European Commission Suspends Marketing Authorization for Viracept

The European Commission (EC) announced the suspension of marketing authorization for Roche’s antiretroviral Viracept following the recall of the product from the European Union market in June.

The suspension follows the contamination of certain batches of Viracept with ethyl mesilate, a genotoxic substance, the EC said.

The decision is based on scientific conclusions of the European Medicines Agency (EMEA), and follows consultation with member states. The suspension can only be lifted by a further decision of the EC, after an assessment by the EMEA of new data, the EC said.

The EMEA recommended June 21 to suspend the marketing authorization of Viracept, according to the EC.