European Commission Issues Positive Decision for Approval of Seroquel XR as an Add-On Treatment of Major Depressive Disorder

Thursday, 2 September 2010 AstraZeneca today announced that the European Commission (EC) has issued a positive decision for the approval of once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy. This decision follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) in April of this year. AstraZeneca will now move forward in obtaining local approvals. This is a 30 day process in the 17 member states that took part in the original Mutual Recognition Procedure. For other member states timelines will vary. Within this application, the product information for SEROQUEL XR has been updated with respect to several individual safety topics such as: suicidality, weight gain, hyperglycaemia, extrapyramidal symptoms, akathisia, somnolence, orthostatic hypotension, and dizziness. Guidance is also provided on safe administration of SEROQUEL XR, including consideration of the safety profile with respect to the individual patient’s diagnosis and the dose being administered. Implementation of this updated product information will occur upon obtaining local approval. NOTES TO EDITORS: About SEROQUEL XR mily: 'Times New Roman'; mso-ansi-language: EN-GB; mso-fareast-language: EN-GB; mso-bidi-language: AR-SA; mso-bidi-font-weight: bold">To date, SEROQUEL XR has been approved in 72 countries for schizophrenia, 57 countries for bipolar mania, 49 countries for bipolar depression, 33 countries for bipolar maintenance, 6 countries for MDD, with US receiving approval of SEROQUEL XR for the adjunctive treatment of MDD in December 2009, and 3 countries for Generalised Anxiety Disorder (GAD). About EC Member States The 17 member states that took part in the original SEROQUEL XR Mutual Recognition Procedure were: Austria, Belgium, Cyprus, Denmark, Finland, Germany, Greece, Iceland, Ireland, Luxembourg, Netherlands, Norway, Malta, Portugal, Poland, Spain, and Sweden. About AstraZeneca AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com . CONTACTS: Media Enquiries: Neil McCrae +44 207 304 5045 (24 hours) Chris Sampson +44 20 7304 5130 (24 hours) Sarah Lindgreen +44 20 7304 5033 (24 hours) Abigail Baron +44 20 7304 5034 (24 hours) Investor Enquiries UK: Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032 Karl Hard +44 207 304 5322 mob: +44 7789 654364 Investor Enquiries US: Ed Seage +1 302 886 4065 mob: +1 302 373 1361 Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043 tags Corporate and financial Science AstraZeneca Websites This website is intended for people seeking information on AstraZeneca's worldwide business. Our country sites can be located in the AZ Network. Veeva ID: Z4-8411 Date of next review: August 2020 Resources All resources Open Innovation Externally sponsored scientific research MedImmune US prescription assistance programmes Global clinical trials information Medicines Report a possible side effect Pearl Therapeutics Quick links Media Investor Relations Partnering Careers Sustainability Modern Slavery Statement Supplier information Social Media Facebook LinkedIn Twitter Glassdoor utility links Legal notice and Terms of Use Privacy notice Cookie policy Site map Contact us © AstraZeneca 2019 You are now leaving AstraZeneca.com You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. AstraZeneca provides this link as a service to website visitors. AstraZeneca is not responsible for the privacy policy of any third party websites. We encourage you to read the privacy policy of every website you visit. Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. Cancel Continue ? Important notice for users You are about to access AstraZeneca historic archive material. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Please refer to your approved national product label (SmPC) for current product information. I have read this warning and will not be using any of the contained product information for clinical purposes. I disagree I agree ? ?

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