Mircera

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methoxy polyethylene glycol-epoetin beta

Authorised
This medicine is authorised for use in the European Union.

Overview

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 08/12/2021

Authorisation details

Product details
Name
Mircera
Agency product number
EMEA/H/C/000739
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
B03XA03
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
20/07/2007
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

08/12/2021 Mircera - EMEA/H/C/000739 - IB/0087

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).

The safety and efficacy of Mircera therapy in other indications has not been established.

Assessment history

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