Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
-
-