Ecoporc Shiga

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genetically modified Shiga-toxin-2e antigen

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 document 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 03/05/2018

Authorisation details

Product details
Name
Ecoporc Shiga
Agency product number
EMEA/V/C/002588
Active substance
genetically modified recombinant Shiga-toxin-2e antigen
International non-proprietary name (INN) or common name
genetically modified Shiga-toxin-2e antigen
Species
Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI09AB02
Publication details
Marketing-authorisation holder
IDT Biologika GmbH
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
10/04/2013
Contact address
Am Pharmapark
D-06861 Dessau-Rosslau
Germany

Product information

20/04/2018 Ecoporc Shiga - EMEA/V/C/002588 - R/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 suidae

  • inactivated bacterial vaccines

Therapeutic indication

Active immunisation of piglets from the age of four days, to reduce the mortality and clinical signs of oedema disease caused by Shiga toxin 2e produced by Escherichia coli (STEC).

Onset of immunity: 21 days after vaccination.

Duration of immunity: 105 days after vaccination.

Assessment history

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