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EU approves Seroquel for bipolar disorder

AstraZeneca has announced that Seroquel and Seroquel XR have been approved in the EU for the prevention of recurrence of bipolar disorder

AstraZeneca has announced that Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate extended-release tablets) have been approved in the EU for the prevention of recurrence of bipolar disorder in patients with manic, mixed or depressive episodes that have responded to quetiapine treatment.

The approval has been made under the European Mutual Recognition Procedure – a process whereby a medicinal product that has already received a marketing authorisation in one member state is recognised in another. AstraZeneca intends to obtain local approvals for Seoquel and Seroquel XR in all participating member states.

This latest approval makes Seroquel and Seroquel XR the only agents approved in the EU for treating all phases (acute depressive episodes, acute manic episodes and maintence treatment) of bipolar disorder. Seroquel XR is approved in 38 countries for bipolar mania, in 37 markets for bipolar depression and in 9 countries for bipolar maintenance.

Seroquel XR is approved in 63 countries and Seroquel in 94 countries, for the treatment of schizophrenia.

29th September 2009


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