Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Vizamyl   
Auth. number : EU/1/14/941
Active substance : flutemetamol (18F)
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V09 - Diagnostic radiopharmaceuticals
Pharmacological subgroup: V09A - Central nervous system
Chemical subgroup: V09AX - Other central nervous system diagnostic radiopharmaceuticals
Chemical substance: V09AX04 - streptoduocin
(See WHO ATC Index)
Indication: This medicinal product is for diagnostic use only.
VIZAMYL is a radiopharmaceutical 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.
Marketing Authorisation Holder: GE Healthcare Ltd
Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
26/08/2014 Centralised - Authorisation EMEA/H/C/2557 (2014)6088 of 22/08/2014
13/11/2014 Centralised - Notification EMEA/H/C/2557/N/1
Updated with Decision(2016)4919 of 22/07/2016
03/08/2015 Centralised - Variation EMEA/H/C/2557/IB/4
Updated with Decision(2016)4919 of 22/07/2016
26/07/2016 PSUSA - Modification EMEA/H/C/2557/PSUSA/10293/201510 (2016)4919 of 22/07/2016
29/07/2016 Centralised - Variation EMEA/H/C/2557/IB/10
Updated with Decision(2017)4656 of 29/06/2017
21/02/2017 Centralised - Variation EMEA/H/C/2557/IB/12
Updated with Decision(2017)4656 of 29/06/2017
03/07/2017 Centralised - Yearly update (2017)4656 of 29/06/2017
31/07/2017 Centralised - Variation EMEA/H/C/2557/IB/13G
05/10/2017 Centralised - Variation EMEA/H/C/2557/IB/14