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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:
09/15/2006
Trade Name:
Noxafil Oral Suspension
Generic Name or Proper Name (*):
posaconazole
Indications Studied:
Prevention of invasive Aspergillis and Candida infections in patients 13 years of age and older
Label Changes Summary:
Information on PK and safety studies in patients 13-17 years of age Safety profile in patients 8-17 years of age similar to adults Safety and effectiveness in patients below 13 years of age have not been established Additional information on pharmacokinetics provided in patients down to 8 years of age Studies deferred in children 0-12 years of age New drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Schering
NNPS:
FALSE'
Therapeutic Category:
Antifungal
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