PreHevbri
Withdrawn
This medicine's authorisation has been withdrawn
hepatitis B surface antigen
MedicineHumanWithdrawn
Hungarian is available via eTranslation, the European Commission's machine translation service.
Translate to Hungarian | Important information about machine translation
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 25 November 2024, the European Commission withdrew the marketing authorisation for PreHevbri (hepatitis B surface antigen) in the European Union (EU).
The withdrawal was at the request of the marketing authorisation holder, VBI Vaccines B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
PreHevbri was granted marketing authorisation in the EU on 25 April 2022 for active immunisation against infection caused by all known subtypes of the hepatitis B virus in adults. The marketing authorisation was initially valid for a 5-year period.
The European Public Assessment Report (EPAR) for PreHevbri is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IB/0008
25/11/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- PreHevbri
- 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
- J07BC01
Pharmacotherapeutic group
VaccinesTherapeutic 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.
Assessment history
News on PreHevbri
This page was last updated on