Florbetapir (18F) for brain amyloid positron emission tomography: highlights on the European marketing approval

Alzheimers Dement. 2014 Oct;10(5 Suppl):S395-9. doi: 10.1016/j.jalz.2013.09.007. Epub 2014 Jan 10.


Florbetapir (18F) for brain amyloid positron emission tomography (PET) imaging has been recently approved in Europe to estimate β-amyloid neuritic plaque density in the brain when the subject is still alive. Such density is one of the key issues for the definitive diagnosis of Alzheimer's disease (AD) at autopsy. This capability of florbetapir (18F) is regarded as a significant improvement in the diagnostic procedures for adult patients with cognitive impairment who are being evaluated for AD and other causes of cognitive impairment. The current paper highlights the specific characteristics of the European marketing authorization of florbetapir (18F).

Keywords: Brain; European Medicines Agency; Florbetapir ((18)F); Marketing approval; Positron emission tomography; β-Amyloid.

MeSH terms

  • Alzheimer Disease / diagnosis
  • Alzheimer Disease / diagnostic imaging
  • Aniline Compounds* / adverse effects
  • Brain / diagnostic imaging*
  • Cognition Disorders / diagnosis
  • Cognition Disorders / diagnostic imaging
  • Drug Approval
  • Ethylene Glycols* / adverse effects
  • Europe
  • Fluorine Radioisotopes* / adverse effects
  • Humans
  • Plaque, Amyloid / diagnostic imaging*
  • Positron-Emission Tomography / adverse effects
  • Positron-Emission Tomography / methods*
  • Radiopharmaceuticals* / adverse effects
  • Risk
  • Sensitivity and Specificity


  • Aniline Compounds
  • Ethylene Glycols
  • Fluorine Radioisotopes
  • Radiopharmaceuticals
  • florbetapir