EMA LAUNCHES FORMAL PHARMACOVIGILANCE PROBE INTO ROCHE
November 1st, 2012
BY KEITH NUTHALL
THE EUROPEAN Medicines Agency (EMA) has launched a formal investigation into Roche Registration Ltd, probing allegations that the company failed to comply with pharmacovigilance obligations in relation to 19 EMA-approved medicines. The concern is that Roche did not alert EU regulators to data collected on patients using these medicines that could have thrown light on their safety. Medicines concerned include Tamiflu, Avastin, Viracept and others. The EMA probe, made at the request of the European Commission, follows a pharmacovigilance ...
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