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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:
04/04/2016
Trade Name:
Descovy
Generic Name or Proper Name (*):
emtricitabine and tenofovir alafenamide
Indications Studied:
Treatment of HIV-1 infection in adults and pediatric patients 12 years of age or older
Label Changes Summary:
* Efficacy and safety of Descovy was established in pediatric patents aged 12 years old with body weight greater than or equal to 35 kg. * Safety and effectiveness in pediatric patients less than 12 years or less than 35 kg have not been established. * Assessment of Bone Mineral Density should be considered for adults and pediatric patients treated with Descovy who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. * Information on dosing, clinical trial and PK. * New drug.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Gilead Sciences
NNPS:
FALSE
Therapeutic Category:
Antiviral
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