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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:  12/22/2016
 
Trade Name:  Lumason
 
Generic Name or Proper Name (*):  Sulfur Hexafluoride Lipid-Type A Microspheres
 
Indications Studied:  Evaluation of suspected or known vesicoureteral reflux in pediatric patients
 
Label Changes Summary:  *Effectiveness in pediatric patients has been established for use in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux from two published studies comprising a total of 411 pediatric patients. *Safety of intravesical use of Lumason was based on evaluation of published literature involving use of Lumason in over 6000 pediatric patients. No adverse reactions were reported. *Information on published studies. *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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