AVASTIN - AVASTIN - CT 6250 - English version

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Description

Introduction AVASTIN 25 mg/ml concentrate for solution for infusion Box of 1 x 4 ml vial (CIP: 566 200-7) Box of 1 x 16 ml vial (CIP: 566 201-3) Posted on Mar 11 2011 Active substance (DCI) bevacizumab CANCEROLOGIE – NOUVELLE INDICATION Progrès thérapeutique mineur en association à une chimiothérapie à base de fluoropyrimidine en deuxième ligne du traitement du cancer colorectal métastatique La nouvelle indication d’AVASTIN est le traitement du cancer colorectal métastatique en association à une chimiothérapie à base de fluoropyrimidine.Dans l’extension en 2ème ligne, l’ajout d’AVASTIN à une chimiothérapie type FOLFOX-4 représente un avantage mineur en termes de survie globale.Pour en savoir plus, téléchargez la synthèse ou l'avis complet ci-dessous. ATC Code code ATC: L01XC07 Laboratory / Manufacturer ROCHE AVASTIN 25 mg/ml concentrate for solution for infusion Box of 1 x 4 ml vial (CIP: 566 200-7) Box of 1 x 16 ml vial (CIP: 566 201-3) Posted on Mar 11 2011

Sujets

• Cancer du sein
• Cancer
• Médecine

Informations

• Publié par: haute-autorite-sante-cancers
• Publié le: 04 mars 2009
• Nombre de lectures: 19
• 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   4 March 2009         AVASTIN 25 mg/ml concentrate for solution for infusion Box of 1 x 4 ml vial (CIP: 566 200-7) Box of 1 x 16 ml vial (CIP: 566 201-3)     Applicant: ROCHE   Bevacizumab  ATC code: L01XC07   List I For hospital use only     Date of centralised marketing authorisation: 12 January 2005   Corrections to the MA: 27 March 2007 (breast cancer) - 21 August 2007 (lung cancer) - 14 December 2007 (renal cell cancer) - 25 January 2008 (indication to be assessed)     Reason for request: inclusion on the list of medicines approved for use by hospitals in the extension of indication (second-line treatment of metastatic cancer of the colon or rectum) and analysis of updated information for the first-line indication.       The former indication wording for treatment of cancer of the colon or rectum was limited to first-line treatment: “AVASTIN is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with 5-fluororacil/folinic intravenous chemotherapy with or without irinotecan.” It has ben extended to second-line treatment: “AVASTIN (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.”                         Medical, Economic and Public Health Assessment Division

 

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