PreHevbri
hepatitis B surface antigen
Table of contents
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.
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PreHevbri : EPAR - Medicine Overview (PDF/112.46 KB)
First published: 18/05/2022
EMA/129611/2022 -
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PreHevbri : EPAR - Risk management plan summary (PDF/226.9 KB)
First published: 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 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 | |
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Marketing-authorisation holder |
VBI Vaccines B.V.
|
Revision |
1
|
Date of issue of marketing authorisation valid throughout the European Union |
25/04/2022
|
Contact address |
Queen’s Tower Office Number 714 |
Product information
17/03/2023 PreHevbri - EMEA/H/C/005466 - IAIN/0003
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).
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.