This medicine is authorised for use in the European Union.


Vafseo is a medicine used to treat the symptoms of anaemia (low red blood cell counts) caused by chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly) in adult patients on dialysis (a technique for removing unwanted substances and excess fluid from the blood when the kidneys do not work well enough).

Vafseo contains the active substance vadadustat.

This EPAR was last updated on 31/05/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Renal Insufficiency, Chronic
  • Anemia
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
Akebia Europe Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

c/o Matheson
70 Sir John Rogerson’s Quay
Dublin 2

Product information

24/04/2023 Vafseo - EMEA/H/C/005131 -

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Product information documents contain:

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

Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

Assessment history

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