Hepsera (adefovir dipivoxil)
- Region
- 🇪🇺 EU
- Active substance
- adefovir dipivoxil
- Company
- Gilead Sciences Ireland UC
- Status
- Withdrawn
- Therapeutic area
- Hepatitis B, Chronic
- CHMP opinion
- Thu 21 Nov 2002
- EU approval
- Thu 06 Mar 2003
- Application
- EMEA/H/C/000485
- ATC
- J05AF08
- Official record
- www.ema.europa.eu
Indication
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.
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.