:  07/25/2001
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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