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U.S. Department of Health and Human Services

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  Opens a new window
 
PREA(P):  P
 
Sponsor:  AstraZeneca
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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