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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:
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
PREA(P):
P
Sponsor:
Gilead
NNPS:
TRUE
Therapeutic Category:
Antiviral
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