Anpheros Search · Treatment

Epoetin zeta

Also known as: Silapo · Retacrit

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In short

In the European Union, epoetin zeta is indicated for the treatment of symptomatic anaemia associated with chronic renal failure in adult and paediatric patients, including those on haemodialysis, adult patients on peritoneal dialysis, and adult patients with renal insufficiency not yet undergoing dialysis. It is also indicated to treat anaemia and reduce transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma, or multiple myeloma who are at risk of transfusion. Additionally, it can be used to increase the yield of autologous blood in a predonation programme, or to reduce exposure to allogeneic blood transfusions in non-iron deficient adults with moderate anaemia prior to major elective orthopaedic surgery.

Source: European Medicines Agency (EMA), Silapo — EPAR, 04/08/2026. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

EMA
EMEA/H/C/000760, EMEA/H/C/000872

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Silapo

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).

Source: European Medicines Agency (EMA), Silapo — EPAR, 04/08/2026. © European Medicines Agency.

Document date: 04/08/2026 · Official document →

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What is Epoetin zeta approved for in the European Union?

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). (Source: European Medicines Agency (EMA), Silapo — EPAR, 04/08/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Silapo — EPAR, 04/08/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →