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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|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
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.
|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|