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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:  06/24/2004
 
Trade Name:  TamiFlu
 
Generic Name or Proper Name (*):  oseltamivir
 
Indications Studied:  Treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older
 
Label Changes Summary:  * Not recommended in pediatric patients less than 1 year of age because of uncertainties regarding the rate of development of the human blood-brain barrier and the unknown clinical significance of animal toxicology data for human infants
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Roche
 
Pediatric Exclusivity Granted Date:  03/22/2004
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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