ATRIANCE - ATRIANCE - CT 5162 - English version

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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

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Published 19 December 2007
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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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