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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:
05/26/2010
Trade Name:
Nasonex
Generic Name or Proper Name (*):
mometasone
Indications Studied:
Nasal congestion associated with seasonal allergic rhinitis
Label Changes Summary:
New indication in pediatric patients 2 years and older Safety and effectiveness evaluated in 3 clinical studies in 12 years and older. Use in pediatric patients 2 - 11 years is supported by data from other pediatric clinical studies Safety and effectiveness for any use in patients < 2 years have not been established Information on dosing, adverse reactions, and clinical studies in 12 years and older New indication
Product Labeling:
Labeling
Sponsor:
Schering-Plough
NNPS:
FALSE'
Therapeutic Category:
Anti-inflammatory, topical
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