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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:
01/27/2017
Trade Name:
AirDuo RespiClick
Generic Name or Proper Name (*):
fluticasone propionate/salmeterol
Indications Studied:
"Maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older"
Label Changes Summary:
*Approved for use in 12 years and older. *Safety and effectiveness in pediatric patients below the age of 12 years have not been established. *Inhaled corticosteroids, including fluticasone propionate, may cause a reduction in growth velocity in adolescents. *Information on dosing, and adverse reactions and clinical trials in adults and pediatric patients 12 years and older. *New dosage form.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Teva
Therapeutic Category:
Antiasthmatic
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