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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:
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
BPCA(B):
B
Sponsor:
Roche
Pediatric Exclusivity Granted Date:
03/22/2004
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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