BUSULFAN Film-coated tablet

Active ingredients: Busulfan

Product name and form

Busulfan 2 mg tablets.

Pharmaceutical Form

Film coated tablet.

Busulfan 2 mg tablets are white, film-coated, round biconvex tablets engraved “GX EF3” on one side and “M” on the other.

Qualitative and quantitative composition

Each 2 mg tablet contains 2 mg of the active substance busulfan.

Excipient with known effect: lactose.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent. In aqueous media, release of the methanesulphonate groups produces carbonium ions which can alkylate DNA, thought to be an important biological mechanism for its cytotoxic effect.

List of Excipients

Tablet core:

Lactose, anhydrous
Pregelatinised starch
Magnesium stearate

Tablet coating:

Hypromellose
Titanium dioxide
Triacetin

Pack sizes and marketing

Busulfan tablets are supplied in amber glass bottles with a child resistant closure containing 25 or 100 tablets.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PL 39699/0042

Date of first authorisation: 13 January 1986
Date of latest renewal: 30 June 2003