• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
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
Sponsor:  Guerbet
Therapeutic Category:  Medical imaging