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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:  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  Opens a new window
Sponsor:  Roche
Pediatric Exclusivity Granted Date:  03/22/2004
Therapeutic Category:  Antiviral