EMA — authorised 22 August 2024
- Application: EMEA/H/C/006064
- Marketing authorisation holder: Eli Lilly Nederland B.V.
- Local brand name: Tauvid
- Indication: This medicinal product is for diagnostic use only. Flortaucipir (18F) is a radiopharmaceutical indicated for positron emission tomography (PET) imaging of the brain to assess the neocortical distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD). Flortaucipir (18F) is an adjunct to clinical and other diagnostic evaluations. For limitations of use, see sections 4.4 and 5.1.
- Status: approved
The European Medicines Agency (EMA) has approved Tauvid (flortaucipir 18F) for diagnostic use in the European Union. This radiopharmaceutical is indicated for positron emission tomography (PET) imaging of the brain to assess the neocortical distribution of aggregated tau neurofibrillary tangles in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease. Tauvid is an adjunct to clinical and other diagnostic evaluations, and its use is limited by certain conditions outlined in the product information.