Hepacare (hepatitis B surface antigens recombinant (S, pre-S1, pre-S2) adsorbed on aluminium hydroxide [produced on genetically engineered murine (C127I) cells])
- Region
- 🇪🇺 EU
- Active substance
- hepatitis B surface antigens recombinant (S, pre-S1, pre-S2) adsorbed on aluminium hydroxide [produced on genetically engineered murine (C127I) cells]
- Company
- Evans Vaccines Ltd.
- Status
- Withdrawn
- Therapeutic area
- Hepatitis B; Immunization
- EU approval
- Fri 04 Aug 2000
- Application
- EMEA/H/C/000261
- ATC
- J07BC
- Official record
- www.ema.europa.eu
Indication
This vaccine is indicated for active immunisation against hepatitis B virus infection in non-immune adults (>=18 years). The specific at risk categories to be immunised are to be determined on the basis of official recommendations.
Regulatory milestones
No milestones recorded in the last year.
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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.