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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:  04/27/2016
 
Trade Name:  Gadavist
 
Generic Name or Proper Name (*):  gadobutrol
 
Indications Studied:  Evaluation of known or suspected supra-aortic or renal artery disease in adult and pediatric patients
 
Label Changes Summary:  * Approved for use in adults and pediatric patients, including term neonates, to evaluate known or suspected supra-aortic or renal artery disease. * Information on clinical trials. * New indication.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bayer
 
NNPS:  FALSE
 
Therapeutic Category:  Medical Imaging
 
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