methoxy polyethylene glycol-epoetin beta

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 11/08/2023

Authorisation details

Product details
Agency product number
Active substance
Methoxy polyethylene glycol-epoetin beta
International non-proprietary name (INN) or common name
methoxy polyethylene glycol-epoetin beta
Therapeutic area (MeSH)
  • Anemia
  • Kidney Failure, Chronic
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen

Product information

26/07/2023 Mircera - EMEA/H/C/000739 - II/0092

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antianemic preparations

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).

Assessment history

Related content

How useful was this page?

Add your rating