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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:  06/06/2019
 
Trade Name:  Nucala
 
Generic Name or Proper Name (*):  mepolizumab
 
Indications Studied:  Add-on maintenance treatment of patients with severe asthma aged 12 years and older
 
Label Changes Summary:  *New liquid formulation approved for subcutaneous injection via Autoinjector (AI) or Safety Syringe Device (SSD). *This formulation is approved for the same dosages, route of administration (SC), and indications for the new SSD and AI presentations as the approved lyophilized drug product. *New dosage form.
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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