Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vizamyl   
Auth. number : EU/1/14/941
INN : 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 - Flutemetamol (18F)
(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. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1.
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