Retacrit (epoetin zeta)
- Region
- 🇪🇺 EU
- Active substance
- epoetin zeta
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Anemia; Blood Transfusion, Autologous; Kidney Failure, Chronic; Cancer
- CHMP opinion
- Thu 18 Oct 2007
- EU approval
- Tue 18 Dec 2007
- Designations
- Biosimilar
- Application
- EMEA/H/C/000872
- 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 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 transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). Retacrit can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood-saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (four or more units of blood for females or five or more units for males). Retacrit can be used to reduce exposure to allogeneic blood transfusions in adult non-iron-deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1800 ml).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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