USA

News

FDA Approves Dotarem®

21.03.2013 07:00

FDA Approves Dotarem® (gadoterate meglumine), first macrocyclic and ionic gadolinium-based contrast agent in USA

Guerbet announced today that the US Food and Drug Administration (FDA) has approved Dotarem® (gadoterate meglumine), a gadolinium-based contrast agent (GBCA) indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Read the press release

Full Dotarem Injection Prescribing Information (Vials and Syringes)

Full Dotarem Injection Prescribing Information (Pharmacy Bulk Package)