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XEROQUEL - XEROQUEL - CT 11064 - Version anglaise

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Présentation XEROQUEL LP 300 mg, comprimé à libération prolongée B/100 - Code CIP : 5787660 B/30 - Code CIP : 4974029 B/60 - Code CIP : 4974035 XEROQUEL LP 400 mg, comprimé à libération prolongée B/100 - Code CIP : 5787677 B/30 - Code CIP : 4974041 B/60 - Code CIP : 4974058 XEROQUEL LP 50 mg, comprimé à libération prolongée B/10 - Code CIP : 4973952 B/100 - Code CIP : 5787631 B/30 - Code CIP : 4973969 Mis en ligne le 19 mars 2013 Substance active (DCI) quétiapine Progrès thérapeutique modéré dans le traitement de la schizophrénie Six antipsychotiques de seconde génération (ASG) ont l'AMM dans la schizophrénie : ABILIFY (aripiprazole), LEPONEX et génériques (clozapine), RISPERDAL et génériques (rispéridone), SOLIAN et génériques (amisulpride), XEROQUEL (quétiapine) et ZYPREXA et génériques (olanzapine).Les ASG constituent une classe hétérogène en termes d’efficacité et de tolérance. Cependant, les données ne permettent pas de privilégier un ASG plutôt qu’un autre. Code ATC N05AH04 Laboratoire / fabricant Laboratoire ASTRAZENECA XEROQUEL LP 300 mg, comprimé à libération prolongée B/100 - Code CIP : 5787660 B/30 - Code CIP : 4974029 B/60 - Code CIP : 4974035 XEROQUEL LP 400 mg, comprimé à libération prolongée B/100 - Code CIP : 5787677 B/30 - Code CIP : 4974041 B/60 - Code CIP : 4974058 XEROQUEL LP 50 mg, comprimé à libération prolongée B/10 - Code CIP : 4973952 B/100 - Code CIP : 5787631 B/30 - Code CIP : 4973969 Mis en ligne le 19 mars 2013

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Published 30 November 2011
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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  Quetiapine ATC 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. "
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