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Silapo (epoetin zeta)

Region

🇪🇺 EU

Active substance

epoetin zeta

Company

Stada Arzneimittel AG

Status

Authorised

Therapeutic area

Anemia; Blood Transfusion, Autologous; Cancer; Kidney Failure, Chronic

CHMP opinion

Thu 18 Oct 2007

EU approval

Tue 18 Dec 2007

Designations

Biosimilar

Application

EMEA/H/C/000760

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). Silapo 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 (4 or more units of blood for females or 5 or more units for males). Silapo is indicated for non-iron deficient adults prior to major elective orthopaedic surgery having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 ml). Silapo can be used to increase haemoglobin concentration in symptomatic anaemia (haemoglobin concentration of ?10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/ml).

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Retacrit Authorised · Pfizer Europe MA EEIG

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.