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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:
11/16/2004
Trade Name:
Zomig
Generic Name or Proper Name (*):
zolmitriptan
Indications Studied:
Migraine
Label Changes Summary:
Clinical trial evaluating zolmitriptan in pediatric patients ages 12 -17 years did not establish the safety and effectiveness when compared to placebo AEs observed in clinical trials were similar to those observed in clinical trials in adults.
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
AstraZeneca
Pediatric Exclusivity Granted Date:
12/18/2003
NNPS:
FALSE'
Therapeutic Category:
Antimigraine
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