ARIXTRA - ARIXTRA - CT 5405 - English version

Has

Description

Introduction ARIXTRA 2.5 mg/0.5 ml, solution for injection in pre-filled syringe Pack of 10 (CIP: 563 619-7) Posted on Mar 14 2011 Active substance (DCI) fondaparinux sodium ATC Code B01AX05 Laboratory / Manufacturer GlaxoSmithKline ARIXTRA 2.5 mg/0.5 ml, solution for injection in pre-filled syringe Pack of 10 (CIP: 563 619-7) Posted on Mar 14 2011

Sujets

• Embolie
• Cardiopathie coronarienne
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-vasculaires
• Publié le: 11 juin 2008
• Nombre de lectures: 15
• 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  

  11 June 2008     ARIXTRA 2.5 mg/0.5 ml, solution for injection in pre-filled syringe Pack of 10 (CIP: 563 619-7)     Applicant: GlaxoSmithKline   Fondaparinux Sodium ATC code : B01AX05   List I   Date of first Marketing Authorisation (MA): 21 March 2002   (Centralised European Registration Procedure)    Variation to the MA and extension of indication: 29 August 2007   Reason for request:inclusion on the list of medicines approved for use by hospitals and various public servicesin the extension of indication: “Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (< 120 min) invasive management (percutaneous coronary intervention: PCI) is not indicated (see sections 4.4 and 5.1 of the SPC)”.                                     Medical, Economic and Public Health Assessment Division

 

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