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XEPLION - XEPLION - CT 11046 - English version

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17 Pages
English

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Introduction XEPLION 25 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code : 417 665-8) XEPLION 50 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 666-4) XEPLION 75 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 667-0) XEPLION 100 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 668-7) XEPLION 150 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 669-3) XEPLION 150 mg and XEPLION 100 mg, prolonged-release suspension for injection 1 150-mg pre-filled polycycloolefin syringe with 2 needles - 1 100-mg pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 670-1) Posted on Feb 01 2012 Active substance (DCI) paliperidone (palmitate) Psychiatrie - Nouveau médicament – Pas d’avantage clinique démontré dans la prise en charge des schizophrènes stabilisés par palipéridone ou rispéridone orale– Avis défavorable au remboursement en l’absence de stabilisation préalable par un traitement antipsychotique oral XEPLION est un antipsychotique à longue durée d’action administré en injection IM mensuelle.Il a l’AMM et est remboursable dans le traitement d’entretien de la schizophrénie chez les patients adultes stabilisés par la rispéridone ou la palipéridone par voie orale (cette dernière n’est pas commercialisée en France). Dans cette situation, il n’a pas démontré d’avantage clinique.Chez les patients qui n’ont pas été stabilisés par un traitement antipsychotique oral, son intérêt clinique est insuffisant pour qu’il soit pris en charge par la solidarité nationale.Pour en savoir plus, téléchargez la synthèse ou l'avis complet XEPLION. ATC Code N05AX13 Laboratory / Manufacturer JANSSEN-CILAG XEPLION 25 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code : 417 665-8) XEPLION 50 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 666-4) XEPLION 75 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 667-0) XEPLION 100 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 668-7) XEPLION 150 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 669-3) XEPLION 150 mg and XEPLION 100 mg, prolonged-release suspension for injection 1 150-mg pre-filled polycycloolefin syringe with 2 needles - 1 100-mg pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 670-1) Posted on Feb 01 2012

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Published 01 February 2012
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The legally binding text is the original French version  TRANSPARENCY COMMITTEE
OPINION  1 February 2012   XEPLION 25 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code : 417 665-8)  XEPLION 50 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 666-4)  XEPLION 75 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 667-0)  XEPLION 100 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 668-7)  XEPLION 150 mg, prolonged-release suspension for injection 1 pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 669-3)  XEPLION 150 mg and XEPLION 100 mg, prolonged-release suspension for injection 1 150-mg pre-filled polycycloolefin syringe with 2 needles - 1 100-mg pre-filled polycycloolefin syringe with 2 needles (CIP code: 417 670-1)   Applicant : JANSSEN-CILAG   Paliperidone (palmitate) ATC code : N05AX13 (antipsychotic)  List I  Date of Marketing Authorisation (centralised procedure) : 04/03/2011   Reason for request : Inclusion on the list of medicines refundable by National Insurance and approved for hospital use          Medical, Economic and Public Health Assessment Division  
 
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