Heplisav B
hepatitis B surface antigen
Table of contents
Overview
Heplisav B is a vaccine for preventing hepatitis B virus infection in adults. It is also likely to prevent infection with the hepatitis D virus as this virus is only present in people with hepatitis B infection.
Heplisav B is used in accordance with official recommendations. It contains a protein from the hepatitis B virus.
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Heplisav B : EPAR - Medicine overview (PDF/110.26 KB)
First published: 01/03/2021
EMA/27931/2021 -
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Heplisav B : EPAR - Risk-management-plan summary (PDF/149.82 KB)
First published: 01/03/2021
Last updated: 05/10/2022
Authorisation details
Product details | |
---|---|
Name |
Heplisav B
|
Agency product number |
EMEA/H/C/005063
|
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 |
Dynavax GmbH
|
Revision |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
18/02/2021
|
Contact address |
Eichsfelder Strasse 11 |
Product information
26/04/2023 Heplisav B - EMEA/H/C/005063 - II/0023
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
Heplisav B is indicated for the active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The use of Heplisav B should be in accordance with official recommendations.
It can be expected that hepatitis D will also be prevented by immunisation with Heplisav B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.