🇪🇺 Epogen in European Union

EMA authorised Epogen on 18 December 2007

Marketing authorisation

EMA — authorised 18 December 2007

  • Application: EMEA/H/C/000872
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Retacrit
  • 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 adult and paediatric 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 transfu
  • Pathway: biosimilar
  • Status: approved

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Epogen in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Hematology approved in European Union

Frequently asked questions

Is Epogen approved in European Union?

Yes. EMA authorised it on 18 December 2007.

Who is the marketing authorisation holder for Epogen in European Union?

Pfizer Europe MA EEIG holds the EU marketing authorisation.