XELODA - XELODA - CT 5238 - English version

Has

Description

Introduction XELODA 150 mg, film-coated tablet 6 PVC/polyethylene/PVDC blister packs of 60 tablets (CIP 365 745-6) XELODA 500 mg, film-coated tablet 12 PVC/polyethylene/PVDC blister packs of 120 tablets (CIP 365 746-2) Posted on Dec 08 2009 Active substance (DCI) capecitabine ATC Code L01BC06 Laboratory / Manufacturer ROCHE XELODA 150 mg, film-coated tablet 6 PVC/polyethylene/PVDC blister packs of 60 tablets (CIP 365 745-6) XELODA 500 mg, film-coated tablet 12 PVC/polyethylene/PVDC blister packs of 120 tablets (CIP 365 746-2) Posted on Dec 08 2009

Sujets

• Cancer
• Médecine

Informations

• Publié par: haute-autorite-sante-cancers
• Publié le: 06 février 2008
• Nombre de lectures: 27
• 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

  6 February 2008       XELODA 150 mg, film-coated tablet 6 PVC/polyethylene/PVDC blister packs of 60 tablets (CIP 365 745-6)   XELODA 500 mg, film-coated tablet 12 PVC/polyethylene/PVDC blister packs of 120 tablets (CIP 365 746-2)     Applicant: ROCHE   capecitabine    ATC code: L01BC 06   List I   Medicinal product available only on hospital prescription. Prescription restricted to specialists in oncology or haematology or oncologists. Medicinal product requiring specific monitoring during treatment.       Date of Marketing Authorisation (centralised European procedure): 2 February 2001   Revisions: 21 March 2002 - 30 March 2005 - 28 March 2007 (indication to be assessed)        Reason for request: Inclusion on the list of medicines reimbursed by National Insurance and approved for use by hospitals in the extension of indication "Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen".                       Medical, Economic and Public Health Assessment Division

 

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