BUSILVEX Concentrate for solution Ref.[6718] Active ingredients: Busulfan

Source: European Medicines Agency (EU)  Revision Year: 2017  Publisher: Pierre Fabre Mรฉdicament, 45, Place Abel Gance, F-92654, Boulogne Billancourt Cedex, France

Product name and form

Busilvex 6 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion (sterile concentrate).

Clear, colourless solution.

Qualitative and quantitative composition

One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).

After dilution: 1 ml of solution contains 0.5 mg of busulfan.

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

Macrogol 400

Pack sizes and marketing

10 ml of concentrate for solution for infusion in clear glass vials (type I) with a butyl rubber stopper covered by a purple flip-off aluminium seal cap.

Multipack containing 8 (2 packs of 4) vials.

Marketing authorization holder

Pierre Fabre Mรฉdicament, 45, Place Abel Gance, F-92654, Boulogne Billancourt Cedex, France

Marketing authorization dates and numbers


Date of first authorisation: 09 July, 2003
Date of latest renewal: 08 July, 2008


Drug Countries
BUSILVEX Austria, Brazil, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Turkey, United Kingdom, South Africa

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