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Nobilis Multriva IBm+ND+Gm+REOm+EDS | European Medicines Agency (EMA)

Published 16 hours ago3 minute read

On 15 May 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 IBm+ND+Gm+REOm+EDS emulsion for injection, intended for chickens. The applicant for this veterinary medicinal product is Intervet International B.V.

Nobilis Multriva IBm+ND+Gm+REOm+EDS is an immunological veterinary medicinal product containing infectious bronchitis virus, type Massachusetts, strain M41, inactivated; avian infectious bronchitis virus, type 793/B, strain 4/91, inactivated; Newcastle disease virus, strain Ulster, inactivated; infectious bursal disease virus, strain GB02, inactivated; infectious bursal disease virus, strain 89/03, inactivated; avian reovirus, strain ARV-1, inactivated; avian reovirus, strain ARV-4, inactivated and eggdrop syndrome-1976 virus, strain BC14, inactivated, as active substances. These active substances act by stimulating active immunity against infectious bronchitis virus, Newcastle disease virus, and eggdrop syndrome-1976 virus and by stimulating active immunity in order to provide passive immunity to the progeny against infectious bursal (Gumboro) disease and avian reovirus.

The benefits of Nobilis Multriva IBm+ND+Gm+REOm+EDS are its efficacy against IBV, NDV, IBDV, ARV and EDSV, reducing the need for the application (injection) of different vaccines within a short timeframe. Compared to existing inactivated viral vaccine combinations, the dose volume is smaller which is an advantage with respect to injection-site safety and animal welfare.

The most common side effects are injection site lumps, which generally disappear within 3 weeks.

The full indication is:

“For the active immunisation of chickens for:

- reduction of respiratory signs and egg drop caused by infectious bronchitis virus (IBV) strains Massachusetts (GI-1 genotype) and 4/91-793B (GI-13 genotype).

- reduction of mortality and clinical signs caused by Newcastle disease virus (NDV).

- 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).

- reduce viraemia and clinical signs of disease caused by avian reovirus (ARV) genotypes 1 and 4.

- reduction of egg drop and eggshell defects caused by eggdrop syndrome-1976 virus (EDSV).

Onset of immunity:

4 weeks post-vaccination.

IBDV and ARV in progeny: 1 day of age

Duration of immunity:           

80 weeks post-vaccination

IBDV and ARV in progeny: 3 weeks of age

Cross protection has been established for IBV strains QX-D388 (GI-19 genotype), Var2 (GI-23 genotype) and Q1 (GI-16 genotype).

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.

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 IBm+ND+Gm+REOm+EDS and therefore recommends the granting of the marketing authorisation.


1 Applicants 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.

Name of medicine

Nobilis Multriva IBm+ND+Gm+REOm+EDS

Active substance

International non-proprietary name (INN) or common name

Avian infectious bronchitis, Newcastle disease, avian infectious bursal disease, avian reovirus and egg drop syndrome virus vaccine (inactivated)

Species

Chicken

Anatomical therapeutic chemical veterinary (ATCvet) code

QI01AA25

EMA product number

EMEA/V/C/005987

Marketing authorisation applicant

Intervet International B.V.

Opinion adopted

15/05/2025

Opinion status

Positive

News on Nobilis Multriva IBm+ND+Gm+REOm+EDS

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European Medicines Agency (EMA)
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