This is a summary of the European public assessment report (EPAR) for Febuxostat Viatris (previously Febuxostat Mylan). It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Febuxostat Viatris. For practical information about using Febuxostat Viatris, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication Febuxostat Viatris is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Viatris is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Febuxostat Viatris is indicated in adults.
Therapeutic Area (MeSH)
ATC Code
M04AA03
ATC Item
febuxostat
Pharmacotherapeutic Group
Antigout preparations
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| febuxostat | N/A | 非布司他 |
EMA Name
Febuxostat Viatris (previously Febuxostat Mylan)
Medicine Name
Febuxostat Viatris (previously Febuxostat Mylan)
Aliases
N/ANo risk management plan link.
