PEGASYS - PEGASYS - CT-032520 - English version

Has

Description

Introduction Pegasys 135 mcg, solution for injection in prefilled syringe Box of 1 (CIP code: 359 958-1) Pegasys 135 mcg, solution for injection in prefilled syringe Box of 4 (CIP code: 359 959-8) Pegasys 180 mcg, solution for injection in prefilled syringe Box of 1 (CIP code: 359 960-6) Pegasys 180 mcg, solution for injection in prefilled syringe Box of 4 (CIP code: 359 961-2) Posted on Mar 15 2006 Active substance (DCI) peginterferon alpha-2a ATC Code ATC :L03AB11 Laboratory / Manufacturer Roche Laboratories Pegasys 135 mcg, solution for injection in prefilled syringe Box of 1 (CIP code: 359 958-1) Pegasys 135 mcg, solution for injection in prefilled syringe Box of 4 (CIP code: 359 959-8) Pegasys 180 mcg, solution for injection in prefilled syringe Box of 1 (CIP code: 359 960-6) Pegasys 180 mcg, solution for injection in prefilled syringe Box of 4 (CIP code: 359 961-2) Posted on Mar 15 2006

Sujets

• Infection sexuellement transmissible
• Maladie infectieuse
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-infectieuses
• Publié le: 15 mars 2006
• Nombre de lectures: 10
• 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

  OPI O NI N

  15 March 2006     Pegasys 135 mcg, solution for injection in prefilled syringe Box of 1 (CIP code: 359 958-1)   Pegasys 135 mcg, solution for injection in prefilled syringe Box of 4 (CIP code: 359 959-8)   Pegasys 180 mcg, solution for injection in prefilled syringe Box of 1 (CIP code: 359 960-6)   Pegasys 180 mcg, solution for injection in prefilled syringe Box of 4 (CIP code: 359 961-2)   Applicant: Roche Laboratories   peginterferon alpha-2a   List I Medicinal product requiring close monitoring during treatment. Medicinal product subject to six-monthly prescription initially, reserved for specialists and/or departments specialising in gastroenterology, hepatology, internal medicine or infectious disease. Unrestricted renewal.   Medicine dispensed in both pharmacies and hospitals. Listed as a medicine which can be sold by hospitals to outpatients.   Date of Marketing Authorisation and amendments to Marketing Authorisation: 20 June 2002, 23 July 2003, 29 October 2004, 26 January 2005, 23 February 2005.     Reason for request:    indication in the treatment of HBeAg positive or negative chronicExtension of  hepatitis B in adults with compensated liver disease.    Extension of indication in the treatment of chronic hepatitis C in adults  coinfected with HIV (stable HIV infection), who are serum HCV-RNA positive, including patients with compensated cirrhosis.         Health Technology Assessment Division

 

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