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U.S. Department of Health and Human Services

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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Lilly
 
NNPS:  FALSE
 
Therapeutic Category:  Antidiabetic
 
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