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ILARIS - ILARIS - CT 7256 - English version

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Introduction ILARIS 150 mg powder for solution for injection B/1 vial (CIP: 397 457-6) Posted on Mar 01 2011 Active substance (DCI) canakinumab Maladie rare - Nouveau médicament Progrès thérapeutique important dans le traitement des cryopyrinopathies ILARIS est indiqué chez les enfants de plus de 4 ans, les adolescents et les adultes, dans le traitement des cryopyrinopathies (CAPS) regroupant :le syndrome de Muckle-Wells (MWS) ;le syndrome chronique infantile neurologique, cutané et articulaire (CINCA ou NOMID) ;les formes sévères du syndrome familial auto-inflammatoire au froid (FCAS) ou de l’urticaire familiale au froid (FCU).Il s’agit du seul traitement ayant une AMM dans ces affections à l’heure actuelle.Pour en savoir plus, téléchargez la synthèse ou l'avis complet ci-dessous ATC Code L04AC08 Laboratory / Manufacturer NOVARTIS PHARMA SAS ILARIS 150 mg powder for solution for injection B/1 vial (CIP: 397 457-6) Posted on Mar 01 2011

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Published 10 February 2010
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Language English
   
 The legally binding text is the original French version  TRANSPARENCY COMMITTEE
 OPINION  10 February 2010   ILARIS 150 mg powder for solution for injection B/1 vial (CIP: 397 457-6)  Applicant: NOVARTIS PHARMA SAS  canakinumab  List I Medicine for hospital prescription only. Initial prescription and renewal restricted to specialists in rheumatology, internal medicine, dermatology, or paediatrics. Medicine requiring special monitoring during treatment.  Orphan medicinal product (date of designation: 20 March 2007)  ATC code: L04AC08  Exceptional-prescription drug  Date of Marketing Authorisation (centralised procedure): 23 October 2009   Reason for request: Inclusion on the list of medicines reimbursed by National Insurance and approved for hospital use.  This medicine has been authorised under "Exceptional Circumstances". This means that because of the rarity of the disease it has been impossible to get complete information on the medicine. The EMA will review any new information on the medicine every year, and the SPC will be updated as necessary.          Medical, Economic, and Public Health Assessment Division   
 
 
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