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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:
07/06/2016
Trade Name:
Xolair
Generic Name or Proper Name (*):
omalizumab
Indications Studied:
Moderate to severe persistent asthma in pediatric patients 6 to 11 years of age
Label Changes Summary:
*Safety and efficacy of Xolair for asthma were evaluated in 2 trials in 926 (Xolair 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma. *Safety and efficacy in pediatric patients with asthma below 6 years of age have not been established. *Information on dosing, immunogenicity, adverse reactions, clinical trials. *Postmarketing study.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Genentech
NNPS:
FALSE
Therapeutic Category:
Antiasthmatic
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