ribavirin SP - EPARs for authorised medicinal products for human use - Rebetol

FICHA FARMACOLÓGICA de ribavirin 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 - Rebetol

Active Substance
ribavirin
International Nonproprietary Name or Common Name
ribavirin
Pharmaco-therapeutic Group
Direct acting antivirals, nucleosides and nucleotides (excl. reverse transcriptase inhibitors)
ATC Code
J05A B04

Therapeutic Indication:
Rebetol is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b. Rebetol monotherapy must not be used.

There is no safety or efficacy information on the use of Rebetol with other forms of interferon (i.e., not alfa-2b).


Naïve patients
Adult patients: Rebetol is indicated, in combination with interferon alfa-2b or peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid (HCV-RNA). In combination with peginterferon alfa-2b also patients with compensated cirrohosis and/or clinically stable HIV co-infection are included.

Children 3 years of age and older and adolescents: Rebetol is indicated, in a combination regimen with peginterferon alfa-2b or interferon alfa-2b, 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 to 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.

Previously treated patients:
Adult patients: Rebetol is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alfa monotherapy but who have subsequently relapsed. Rebetol is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have failed previous treatment with interferon alpha (pegylated or non-pegylated) alone or in combination with ribavirin.

Date of issue of Marketing Authorisation valid throughout the European Union
7 May 1999

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use