Active ingredients: Busulfan
Busulfan 2 mg tablets.
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.
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.
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.
Busulfan tablets are supplied in amber glass bottles with a child resistant closure containing 25 or 100 tablets.
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Date of first authorisation: 13 January 1986
Date of latest renewal: 30 June 2003