Vaxxitek HVT+IBD+H5

Authorised

This medicine is authorised for use in the European Union

avian influenza vaccine (live recombinant)

Overview

Up-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website

Product details

• Name of medicine:
  Vaxxitek HVT+IBD+H5
• Active substance:
  Turkey herpesvirus, strain rHVT-IBD-H5 (cell-associated), expressing the VP2 protein gene of Infectious bursal disease virus and haemagglutinin gene of Avian influenza virus subtype H5, live
• International non-proprietary name (INN) or common name:
  avian influenza vaccine (live recombinant)

Pharmacotherapeutic group

• Immunologicals for aves
• Domestic fowl
• Live viral vaccines

Authorisation details

• EMA product number:
  EMEA/V/C/006751
• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Assessment history

Initial marketing authorisation documents

CVMP summary of positive opinion for Vaxxitek HVT+IBD+H5

Adopted Reference Number: EMA/CVMP/307532/2025