GE Healthcare announces European Union approval of Vizamyl (Flutemetamol (18F) solution for injection) for PET imaging of beta amyloid plaque in suspected Alzheimer’s disease

EMA

GE Healthcare announced today that Vizamyl (flutemetamol (18F) solution for injection) has received marketing authorisation from the European Commission as 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 the only PET imaging tracer for detection of amyloid approved in Europe for visual interpretation of colour images and will be commercially available in selected European countries from early 2015. Vizamyl is for diagnostic use only and should be used in conjunction with a clinical evaluation.

“Dementia is one of the biggest health and social challenges in the world and receiving marketing authorisation for Vizamyl in the European Union (EU) demonstrates our continued commitment to helping to meet this challenge and support the diagnosis of Alzheimer’s disease” said Kieran Murphy, President and CEO, Life Sciences, GE Healthcare. “This approval will provide physicians in the EU with an important tool that may help them better assess specific patients who are being evaluated for Alzheimer’s disease and will also support further research into greatly needed disease modifying agents.”

For more details, go to: http://www.genewscenter.com/Press-Releases/GE-Healthcare-Announces-European-Union-Approval-of-VIZAMYL-Flutemetamol-18F-solution-for-injecti-48d7.aspx

Michael Wonder

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Michael Wonder

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