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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:
10/14/2008
Trade Name:
Zomig Nasal Spray
Generic Name or Proper Name (*):
zolmitriptan
Indications Studied:
Migraine
Label Changes Summary:
Safety and effectiveness have not been established in pediatric patients less than18 years of age. A single, multi-center, double-blind randomized placebo-controlled study failed to demonstrate efficacy in pediatric patients ages 12 -17 years for the acute treatment of migraine headaches Adverse events similar to those observed in adults.
BPCA(B) and PREA(P):
B, P
Sponsor:
AstraZeneca
Pediatric Exclusivity Granted Date:
12/18/2003
NNPS:
FALSE'
Therapeutic Category:
Antimigraine
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