Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Busulfan 2 mg tablets.
| Pharmaceutical Form |
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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.
| Active Ingredient |
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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 |
|---|
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Tablet core: Lactose, anhydrous Tablet coating: Hypromellose |
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
PL 39699/0042
Date of first authorisation: 13 January 1986
Date of latest renewal: 30 June 2003
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