EU Clears Roche For Failing To Report Side Effects

Published: Nov 19, 2013

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After spending a year investigating Roche for a failure to report tens of thousands of adverse events in connection with various drugs, the European Medicines Agency has concluded its review and “has not identified any important new safety concerns.”

“The balance of benefits and risks of these medicines has not been affected and there is no new advice regarding their use,” the EMA says in a statement. The regulator adds that Roche is expected to ensure such data are included and considered in routine pharmacovigilance activities, though. The so-called “infringement procedure” was conducted by the agency’s Pharmacovigilance Risk Assessment Committee.

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