Respivac TRT

Opinion

EMA has issued an opinion on this medicine

Turkey rhinotracheitis virus, strain 1062, live

Overview

On 18 April 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a marketing authorisation for the veterinary medicinal product Respivac TRT, lyophilisate for oculonasal suspension/use in drinking water, intended for chickens. The applicant for this veterinary medicinal product is Laboratorios Hipra, S.A.

Respivac TRT is an immunological medicinal product containing avian metapneumovirus subtype B, strain 1062, live (ATCvet code: QI01AD01) as active substance.

The benefit of Respivac TRT is the active immunisation of chickens to reduce the detrimental effect caused by virulent avian metapneumovirus on the ciliary activity, which may be manifested in respiratory clinical signs. The onset of immunity is 3 weeks and the duration of immunity is 9 weeks.

Respivac TRT 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 Respivac TRT and therefore recommends the granting of the marketing authorisation.

---

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 Respivac TRT

AdoptedReference Number: EMA/CVMP/136137/2024

Product details

• Name of medicine:
  Respivac TRT
• Active substance:
  Turkey rhinotracheitis virus, strain 1062, live
• International non-proprietary name (INN) or common name:
  Turkey rhinotracheitis virus, strain 1062, live
• Species:
  Chicken
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI01AD01
• EMA product number:
  EMEA/V/C/006160
• Marketing authorisation applicant:
  Laboratorios Hipra, S.A.
• Opinion adopted:
  18/04/2024
• Opinion status:
  Positive