PreHevbri

Withdrawn

This medicine's authorisation has been withdrawn

hepatitis B surface antigen

Overview

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The European Public Assessment Report (EPAR) for PreHevbri is updated to indicate that the marketing authorisation is no longer valid.

PreHevbri : EPAR - Medicine Overview

Reference Number: EMA/129611/2022

PreHevbri : EPAR - Risk management plan summary

Product information

PreHevbri : EPAR - Product Information

PreHevbri : EPAR - All authorised presentations

Product details

• Name of medicine:
  PreHevbri
• Active substance:
  hepatitis B surface antigen
• International non-proprietary name (INN) or common name:
  hepatitis B surface antigen
• Therapeutic area (MeSH):
  Hepatitis B
• Anatomical therapeutic chemical (ATC) code:
  J07BC01

Pharmacotherapeutic group

Vaccines

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.

Authorisation details

• EMA product number:
  EMEA/H/C/005466
• Marketing authorisation holder:
  VBI Vaccines B.V.

  Queen’s Tower Office Number 714; Delflandlaan 1; 1062 EA; Amsterdam; Netherlands

• Opinion adopted:
  24/02/2022
• Marketing authorisation issued:
  25/04/2022
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

PreHevbri : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

PreHevbri : EPAR - Public Assessment Report

Adopted Reference Number: EMA/CHMP/86102/2022

CHMP summary of opinion for PreHevbri

Adopted Reference Number: EMA/CHMP/87383/2022