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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:
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
BPCA(B) and PREA(P):
B,P
Sponsor:
Bristol-Myers Squibb
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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