NILEMDO Film-coated tablet Ref.[27925] Active ingredients: Bempedoic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany

Product name and form

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.

Qualitative and quantitative composition

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.

List of Excipients

Tablet core:

Lactose monohydrate
Microcrystalline cellulose (E460)
Sodium starch glycolate (Type A grade)
Hydroxypropyl cellulose (E463)
Magnesium stearate (E470b)
Silica, colloidal anhydrous (E551)

Film-coating:

Partially hydrolysed poly(vinyl alcohol) (E1203)
Talc (E553b)
Titanium dioxide (E171)
Macrogol/PEG (E1521)

Pack sizes and marketing

Polyvinyl chloride (PVC)/aluminum blisters.

Pack sizes of 10, 28, 30, 90, 98, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany

Marketing authorization dates and numbers

EU/1/20/1425

Date of first authorisation: 01/04/2020

Drugs

Drug Countries
NILEMDO Austria, Estonia, Ireland, Lithuania, Poland, Turkey, United Kingdom

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