TAREG - TAREG - CT 9680 - English version

Has

Description

Introduction TAREG 40 mg, film-coated tablet B/30 (CIP code: 381 540-6) B/56 (CIP code: 381 541-2) B/90 (CIP code: 381 543-5) TAREG 80 mg, film-coated tablet B/30 (CIP code: 381 546-4) B/56 (CIP code: 381 547-0) B/90 (CIP code: 381 549-3) TAREG 160 mg, film-coated tablet B/30 (CIP code: 381 552-4) B/56 (CIP code: 381 553-0) B/90 (CIP code: 381 555-3) Posted on Mar 09 2011 Active substance (DCI) valsartan Cardiologie - Nouvelle indication Pas d’avantage clinique démontré dans l’hypertension artérielle essentielle de l’enfant à partir de 6 ans TAREG comprimé et solution buvable est indiqué dans le traitement de l’hypertension artérielle (HTA) de l’enfant et de l’adolescent âgés de 6 à 18 ans.Dans les données disponibles, il n’y a pas de démonstration d’un avantage clinique du valsartan. 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/56 (CIP code: 381 541-2) B/90 (CIP code: 381 543-5) TAREG 80 mg, film-coated tablet B/30 (CIP code: 381 546-4) B/56 (CIP code: 381 547-0) B/90 (CIP code: 381 549-3) TAREG 160 mg, film-coated tablet B/30 (CIP code: 381 552-4) B/56 (CIP code: 381 553-0) B/90 (CIP code: 381 555-3) Posted on Mar 09 2011

Sujets

• Pédiatrie
• Hypertension artérielle
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-vasculaires
• Publié le: 09 mars 2011
• Nombre de lectures: 32
• 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   9 March 2011     TAREG 40 mg, film-coated tablet B/30 (CIP code: 381 540-6) B/56 (CIP code: 381 541-2) B/90 (CIP code: 381 543-5)   TAREG 80 mg, film-coated tablet B/30 (CIP code: 381 546-4) B/56 (CIP code: 381 547-0) B/90 (CIP code: 381 549-3)   TAREG 160 mg, film-coated tablet B/30 (CIP code: 381 552-4) B/56 (CIP code: 381 553-0) B/90 (CIP code: 381 555-3)     Applicant: NOVARTIS PHARMA SAS   valsartan ATC code: C09CA03 List I   Dates of initial Marketing Authorisations (mutual recognition, reference member state: Sweden):   TAREG 40 mg, film-coated tablet: 23 January 2006 TAREG 80 and 160 mg, film-coated tablet: 31 May 2001   Date of extension of the paediatric indication: 9 June 2010     Reason for request: Inclusion on the list of medicines refundable by National Health Insurance (B/30 and B/90 pack sizes only) and approved for hospital use in the extension of indication: “treatment of hypertension in children and adolescents aged 6 to 18 years of age”.                     Medical, Economic and Public Health Assessment Division   1/10