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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:
02/28/2006
Trade Name:
Flovent HFA
Generic Name or Proper Name (*):
fluticasone propionate
Indications Studied:
Asthma in 4 - 11 years
Label Changes Summary:
Flovent HFA should be administered by the orally inhaled route only in patients 4 years and older. Clinical studies were conducted in children with asthma 6 months to less than 4 years Information added to Pediatric Use
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
GlaxoSmithKline
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic
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