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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:
09/02/2016
Trade Name:
Canasa Suppositories
Generic Name or Proper Name (*):
mesalamine
Indications Studied:
Mildly to moderately active ulcerative proctitis
Label Changes Summary:
*Safety and effectiveness in pediatric patients have not been established. *Canasa was evaluated for the treatment of ulcerative proctitis in a 6-week, open-label, single-arm study in 49 patients 5 to 17 years of age. *Adverse reactions were similar to those seen in adult patients. *Information on adverse reactions, and clinical trial. *Postmarketing study.
PREA(P):
P
Sponsor:
Forest
NNPS:
FALSE
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