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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:  06/12/2015
 
Trade Name:  Zomig Nasal Spray
 
Generic Name or Proper Name (*):  zolmitriptan
 
Indications Studied:  Acute treatment of migraine with or without aura in adolescents 12 to 17 years old
 
Label Changes Summary:  * Efficacy in pediatric patients 12 to 17 years was established in a placebo-controlled study with 81 pediatric patients receiving Zomig 2.5 mg and 229 pediatric patients receiving Zomig 5 mg * Safety of Zomig nasal spray in the acute treatment of migraine in pediatric patients 12 to 17 years of age was established i n two studies * Safety and effectiveness of in pediatric patients under 12 years have not been established * Adverse reactions were similar to those observed in adults * Information on dosing, clinical trials, adverse reactions * Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  AstraZeneca
 
NNPS:  FALSE
 
Therapeutic Category:  Antimigraine
 
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