RISPERDALCONSTA L.P. - RISPERDALCONSTA LP - CT 7257 - English version

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Description

Introduction RISPERDALCONSTA L.P. 25 mg/2 ml, powder and solvent for prolonged-release suspension for injection in prefilled syringe (CIP: 362 491-3) RISPERDALCONSTA L.P. 37.5 mg/2 ml, powder and solvent for prolonged-release suspension for injection in prefilled syringe (CIP: 362 493-6) RISPERDALCONSTA L.P. 50 mg/2 ml, powder and solvent for prolonged-release suspension for injection in prefilled syringe (CIP: 362 494-2) Posted on May 24 2011 Active substance (DCI) risperidone ATC Code N05AX08 Laboratory / Manufacturer JANSSEN-CILAG RISPERDALCONSTA L.P. 25 mg/2 ml, powder and solvent for prolonged-release suspension for injection in prefilled syringe (CIP: 362 491-3) RISPERDALCONSTA L.P. 37.5 mg/2 ml, powder and solvent for prolonged-release suspension for injection in prefilled syringe (CIP: 362 493-6) RISPERDALCONSTA L.P. 50 mg/2 ml, powder and solvent for prolonged-release suspension for injection in prefilled syringe (CIP: 362 494-2) Posted on May 24 2011

Sujets

• Médecine

Informations

• Publié par: haute-autorite-sante-troubles-mentaux-et-comportementaux
• Publié le: 05 mai 2010
• Nombre de lectures: 23
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

Extrait

         

The legally binding text is the original French version  

 

TRANSPARENCY COMMITTEE   OPINION   5 May 2010     RISPERDALCONSTA L.P. 25 mg/2 ml, powder and solvent for prolonged-release suspension for injection in prefilled syringe (CIP: 362 491-3 4) RISPERDALCONSTA L.P. 37.5 mg/2 ml, powder and solvent for prolonged-release suspension for injection in prefilled syringe (CIP: 362 493-6 3) RISPERDALCONSTA L.P. 50 mg/2 ml, powder and solvent for prolonged-release suspension for injection in prefilled syringe (CIP: 362 494-2 4)     Applicant: JANSSEN-CILAG   Risperidone    ATC: N05AX08   List I   Date of Marketing Authorisation (mutual recognition procedure introduced in October 2008): 7 October 2003, 14 April 2004, 1 June 2006, 22 December 2008 (change in the indication text following a European arbitration procedure: "Maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics")   Reason for request: Reassessment of the IAB.                                   Medical, Economic, and Public Health Assessment Division

 

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