AviGate S. Infantis

Opinion

EMA has issued an opinion on this medicine

Salmonella Infantis vaccine (live)

Overview

On 12 March 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion recommending the granting of a marketing authorisation for the veterinary medicinal product AviGate S. Infantis, lyophilisate for use in drinking water, intended for chickens (broiler, future layer, and future breeder). The applicant for this veterinary medicinal product is HuVepharma.

AviGate S. Infantis is a vaccine containing Salmonella enterica subsp. enterica, serovar Infantis, strain J-6-24 cpxRA- lon1-, live (ATCvet code QI01AE01) as the active substance. The vaccine induces an active immunity against Salmonella Infantis in chickens. 

The benefits of AviGate S. Infantis are:

For active immunisation of healthy chickens to reduce faecal excretion and colonisation of internal organs with Salmonella Infantis.

Onset of immunity: 2 weeks after vaccination.

Duration of immunity:

• Broilers: 8 weeks after one vaccination.
• Layers and future breeders: 30 weeks after second vaccination when administered in accordance with the recommended vaccination schedule.

AviGate S. Infantis is generally well tolerated at the recommended dose.

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 AviGate S. Infantis and therefore recommends the granting of the marketing authorisation.

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Note: 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.

CVMP summary of positive opinion for AviGate S. Infantis

Adopted Reference Number: EMA/CVMP/37522/2026

Product details

• Name of medicine:
  AviGate S. Infantis
• Active substance:
  salmonella enterica, subsp. enterica, serovar Infantis, strain J-6-24 ΔcpxRA Δlon1, Live
• International non-proprietary name (INN) or common name:
  Salmonella Infantis vaccine (live)
• Species:
  Chicken
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI01AE01
• EMA product number:
  EMEA/V/C/006646
• Marketing authorisation applicant:
  HuVepharma
• Opinion adopted:
  12/03/2026
• Opinion status:
  Positive