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🇪🇺EU · EMAWithdrawnATC: J05AF08

Hepsera(adefovir dipivoxil)

Hepatitis B, Chronic

Marketing Authorisation Holder: Gilead Sciences Ireland UC

EMA Authorisation: 06/03/2003

INN: adefovir dipivoxil

Indication

Hepsera 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 liver inflammation and fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1); decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.