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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:  01/17/2008
 
Trade Name:  TamiFlu
 
Generic Name or Proper Name (*):  oseltamivir
 
Indications Studied:  Safety information resulting from studies that established treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older
 
Label Changes Summary:  * Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. * These events have been reported in patients receiving oseltamivir, primarily among pediatric patients, appear to be uncommon, and often had an abrupt onset and rapid resolution * If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Roche
 
Pediatric Exclusivity Granted Date:  03/22/2004
 
NNPS:  TRUE
 
Therapeutic Category:  Antiviral
 
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