This is a summary of the European public assessment report (EPAR) for Mircera. 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 Mircera.
Therapeutic Indication
### Therapeutic indication Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1). Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA (see section 5.1).
Therapeutic Area (MeSH)
ATC Code
B03XA03
ATC Item
methoxy polyethylene glycol-epoetin beta
Pharmacotherapeutic Group
Antianemic preparations
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Methoxy polyethylene glycol-epoetin beta | N/A | 甲氧聚二醇重组人促红素 |
EMA Name
Mircera
Medicine Name
Mircera
Aliases
N/ANo risk management plan link.
