Mircera

methoxy polyethylene glycol-epoetin beta

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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.

What is Mircera?

Mircera is a solution for injection that contains the active substance methoxy polyethylene glycol-epoetin beta. It is available in vials and in pre-filled syringes at various strengths ranging from 50 to 1,000 micrograms per millilitre.

What is Mircera used for?

Mircera is used to treat anaemia (low red blood cell counts) that is causing symptoms in adults with chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly).

The medicine can only be obtained with a prescription.

How is Mircera used?

Treatment with Mircera must be started under the supervision of a doctor who has experience in the management of patients with kidney disease.

Mircera can be injected under the skin or into a vein. The dose and the frequency of dosing depend on whether or not Mircera is replacing another medicine used to stimulate the production of red blood cells. See the summary of product characteristics (also part of the EPAR) for full details. Doses should be adjusted according to the patient’s response, to obtain haemoglobin levels within the recommended range (between 10 and 12 grams per decilitre). Haemoglobin is the protein in red blood cells that carries oxygen around the body. Haemoglobin levels should be monitored every two weeks until they are stable, and then periodically. The lowest dose that provides adequate control of symptoms should be used.

Mircera is intended for long-term use. Patients can inject themselves once they have been trained appropriately.

How does Mircera work?

A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.

Erythropoietin is produced by the kidneys. In patients with chronic kidney disease, the main cause of their anaemia is a lack of natural erythropoietin. The active substance in Mircera, methoxy polyethylene glycol-epoetin beta, works like natural erythropoietin to stimulate red blood cell production, because it can attach itself to the same receptors as erythropoietin. However, the way it interacts with the receptor is slightly different from natural erythropoietin, which gives it a longer effect. It is also cleared from the body less quickly. As a result, Mircera can be given less often than natural erythropoietin.

The active substance in Mircera is made up of epoetin beta attached to a chemical called methoxypolyethylene glycol. The epoetin beta is produced by ‘recombinant DNA technology’: it is made by a cell that has received a gene, which makes it able to produce epoetin beta.

How has Mircera been studied?

Mircera has been studied in six main studies involving a total of 2,399 adults with anaemia associated with chronic kidney disease. Mircera was compared with other medicines used to stimulate red blood cell production. Two of these studies involved patients who were starting treatment for anaemia. The first study, in 181 patients on dialysis (a blood clearance technique used in advanced kidney disease), looked at Mircera injected into a vein every two weeks over 24 weeks and compared it with epoetin alfa or beta. The second study, in 324 patients not on dialysis, looked at Mircera injected under the skin every two weeks over 28 weeks, comparing it with darbepoetin alfa.

The other four studies (in 1,894 patients) were carried out in patients on dialysis who had already been receiving medicines to stimulate red blood cell production. In these studies, patients either remained on the medicines they were already receiving, or changed to Mircera, injected into a vein or under the skin every two or four weeks. The effectiveness of the two treatment options was compared over 36 weeks.

In all six studies, the main measure of effectiveness was the change in haemoglobin levels. Most patients also received iron to prevent deficiency (low iron levels) during the studies.

What benefit has Mircera shown during the studies?

Mircera was as effective as the comparator medicines in correcting and maintaining haemoglobin levels. In the studies of patients starting treatment for anaemia for the first time, 126 (93%) of the 135 patients on dialysis, and 158 (98%) of the 162 not on dialysis had a significant increase in haemoglobin levels with Mircera. Similar response rates were seen in the patients taking the comparator medicines. The second study showed that patients taking Mircera and those taking darbepoetin alfa had similar increases in haemoglobin levels (around 2 g/dl).

In the studies of patients who had already been receiving medicines to stimulate red blood cell production, patients who changed to Mircera maintained their haemoglobin levels as effectively as the patients who remained on their existing medicines. There was no overall change in haemoglobin levels over the course of these studies with any of the treatments.

What is the risk associated with Mircera?

The most common side effect with Mircera (seen in between 1 and 10 patients in 100) is hypertension (high blood pressure). For the full list of all side effects reported with Mircera, see the package leaflet.

Mircera must not be used in people who are hypersensitive (allergic) to methoxy polyethylene glycol-epoetin beta or any of the other ingredients. It must also not be used in patients who have high blood pressure that is not controlled.

Why has Mircera been approved?

The CHMP concluded that Mircera corrected and maintained haemoglobin levels in patients with chronic kidney disease and that its effects are comparable with those of other epoetins. The Committee decided that Mircera’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Mircera

The European Commission granted a marketing authorisation valid throughout the European Union for Mircera on 20 July 2007.

For more information about treatment with Mircera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Mircera : EPAR - Summary for the public BG = bălgarski 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public ES = español 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public CS = čeština 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public DA = dansk 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public DE = Deutsch 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public ET = eesti keel 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public EL = elliniká 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public EN = English 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public FR = français 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public IT = italiano 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public LV = latviešu valoda 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public LT = lietuvių kalba 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public HU = magyar 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public MT = Malti 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public NL = Nederlands 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public PL = polski 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public PT = português 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public RO = română 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public SK = slovenčina 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public SL = slovenščina 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public FI = suomi 14/08/2007 19/06/2012
Mircera : EPAR - Summary for the public SV = svenska 14/08/2007 19/06/2012

This EPAR was last updated on 07/09/2016 .

Authorisation details

Product details

Product details for Mircera
NameMircera
Agency product numberEMEA/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 AnemiaKidney Failure, Chronic
Anatomical therapeutic chemical (ATC) code B03XA03

Publication details

Publication details for Mircera
Marketing-authorisation holder

Roche Registration Ltd

Revision19
Date of issue of marketing authorisation valid throughout the European Union20/07/2007

Contact address:

Roche Registration Ltd
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Product information

Product information

18/08/2016  Mircera -EMEA/H/C/000739 -N/0059

Name Language First published Last updated
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016
Mircera : EPAR - Product Information SV = svenska 13/10/2009 07/09/2016

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.


Name Language First published Last updated
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014
Mircera : EPAR - All Authorised presentations SV = svenska 13/10/2009 02/07/2014

Name Language First published Last updated
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  
Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 02/08/2007  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Mircera : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 13/10/2009 07/09/2016
Mircera-H-C-739-A20-0039 : EPAR - Assessment Report - Article 20 SV = svenska 21/11/2012  

Initial marketing-authorisation documents

Name Language First published Last updated
Mircera : EPAR - Procedural steps taken before authorisation SV = svenska 02/08/2007  
Mircera : EPAR - Scientific Discussion SV = svenska 02/08/2007  

Authorised

This medicine is approved for use in the European Union

More information on Mircera