PEGASYS - PEGASYS - CT-032520 - English version

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2006

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2006

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Publié par

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15 mars 2006

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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

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Publié par

haute-autorite-sante-maladies-infectieuses

Publié le

15 mars 2006

Licence :

En savoir +

Langue

English

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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