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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:
12/19/2007
Trade Name:
Hepsera
Generic Name or Proper Name (*):
adefovir dipivoxil
Indications Studied:
Chronic hepatitis B virus infection
Label Changes Summary:
Extended indication from adults to pediatric patients 12 years and older Not recommended for children <12 years of age. Efficacy was not significantly different from placebo in a clinical study in children <12 years Safety e12 < 18 years was similar to that observed in adults Information on PK, AEs, clinical study, clinical resistance
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Gilead
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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