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SOLIAN - SOLIAN - CT 8948 - Version anglaise

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Présentation SOLIAN 100 mg, comprimé sécable B/150 - Code CIP : 5613121 B/30 - Code CIP : 3487474 SOLIAN 100 mg/ml, solution buvable 1 flacon de 60 ml - Code CIP : 3528701 SOLIAN 200 mg, comprimé sécable B/150 - Code CIP : 5566545 B/60 - Code CIP : 3473621 SOLIAN 400 mg, comprimé pelliculé sécable B/150 - Code CIP : 5613138 B/30 - Code CIP : 3487480 Mis en ligne le 19 mars 2013 Substance active (DCI) amisulpride 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 N05AL05 Laboratoire / fabricant Laboratoire SANOFI-AVENTIS FRANCE SOLIAN 100 mg, comprimé sécable B/150 - Code CIP : 5613121 B/30 - Code CIP : 3487474 SOLIAN 100 mg/ml, solution buvable 1 flacon de 60 ml - Code CIP : 3528701 SOLIAN 200 mg, comprimé sécable B/150 - Code CIP : 5566545 B/60 - Code CIP : 3473621 SOLIAN 400 mg, comprimé pelliculé sécable B/150 - Code CIP : 5613138 B/30 - Code CIP : 3487480 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   Examination of the dossier for proprietary medicinal products included for a 5-year period starting on 7 May 2007 (Official Gazette of 22 April 2008)  SOLIAN 100 mg, scored tablets B/30 (CIP code: 348 747-4) B/150 (CIP code: 561 312-1) SOLIAN 200 mg, scored tablets B/60 (CIP code: 347 362-1) B/150 (CIP code: 556 654-5) SOLIAN 400 mg, scored film-coated tablets B/30 (CIP code: 348 748-0) B/80 (CIP code: 351 207-7) B/150 (CIP code: 561 313-8) SOLIAN 100 mg/ml, oral solution Fl/60 ml (CIP code: 352 870-1)  Applicant: SANOFI-AVENTIS FRANCE  Amisulpride ATC code: N05AL05  List I  Dates of the Marketing Authorisations: SOLIAN 100 mg tablets: 25/11/1998 SOLIAN 200 mg tablets: 20/01/1986 SOLIAN 400 mg tablets: 25/11/1998 SOLIAN 100 mg/ml oral solution: 30/11/1999  Reason for the application: the Actual Benefit and Improvement in Actual Benefit in accordance of  Re-assessment with Article R-163-21 of the French Social Security Code.  Renewal of inclusion on the list of medicines refundable by National Health Insurance.  Therapeutic indications: "Treatment of schizophrenia."  The transparency Committee has re-assessed second generation oral antipsychotics in the treatment of adult schizophrenia (cf. report attached). The Transparency Committee’s conclusions were as follows:
 
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