Seroquel XR is an antipsychotic medicine that contains quetiapine, used in patients with schizophrenia. Quetiapine attaches to several receptors on the surface of nerve cells and helps to normalise the activity of the brain, reducing the symptoms of these diseases.
AstraZeneca said that the application was referred to the CHMP following a negative outcome for the application in 2009, during an assessment via the Mutual Recognition Procedure.
Earlier, on March 23, 2010 Seroquel XR has been approved in 68 countries for schizophrenia, 56 countries for bipolar mania, in 47 countries for bipolar depression, in 27 markets for bipolar maintenance, in 3 markets for Generalised Anxiety Disorder (GAD) and in 4 markets for Major Depressive Disorder (MDD), with US receiving approval of Seroquel XR for the adjunctive treatment of MDD in December 2009.