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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:
12/22/2006
Trade Name:
Emtriva
Generic Name or Proper Name (*):
emtricitabine
Indications Studied:
HIV-1 infection in combination with other antiretroviral agents
Label Changes Summary:
Efficacy in preventing or treating HIV in neonates to 3 month olds could not be determined after a PK study in 20 neonates born to HIV positive mothers Information on dose in 0-3 months, additional safety and PK parameters
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Gilead Sciences
Pediatric Exclusivity Granted Date:
05/24/2006
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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