FENOFIBRATE Tablet Ref.[51352] Active ingredients: Fenofibrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Genus Pharmaceuticals Limited, T/A Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK

Product name and form

Fenofibrate 160 mg Tablets.

Pharmaceutical Form

Tablet.

White to off-white oblong 15mm x 7mm tablet.

Qualitative and quantitative composition

Fenofibrate 160 mg.

Excipients with known effect: Each Fenofibrate 160 mg tablet contains lactose monohydrate 238.45 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fenofibrate

Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type α (PPARα). Through activation of PPARα, fenofibrate increases lipolysis and elimination of atherogenic triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of Apoprotein C-III.

List of Excipients

Sodium laurilsulfate
Lactose monohydrate
Hypromellose
Microcrystalline cellulose
Croscarmellose sodium
Magnesium stearate

Pack sizes and marketing

Blister strips (PVC/PVDC – Aluminium).

Boxes of 10, 20, 28, 30, 50, 84, 90, 98 and 100 tablets.

Hospital pack sizes: 280 and 300 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Genus Pharmaceuticals Limited, T/A Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK

Marketing authorization dates and numbers

PL 06831/0204

13/07/2011

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