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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:  03/20/2014
 
Trade Name:  Baraclude
 
Generic Name or Proper Name (*):  entecavir
 
Indications Studied:  Treatment of chronic hepatitis B virus (HBV) infection
 
Label Changes Summary:  Approved for use in pediatric patients 2 years and older Safety and effectiveness have not been established in pediatric patients less than 2 years. Use in this age group has not been evaluated because treatment of HBV in this age group is rarely required There are limited data available on the use of Baraclude in lamivudine-experienced pediatric patients Adverse reactions in clinical trials were similar to those observed in adults Information on dosing in pediatric patients 2 years and weighing at least 10 kg, adverse reactions, PK parameters and clinical trials New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Bristol-Myers Squibb
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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