Vaxxitek HVT+IBD+H5

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Authorised

This medicine is authorised for use in the European Union

avian influenza vaccine (live recombinant)
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  • Application under evaluation
  • CVMP opinion
  • European Commission decision

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

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

Adopted Reference Number: EMA/CVMP/307532/2025

English (EN) (135.79 KB - PDF)

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