TEGELINE - TEGELINE - CT 7337 - English version

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Description

Introduction TEGELINE 50 mg/ml, powder and solvent for solution for infusion Vial containing 0.5 g of powder and vial containing 10 ml of solvent plus transfer device and needles (CIP: 559 895-3) Vial containing 2.5 g of powder and vial containing 50 ml of solvent plus transfer device and needles (CIP: 559 897-6) Vial containing 5 g of powder and vial containing 100 ml of solvent plus transfer device and needles (CIP: 559 898-2) Vial containing 10 g of powder and vial containing 200 ml of solvent plus transfer device and needles (CIP: 559 899-9) Posted on May 17 2011 Active substance (DCI) normal human immunoglobulin Neurologie-Nouvelle indication Progrès thérapeutique mineur dans la prise en charge des polyradiculonévrites inflammatoires démyélinisantes chroniques Les immunoglobulines humaines administrées en IV (Ig IV) ont une action immunomodulatrice mise à profit pour traiter diverses maladies auto-immunes. TEGELINE est désormais indiqué dans les polyradiculonévrites inflammatoires démyélinisantes chroniques (PIDC).Les Ig IV représentent un traitement de première intention des PIDC, au même titre que la corticothérapie et les échanges plasmatiques.TEGELINE apporte, dans les PIDC, un progrès thérapeutique considéré comme mineur, en raison du faible niveau de preuve de son efficacité.Pour en savoir plus, téléchargez la synthèse ou l'avis complet ci-dessous ATC Code J06BA02 Laboratory / Manufacturer LFB-BIOMEDICAMENTS TEGELINE 50 mg/ml, powder and solvent for solution for infusion Vial containing 0.5 g of powder and vial containing 10 ml of solvent plus transfer device and needles (CIP: 559 895-3) Vial containing 2.5 g of powder and vial containing 50 ml of solvent plus transfer device and needles (CIP: 559 897-6) Vial containing 5 g of powder and vial containing 100 ml of solvent plus transfer device and needles (CIP: 559 898-2) Vial containing 10 g of powder and vial containing 200 ml of solvent plus transfer device and needles (CIP: 559 899-9) Posted on May 17 2011

Sujets

• Maladie génétique
• RARE
• Maladie auto-immune
• Maladie infectieuse
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-infectieuses
• Publié le: 27 janvier 2010
• Nombre de lectures: 74
• 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   27 January 2010

      TEGELINE 50 mg/ml, powder and solvent for solution for infusion Vial containing 0.5 g of powder and vial containing 10 ml of solvent plus transfer device and needles (CIP: 559 895-3)   Vial containing 2.5 g of powder and vial containing 50 ml of solvent plus transfer device and needles (CIP: 559 897-6)   Vial containing 5 g of powder and vial containing 100 ml of solvent plus transfer device and needles (CIP: 559 898-2)   Vial containing 10 g of powder and vial containing 200 ml of solvent plus transfer device and needles (CIP: 559 899-9)       Applicant: LFB-BIOMEDICAMENTS   “Normal human immunoglobulin”   TC code: J06BA02   A  

List I Medicine for hospital prescription only. Prescription by doctors practising in a blood transfusion establishment who are authorised to dispense medicines to patients being treated there is also authorised.     Date of Marketing Authorisation: 2 September 1996   Amendment of Marketing Authorisation: 24 February 2009 (extension of the indication to chronic inflammatory demyelinating polyradiculoneuropathy)     Reason for the request: Inclusion on the list of medicines approved for hospital use in the extension of the indication to chronic inflammatory demyelinating polyradiculoneuropathy.                     Medical, Economic and Public Health Assessment Division

 

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