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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:  03/27/2015
 
Trade Name:  Eovist
 
Generic Name or Proper Name (*):  gadoxetate disodium
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  *An adequate and well-controlled study was not conducted. An observational study was performed in 52 patients 2 months and less than18 years with suspected or known focal liver lesions. Eovist improved border delineation and increased contrast of the lesion in the majority of patients when compared to non-contrast images. *Safety and effectiveness have not been established in premature infants *No new safety issues were identified *No case of nephrogenic systemic fibrosis associated with Eovist or any other Gadolinium-based contrast agent has been identified in pediatric patients ages 6 years and younger *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bayer
 
Therapeutic Category:  Medical Imaging
 
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