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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:
02/01/2008
Trade Name:
Asmanex Twisthaler 110mcg inhalation powder
Generic Name or Proper Name (*):
mometasone furoate
Indications Studied:
Maintenance treatment of asthma as prophylactic therapy in children 4 years of age and older
Label Changes Summary:
Not indicated for relief of acute bronchospasm or in children less than 4 years of age Clinical studies, including 52 week safety trial conducted in children 4 11 years of age Pediatric dosing information provided Child may not get the most benefit for 1 to 2 weeks or longer after starting treatment New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Schering Corporation
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic
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