Evrenzo

RSS

roxadustat

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 24/08/2021

Authorisation details

Product details
Name
Evrenzo
Agency product number
EMEA/H/C/004871
Active substance
Roxadustat
International non-proprietary name (INN) or common name
roxadustat
Therapeutic area (MeSH)
  • Anemia
  • Kidney Failure, Chronic
Anatomical therapeutic chemical (ATC) code
B03XA05
Additional monitoringAdditional 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
Marketing-authorisation holder
Astellas Pharma Europe B.V.
Date of issue of marketing authorisation valid throughout the European Union
18/08/2021
Contact address

Sylviusweg 62
2333 BE Leiden
The Netherlands

Product information

18/08/2021 Evrenzo - EMEA/H/C/004871 -

Contents

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Pharmacotherapeutic group

Antianemic preparations

Therapeutic indication

Evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD).

Assessment history

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