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 17/09/2018

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
27
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

09/08/2018 NeoRecormon - EMEA/H/C/000116 - N/0099

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

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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