PreHevbri (hepatitis B surface antigen)
- Region
- 🇪🇺 EU
- Active substance
- hepatitis B surface antigen
- Company
- VBI Vaccines B.V.
- Status
- Withdrawn
- Therapeutic area
- Hepatitis B
- CHMP opinion
- Thu 24 Feb 2022
- EU approval
- Mon 25 Apr 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005466
- ATC
- J07BC01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Heplisav B Authorised · Dynavax GmbH
- 🇪🇺 Hepacare Withdrawn · Evans Vaccines Ltd.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.