On 31 December 2022, the European Commission withdrew the marketing authorisation for Hepsera (adefovir dipivoxil) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Gilead Sciences Ireland UC, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Hepsera was granted marketing authorisation in the EU on 6 March 2003 for the treatment of adults with chronic hepatitis B. The marketing authorisation was initially valid for a 5\-year period. It was then granted unlimited validity in 2008\. The European Public Assessment Report (EPAR) for Hepsera is updated to indicate that the marketing authorisation is no longer valid.
Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
J05AF08
ATC Item
N/A
Pharmacotherapeutic Group
Nucleoside and nucleotide reverse transcriptase inhibitors
Active Substance (Summary)
INN / Common Names
EMA Name
Hepsera
Medicine Name
Hepsera
Aliases
N/ANo risk management plan link.
