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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:  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  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Gilead
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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