Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
Nilemdo 180 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White to off-white, oval, film-coated tablet of approximately 13.97 mm × 6.60 mm × 4.80 mm debossed with “180” on one side and “ESP” on the other side. |
Each film-coated tablet contains 180 mg of bempedoic acid.
Excipient(s) with known effect: Each 180 mg film-coated tablet contains 28.5 mg of lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Bempedoic acid |
Bempedoic acid is an adenosine triphosphate citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibition of cholesterol synthesis in the liver. Bempedoic acid requires coenzyme A (CoA) activation by very long-chain acyl-CoA synthetase 1 (ACSVL1) to ETC-1002-CoA. Inhibition of ACL by ETC-1002-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of low-density lipoprotein receptors. Additionally, inhibition of ACL by ETC-1002-CoA results in concomitant suppression of hepatic fatty acid biosynthesis. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film-coating: Partially hydrolysed poly(vinyl alcohol) (E1203) |
Polyvinyl chloride (PVC)/aluminum blisters.
Pack sizes of 10, 14, 28, 30, 84, 90, 98 or 100 film-coated tablets.
Polyvinyl chloride (PVC)/aluminum perforated unit dose blisters.
Pack sizes of 10 × 1, 50 × 1 or 100 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
EU/1/20/1425/001 – 011
Date of first authorisation: 01/04/2020
| Drug | Countries | |
|---|---|---|
| NILEMDO | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Turkey, United Kingdom |
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