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
Phase of Trial: Phase I
Latest Information Update: 01 Jan 2016
At a glance
- Drugs Gadobutrol (Primary)
- Indications Vascular disorders
- Focus Pharmacokinetics
- Sponsors Bayer; Bayer HealthCare
- 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.