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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:
06/02/2004
Trade Name:
Humalog Injection
Generic Name or Proper Name (*):
insulin lispro
Indications Studied:
Treatment of patients with diabetes mellitus for the control of hyperglycemia (high blood sugar) in children 3-11 years of age
Label Changes Summary:
Safety and effectiveness established from studies in patients 3-11 years of age Dosing information added for external insulin pumps New route of administration
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Lilly
NNPS:
FALSE'
Therapeutic Category:
Antidiabetic
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