AstraZeneca receives European approval for Seroquel in bipolar mania

Published: 15-Oct-2003

AstraZeneca has successfully completed the Mutual Recognition Procedure (MRP) involving 14 European countries to extend the use of Seroquel (quetiapine) to the treatment of mania associated with bipolar disorder.


AstraZeneca has successfully completed the Mutual Recognition Procedure (MRP) involving 14 European countries to extend the use of Seroquel (quetiapine) to the treatment of mania associated with bipolar disorder.

Seroquel is also under review for bipolar mania in the US with the FDA and in the UK with the MHRA. Individual licenses in the 14 European countries involved in the MRP will follow from the completion of this procedure. Health Authority approvals have also been received in Mexico and New Zealand.

More than half of all patients with bipolar disorder stop taking their medication at some point during their illness. This lack of compliance is strongly associated with the occurrence of side effects. 'This approval is great news for clinicians involved in the treatment of bipolar disorder,' commented Dr Eduard Vieta, director of research, department of psychiatry, University of Barcelona. 'The results from the clinical trial programme confirm that Seroquel holds real benefits for clinicians looking to treat the symptoms of the disease while keeping side effects to a minimum.'

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