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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:
04/27/2006
Trade Name:
Genotropin Injection
Generic Name or Proper Name (*):
somatropin (rDNA origin)
Indications Studied:
Long-term treatment of growth failure associated with Turner syndrome
Label Changes Summary:
Indicated for use in pediatric patients with open epiphyses Effectiveness and safety based on studies in pediatric patients New indication
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Pharmacia & Upjohn
NNPS:
FALSE'
Therapeutic Category:
Growth hormone
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