Tauvid (flortaucipir (18F))
- Region
- 🇪🇺 EU
- Active substance
- flortaucipir (18F)
- Company
- Eli Lilly Nederland B.V.
- Status
- Authorised
- Therapeutic area
- Radionuclide Imaging
- CHMP opinion
- Thu 27 Jun 2024
- EU approval
- Thu 22 Aug 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006064
- ATC
- V09AX07
- Official record
- www.ema.europa.eu
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.
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.