Peginterferon alfa-2b // EPARs for authorised medicinal products for human use - ViraferonPeg

FICHA FARMACOLÓGICA de Peginterferon alfa-2b Contiene la Monografía en distintos idiomas (de la Unión 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. ENERO 23, 2010.-

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EPARs for authorised medicinal products for human use - ViraferonPeg

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:
Adult patients:
ViraferonPeg is indicated for the treatment of adult patients with chronic hepatitis Cwho are positive for HCV-RNA , including patients with compensated cirrhosis and/or co-infected with clinically stable HIV (see section 4.4).
The best way to use ViraferonPeg 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.
Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin.



Children 3 years of age and older and adolescents:
ViraferonPeg is indicated in a combination regimen with ribavirin for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for HCV-RNA.
When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis, (see section 4.4
Please refer also to the ribavirin Summary of Product Characteristics (SPC) for capsules or oral solution when ViraferonPeg is to be used in combination with ribavirin.


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

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use