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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:
12/14/2000
Trade Name:
TamiFlu
Generic Name or Proper Name (*):
oseltamivir
Indications Studied:
Treatment of uncomplicated acute illness due to influenza
Label Changes Summary:
Safety and effectiveness established for treatment in patients 1-12 years of age The safety and effectiveness in pediatric patients younger than 1 year of age have not been established Safety and effectiveness for prophylaxis in pediatric patients younger than 13 years of age have not been established (Note: labeled for prophylaxis down to 1 year due to PREA on 12/21/2005) The adverse event profile in adolescents is similar to that for adults and pediatric patients aged 1 to 12 years Information on dosing, PK parameters, AE profile, and clinical studies
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Roche
Pediatric Exclusivity Granted Date:
03/22/2004
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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