DaTSCAN - DaTSCAN - CT 4058 - English version

Has

Description

Introduction DaTSCAN 74 MBq/ml, solution for injection Box of 1 – CIP 375 482-8 Posted on Aug 01 2008 Active substance (DCI) Ioflupane [123I] ATC Code V09AB03 Laboratory / Manufacturer GE HEALTHCARE SA DaTSCAN 74 MBq/ml, solution for injection Box of 1 – CIP 375 482-8 Posted on Aug 01 2008

Sujets

• Médecine

Informations

• Publié par: haute-autorite-sante-traitement-medicamenteux
• Publié le: 14 mars 2007
• Nombre de lectures: 18
• 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 March 2007     DaTSCAN 74 MBq/ml, solution for injection Box of 1 – CIP 375 482-8   Applicant : GE HEALTHCARE SA   Ioflupane [ 123 I] List I   Restricted for hospital use  DaTSCAN should only be used in patients referred by physicians with experience in the management of movement disorders and/or dementia. Radiopharmaceutical agents should only be used by qualified personnel with the appropriate government authorisations for the use and manipulation of radionuclides within a designated clinical setting.       Date of Marketing Authorisation: 27 July 2000 (centralised Marketing Authorisation)  28 July 2006 (Extension of indication)     Reason for request: Inclusion on the list of medicines approved for use by hospitals in the indication “to assist in the differential diagnosis of probable dementia with Lewy bodies from Alzheimer’s disease”. DaTSCAN is unable to discrimni ate between dementia with Lewy bodies and Parkinson’s disease dementia.                                   Health Technology Assessment Division

 

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