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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:
02/03/2006
Trade Name:
ProAir HFA Inhalation Aerosol
Generic Name or Proper Name (*):
albuterol
Indications Studied:
Prevention of exercise-induced bronchospasm in children 12 years of age and older
Label Changes Summary:
Expands use from previously approved bronchospasm with reversible obstructive airway disease Effectiveness based on study in adults and adolescents Safety and effectiveness in pediatric patients below 12 years of age have not been established New indication
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
IVAX
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic
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