On 19 June 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Rabitec. The marketing authorisation holder for this veterinary medicinal product is CEVA Santé Animale
Rabitec is currently authorised as oral suspension. The variation concerns to add:
• a new a strength (infectivity titre) including a new target species (dogs)
• a new composition of the bait (for the new target species dogs)
• a new vaccine container (sachet - for the new target species dogs)
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.
CVMP post-authorisation summary of positive opinion for Rabitec (VRA-0011)
English (EN) (139.83 KB - PDF)