EMA finds no new safety concerns following Roche pharmacovigilance inspection

19 November 2013

The European Medicines Agency has finalized a thorough review of all medicines manufactured by Swiss pharma major Roche (ROG: SIX) that was initiated following a routine pharmacovigilance inspection in early 2012 (The Pharma Letter October 23, 2012), saying that no new safety concerns have been identified.

The 2012 inspection had identified some safety data relating to these medicines that had not previously been provided by Roche. The EMA review examined whether these further data impacted on the balance of benefits and risks of these medicines. Included in this review were 19 centrally-authorized drugs, as well as various medicines that have been nationally approved.

Follows initial inspection by UK’s MHRA

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