On 24th September 2020, the European Commission withdrew the marketing authorisation for Vepacel (prepandemic influenza vaccine H5N1 (whole virion, vero cell derived, inactivated)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Ology Bioservices Ireland Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Vepacel was granted marketing authorisation in the EU on 17 February 2012 for prophylaxis of H5N1 subtype of influenza A. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2017. The product had not been marketed in the EU.
The European Public Assessment Report (EPAR) for Vepacel is updated to indicate that the marketing authorisation is no longer valid.
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:
Active immunisation against H5N1 subtype of influenza A virus.
This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains.
Vepacel should be used in accordance with Official guidance.