On 13 March 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 Prevexxion RN+HVT+IBD. The marketing authorisation holder for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.
Prevexxion RN+HVT+IBD is currently authorised as concentrate and solvent for suspension for injection. The variation concerns the addition of a new route of administration: in ovo.
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.
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.
CVMP post-authorisation summary of positive opinion for Prevexxion RN+HVT+IBD
English (EN) (96.91 KB - PDF)