NeoRecormon

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epoetin beta

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

Overview

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

This EPAR was last updated on 24/11/2021

Authorisation details

Product details
Name
NeoRecormon
Agency product number
EMEA/H/C/000116
Active substance
epoetin beta
International non-proprietary name (INN) or common name
epoetin beta
Therapeutic area (MeSH)
  • Kidney Failure, Chronic
  • Anemia
  • Cancer
  • Blood Transfusion, Autologous
Anatomical therapeutic chemical (ATC) code
B03XA01
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
31
Date of issue of marketing authorisation valid throughout the European Union
16/07/1997
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

04/11/2021 NeoRecormon - EMEA/H/C/000116 - N/0115

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antianemic preparations

Therapeutic indication

  • Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients;
  • treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy;
  • increasing the yield of autologous blood from patients in a pre-donation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving 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).

Assessment history

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