Mircera

RSS

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 05/09/2018

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
23
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

09/08/2018 Mircera - EMEA/H/C/000739 - N/0069

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

How useful was this page?

Add your rating