Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Bayer AG, 51368 Leverkusen, Germany
Kerendia 10 mg film-coated tablets.
Kerendia 20 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Kerendia 10 mg film-coated tablets: Pink, oval-oblong film-coated tablet with a length of 10 mm and a width of 5 mm, marked ‘10’ on one side and ‘FI’ on the other side. Kerendia 20 mg film-coated tablets: Yellow, oval-oblong film-coated tablet with a length of 10 mm and a width of 5 mm, marked ‘20’ on one side and ‘FI’ on the other side. |
Each film-coated tablet contains 10 mg of finerenone.
Excipient with known effect: Each film-coated tablet contains 45 mg of lactose (as monohydrate), see section 4.4.
Each film-coated tablet contains 20 mg of finerenone.
Excipient with known effect: Each film-coated tablet contains 40 mg of lactose (as monohydrate), see section 4.4.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Finerenone |
Finerenone is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR) which is activated by aldosterone and cortisol and regulates gene transcription. Its binding to the MR leads to a specific receptor-ligand complex that blocks recruitment of transcriptional coactivators implicated in the expression of pro-inflammatory and pro-fibrotic mediators. |
| List of Excipients |
|---|
|
Tablet core: Cellulose, microcrystalline Tablet coating: Hypromellose 2910 Kerendia 10 mg film-coated tablets: Iron oxide red (E172) Kerendia 20 mg film-coated tablets: Iron oxide yellow (E172) |
PVC/PVDC/Aluminium transparent calendarised blisters with 14 film-coated tablets. Pack sizes of 14, 28 or 98 film-coated tablets.
PVC/PVDC/Aluminium transparent perforated unit dose blisters with 10 × 1 film-coated tablets. Pack size of 100 × 1 film-coated tablets.
White opaque HDPE bottle with white opaque polypropylene child-resistant screw cap with sealing insert. Pack size of 100 film-coated tablets.
Not all pack sizes may be marketed.
Bayer AG, 51368 Leverkusen, Germany
Kerendia 10 mg film-coated tablets: EU/1/21/1616/001-005
Kerendia 20 mg film-coated tablets: EU/1/21/1616/006-010
| Drug | Countries | |
|---|---|---|
| KERENDIA | Estonia, Finland, Croatia, Israel, Italy, Japan, Lithuania, Poland, Romania, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
