Febuxostat Viatris (previously Febuxostat Mylan) (febuxostat)
- Region
- 🇪🇺 EU
- Active substance
- febuxostat
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Hyperuricemia; Arthritis, Gouty; Gout
- CHMP opinion
- Fri 21 Apr 2017
- EU approval
- Thu 15 Jun 2017
- Designations
- Generic
- Application
- EMEA/H/C/004374
- ATC
- M04AA03
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Adenuric Authorised · Menarini International Operations Luxembourg S.A. (MIOL)
- 🇪🇺 Febuxostat Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
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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.