KERENDIA Film-coated tablet Ref.[49668] Active ingredients: Finerenone

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Bayer AG, 51368 Leverkusen, Germany

Product name and form

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.

Qualitative and quantitative composition

Kerendia 10 mg film-coated tablets

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.

Kerendia 20 mg film-coated tablets

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
Croscarmellose sodium
Hypromellose 2910
Lactose monohydrate
Magnesium stearate
Sodium laurilsulfate

Tablet coating:

Hypromellose 2910
Titanium dioxide
Talc

Kerendia 10 mg film-coated tablets:

Iron oxide red (E172)

Kerendia 20 mg film-coated tablets:

Iron oxide yellow (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Bayer AG, 51368 Leverkusen, Germany

Marketing authorization dates and numbers

Kerendia 10 mg film-coated tablets: EU/1/21/1616/001-005
Kerendia 20 mg film-coated tablets: EU/1/21/1616/006-010

Drugs

Drug Countries
KERENDIA Estonia, Finland, Israel, Japan, Lithuania, Poland, Romania, United States

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