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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:  03/29/2006
 
Trade Name:  Relenza
 
Generic Name or Proper Name (*):  zanamivir
 
Indications Studied:  Prevention of influenza in children 5 years of age and older
 
Label Changes Summary:  * Safety and effectiveness for prophylaxis based on 4 clinical studies in patients 5-16 years of age * No differences in safety and effectiveness were observed between pediatric and adult subjects. * Dosing information provided * Studies waived in children <5 years of age * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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