EPARs human use - Viread//Tenofovir disoproxil

FICHA FARMACOLÓGICA de Tenofovir disoproxil. 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. AGOSTO 03, 2009.-

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EPARs for authorised medicinal products for human use - Viread

Active Substance
Tenofovir disoproxil
International Nonproprietary Name or Common Name
Tenofovir disoproxil fumarate
Pharmaco-therapeutic Group
Nucleoside and nucleotide reverse transcriptase inhibitors
ATC Code
JO5AF07

Therapeutic Indication:
HIV-1 infection: Viread is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults over 18 years of age.

The demonstration of benefit of Viread in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).

The choice of Viread to treat antiretroviral experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients.

Hepatitis B infection: Viread is indicated for the treatment of chronic hepatitis B in adults with compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.

This indication is based on histological, virological, biochemical and serological responses mainly in adult nucleoside-naïve patients with HBeAg positive and HBeAg negative chronic hepatitis B with compensated liver function.

Date of issue of Marketing Authorisation valid throughout the European Union
5 February 2002

Orphan medicinal product designation date
Not applicable

EPARs for authorised medicinal products for human use