Startvac

RSS

adjuvanted inactivated vaccine for cattle against Staphylococcus aureus, coliforms and coagulase-negative staphylococci

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

Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 07/05/2018

Authorisation details

Product details
Name
Startvac
Agency product number
EMEA/V/C/000130
Active substance
Escherichia coli J5 inactivated / Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime-associated antigenic complex
International non-proprietary name (INN) or common name
adjuvanted inactivated vaccine for cattle against Staphylococcus aureus, coliforms and coagulase-negative staphylococci
Species
Cattle (cows and heifers)
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI02AB
Publication details
Marketing-authorisation holder
Laboratorios Hipra S.A.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
11/02/2009
Contact address
Avda. La Selva, 135
17170- Amer (Girona)
Spain

Product information

02/03/2018 Startvac - EMEA/V/C/000130 - IB/0006

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 herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci.

The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection (equivalent to 130 days post-parturition).

Assessment history

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