The European Commission has suspended Swiss drugmaker Roche's licence to market the HIV drug Viracept (Nelfinavir) in the European Union.
"The suspension is due to the contamination of certain lots of Viracept with ethyl mesilate, a genotoxic substance," the EU executive said in a statement.
The suspension follows the withdrawal of the drug from the market in June when Roche said its licence for Viracept was being temporarily suspended pending a review by authorities.
The Commission said Tuesday's announcement was based on the scientific conclusions from the European Medicines Agency (EMEA) and consultations with EU member states.
"The suspension could only be lifted by a further decision by the Commission, after the evaluation of new data given by the Agency," the EU executive said.
In June, Roche said it had identified a chemical impurity in the product, leading to the recall in Europe and some other regions.
Source: http://www.reuters.com/article/companyNewsAndPR/idUSL0734726920070807
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