ATRIANCE - ATRIANCE - CT 5162 - English version

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Description

Introduction ATRIANCE 5 mg/ml, Solution for Infusion Pack of 6 vials (571 348-9) Posted on Feb 15 2010 Active substance (DCI) nelarabine ATC Code L01BB07 Laboratory / Manufacturer GLAXOSMITHKLINE ATRIANCE 5 mg/ml, Solution for Infusion Pack of 6 vials (571 348-9) Posted on Feb 15 2010

Sujets

• Médecine

Informations

• Publié par: haute-autorite-sante-traitement-medicamenteux
• Publié le: 19 décembre 2007
• Nombre de lectures: 24
• 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 COMMITTE

  OPINION   19 December 2007     ATRIANCE 5 mg/ml, Solution for Infusion Pack of 6 vials (571 348-9)   Applicant: GlaxoSmithKline   nelarabine    List I Medicinal product for hospital use only. Only for prescription by oncologists, haematologists and experienced physicians in oncology.   Orphan medicinal product status   Date of centralised MA granted “under exceptional circumstances”: 22 August 2007   A marketing authorisation “under exceptional circumstances” was granted for this medicinal product.   This means that due to the rarity of this disease it was impossible to obtain complete information about this proprietary drug. The European Drug Agency (EMEA) will review any new published information on a yearly basis and where necessary the SPC will be updated.     Reason for request: Inclusion on the list of medicines approved for hospital use.                           Health Technology Assessment Division    

 

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