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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:  11/04/2015
 
Trade Name:  Nucala
 
Generic Name or Proper Name (*):  mepolizumab
 
Indications Studied:  Treatment in severe asthma in patients 12 years and older older and with an eosinophilic phenotype
 
Label Changes Summary:  *Indicated for adults and pediatric patients 12 years and older * A total of 28 adolescents aged 12 to 17 years with asthma were enrolled in the phase 3 studies. *Safety and efficacy in pediatric patients less than 12 years have not been established. *Information on dosing, and clinical trials *New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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