Kerendia - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

finerenone

Opinion

On 29 January 2026 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Kerendia. The marketing authorisation holder for this medicinal product is Bayer AG.

The CHMP adopted a new indication associated with a new strength, 40 mg film-coated tablets, as follows:

Kerendia is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults.

For information, the full indications for Kerendia will now be:

Kerendia is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults.

For study results with respect to renal and cardiovascular events, see section 5.1.

Kerendia is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold

CHMP post-authorisation summary of positive opinion for Kerendia (EMA/X/0000248026)

Adopted Reference Number: EMADOC-1700519818-2833585

Key facts

• Name of medicine:
  Kerendia
• EMA 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
  • Heart Failure
• Anatomical therapeutical 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.

• Marketing authorisation holder:
  Bayer AG
• Date of opinion:
  29/01/2026
• Статус:
  Positive