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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:
11/25/2013
Trade Name:
Noxafil
Generic Name or Proper Name (*):
posaconazole
Indications Studied:
Prophylaxis of invasive Aspergillus and Candida infections in high risk patients
Label Changes Summary:
Safety and effectiveness have been established in pediatric patients 13 - 17 years. Use is supported by evidence from adequate and well-controlled studies in adults. PK and safety in pediatric patients 13 - 17 years were also assessed and are similar to adults.Safety and effectiveness in pediatric patients less than 13 years have not been establishedInformation on dosing, PK, and clinical trials
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B,P
Sponsor:
Merck Sharp & Dohme Corp.
NNPS:
FALSE'
Therapeutic Category:
Antifungal
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