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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:
03/11/2019
Trade Name:
Dupixent
Generic Name or Proper Name (*):
dupilumab
Indications Studied:
Moderate-to-severe atopic dermatitis
Label Changes Summary:
*Safety and efficacy have been established in pediatric patients 12 years and older. *A total of 251 adolescents ages 12 to 17 years old with moderate-to-severe atopic dermatitis were enrolled in the clinical trial. *Safety and efficacy in pediatric patients less than12 years with atopic dermatitis have not been established. *The safety profile in pediatric patients is similar to that in adults. *Information on adverse reactions, PK parameters and clinical trial. *Postmarketing study.
Product Labeling:
[INVALID]
PREA(P):
P
Sponsor:
Regeneron Pharmaceuticals
NNPS:
FALSE
Therapeutic Category:
Monoclonal antibody
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