Pharmaceuticals - Community Register

  

List of nationally authorised medicinal products for human use

Seroquel XR and associated names

Product name: Seroquel XR and associated names
Also marketed in the EU under the name(s): Seroquel Depot, Seroquel Prolong, Seroquel SR
Active substance: quetiapine
Indication: - treatment of Schizophrenia
- treatment of bipolar disorder
- add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
30/08/2010 Referral EMEA/H/A-6(13)/1190 (2010)6001 of 26/08/2010