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. ABRIL 18, 2009.-

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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