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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:
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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