Epoetin Alfa Hexal (epoetin alfa)
- Region
- 🇪🇺 EU
- Active substance
- epoetin alfa
- Company
- Hexal AG
- Status
- Authorised
- Therapeutic area
- Anemia; Kidney Failure, Chronic; Blood Transfusion, Autologous; Myelodysplastic Syndromes
- EU approval
- Mon 27 Aug 2007
- Designations
- Biosimilar
- Application
- EMEA/H/C/000726
- ATC
- B03XA01
- Official record
- www.ema.europa.eu
Indication
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis; Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Aranesp Authorised · Amgen Europe B.V.
- 🇪🇺 Binocrit Authorised · Sandoz GmbH
- 🇪🇺 Abseamed Authorised · Medice Arzneimittel Pütter GmbH Co. KG
- 🇪🇺 Epostim Application withdrawn · Reliance GeneMedix Plc
- 🇪🇺 Nespo Withdrawn · Dompé Biotec S.p.A.
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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.