Respivac aMPV (previously Respivac TRT) - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation
turkey rhinotracheitis virus, strain 1062, live
Post-authorisationVeterinary
On 21 May 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Respivac aMPV. The marketing authorisation holder for this veterinary medicinal product is Laboratorios HIPRA S.A.
Respivac aMPV is currently authorised for 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.
This variation concerns the addition of turkeys as a new target species and the establishment of a higher minimum composition per dose in chickens than the one currently authorised. Additionally, the product information is aligned with version 9.1 of the QRD template.
As a result of this variation, the full indication has been amended to: “Chickens: 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.
Onset of immunity: 3 weeks post vaccination
Duration of immunity: 9 weeks post vaccination
Turkeys: Active immunisation of turkeys to:
- reduce clinical signs or lesions caused by virulent avian metapneumovirus
- reduce the duration and the severity of clinical signs caused by virulent avian metapneumovirus.
Onset of immunity: 2 weeks post basic vaccination.
Duration of immunity: 12 weeks post basic vaccination; 10 weeks post re-vaccination.”
Detailed conditions for the use of this product are described in the updated summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
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 post-authorisation summary of positive opinion for Respivac aMPV (VRA/0000309778)
Reference Number: EMADOC-1700519818-3136867
English (EN) (141.95 KB - PDF)
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