The Swiss pharmaceutical group announced the major recall of the anti-HIV drug in June after discovering "the contamination of certain batches with ethyl mesilate, a genotoxic substance, which could cause tumors,” the Commission said in a statement.
The EU's decision is based on scientific conclusions of the European Medicines Agency (EMEA and follows consultation with 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 arm said. – Sapa
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