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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:
09/28/2005
Trade Name:
Emtriva
Generic Name or Proper Name (*):
emtricitabine
Indications Studied:
HIV-1 infection in combination with other antiretroviral agents
Label Changes Summary:
Safety and effectiveness in pediatric patients 3 months and older supported by data from 3 open-label, nonrandomized clinical studies Safety and effectiveness in patients < 3 months have not been established Relative bioavailability of Emtriva oral solution is approximately 80% of Emtriva capsules. Thus, maximum dosage is different for these 2 formulations: Solution max - 240 mg once daily; Capsules max - children weighing > 33 kg one 200 mg capsule once daily The AE profile in pediatric patients was comparable to that observed in adults Information on dose, PK parameters, AE profile and clinical studies
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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