Febuxostat Krka (febuxostat)
Generic
- Region
- 🇪🇺 EU
- Active substance
- febuxostat
- Company
- KRKA tovarna zdravil d.d. Novo mesto
- Status
- Authorised
- Therapeutic area
- Hyperuricemia; Gout
- CHMP opinion
- Thu 31 Jan 2019
- EU approval
- Thu 28 Mar 2019
- Designations
- Generic
- Application
- EMEA/H/C/004773
- ATC
- M04AA03
- Official record
- www.ema.europa.eu
Indication
Febuxostat Krka 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 Krka 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
- 🇪🇺 Adenuric Authorised · Menarini International Operations Luxembourg S.A. (MIOL)
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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.