Sebivo (telbivudine)
- Region
- 🇪🇺 EU
- Active substance
- telbivudine
- Company
- Novartis Europharm Limited
- Status
- Withdrawn
- Therapeutic area
- Hepatitis B, Chronic
- CHMP opinion
- Thu 22 Feb 2007
- EU approval
- Tue 24 Apr 2007
- Application
- EMEA/H/C/000713
- ATC
- J05AF11
- Official record
- www.ema.europa.eu
Indication
Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. Initiation of Sebivo 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.
Regulatory milestones
No milestones recorded in the last year.
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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.