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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:
09/09/2016
Trade Name:
Noxafil
Generic Name or Proper Name (*):
posaconazole
Indications Studied:
Postmarketing study
Label Changes Summary:
*In a study of 136 neutropenic pediatric patients 11 months to less than 18 years treated with posaconazole oral suspension, the exposure was attained in approximately 50% of patients instead of the pre-specified 90% of patients. *Postmarketing study.
BPCA(B) and PREA(P):
B,P
Sponsor:
Merck
NNPS:
FALSE
Therapeutic Category:
Antiviral
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