Heplisav B (hepatitis B surface antigen)
- Region
- 🇪🇺 EU
- Active substance
- hepatitis B surface antigen
- Company
- Dynavax GmbH
- Status
- Authorised
- Therapeutic area
- Hepatitis B
- CHMP opinion
- Thu 10 Dec 2020
- EU approval
- Thu 18 Feb 2021
- Application
- EMEA/H/C/005063
- ATC
- J07BC01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 PreHevbri Withdrawn · VBI Vaccines B.V.
- 🇪🇺 Hepacare Withdrawn · Evans Vaccines Ltd.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.