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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:
07/21/2006
Trade Name:
Symbicort Inhalation Aerosol
Generic Name or Proper Name (*):
Formoterol / budesonide
Indications Studied:
Long-term maintenance treatment of asthma in children 12 years of age and older
Label Changes Summary:
Effectiveness and safety in patients 12 years of age and older established in studies up to 12 months long PK studies in patients 6-11 years of age Effectiveness in patients 6 to < 12 years of age has not been established Overall safety profile in patients 6 to < 12 years of age was similar to that observed in patients 12 years of age and older Studies waived in children 0-6 years of age; deferred in children 6-12 years of age New active ingredient
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
AstraZeneca
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic
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