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 18/09/2020

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
CEVA Santé Animale
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
10/04/2013
Contact address

10 avenue de La Ballastière
33500 Libourne
France

Product information

15/09/2020 Ecoporc Shiga - EMEA/V/C/002588 - IG/1256/G

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Immunologicals for suidae

  • Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)

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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