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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:  03/20/2013
 
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 years*Safety and efficacy have not been established in pediatric patients < 2 years*Information on clinical trial, dosing, adverse reactions*New Drug
 
Product Labeling:    Opens a new window
 
PREA(P):  P
 
Sponsor:  Guerbet
 
NNPS:  FALSE
 
Therapeutic Category:  Medical imaging
 
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