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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: highlights on the European marketing approval.

Author information

  • 1Pharmacology and Clinical Evaluation Division, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain. Electronic address: acortesb_autonomo@aemps.es.
  • 2Pharmacology and Clinical Evaluation Division, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
  • 3Nuclear Medicine Department, idcsalud Hospital Albacete, Albacete, Spain.
  • 4Clinical Biostatistics Department, Hospital Ramón y Cajal, Madrid, Spain.
  • 5Neurology Department, Hospital Ruber Internacional, Madrid, Spain.
  • 6Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany.

Abstract

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).

Copyright © 2014 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

KEYWORDS:

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

PMID:
24418060
[PubMed - in process]
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