Aranesp (darbepoetin alfa)
- Region
- 🇪🇺 EU
- Active substance
- darbepoetin alfa
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Anemia; Cancer; Kidney Failure, Chronic
- CHMP opinion
- Tue 01 May 2001
- EU approval
- Fri 08 Jun 2001
- Application
- EMEA/H/C/000332
- ATC
- B03XA02
- Official record
- www.ema.europa.eu
Indication
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Nespo Withdrawn · Dompé Biotec S.p.A.
Follow Aranesp
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.