EU suspends Roche HIV drug due to toxic contamination
(BRUSSELS) - The European Commission said Tuesday it had suspended a license granted to Swiss drugmaker Roche to market the HIV drug Viracept in the European Union due to the toxic contamination of some tablets.
The suspension followed the drug's withdrawal from the market in June.
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 tumours, 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.
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