Basic Information
Heplisav B
Regulatory Information
EMEA/H/C/005063
February 18, 2021
December 10, 2020
7
May 13, 2024
Company Information
Germany
Eichsfelder Strasse 11 D-40595 Dusseldorf
Dynavax GmbH
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.