Heplisav B


hepatitis B surface antigen

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 23/05/2023

Authorisation details

Product details
Heplisav B
Agency product number
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
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
Dynavax GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Eichsfelder Strasse 11
D-40595 Dusseldorf

Product information

26/04/2023 Heplisav B - EMEA/H/C/005063 - II/0023

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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


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.

Assessment history

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