ribavirin - EPARs for authorised medicinal products for human use - Ribavirin Teva Pharma B.V.

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 - Ribavirin Teva Pharma B.V.

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
J05AB04

Therapeutic Indication:
Ribavirin Teva Pharma B.V. is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa 2b (adults, children (3 years of age or older), and adolescents). Ribavirin monotherapy must not be used.

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

Please refer also to the interferon alfa 2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.

Naïve patients:
Adult patients: Ribavirin Teva Pharma B.V. is indicated, in combination with interferon alfa 2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV RNA



Children and adolescents:

Ribavirin Teva Pharma B.V. is intended for use, in a combination regimen with interferon alfa2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum HCV RNA. The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load. The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials.


Previous treatment failure patients:
Adult patients: Ribavirin Teva Pharma B.V. 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 alpha monotherapy but who have subsequently relapsed.

Date of issue of Marketing Authorisation valid throughout the European Union
1 July 2009

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use