The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended GE Healthcare's Vizamyl be cleared for marketing.
Vizamyl (flutemetamol F-18 injection) is intended for PET brain imaging to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease or other causes of cognitive decline.
The U.S. Food and Drug Administration (FDA) approved Vizamylfor PET imaging in October 2013.
