<p>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.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1).</p> <p>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).</p> </div>
Therapeutic Area (MeSH)
ATC Code
B03XA03
ATC Item
N/A
Pharmacotherapeutic Group
Antianemic preparations
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Methoxy polyethylene glycol-epoetin beta | N/A | Methoxy polyethylene glycol-epoetin beta |
EMA Name
Mircera
Medicine Name
Mircera
Aliases
N/ANo risk management plan link.
