Fasturtec (rasburicase)
- Region
- 🇪🇺 EU
- Active substance
- rasburicase
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- Therapeutic area
- Hyperuricemia
- EU approval
- Fri 23 Feb 2001
- Application
- EMEA/H/C/000331
- ATC
- V03AF07
- Official record
- www.ema.europa.eu
Indication
Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
Regulatory milestones
No milestones recorded in the last year.
Follow Fasturtec
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.