Amyvid (florbetapir (18F))
- Region
- 🇪🇺 EU
- Active substance
- florbetapir (18F)
- Company
- Eli Lilly Nederland B.V.
- Status
- Authorised
- Therapeutic area
- Radionuclide Imaging
- CHMP opinion
- Thu 18 Oct 2012
- EU approval
- Mon 14 Jan 2013
- Application
- EMEA/H/C/002422
- ATC
- V09AX05
- Official record
- www.ema.europa.eu
Indication
This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical 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. Amyvid 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.