BUSILVEX - BUSILVEX - CT 3958 - English version

Has

Description

Introduction BUSILVEX 6 mg/ml, solution to be diluted for intravenous infusion Box of 8 vial (CIP: 564 923-1) Posted on Nov 10 2009 Active substance (DCI) busulfan ATC Code L01AB01 Laboratory / Manufacturer PIERRE FABRE MEDICAMENT BUSILVEX 6 mg/ml, solution to be diluted for intravenous infusion Box of 8 vial (CIP: 564 923-1) Posted on Nov 10 2009

Sujets

• Médecine

Informations

• Publié par: haute-autorite-sante-traitement-medicamenteux
• Publié le: 14 février 2007
• Nombre de lectures: 29
• 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 14 February 2007 BUSILVEX 6 mg/ml, solution to be diluted for intravenous infusion Box of 8 vial (CIP: 564 923-1) Applicant : PIERRE FABRE MEDICAMENT busulfan ATC code: L01AB01 List I Medicine restricted for hospital use Orphan medicinal product status Date of centralised Marketing Authorisation: 9 July 2003 – revision: 27 October 2005 (extension of indication in paediatric use) Reason for request: inclusion on the list of medicines approved for use by hospitals in the extension of indication “BUSILVEX followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in newborn, children and adolescent patients”. Medical, Economic and Public Health Assessment Division

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