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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:
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
PREA(P):
P
Sponsor:
AstraZeneca
NNPS:
FALSE
Therapeutic Category:
Antimigraine
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