Basic Information
Febuxostat Viatris (previously Febuxostat Mylan)
Regulatory Information
EMEA/H/C/004374
June 15, 2017
April 21, 2017
13
April 11, 2024
Company Information
Ireland
Damastown Industrial Park Dublin 15
VIATRIS PHARMA LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
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.
Overview Summary
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.