FACTANE - FACTANE - CT 3967 - English version

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Description

Introduction FACTANE 100 I.U. /ml, powder and solvent for solution for injection Box of 1 – 2.5 ml vial (CIP: 562 115-5) Box of 1 – 5 ml vial (CIP: 562 116-1) Box of 1 – 10 ml vial (CIP: 562 117-8) Posted on Aug 01 2008 Active substance (DCI) Human Coagulation Factor VIII ATC Code B02BD02 Laboratory / Manufacturer LFB BIOMEDICAMENTS FACTANE 100 I.U. /ml, powder and solvent for solution for injection Box of 1 – 2.5 ml vial (CIP: 562 115-5) Box of 1 – 5 ml vial (CIP: 562 116-1) Box of 1 – 10 ml vial (CIP: 562 117-8) Posted on Aug 01 2008

Sujets

• Médecine

Informations

• Publié par: haute-autorite-sante-traitement-medicamenteux
• Publié le: 28 mars 2007
• 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   28 March 2007     FACTANE 100 I.U. /ml, powder and solvent for solution for injection Box of 1 – 2.5 ml vial (CIP: 562 115-5) Box of 1 – 5 ml vial (CIP: 562 116-1) Box of 1 – 10 ml vial (CIP: 562 117-8)   Applicant : LFB BIOMEDICAMENTS   Human Coagulation Factor VIII   List I Medicine for initial hospital prescription of six months (including blood transfusion organisations authorised to dispense medicinal products derived from the blood of patients treated). Issuance is restricted to pharmacies of healthcare organisations or blood transfusion organisations for patients treated therein.     Date of Marketing Authorisation: 30 December, 1994 Revision (extension of indication): 4 July, 2006   Reason for request: Inclusion on the list of medicines for use by hospitals in the extension of indication: “coagulation factor VIII is indicated for the treatment of inhibitors byHuman immune tolerance induction (ITI)”.                                    Health Technology Assessment Division  

 

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