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/127.62 KB)
First published: 14/08/2007
Last updated: 11/08/2023 -
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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
|
Publication details | |
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Marketing-authorisation holder |
Roche Registration GmbH
|
Revision |
29
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Date of issue of marketing authorisation valid throughout the European Union |
20/07/2007
|
Contact address |
Emil-Barell-Strasse 1 |
Product information
26/07/2023 Mircera - EMEA/H/C/000739 - II/0092
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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).