FOSCAN - FOSCAN - CT 5919 - English version

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Description

Introduction FOSCAN 1 mg, solution for injection B/1 bottle containing 1 mL (CIP: 573 566-3) B/1 bottle containing 3 mL (CIP: 573 568-6) B/1 bottle containing 6 mL (CIP: 573 569-2) Posted on Feb 18 2009 Active substance (DCI) temoporfin ATC Code L01XX Laboratory / Manufacturer BIOLITECH PHARMA LTD FOSCAN 1 mg, solution for injection B/1 bottle containing 1 mL (CIP: 573 566-3) B/1 bottle containing 3 mL (CIP: 573 568-6) B/1 bottle containing 6 mL (CIP: 573 569-2) Posted on Feb 18 2009

Informations

• Publié par: haute-autorite-sante-traitement-medicamenteux
• Publié le: 18 février 2009
• Nombre de lectures: 8
• 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   18 February 2009     FOSCAN 1 mg, solution for injection B/1 bottle containing 1 mL (CIP: 573 566-3) B/1 bottle containing 3 mL (CIP: 573 568-6) B/1 bottle containing 6 mL (CIP: 573 569-2)     Applicant: BIOLITECH PHARMA LTD   temoporfin   List I Medicinal product for hospital use only. Can only be prescribed by oncologists.     Date of European marketing authorisation (centralised procedure): 06 August 2008     Reason for request: Inclusion on the list of medicines approved for use by hospitals .  

Indication:  "Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy. "     The actual benefit provided by FOSCAN is low.   This product given in addition to the other treatments, does not provide any improvement in actual benefit (IAB V).   The Transparency Committee recommends inclusion on the list of medicines approved for use by hospitals and various public services in the marketing authorisation.           Medical, Economic and Public Health Assessment Division