Evrenzo
roxadustat
Table of contents
Overview
Evrenzo is a medicine used in adults to treat the symptoms of anaemia (low red blood cell counts) caused by chronic kidney failure (long-term, progressive decrease in the ability of the kidneys to work properly).
Evrenzo contains the active substance roxadustat.
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List item
Evrenzo : EPAR - Medicine overview (PDF/120.73 KB)
First published: 24/08/2021
EMA/453588/2021 -
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List item
Evrenzo : EPAR - Risk-management-plan summary (PDF/205.99 KB)
First published: 24/08/2021
Authorisation details
Product details | |
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Name |
Evrenzo
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Agency product number |
EMEA/H/C/004871
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Active substance |
Roxadustat
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International non-proprietary name (INN) or common name |
roxadustat
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
B03XA05
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Astellas Pharma Europe B.V.
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Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
18/08/2021
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Contact address |
Sylviusweg 62 |
Product information
02/06/2023 Evrenzo - EMEA/H/C/004871 - IB/0006/G
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
Evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD).