| EMA number | EMEA/H/C/000485 |
| ATC code | J05AF08 |
| Authorisation | 6 March 2003 |
| Withdrawn | 31 December 2022 |
| Revision | 27 |
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.