EMA — authorised 16 February 2022
- Marketing authorisation holder: BAYER AG
- Status: approved
🇪🇺 Kerendia in European Union
EMA authorised Kerendia on 16 February 2022
Marketing authorisations
EMA — authorised 16 February 2022
- Application: EMEA/H/C/005200
- Marketing authorisation holder: Bayer AG
- Local brand name: Kerendia
- Indication: 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.
- Status: approved
Kerendia in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Kerendia approved in European Union?
Yes. EMA authorised it on 16 February 2022; EMA authorised it on 16 February 2022.
Who is the marketing authorisation holder for Kerendia in European Union?
BAYER AG holds the EU marketing authorisation.