Mircera
methoxy polyethylene glycol-epoetin beta
Table of contents
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.
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Mircera : EPAR - Summary for the public (PDF/61.46 KB)
First published: 14/08/2007
Last updated: 19/06/2012 -
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Mircera : EPAR - Risk-management-plan summary (PDF/203.62 KB)
First published: 20/12/2019
Authorisation details
Product details | |
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Name |
Mircera
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Agency product number |
EMEA/H/C/000739
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Active substance |
Methoxy polyethylene glycol-epoetin beta
|
International non-proprietary name (INN) or common name |
methoxy polyethylene glycol-epoetin beta
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
B03XA03
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Publication details | |
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Marketing-authorisation holder |
Roche Registration GmbH
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Revision |
25
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Date of issue of marketing authorisation valid throughout the European Union |
20/07/2007
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Contact address |
Product information
31/10/2019 Mircera - EMEA/H/C/000739 - II/0068
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.