The European Commission has suspended Roche’s licence to market Viracept® (nelfinavir) in the EU. This follows a complete recall of the medicine from the European market in June 2007, due to the identification of a contaminant, ethyl mesylate – a known genotoxic substance – in some batches.
The decision was reportedly based on scientific conclusions from the EMEA and consultations with EU member states. A Roche spokeswoman said the company was trying to solve the manufacturing problem with European health authorities and aimed to manufacture the drug again by September or October 2007. The EC said: “The suspension can only be lifted by a further decision of the Commission, after an assessment by the agency of new data.”
National Electronic Library for Medicines 8/8/2007