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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:  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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  12/18/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Antimigraine
 
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