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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:  08/25/2017
 
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:  *Expanded indication down to term neonates; previously approved for use in 2 years and older. *A non-randomized study with 28 pediatric patients under 2 years who were referred for contrast MRI of the CNS supported extrapolation of CNS efficacy findings from adults and older children. *Safety has not been established in preterm neonates. *No cases of Nephrogenic Systemic Fibrosis associated with Dotarem or any other gadolinium-based contrast agents have been identified in pediatric patients age 6 years and younger. *Information on dosing, PK parameters, adverse reactions in pediatric patients, and clinical trial.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Guerbet
 
NNPS:  FALSE
 
Therapeutic Category:  Medical imaging
 
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