Kerendia
finerenone
Table of contents
Overview
Kerendia is a medicine used to treat chronic kidney disease in adults with type 2 diabetes.
It is used for patients with moderate or severe kidney damage who pass albumin (a type of protein) in their urine.
Kerendia contains the active substance finerenone.
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List item
Kerendia : EPAR - Medicine Overview (PDF/119.39 KB)
First published: 11/03/2022
EMEA/H/C/005200 -
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List item
Kerendia : EPAR - Risk management plan summary (PDF/118.66 KB)
First published: 11/03/2022
Last updated: 20/03/2023
Authorisation details
Product details | |
---|---|
Name |
Kerendia
|
Agency product number |
EMEA/H/C/005200
|
Active substance |
Finerenone
|
International non-proprietary name (INN) or common name |
finerenone
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
C09
|
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 |
Bayer AG
|
Revision |
1
|
Date of issue of marketing authorisation valid throughout the European Union |
16/02/2022
|
Contact address |
51368 Leverkusen
Germany |
Product information
06/02/2023 Kerendia - EMEA/H/C/005200 - II/0001/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
Agents acting on the renin-angiotensin system
Therapeutic indication
Kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.