Ubac

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On 25 May 2018,the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion*, recommending the granting of a marketing authorisation for the veterinary medicinal product UBAC, emulsion for injection intended for active immunisation of healthy cows and heifers to reduce the incidence of clinical intramammary infection caused by Streptococcus uberis, to reduce the somatic cell count in Streptococcus uberis positive quarter milk samples and to reduce milk production losses caused by Streptococcus uberis intramammary infections. The applicant for this veterinary medicinal product is Laboratorios Hipra, S.A.

UBAC is an immunological medicinal product containing Lipoteichoic acid (LTA) within the Biofilm Adhesion component (BAC) including Streptococcus uberis, strain 5616 (ATCvet code QI02AB) as active substance.

The benefits of UBAC are its reduction of the incidence of clinical intramammary infection caused by Streptococcus uberis, reduction of the somatic cell count in Streptococcus uberis positive quarter milk samples and reduction of milk production losses caused by Streptococcus uberis intramammary infections which was investigated in well-designed laboratory and field studies conducted to an acceptable standard.

The onset of immunity is approximately 36 days after the second dose and the duration of immunity is approximately the first 5 months of lactation.

The most common side effects are local reactions at the injection site and transient temperature increase.

Detailed conditions for the use of this product will be 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 UBAC and therefore recommends the granting of the marketing authorisation.


* 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.

Name Language First published Last updated
CVMP summary of positive opinion for UBAC (English only) 2018-05-28  

Key facts

Product details for Ubac
NameUbac
INN or common name

biofilm adhesion component of streptococcus uberis, strain 5616

Active substance

Biofilm Adhesion Component of Streptococcus uberis, strain 5616

Date opinion adopted25/05/2018
Company name

Laboratorios Hipra, S.A

StatusPositive
Application typeInitial authorisation