Proteq West Nile

RSS

West Nile recombinant canarypox virus (vCP2017 virus)

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 26/05/2016

Authorisation details

Product details
Name
Proteq West Nile
Agency product number
EMEA/V/C/002005
Active substance
vCP2017 virus
International non-proprietary name (INN) or common name
West Nile recombinant canarypox virus (vCP2017 virus)
Species
Horses
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI05AX
Publication details
Marketing-authorisation holder
Merial
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
05/08/2011
Contact address
29 avenue Tony Garnier
69007 Lyon
France

Product information

17/05/2016 Proteq West Nile - EMEA/V/C/002005 - R/0007

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

Therapeutic indication

Active immunisation of horses from five months of age against West Nile disease by reducing the number of viraemic horses. If clinical signs are present, their duration and severity are reduced.

Assessment history

How useful was this page?

Add your rating