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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:
03/24/2010
Trade Name:
Viread
Generic Name or Proper Name (*):
tenofovir disoproxil fumarate
Indications Studied:
Treatment of HIV infection in combination with other antiretroviral agents
Label Changes Summary:
Expanded indication from adults to pediatric patients 12- <18 years Safety and effectiveness in patients < 12 years have not been established In a clinical study of HIV-1 infected adolescents bone effects were similar to adults The adverse reactions in trial in adolescents were consistent with those observed in clinical trials in adults Information on dosing in adolescents weighing e35 kg, adverse reactions, and PK parameters
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Gilead
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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