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U.S. Department of Health and Human Services

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  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Gilead
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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