Bayer HealthCare announced today that Gadovist (gadobutrol) has received a label extension in the European Union (EU) for diagnostic use with magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) in pediatric patients less than 2 years of age, including term newborns. Gadovist was approved for this expanded use through an EU variation procedure in which Germany acted as the reference member state. Country approvals by regulatory bodies across the EU will follow.

“This approval provides radiologists in Europe with an important diagnostic tool for use in the youngest pediatric population,” said Dr. Gabriele Hahn, study investigator and radiologist, University of Dresden, Germany. “The study data confirm the safety profile, dose and efficacy of gadobutrol in young patients under the age of 2, including newborns.”

For more details, go to: http://www.news.bayer.com/baynews/baynews.nsf/id/Bayer-receives-European-approval-Gadovist-gadobutrol-pediatric-patients-2-years?OpenDocument&sessionID=1437108257