Lamivudine Teva (lamivudine)
- Region
- 🇪🇺 EU
- Active substance
- lamivudine
- Company
- Teva B.V.
- Status
- Authorised
- Therapeutic area
- Hepatitis B, Chronic
- EU approval
- Fri 23 Oct 2009
- Designations
- Generic
- Application
- EMEA/H/C/001113
- ATC
- J05AF05
- Official record
- www.ema.europa.eu
Indication
Lamivudine Teva 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 (see in section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Trizivir Withdrawn · ViiV Healthcare BV
- 🇪🇺 Lamivudine Teva Pharma B.V. Authorised · Teva B.V.
- 🇪🇺 Delstrigo Authorised · Merck Sharp & Dohme B.V.
- 🇪🇺 Epivir Authorised · ViiV Healthcare BV
- 🇪🇺 Zeffix Authorised · GlaxoSmithKline Trading Services Limited
- 🇪🇺 Dovato Authorised · ViiV Healthcare B.V.
- 🇪🇺 Triumeq Authorised · ViiV Healthcare B.V.
- 🇪🇺 Kivexa Authorised · ViiV Healthcare BV
- 🇪🇺 Lamivudine/Zidovudine Teva Withdrawn · Teva Pharma B.V.
- 🇪🇺 Combivir Authorised · ViiV Healthcare BV
- 🇪🇺 Dutrebis Withdrawn · Merck Sharp Dohme Limited
Follow Lamivudine Teva
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.