Vafseo
vadadustat
Table of contents
Overview
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.
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List item
Vafseo: EPAR - Medicine overview (PDF/116.32 KB)
First published: 31/05/2023
EMA/100938/2023 -
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List item
Vafseo: EPAR - Risk-management-plan (PDF/756.02 KB)
First published: 31/05/2023
Authorisation details
Product details | |
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Name |
Vafseo
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Agency product number |
EMEA/H/C/005131
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Active substance |
Vadadustat
|
International non-proprietary name (INN) or common name |
vadadustat
|
Therapeutic area (MeSH) |
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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 |
Akebia Europe Limited
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Date of issue of marketing authorisation valid throughout the European Union |
24/04/2023
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Contact address |
c/o Matheson |
Product information
24/04/2023 Vafseo - EMEA/H/C/005131 -
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
Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.