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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:
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
PREA(P):
P
Sponsor:
Bayer
NNPS:
FALSE
Therapeutic Category:
Medical Imaging
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