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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:
03/01/2016
Trade Name:
Odefsey
Generic Name or Proper Name (*):
emtricitabine, rilpivirine, and tenofovir alafenamide
Indications Studied:
Treatment of HIV-1 infection in patients 12 years of age and older
Label Changes Summary:
* Safety and efficacy of Odefsey was established in pediatric patients 12 years and older weighing 35 kg or more. * Use of Odefsey in this age group is supported by adequate and well-controlled studies in adults with HIV-1 infection, and by 2 pediatric studies in 59 pediatric patients 12 to < 18 years. * Safety and efficacy have not been established in pediatric patients less than 12 years of age or weighing less than 35 kg. * Safety was similar to that observed in adults. * Information on clinical trials, adverse reactions. * New drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Gilead Sciences
NNPS:
FALSE
Therapeutic Category:
Antiviral
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