Log In

Innovax-ND-IBD-ILT | European Medicines Agency (EMA)

Published 17 hours ago2 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 Innovax-ND-IBD-ILT, concentrate and solvent for suspension for injection, intended for chicken and chicken embryonated eggs. The applicant for this veterinary medicinal product is Intervet International B.V.

Innovax-ND-IBD-ILT is an immunological medicinal product containing turkey herpesvirus strain HVT/ND/IBD/ILT (cell-associated), expressing the fusion protein gene of Newcastle disease virus, the VP2 protein of infectious bursal disease virus and the glycoproteins gD and gI of infectious laryngotracheitis virus, live (ATCvet code QI01AD20) as active substance.

The benefits of Innovax-ND-IBD-ILT are its efficacy in active immunisation of one-day-old chicks or 18-19-day-old embryonated chicken eggs against Newcastle disease, Marek’s disease virus, avian infectious laryngotracheitis virus and infectious bursal disease virus.

The product is generally well tolerated in the target animal. No adverse reactions were observed after a tenfold overdose of Innovax-ND-ILT-IBD by the subcutaneous or in ovo route.

The full indication is:

For active immunisation of one-day-old chicks or 18-19 day-old embryonated chicken eggs:

Onset of immunity: ND: 4 weeks of age,

IBD: 3 weeks of age,

ILT: 4 weeks of age,

MD: 5 days of age.

Duration of immunity: ND: 62 weeks,

IBD: 100 weeks,

ILT: 100 weeks,

MD: entire risk period.

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 Innovax-ND-IBD-ILT 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

Innovax-ND-IBD-ILT

Active substance

Turkey herpesvirus strain HVT/ND/IBD/ILT (cell-associated), expressing the fusion protein gene of Newcastle disease virus, the VP2 protein gene of infectious bursal disease virus and the glycoproteins gD and gI genes of infectious laryngotracheitis virus, live

International non-proprietary name (INN) or common name

Avian infectious laryngotracheitis, infectious bursal disease, Marek’s disease and Newcastle disease vaccine (live recombinant)

Species

Anatomical therapeutic chemical veterinary (ATCvet) code

QI01AD

EMA product number

EMEA/V/C/006442

Marketing authorisation applicant

Intervet International B.V.

Opinion adopted

15/05/2025

Opinion status

Positive

News on Innovax-ND-IBD-ILT

Origin:
publisher logo
European Medicines Agency (EMA)

Recommended Articles

Loading...

You may also like...