🇪🇺 erythropoietin beta in European Union

EMA authorised erythropoietin beta on 16 July 1997

Marketing authorisation

EMA — authorised 16 July 1997

  • Application: EMEA/H/C/000116
  • Marketing authorisation holder: Roche Registration GmbH
  • Local brand name: NeoRecormon
  • 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
  • Status: approved

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Other Hematology approved in European Union

Frequently asked questions

Is erythropoietin beta approved in European Union?

Yes. EMA authorised it on 16 July 1997.

Who is the marketing authorisation holder for erythropoietin beta in European Union?

Roche Registration GmbH holds the EU marketing authorisation.