Hepsera
Withdrawn
This medicine's authorisation has been withdrawn
adefovir dipivoxil
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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The European Public Assessment Report (EPAR) for Hepsera is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
IB/0086
20/04/2021
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Hepsera
- Active substance
- adefovir dipivoxil
- International non-proprietary name (INN) or common name
- adefovir dipivoxil
- Therapeutic area (MeSH)
- Hepatitis B, Chronic
- Anatomical therapeutic chemical (ATC) code
- J05AF08
Pharmacotherapeutic group
Nucleoside and nucleotide reverse transcriptase inhibitorsTherapeutic 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.
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