Trial Profile

Open-label, Multicenter, Pharmacokinetic, and Safety Study in Children (Term Newborn Infants to 23 Months of Age) Undergoing a Contrast-enhanced MRI With an Intravenous Injection of 0.1 mmol/kg BW Gadobutrol 1.0 M

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 21 Dec 2020

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At a glance

14 Jul 2015 According to a Bayer HealthCare media release, gadobutrol (Gadovist) has received approval for diagnostic use in pediatric patients less than 2 years of age in the European Union. The approval was based on results from this trial.
22 Jan 2015 New trial record
05 Jan 2015 According to the media release, the US FDA has approved gadobutrol for use with magnetic resonance imaging in pediatric patients less than 2 years of age, including term neonates. Based on the data from this trial, priority review was granted by the FDA.

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