Peginterferon alfa-2a / EPARs for human use - Pegasys

FICHA FARMACOLÓGICA de Peginterferon alfa-2a Contiene 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. NOVIEMBRE 16, 2009.

abrir aquí para acceder al documento EMEA completo:
EPARs for authorised medicinal products for human use - Pegasys

Active Substance
Peginterferon alfa-2a
International Nonproprietary Name or Common Name
Peginterferon alfa-2a
Pharmaco-therapeutic Group
Immunostimulating Agent/Cytokine
ATC Code
L03AB11

Therapeutic Indication:
Chronic hepatitis B:

Pegasys is indicated for the treatment of HBeAg-positive or HBeAg-negative chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, increased ALT and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1).


Chronic hepatitis C:
Pegasys is indicated for the treatment of chronic hepatitis C in adult patients who are positive for serum HCV-RNA, including patients with compensated cirrhosis and/or co-infected with clinically stableHIV (see section 4.4).

The optimal way to use Pegasys in patients with chronic hepatitis C is in combination with ribavirin. The combination of Pegasys and ribavirin is indicated in naive patients and patientswho have failed previous treatment with interferon alpha (pegylated or non-pegylated) alone or in combination therapy with ribavirin.

Monotherapy is indicated mainly in case of intolerance or contraindication to ribavirin.

Date of issue of Marketing Authorisation valid throughout the European Union
20 June 2002

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use