In January 2025, the Committee for Veterinary Medicinal Products of the European Medicines Agency issued a positive opinion on an application for authorisation under Article 25 for the immunological veterinary medicinal products Syvazul BTV-3 and Bluevac-3. Both products will therefore shortly be given a marketing authorisation.
In January 2025, the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) expressed a positive opinion on an application for authorisation under Article 25 (application in exceptional circumstances) for the immunological veterinary medicinal products Syvazul BTV-3 and Bluevac-3.
These products will therefore shortly be given a marketing authorisation (MA).
The European Commission will adopt a decision to grant these marketing authorisations by means of implementing acts. As soon as the decision is published on its website, the products will have to be used in accordance with the Summary of Product Characteristics (SPC), in compliance with Article 25. This means that Syvazul BTV3 can no longer be used in cattle from the date on which the decision will be published. However, Bluevac-3 remains authorised for use in cattle and sheep. Use in domestic or wild ruminants other than cattle will also no longer be mentioned for both vaccines (Syvazul BTV 3 and Bluevac-3). Other changes (e.g. indications) have been made to the SPC. Please read the leaflet carefully to ensure correct use of the product.
In order to avoid unavailability, a period of tolerance for the release of batches with the old packaging has been granted until 7 June 2025, on condition that a QR code is applied to the packaging referring to the updated SPC following marketing authorisation.
As a reminder, in response to the bluetongue epidemic in our country, the Federal Agency for Medicines and Health Products (FAMHP) granted an authorisation for use in accordance with Article 110(2) of Regulation 2019/6 for Syvazul BTV 3 and Bluevac-3, respectively since 8 May 2024 and 7 June 2024. This authorisation is valid for a limited period, i.e. for one year, or until the medicinal product has a marketing authorisation if given prior to this expiration date.