Adenuric (febuxostat)
- Region
- 🇪🇺 EU
- Active substance
- febuxostat
- Company
- Menarini International Operations Luxembourg S.A. (MIOL)
- Status
- Authorised
- Therapeutic area
- Gout
- EU approval
- Mon 21 Apr 2008
- Application
- EMEA/H/C/000777
- ATC
- M04AA03
- Official record
- www.ema.europa.eu
Indication
80 mg strength: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated in adults. 120 mg strength: Adenuric 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). Adenuric 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). Adenuric is indicated in adults.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Febuxostat Viatris (previously Febuxostat Mylan) Authorised · Viatris Limited
- 🇪🇺 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.