Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
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The legally binding text is the original French version TRANSPARENCY COMMITTEE
OPINION 30 November 2011 XEROQUEL LP 50 mg, prolonged-release tablets B/10 (CIP code: 497 395-2) B/30 (CIP code: 497 396-9) B/100 (CIP code: 578 763-1) XEROQUEL LP 300 mg, prolonged-release tablet B/30 (CIP code: 497 402-9) B/60 (CIP code: 497 403-5) B/100 (CIP code: 578 766-0) XEROQUEL LP 400 mg, prolonged-release tablet B/30 (CIP code: 497 404-1) B/60 (CIP code: 497 405-8) B/100 (CIP code: 578 767-7) Applicant: ASTRAZENECA QuetiapineATC Code: N05AH04 List I Date of Marketing Authorisation (decentralised procedure): 23/11/2010 Reason for request: Re-assessment of the Actual Benefit and Improvement in Actual Benefit in accordance with article R-163-21 of the Social Security Code. Therapeutic indications: "XEROQUEL is indicated for: ▪ The treatment of schizophrenia. ▪ The treatment of bipolar disorder: o in the treatment of moderate to severe manic episodes associated with bipolar disorder. o inthe treatment of major depressive episodes in bipolar disorder.o preventing recurrence of bipolar disorder in patients whose manic, or depressive episodes have responded to quetiapine treatment. ▪ Add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD), who have had a sub-optimal response to antidepressant monotherapy
(see section 5.1 of the SPC). Prior to initiating treatment, clinicians should consider the safety profile of XEROQUEL. "