Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
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The legally binding text is the original French versionTRANSPARENCY COMMITTEEOPINION 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 AmisulprideATC 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. Renewalof 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: