Improvac

On 08 September 2022, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Improvac. The marketing authorisation holder for this veterinary medicinal product is Zoetis Belgium SA.

Improvac is currently authorised for administration to female pigs from 14 weeks of age onwards with 2 doses of 2 ml administered approximately 4 weeks apart. The variation concerns the extension of the inter-dose interval from 4 to 8 weeks, and to reduce the minimum age of vaccination accordingly (from 14 to 10 weeks of age) in female pigs. The additional variation is to update the product information according to QRD template version 9.0.

Detailed conditions for the use of this product are described in the summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the revised European public assessment report (EPAR) 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.