Ubac

RSS

Streptococcus uberis vaccine (inactivated)

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Ubac and why it is authorised in the EU

Ubac is a vaccine used in cows and heifers (female cattle that have not yet calved) to reduce clinical mastitis (udder infections with visible signs in milk or the udder) caused by bacteria called Streptococcus uberis, which can reduce milk production. Ubac is also used to reduce the somatic cell count (SCC) in milk, which is a measure of mastitis without visible signs (subclinical mastitis). Ubac contains the active substance called biofilm adhesion component including lipoteichoic acid, which is derived from the sticky film produced by Streptococcus uberis strain 5616.

This EPAR was last updated on 14/08/2018

Authorisation details

Product details
Name
Ubac
Agency product number
EMEA/V/C/004595
Active substance
Lipoteichoic acid from Biofilm Adhesion Component of Streptococcus uberis, strain 5616
International non-proprietary name (INN) or common name
Streptococcus uberis vaccine (inactivated)
Species
Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI02AB
Publication details
Marketing-authorisation holder
Laboratorios Hipra, S.A.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
26/07/2018
Contact address
Avda. La Selva,
135 Amer
17170 Girona
Spain

Product information

26/07/2018 Ubac - EMEA/V/C/004595 -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

IMMUNOLOGICALS FOR BOVIDAE

Therapeutic indication

For active immunisation of healthy cows and heifers to reduce the incidence of clinical intramammary infections 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.

Assessment history

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