Coliprotec F4

Withdrawn

This medicine's authorisation has been withdrawn

Escherichia coli, type 08, strain K87 (live)

Overview

The marketing authorisation for Coliprotec F4 has been withdrawn at the request of the marketing authorisation holder.

Coliprotec F4 : EPAR - Summary for the public

Product information

Coliprotec F4 : EPAR - Product Information

Coliprotec F4 : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Coliprotec F4
• Active substance:
  live non-pathogenic Escherichia coli O8:K87
• International non-proprietary name (INN) or common name:
  Escherichia coli, type 08, strain K87 (live)
• Species:
  Pigs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI09AE03

Pharmacotherapeutic group

• Immunologicals for suidae
• Live bacterial vaccines
• Pig

Therapeutic indication

For active immunisation of pigs against enterotoxigenic F4-positive Escherichia coli in order to:

• reduce the incidence of moderate to severe post-weaning Escherichia coli diarrhoea (PWD) in pigs;
• reduce the colonisation of the ileum and faecal shedding of enterotoxigenic F4-positive Escherichia coli from infected pigs.

Authorisation details

• EMA product number:
  EMEA/V/C/003797
• Marketing authorisation holder:
  Prevtec Microbia GmbH

  Geyerspergerstrasse 27; 80689 München; Germany

• Marketing authorisation issued:
  16/03/2015
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Coliprotec F4 : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Coliprotec F4 : EPAR - Public assessment report

Adopted Reference Number: EMA/39171/2015

CVMP summary of positive opinion for Coliprotec F4

Adopted Reference Number: EMA/CVMP/742823/2014