ZAFIBRAL Film-coated tablet Ref.[28168] Active ingredients: Bezafibrate

Source: Υπουργείο Υγείας (CY)  Revision Year: 2011  Publisher: Medochemie Ltd, p.o box 51409, Limassol, Cyprus

Product name and form

Zafibral.

Pharmaceutical Form

Film-coated tablet for oral administration.

“Zafibral” 200 mg are yellow, round, convex film coated tablets, with a diameter of 9.5 mm.

Qualitative and quantitative composition

Each tablet contains bezafibrate 200 mg.

For excipients, see 6.1.

Active Ingredient Description
Bezafibrate

Bezafibrate lowers elevated blood lipids (triglycerides and cholesterol). Elevated VLDL and LDL are reduced by treatment with bezafibrate, whilst HDL-levels are increased. Furthermore, cholesterol biosynthesis is reduced by bezafibrate, which is accompanied by a stimulation of the LDL receptor-mediated lipoprotein catabolism.

List of Excipients

“Zafibral” tablets also contain microcrystallinEcellulose, maizEstarch, povidone, sodium starch glycollate, colloidal anhydrous silica, and magnesium stearate. ThEfilm coating contains Opadry Yellow OY-6137 which consists of hydroxypropylmethylcellulose, macrogol 400, titanium dioxide (E171), iron oxidEyellow (E172), Sunset yellow (E110), and quinolinEyellow (E104).

Pack sizes and marketing

PVC-Al blisters.

Boxes of 50, 100, 200 and 1000 tablets.

Marketing authorization holder

Medochemie Ltd, p.o box 51409, Limassol, Cyprus

Marketing authorization dates and numbers

13763

First authorisation: 8 October 1992

Drugs

Drug Countries
ZAFIBRAL Cyprus, Hong Kong, Singapore

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