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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:
11/01/2006
Trade Name:
Humatrope for injection
Generic Name or Proper Name (*):
somatropin (rDNA origin)
Indications Studied:
Treatment of short stature or growth failure in children with short stature homeobox-containing gene (SHOX) deficiency
Label Changes Summary:
Effectiveness established from one 2-year study for SHOX in 52 pediatric patients Information on adverse events provided Dosing information provided New indication
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Lilly
NNPS:
FALSE'
Therapeutic Category:
Growth hormone
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