Nobilis Multriva Gm+REOm

Opinion

EMA has issued an opinion on this medicine

avian infectious bursal disease / avian reovirus vaccine (inactivated)

Overview

On 9 April 2025, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a marketing authorisation for the veterinary medicinal product Nobilis Multriva Gm+REOm, emulsion for injection, intended for chickens. The applicant for this veterinary medicinal product is Intervet International B.V.

Nobilis Multriva Gm+REOm is an immunological veterinary medicinal product containing inactivated infectious bursal disease virus, strain GB02, inactivated infectious bursal disease virus, strain 89/03, inactivated avian reovirus, strain ARV-1 and inactivated avian reovirus, strain ARV-4 (ATCvet code QI01AA13) as active substances. The vaccine is intended to stimulate active immunity against infectious bursal disease virus and avian reovirus.

The benefits of Nobilis Multriva Gm+REOm is the active immunisation of chickens for passive immunisation of the progeny of the vaccinated chickens to reduce mortality and clinical signs of disease caused by very virulent (CS89) and classical (STC) strains of infectious bursal disease virus (IBDV), and to reduce viraemia and clinical signs of disease caused by avian reovirus (ARV) genotypes 1 and 4.

Onset of immunity: 
• 4 weeks post-vaccination 
• In progeny: 1 day of age

Duration of immunity:            
• 80 weeks post-vaccination
• In progeny: 3 weeks of age

Cross protection has been established for IBDV antigenic variant strains (variant E and GLS).

Cross protection has been established for ARV genotypes 2, 3 and 5.

The most common side effects are injection site lumps which occur uncommonly and disappear within 3 weeks after vaccination.

Detailed conditions for the use of this product are described in the summary of product characteristics (SPC) which will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Nobilis Multriva Gm+REOm and therefore recommends the granting of the marketing authorisation.

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¹Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.

CVMP summary of positive opinion for Nobilis Multriva Gm+REOm

AdoptedReference Number: EMA/CVMP/113812/2025

Product details

• Name of medicine:
  Nobilis Multriva Gm+REOm
• Active substance:
  • inactivated avian reovirus strain ARV-1
  • inactivated avian reovirus strain ARV-4
  • Inactivated infectious bursal disease virus, strain 89/03
  • Inactivated infectious bursal disease virus, strain GB02
• International non-proprietary name (INN) or common name:
  • avian infectious bursal disease
  • avian reovirus vaccine (inactivated)
• Species:
  Chicken
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI01AA22
• EMA product number:
  EMEA/V/C/006614
• Marketing authorisation applicant:
  Intervet International B.V.
• Opinion adopted:
  10/04/2025