Brucellin Aquilon
Opinion
On 8 December 2022, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product Brucellin Aquilon, Solution for injection, intended for pig. The applicant for this veterinary medicinal product is Aquilon Cyl S.L. The applicant is registered as an SME pursuant to the definition set out in Commission Recommendation 2003/361/EC.
Brucellin Aquilon is an immunological veterinary medicinal product containing Brucella abortus, strain AQ1302, protein extract (ATCvet code QI09AR) as active substance.
The benefit of Brucellin Aquilon is its use for in vivo diagnosis of Brucella-infected pigs through a positive skin reaction after a positive serological Brucella test. Brucellin Aquilon has been specifically designed as a second line diagnostic test to differentiate Brucella-infected pigs, from the age of 5 months, from the Brucella-free pigs having given false positive serological reactions (FPSR) in brucellosis serological tests based on anti-O-PS antibodies (e.g. Rose Bengal).
Brucellin Aquilon is generally well tolerated at the recommended dose, no adverse reactions are seen at overdoses.
The appropriate CVMP guideline on data requirements for veterinary medicinal products intended for minor use or minor species/limited markets has been applied in the assessment of the application.
Detailed conditions for the use of this product are described in the summary of product characteristics (SPC) which will be published in the European public assessment report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Brucellin Aquilon and therefore recommends the granting of the marketing authorisation.
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.