Vizamyl (flutemetamol (18F))
- Region
- 🇪🇺 EU
- Active substance
- flutemetamol (18F)
- Company
- GE Healthcare AS
- Status
- Authorised
- Therapeutic area
- Radionuclide Imaging; Alzheimer Disease
- CHMP opinion
- Thu 26 Jun 2014
- EU approval
- Fri 22 Aug 2014
- Application
- EMEA/H/C/002557
- ATC
- V09AX04
- Official record
- www.ema.europa.eu
Indication
This medicinal product is for diagnostic use only. Vizamyl is a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of ? 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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.