Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1876170
Name of medicinal product: KERENDIA
Active substances:
Finerenone
Estonian, English, Latin
ATC code: C03DA05
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 10mg
Amount in package: 14TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Bayer AG 
Marketing authorization number: EU/1/21/1616 
Marketing authorization issued on: February 16, 2022 
Marketing authorization expires on: February 17, 2027 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
Entry/Changing date: February 16, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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