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:  02/23/2016
 
Trade Name:  Complera
 
Generic Name or Proper Name (*):  emtricitabine/rilpivirine/tenofovir disoproxil fumarate
 
Indications Studied:  Treatment of HIV-1 infection
 
Label Changes Summary:  * Extended the indication from adults to pediatric patients in 12 to less than 18 years. *Safety and efficacy have not been established in pediatric patients less than 12 years or weighing less than 35 kg. * Pediatric trials have not been conducted using the emtricitabine, rilpivirine, tenofovir disoproxil fumarate fixed-dose combination tablets. Pediatric information is based on trials conducted with the individual entities. * Information on pharmacokinetics, and dosing. * Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Gilead
 
NNPS:  TRUE
 
Therapeutic Category:  Antiviral
 
-
-