Equilis StrepE

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live vaccine against Streptococcus equi

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 20/10/2014

Authorisation details

Product details
Name
Equilis StrepE
Agency product number
EMEA/V/C/000078
Active substance
live deletion-mutant Streptococcus equi strain TW928
International non-proprietary name (INN) or common name
live vaccine against Streptococcus equi
Species
Horses
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI05AE
Publication details
Marketing-authorisation holder
Intervet International BV
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
06/05/2004
Contact address
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

09/04/2014 Equilis StrepE - EMEA/V/C/000078 - II/0012/G

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 EQUIDAE

Therapeutic indication

For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph-node abscesses.

Onset of immunity: The onset of immunity is established as two weeks after basic vaccination.

Duration of immunity: The duration of immunity is up to three months.

The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e.g. stables with horses that travel to shows or competitions in such areas, or stables that obtain or have livery horses from such areas.

Assessment history

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