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ABILIFY - ABILIFY - CT 9034 - Version anglaise

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Présentation ABILIFY 10 mg, comprimé B/28 - Code CIP : 3640734 ABILIFY 10 mg, comprimé orodispersible B/28 - Code CIP : 3692145 ABILIFY 15 mg, comprimé B/28 - Code CIP : 3640786 ABILIFY 15 mg, comprimé orodispersible B/28 - Code CIP : 3692174 ABILIFY 5 mg, comprimé B/28 - Code CIP : 3640697 Mis en ligne le 19 mars 2013 Substance active (DCI) aripiprazole 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 N05AX12 Laboratoire / fabricant Laboratoire OTSUKA PHARMACEUTICAL FRANCE SAS ABILIFY 10 mg, comprimé B/28 - Code CIP : 3640734 ABILIFY 10 mg, comprimé orodispersible B/28 - Code CIP : 3692145 ABILIFY 15 mg, comprimé B/28 - Code CIP : 3640786 ABILIFY 15 mg, comprimé orodispersible B/28 - Code CIP : 3692174 ABILIFY 5 mg, comprimé B/28 - Code CIP : 3640697 Mis en ligne le 19 mars 2013

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Published 14 March 2012
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The legally binding text is the original French version  TRANSPARENCY COMMITTEE
 OPINION  14 March 2012   ABILIFY 10 mg, tablet B/28 (CIP code: 364 073-4) ABILIFY 15 mg, tablet B/28 (CIP code: 364 078-6) ABILIFY 5 mg, tablet B/28 (CIP code: 364 069-7) ABILIFY 10 mg, orodispersible tablet B/28 (CIP code: 369 214-5) ABILIFY 15 mg, orodispersible tablet B/28 (CIP code: 369 217-4)   Applicant: OTSUKA PHARMACEUTICAL FRANCE SAS  Aripiprazole ATC Code: N05AX12  List I  Dates of Marketing Authorisations (centralised procedure): ABILIFY 5 mg, 10 mg, 15 mg tablet: 04/06/2004 ABILIFY 10 mg, 15 mg orodispersible tablet: 20/06/2005  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: “ABILIFY is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 and older. ABILIFY is indicated for the treatment of moderate to severe manic episodes in Bipolar I disorder and for the prevention of a new manic episode in patients who have experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.”  The transparency Commission has re-assessed oral atypical antipsychotics in the treatment of adult schizophrenia (c.f. report attached). The results of the epidemiological study (STAR study) done at the request of the Transparency Committee were taken into account as part of this re-evaluation (cf. attached report of the public health benefit group). The conclusions of the Transparency Committee were as follows:
 
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