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

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2010

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2010

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05 mai 2010

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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

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Publié par

haute-autorite-sante-troubles-mentaux-et-comportementaux

Publié le

05 mai 2010

Licence :

En savoir +

Langue

English

Médecine

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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