EPARs human use - PegIntron//Peginterferon alfa-2b

FICHA FARMACOLÓGICA de Peginterferon alfa-2bContiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. SEPTIEMBRE 18, 2009.

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EPARs for authorised medicinal products for human use - PegIntron

Active Substance
Peginterferon alfa-2b
International Nonproprietary Name or Common Name
Peginterferon alfa-2b
Pharmaco-therapeutic Group
Immunostimulants, cytokines and immunomodulators, interferons, peginterferon alfa-2b
ATC Code
L03A B10

Therapeutic Indication:
PegIntron is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV, including naïve patients with clinically stable HIV co-infection (see section 4.4).

The best way to use PegIntron in this indication is in combination with ribavirin.

This combination is indicated in naïve patients including patients with clinically stable HIV co-infection and in patients who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy (see section 5.1).

Interferon monotherapy, including PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin.

Please refer also to the ribavirin Summary of Product Characteristics (SPC) when PegIntron is to be used in combination with ribavirin.


Date of issue of Marketing Authorisation valid throughout the European Union
25 May 2000

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use