Coxevac

RSS

inactivated Coxiella burnetii vaccine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European Public Assessment Report. 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 05/01/2018

Authorisation details

Product details
Name
Coxevac
Agency product number
EMEA/V/C/000155
Active substance
inactivated Coxiella burnetii vaccine, strain Nine Mile
International non-proprietary name (INN) or common name
inactivated Coxiella burnetii vaccine
Species
  • Goats
  • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI02AB
Publication details
Marketing-authorisation holder
CEVA Santé Animale
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
30/09/2010
Contact address

10 avenue de la Ballastiere
33500 Libourne
France

Product information

08/12/2017 Coxevac - EMEA/V/C/000155 - IB/0013

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 bovidae
  • inactivated bacterial vaccines for cattle

Therapeutic indication

Cattle:

For the active immunisation of cattle to lower the risk for non-infected animals vaccinated when non-pregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of Coxiella burnetii in these animals via milk and vaginal mucus.

Onset of immunity: not established.

Duration of immunity: 280 days after completion of the primary vaccination course.

Goats:

For the active immunisation of goats to reduce abortion caused by Coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta.

Onset of immunity: not established.

Duration of immunity: one year after completion of the primary vaccination course.

Assessment history

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