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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:  03/10/2016
 
Trade Name:  Truvada
 
Generic Name or Proper Name (*):  emtricitabine/tenofovir disoproxil fumarate
 
Indications Studied:  Treatment of HIV-1 infection in pediatric patients weighing at least 17 kilograms
 
Label Changes Summary:  * Expanded the indication from pediatric patients 12 years and older down to pediatric patients weighing at least 17 kg. * Truvada should only be administered to HIV-1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a whole tablet. *Truvada has not been evaluated for use in pediatric patients weighing less than 17 kg. *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Gilead Sciences
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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