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.
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).
Therapeutic Area (MeSH)
ATC Code
B03XA01
ATC Item
erythropoietin
Pharmacotherapeutic Group
Antianemic preparations
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| epoetin beta | N/A | 人促红素 |
EMA Name
NeoRecormon
Medicine Name
NeoRecormon
Aliases
N/ANo risk management plan link.
