Retacrit

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epoetin zeta

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Retacrit. 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 Retacrit.

This EPAR was last updated on 31/08/2018

Authorisation details

Product details
Name
Retacrit
Agency product number
EMEA/H/C/000872
Active substance
epoetin zeta
International non-proprietary name (INN) or common name
epoetin zeta
Therapeutic area (MeSH)
  • Anemia
  • Blood Transfusion, Autologous
  • Kidney Failure, Chronic
  • Cancer
Anatomical therapeutic chemical (ATC) code
B03XA01
Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Hospira UK Limited
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
18/12/2007
Contact address
Horizon, Honey Lane
Hurley, Maidenhead, SL6 6RJ
United Kingdom

Product information

03/08/2018 Retacrit - EMEA/H/C/000872 - IB/0085

Contents

  • 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.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Anti anaemic preparations

Therapeutic 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).

Assessment history

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