EPARs - Baraclude/Entecavir

FICHA FARMACOLÓGICA de ENTECAVIR. 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. Cerasale. Febrero 2009.

EPARs for authorised medicinal products for human use - Baraclude

Active Substance
Entecavir
International Nonproprietary Name or Common Name
Entecavir
Pharmaco-therapeutic Group
Nucleoside and nucleotide reverse transcriptase inhibitors
ATC Code
J05FA10

Therapeutic Indication: Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and 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 clinical trial data in patients with HBeAg positive and HBeAg negative HBV infection, nucleoside naive patients and patients with lamivudine-refractory hepatitis B (see sections 4.4 and 5.1 of the Summary of Product Characteristics).

Date of issue of Marketing Authorisation valid throughout the European Union
26 June 2006