CVMP grants Positive opinion for Syvazul® BTV3 for Europe
Syvazul® BTV 3 has received a positive opinion from the CVMP for administration at a dose of 2 mL in cattle.
León, 21 July 2025 – Syva is pleased to announce that on 17 July 2025, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the approval of a variation to the terms of the marketing authorisation for the vaccine Syvazul® BTV 3.
A key breakthrough in the variation is the inclusion of the bovine species at the dose of 2 ml, improving convenience and aligning with the latest regulatory data.
The proposed indication is the active immunisation of cattle to reduce viraemia caused by bluetongue serotype 3, using a vaccination schedule of two intramuscular injections of 2 mL administered three weeks apart.
Syvazul® BTV 3 is currently authorised for the active immunisation of sheep to reduce viraemia, mortality, clinical signs and lesions caused by bluetongue serotype 3, using a vaccination schedule of one subcutaneous injection of 2 mL from 3 months of age.
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