Regulatory PathRegulatory requirements compared

Active substance

Flortaucipir

Open in the medicines table

EMA European Union — centrally authorised medicines

Tauvid Eli Lilly Nederland B.V. · Authorised · authorised 22 Aug 2024 · ATC V09AX07

Therapeutic indication (EMA)

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.

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
TAUVID 1 900 MBQ/ML SOLUTION FOR INJECTIONPLGB 14895/0329ELI LILLY NEDERLAND B.V.POM
TAUVID 800 MBQ/ML SOLUTION FOR INJECTIONPLGB 14895/0330ELI LILLY NEDERLAND B.V.POM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.