• 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
Therapeutic Category:  Antiviral