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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:
03/20/2013
Trade Name:
Dotarem
Generic Name or Proper Name (*):
gadoterate meglumine
Indications Studied:
Contrast agent for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity
Label Changes Summary:
Safety and efficacy have been established in pediatric patients from 2 to 17 yearsSafety and efficacy have not been established in pediatric patients < 2 yearsInformation on clinical trial, dosing, adverse reactionsNew Drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Guerbet
NNPS:
FALSE'
Therapeutic Category:
Medical imaging
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