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DOTAREM® Pharmacokinetics, Safety and Efficacy Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

Trial Profile

DOTAREM® Pharmacokinetics, Safety and Efficacy Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 01 Feb 2018

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At a glance

  • Drugs Gadoterate-meglumine (Primary)
  • Indications CNS disorders; Vascular disorders
  • Focus Pharmacokinetics
  • Sponsors Guerbet
  • Most Recent Events

    • 05 Sep 2017 According to a Guerbet media release, US Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine) for intravenous use with magnetic resonance imaging (MRI) in pediatric patients under two years, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system (CNS). FDA's decision was based on this study.
    • 22 Oct 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 24 Oct 2014 New trial record
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