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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:
07/08/2011
Trade Name:
Truvada
Generic Name or Proper Name (*):
emtricitabine/tenofovir disoproxil fumarate
Indications Studied:
Treatment of HIV-1 infection in adolescents
Label Changes Summary:
* Expanded indication from adults to pediatric patients 12 years and older. * Safety and efficacy have not been established in pediatric patients less than 12 years or weighing less than 35 kg. * Truvada should only be administered to pediatric patients 12 years and older with body weight greater than or equal to 35 kg. * Information on dosing, adverse reactions, PK and clinical trial. * Postmarketing study
PREA(P):
P
Sponsor:
Gilead
NNPS:
FALSE
Therapeutic Category:
Antiviral
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