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
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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 |
7
|
Date of issue of marketing authorisation valid throughout the European Union |
30/09/2010
|
Contact address |
10 avenue de La Ballastière |
Product information
17/07/2020 Coxevac - EMEA/V/C/000155 - IB/0014
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Immunologicals for bovidae
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Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
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.