This is a summary of the European public assessment report (EPAR) for Zeffix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zeffix.
Therapeutic Indication
### Therapeutic indication Zeffix 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 / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate; - decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.
Therapeutic Area (MeSH)
ATC Code
J05AF05
ATC Item
lamivudine
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| lamivudine | N/A | 拉米夫定 |
EMA Name
Zeffix
Medicine Name
Zeffix
Aliases
N/ANo risk management plan link.
