Kerendia

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finerenone

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

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.

This EPAR was last updated on 20/02/2023

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)
  • Renal Insufficiency, Chronic
  • Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
C09
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
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

Other EU languages available icon 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:

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.

Assessment history

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