NeoRecormon (epoetin beta)
- Region
- 🇪🇺 EU
- Active substance
- epoetin beta
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Kidney Failure, Chronic; Anemia; Cancer; Blood Transfusion, Autologous
- CHMP opinion
- Wed 16 Oct 1996
- EU approval
- Wed 16 Jul 1997
- Application
- EMEA/H/C/000116
- 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 symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy; increasing the yield of autologous blood from patients in a pre-donation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Mircera Authorised · Roche Registration GmbH
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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.