ProteqFlu-Te

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equine influenza and tetanus vaccine

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 17/10/2014

Authorisation details

Product details
Name
ProteqFlu-Te
Agency product number
EMEA/V/C/000074
Active substance
A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242), influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) and Clostridium tetani toxoid
International non-proprietary name (INN) or common name
equine influenza and tetanus vaccine
Species
Horses
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI05AI01
Publication details
Marketing-authorisation holder
Merial
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
06/03/2003
Contact address
29 avenue Tony Garnier
69007 Lyon
France

Product information

11/07/2014 ProteqFlu-Te - EMEA/V/C/000074 - II/0017

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

Active immunisation of horses of four months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality.

Assessment history

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