Hepizovac

Authorised

This medicine is authorised for use in the European Union

epizootic haemorrhagic disease vaccine (inactivated)

Overview

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

Product details

• Name of medicine:
  Hepizovac
• Active substance:
  epizootic haemorrhagic disease virus (EHDV), serotype 8, strain EHDV8 SPA 2022/LCV_03 LCV Cod.:O78
• International non-proprietary name (INN) or common name:
  epizootic haemorrhagic disease vaccine (inactivated)

Pharmacotherapeutic group

• Immunologicals for Bovidae
• Inactivated viral vaccines

Authorisation details

• EMA product number:
  EMEA/V/C/006592
• 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 Hepizovac

Adopted Reference Number: EMA/CVMP/82379/2025