Zeffix (lamivudine)
- Region
- 🇪🇺 EU
- Active substance
- lamivudine
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Authorised
- Therapeutic area
- Hepatitis B, Chronic
- CHMP opinion
- Thu 22 Apr 1999
- EU approval
- Thu 29 Jul 1999
- Application
- EMEA/H/C/000242
- ATC
- J05AF05
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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