flutemetamol (18F)

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Vizamyl. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vizamyl.

For practical information about using Vizamyl, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 20/09/2023

Authorisation details

Product details
Agency product number
Active substance
flutemetamol (18F)
International non-proprietary name (INN) or common name
flutemetamol (18F)
Therapeutic area (MeSH)
  • Radionuclide Imaging
  • Alzheimer Disease
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
GE Healthcare AS
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Nycoveien 1
NO-0401 Oslo

Product information

20/09/2023 Vizamyl - EMEA/H/C/002557 - IB/0035/G

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Diagnostic radiopharmaceuticals

Therapeutic indication

This medicinal product is for diagnostic use only.

Vizamyl is a radiopharmaceutical medicinal product indicated 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 (AD) and other causes of cognitive impairment. Vizamyl should be used in conjunction with a clinical evaluation.

A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD.

Assessment history

How useful was this page?

Add your rating
1 rating