Epoetin Alfa Hexal
Epoetin Alfa Hexal is a medicine used for the following:
- to treat anaemia (low red blood cell counts) that is causing symptoms in patients with ‘chronic kidney failure’ (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
- to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions;
- to increase the amount of blood that can be taken in adult patients with moderate anaemia and normal blood iron levels who are going to have an operation and donate their own blood before surgery (autologous blood transfusion);
- to reduce the need for blood transfusions in adults with moderate anaemia who are about to undergo major orthopaedic (bone) surgery, such as hip surgery. It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood;
- to treat anaemia in adults with myelodysplastic syndromes (conditions in which the production of healthy blood cells is defective). Epoetin Alfa Hexal is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.
Epoetin Alfa Hexal contains the active substance epoetin alfa and is a ‘biosimilar medicine’. This means that Epoetin Alfa Hexal is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Epoetin Alfa Hexal is Eprex/Erypo. This is a summary of the European public assessment report (EPAR) for Epoetin Alfa Hexal. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Epoetin Alfa Hexal.
Epoetin Alfa Hexal : EPAR - Summary for the public (PDF/87.92 KB)
First published: 12/10/2009
Last updated: 02/10/2018
Epoetin Alfa Hexal : EPAR Risk-management-plan summary (PDF/106.55 KB)
First published: 02/10/2018
Epoetin Alfa Hexal
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07/12/2018 Epoetin Alfa Hexal - EMEA/H/C/000726 - WS/1507
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:
- treatment of anaemia associated with chronic renal failure in paediatric and adult 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).