PreHevbri

RSS

hepatitis B surface antigen

Authorised
This medicine is authorised for use in the European Union.

Overview

PreHevbri is a vaccine for adults that is used in line with official recommendations to protect against hepatitis B (an infectious disease of the liver caused by hepatitis B virus). By preventing hepatitis B, the vaccine is also expected to protect against hepatitis D (another disease of the liver, caused by the hepatitis D virus).

PreHevbri contains three proteins from the outer part of the hepatitis B virus.

This EPAR was last updated on 18/05/2022

Authorisation details

Product details
Name
PreHevbri
Agency product number
EMEA/H/C/005466
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
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
VBI Vaccines B.V.
Date of issue of marketing authorisation valid throughout the European Union
25/04/2022
Contact address

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

Product information

PreHevbri - EMEA/H/C/005466 -

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

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