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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:  01/19/2011
 
Trade Name:  Nasonex
 
Generic Name or Proper Name (*):  mometasone
 
Indications Studied:  Treatment of nasal polyps
 
Label Changes Summary:  * Safety and effectiveness for the treatment of nasal polyps in children < 18 years have not been established* A trial in pediatric patients 6 to 17 years did not support the efficacy of Nasonex Nasal Spray in the treatment of nasal polyps * The adverse events were similar to adults* Information on clinical tria
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Schering Plough
 
NNPS:  TRUE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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