NeoRecormon
epoetin beta
Table of contents
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 21/12/2020
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) |
|
Anatomical therapeutic chemical (ATC) code |
B03XA01
|
Publication details | |
---|---|
Marketing-authorisation holder |
Roche Registration GmbH
|
Revision |
29
|
Date of issue of marketing authorisation valid throughout the European Union |
16/07/1997
|
Contact address |
Emil-Barell-Strasse 1 |
Product information
08/12/2020 NeoRecormon - EMEA/H/C/000116 - IB/0111
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antianemic preparations
Therapeutic indication
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).