TEGELINE - TEGELINE - CT 7337 - English version
10 pages
English
Obtenez un accès à la bibliothèque pour le consulter en ligne
En savoir plus

TEGELINE - TEGELINE - CT 7337 - English version

-

Obtenez un accès à la bibliothèque pour le consulter en ligne
En savoir plus
10 pages
English

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

Informations

Publié par
Publié le 27 janvier 2010
Nombre de lectures 53
Langue English

Exrait

  
 
 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
 
1
  • Accueil Accueil
  • Univers Univers
  • Livres Livres
  • Livres audio Livres audio
  • Presse Presse
  • BD BD
  • Documents Documents