February 23, 2011


EU authorises CZ Veterinaria's Bluetongue vaccine Bluevac BTV8



EU's Committee for Medicinal Products for Veterinary Use (CVMP) has authorised Spanish company CZ Veterinaria for its bluetongue vaccine Bluevac BTV8.


The product received a marketing authorisation intended for the active immunisation of sheep and cattle for the prevention of viraemia and reduction of clinical signs caused by bluetongue virus serotype 8 in sheep from 2.5 months of age and the prevention of viraemia caused by Bluetongue Virus, serotype 8 in cattle from 2.5 months of age. The active substance of Bluevac BTV8 is the inactivated Bluetongue Virus (BTV) Serotype 8.


The most common side effects are an average increase in body temperature that can occasionally be observed varying between 0.5 and 1.0 degrees Celsius in sheep and cattle and should last no longer than 24 to 48 hours. Transient fever was observed in rare cases. Occasionally, temporary local reactions occur at the injection site in the form of a normally painless nodule of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappear within 14 days, at the latest. In some cases loss of appetite can occur.


The CVMP is responsible for providing scientific opinions on all questions concerning veterinary medicinal products in the EU, in accordance with Regulation N° 726/2004/EC and concerning maximum residue limits, in accordance with Regulation N° 470/2009/EC.

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