Coxevac
inactivated Coxiella burnetii vaccine
Table of contents
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).
Authorisation details
Product details | |
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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 |
|
Anatomical therapeutic chemical veterinary (ATCvet) codes |
QI02AB
|
Publication details | |
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Marketing-authorisation holder |
CEVA Santé Animale
|
Revision |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
30/09/2010
|
Contact address |
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
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Immunologicals for bovidae
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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.