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Pediatric Studies Characteristics - Detail
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Pediatrics
Pediatric Studies Characteristics
Detail
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Approval Date:
01/04/2010
Trade Name:
Xolair
Generic or Proper Name (*):
omalizumab
Indications Studied:
Moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
Therapeutic Category:
Antiasthmatic
Ages Studied:
6-11 years
Study #:
1
Study Type:
Efficacy/Safety/Pharmacokinetic/Pharmacodynamic
Study Design:
Single-Blind/Placebo/Population Pharmacokinetic
No Patients:
628
No Centers:
87
No Countries:
7
BPCA(B), PREA(P):
P
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