Orbyk EHD (previously Epizootic haemorrhagic disease vaccine (recombinant protein) Laboratorios Syva S.A.)

Authorised

This medicine is authorised for use in the European Union

Epizootic haemorrhagic disease vaccine (recombinant protein)

Overview

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

Product details

• Name of medicine:
  Orbyk EHD (previously Epizootic haemorrhagic disease vaccine (recombinant protein) Laboratorios Syva S.A.)
• Active substance:
  Epizootic hemorrhagic disease virus, serotype 8, VP2 protein
• International non-proprietary name (INN) or common name:
  Epizootic haemorrhagic disease vaccine (recombinant protein)

Pharmacotherapeutic group

• Immunologicals for Bovidae
• Inactivated viral vaccines

Authorisation details

• EMA product number:
  EMEA/V/C/006804
• 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 Epizootic haemorrhagic disease vaccine (recombinant protein) Laboratorios Syva S.A.

Adopted Reference Number: EMA/CVMP/368551/2025