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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:  03/31/2016
 
Trade Name:  Lumason
 
Generic Name or Proper Name (*):  Sulfur Hexafluoride Lipid-Type A Microspheres
 
Indications Studied:  Ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
 
Label Changes Summary:  * Effectiveness in pediatric patients has been established for use in ultrasonography of the liver for characterization of focal liver lesions from adequate and well controlled trials in adult patients and a clinical study of 44 pediatric patients. Safety was based on evaluation of published literature involving use of Lumason in over 900 pediatric patients. Non-fatal anaphylaxis was reported in one pediatric patient. * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bracco Diagnostics
 
NNPS:  FALSE
 
Therapeutic Category:  Medical Imaging
 
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