VIZAMYL (flutemetamol, 18F), diagnostic product for the central nervous system

DIAGNOSIS - New medicinal product
Opinions on drugs - Posted on May 11 2017

Reason for request


Insufficient actual benefit in the absence of any role in the diagnostic strategy for dementia


  • VIZAMYL is a radiopharmaceutical with marketing authorisation for positron emission tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease or other causes of cognitive impairment.
  • Based on poor diagnostic performance and the lack of any proven advantage over the diagnostic tools already available, particularly in situations where differential diagnosis is difficult, VIZAMYL has no role as a diagnostic test for cognitive impairment.



Clinical Benefit



Clinical Added Value

Not applicable


Therapeutic use


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