8 Pages
English

TAREG - TAREG - CT 8529 - English version

-

Gain access to the library to view online
Learn more

Description

Introduction TAREG 40 mg, film-coated tablet B/30 (CIP code: 381 540-6) B/90 (CIP code: 381 543-5) B/56 (CIP code: 381 541-2) TAREG 80 mg, film-coated tablet B/30 (CIP code: 381 546-4) B/90 (CIP code: 381 549-3) B/56 (CIP code: 381 547-0) TAREG 160 mg, film-coated tablet B/30 (CIP code: 381 552-4) B/90 (CIP code: 381 555-3) B/56 (CIP code: 381 553-0) Posted on Oct 20 2010 Active substance (DCI) valsartan Cardiologie - Nouvelle indication Pas d’avantage clinique démontré dans le post-infarctus du myocarde récent du patient cliniquement stable ayant une insuffisance cardiaque ou une dysfonction systolique ventriculaire gauche NISIS ou TAREG est indiqué dans le traitement des patients cliniquement stables ayant une insuffisance cardiaque symptomatique ou une dysfonction systolique ventriculaire gauche asymptomatique post-infarctus du myocarde récent (entre la 12e heure et le 10e jour).Les données disponibles n’ont pas permis de démontrer que le valsartan représente un avantage clinique chez ces patients.Pour en savoir plus, téléchargez la synthèse ou l'avis complet ci-dessous ATC Code C09CA03 Laboratory / Manufacturer NOVARTIS PHARMA SAS TAREG 40 mg, film-coated tablet B/30 (CIP code: 381 540-6) B/90 (CIP code: 381 543-5) B/56 (CIP code: 381 541-2) TAREG 80 mg, film-coated tablet B/30 (CIP code: 381 546-4) B/90 (CIP code: 381 549-3) B/56 (CIP code: 381 547-0) TAREG 160 mg, film-coated tablet B/30 (CIP code: 381 552-4) B/90 (CIP code: 381 555-3) B/56 (CIP code: 381 553-0) Posted on Oct 20 2010

Subjects

Informations

Published by
Published 20 October 2010
Reads 0
Language English
  
  The legally binding text is the original French version  
TRANSPARENCY COMMITTEE  OPINION  20 October 2010   TAREG 40 mg, film-coated tablet B/30 (CIP code: 381 540-6) B/90 (CIP code: 381 543-5) B/56 (CIP code: 381 541-2)  TAREG 80 mg, film-coated tablet B/30 (CIP code: 381 546-4) B/90 (CIP code: 381 549-3) B/56 (CIP code: 381 547-0)  TAREG 160 mg, film-coated tablet B/30 (CIP code: 381 552-4) B/90 (CIP code: 381 555-3) B/56 (CIP code: 381 553-0)   Applicant: NOVARTIS PHARMA SAS  valsartan ATC code: C09CA03  List I  Dates of first Marketing Authorisation (mutual recognition): TAREG 40 mg : 23 /01/2006 TAREG 80 et 160 mg : 31/05/2001  Date of extension of the indication: 5 June 2009  Reason for request:Inclusion on the list of medicines refundable by National Health Insurance and approved for hospital use in the extension of the indication “Treatment of clinically stable patients with symptomatic heart failure (HF) or asymptomatic left-ventricular systolic dysfunction (LVSD) after recent (between 12 hours and 10 days) myocardial infarction”.        Medical, Economic and Public Health Assessment Division  1/8