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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:
05/30/2013
Trade Name:
Kepivance
Generic Name or Proper Name (*):
palifermin
Indications Studied:
Acute leukemias undergoing myeloablative therapy and allogeneic hematopoietic stem cell transplant
Label Changes Summary:
Use in pediatric patients ages 1 - 16 years is supported by evidence from adequate and well-controlled studies in adults and a phase 1 study that included 27 pediatric patients with acute leukemia undergoing hematopoietic stem cell transplant Postmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Quintiles, Inc.
NNPS:
FALSE'
Therapeutic Category:
Immunologic agent
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