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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:
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
PREA(P):
P
Sponsor:
GlaxoSmithKline
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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