YONDELIS - YONDELIS - CT 7917 - English version

Has

Description

Introduction YONDELIS 0.25 mg, powder for concentrate for solution for infusion B/1 (CIP code: 571 522-9) YONDELIS 1 mg, powder for concentrate for solution for infusion B/1(CIP code: 571 524-1) Posted on May 04 2012 Active substance (DCI) trabectedine Cancérologie - Nouvelle indication Pas d’avantage clinique démontré dans le traitement du cancer des ovaires récidivant sensible au platine YONDELIS, en association à la doxorubicine liposomale pégylée (DLP), est indiqué chez les patientes atteintes d’un cancer des ovaires récidivant sensible au platine.Il constitue un moyen thérapeutique supplémentaire sans amélioration de la survie globale et au prix d’une augmentation de la toxicité hématologique et hépatique.Pour en savoir plus, téléchargez la synthèse ou l'avis complet ci-dessous ATC Code L01CX01 Laboratory / Manufacturer PHARMA MAR S.A. YONDELIS 0.25 mg, powder for concentrate for solution for infusion B/1 (CIP code: 571 522-9) YONDELIS 1 mg, powder for concentrate for solution for infusion B/1(CIP code: 571 524-1) Posted on May 04 2012

Sujets

• Cancer
• Médecine

Informations

• Publié par: haute-autorite-sante-cancers
• Publié le: 16 juin 2010
• Nombre de lectures: 26
• 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 16 June 2010 YONDELIS 0.25 mg, powder for concentrate for solution for infusion B/1 (CIP code: 571 522-9) YONDELIS 1 mg, powder for concentrate for solution for infusion B/1(CIP code: 571 524-1) Applicant: PHARMA MAR S.A. trabectedine ATC code: L01CX01 List I Medicine restricted to hospital use. Prescription is restricted to specialists in oncology or in haematology, or to physicians with competence in oncology. Medicine requiring special monitoring during treatment. Orphan medicinal product status (30 May 2001) Date of Marketing Authorisation (centralised European): 17 September 2007 – Variation of 28 October 2009 Reason for request: Inclusion on the list of medicines approved for hospital use in extension of indication “in combination with pegylated liposomal doxorubicin (PLD) in the treatment of platinum-sensitive recurring ovarian cancer”. Medical, Economic and Public Health Assessment Division

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