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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:
06/22/2010
Trade Name:
Dulera Inhalation Aerosol
Generic Name or Proper Name (*):
mometasone furoate and formoterol fumarate
Indications Studied:
Asthma
Label Changes Summary:
Safety and effectiveness have been established in patients 12 years and older in 3 clinical studies Safety and efficacy have not been established in children <12 years Data from clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients Information on adverse events and clinical studies New combination
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Schering
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic
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