On 25 November 2024, the European Commission withdrew the marketing authorisation for PreHevbri (hepatitis B surface antigen) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, VBI Vaccines B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. PreHevbri was granted marketing authorisation in the EU on 25 April 2022 for active immunisation against infection caused by all known subtypes of the hepatitis B virus in adults. The marketing authorisation was initially valid for a 5\-year period. The European Public Assessment Report (EPAR) for PreHevbri is updated to indicate that the marketing authorisation is no longer valid.
Therapeutic Indication
PreHevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis B virus in adults. It can be expected that hepatitis D will also be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. The use of PreHevbri should be in accordance with official recommendations.
Therapeutic Area (MeSH)
ATC Code
J07BC01
ATC Item
N/A
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
EMA Name
PreHevbri
Medicine Name
PreHevbri
Aliases
N/ANo risk management plan link.
