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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:
11/14/2008
Trade Name:
Neulasta
Generic Name or Proper Name (*):
Pefilgrastim
Indications Studied:
Decrease the incidence of infection in pediatric patients with sarcoma
Label Changes Summary:
Safety and effectiveness in pediatric patients have not been established Safety and PK were studied in 37 pediatric patients with sarcoma Information added to Pediatric Use
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Amgen
NNPS:
FALSE'
Therapeutic Category:
Hematopoietic
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