PreHevbri

Withdrawn

This medicine's authorisation has been withdrawn

hepatitis B surface antigen

Overview

The marketing authorisation for PreHevbri (SRD) has been withdrawn at the request of the marketing-authorisation holder.

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

AdoptedReference Number: EMA/CHMP/86102/2022

CHMP summary of opinion for PreHevbri

AdoptedReference Number: EMA/CHMP/87383/2022