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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:
05/06/2019
Trade Name:
Sorilux
Generic Name or Proper Name (*):
calcipotriene
Indications Studied:
Topical treatment of plaque psoriasis of the scalp and body in patients 12 years and older
Label Changes Summary:
*Safety and effectiveness have been established in pediatric patients age 12 years and older for topical treatment of plaque psoriasis of the scalp and body. *Use of in this age group is supported by two adequate and well controlled 8-week trials in adults and adolescents 12 years and older, with additional data from an open-label safety and pharmacokinetics study. *The safety and effectiveness of in pediatric patients less than 12 years of age have not been established. *Information on adverse reactions, PK parameters, and clinical trials.
PREA(P):
P
Sponsor:
Mayne Pharma International
NNPS:
FALSE
Therapeutic Category:
Antipsoriatic, topical
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