Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 31 October 2017

Indication(s)

- Febuxostat Mylan 80 mg film-coated tablets
Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Mylan is indicated in adults.



- Febuxostat Mylan 120 mg film-coated tablets
Febuxostat Mylan 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 Mylan 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).

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/004374
Orphan designation No
Date First Approved 15-06-2017
Type Medicinal product subject to medical prescription
Marketing authorisation holder Mylan S.A.S