BUSILVEX Concentrate for solution (2017)
Active ingredients: Busulfan
Product Name and Form
Busilvex 6 mg/ml concentrate for solution for infusion.
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.
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.
Pierre Fabre Médicament, 45, Place Abel Gance, F-92654, Boulogne Billancourt Cedex, France
Date of first authorisation: 09 July, 2003
Date of latest renewal: 08 July, 2008