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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Bayer
Therapeutic Category:
Medical Imaging
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