LIPIDIL NT Film coated tablet Ref.[51020] Active ingredients: Fenofibrate

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland

Product name and form

Lipidil NT 145 mg film-coated tablet.

Pharmaceutical Form

Film coated tablet.

White, oblong, film-coated tablets engraved “145” on one side and “Fournier logo” on the other side.

Qualitative and quantitative composition

Each tablet contains 145.0 mg fenofibrate (nanoparticles).

Excipients with known effect: each tablet contains:

  • 132.00 mg of lactose monohydrate
  • 145.00 mg of sucrose
  • 0.50 mg of soybean lecithin.

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

Core:

Sucrose
Lactose monohydrate
Silicified microcrystalline cellulose
Crospovidone
Hypromellose
Sodium lauril sulfate
Docusate sodium
Magnesium stearate

Coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Talc
Soybean lecithin
Xanthan gum

Pack sizes and marketing

Thermoformed blister strips (clear PVC/PE/PVDC sealed with aluminium complex).

Packs of 10 or 14 tablets.

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

Hospital pack sizes: 280 (10 × 28) and 300 (10 × 30) tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland

Marketing authorization dates and numbers

21153

Date of First Authorisation: 19/12/11
Date of Latest Renewal: 12/04/17

Drugs

Drug Countries
LIPIDIL Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Japan, Mexico

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