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BEZAFIBRATE Film-coated tablets (2018)

Product Name and Form

Bezafibrate 200 mg Film-coated Tablets.

Pharmaceutical form

Film-coated tablet.

Bezafibrate 200 mg Film-coated Tablets are 10mm, round normal convex white film-coated tablets, debossed “BZ/200” on one side and “G” on the other.

Qualitative and Quantitative Composition

Each tablet contains: 200 mg of bezafibrate.

Excipient with known effect: Each tablet contains 1.56 mg lactose.

For the full list of excipients, see section 6.1.

List of excipients

Bezafibrate 200 mg Film-coated Tablets contain the following excipients:

Tablet core excipients:

Silica, colloidal anhydrous
Magnesium stearate
Maize starch
Cellulose, microcrystalline
Povidone
Purified talc
Sodium starch glycolate

Film coat excipients:

Hypromellose
Lactose
Macrogol
Titanium dioxide (E171)

Pack sizes and Marketing

Bezafibrate 200 mg Film-coated Tablets are available in either: -

  • cartoned PVC/PVdC/Aluminium foil blister packs along with patient leaflets as packs of 84 or 100 or
  • HDPP containers with tamper evident polyethylene caps (with optional polyethylene ullage filler) as packs of 84 or 100.
  • HDPP containers with tamper evident and child-resistant polyethylene caps (with optional polyethylene ullage filler) as packs of 84 or 100.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

26 October 1999 / 8 April 2005

Marketing authorization number:

PL 04569/0390