10 Pages
English
Gain access to the library to view online
Learn more

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

Gain access to the library to view online
Learn more
10 Pages
English

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

Subjects

Informations

Published by
Published 05 May 2010
Reads 23
Language English

Exrait

     
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
 
1/10