GE Healthcare Release: CHMP Recommends EU Approval Of VIZAMYL (Flutemetamol F18 Injection) For PET Imaging Of Beta Amyloid Plaque
6/30/2014 10:58:45 AM
CHALFONT ST. GILES, England--(BUSINESS WIRE)--GE Healthcare today announced the receipt of a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This opinion recommends the granting of a marketing authorisation for VIZAMYL™ (Flutemetamol F18 injection), a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of beta amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. VIZAMYL™ is for diagnostic use only and should be used in conjunction with a clinical evaluation.
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