Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Coxevac   
Auth. number : EU/2/10/110
INN : Inactivated Coxiella burnetii vaccine
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI03 - Immunologicals for capridae
Pharmacological subgroup: QI03A - Goat
Chemical subgroup: QI03AB - Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Chemical substance: QI03AB - Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
(See WHO ATCvet Index)
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.GoatsFor 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: not established. Protection has been demonstrated by challenge 8 weeks post-primary vaccination
Marketing Authorisation Holder: CEVA SANTE ANIMALE
10 avenue de la Ballastière, F-33500 Libourne, France

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
05/10/2010 Centralised - Authorisation EMEA/V/C/155 (2010)6909 of 30/09/2010
23/11/2010 Corrigendum (2010)8302 corr of 19/11/2010
10/05/2011 Centralised - Variation EMEA/V/C/155/IB/1/G
Updated with Decision(2011)8848 of 24/11/2011
15/09/2011 Centralised - Annual reassessment EMEA/V/C/155/S/2
29/11/2011 Centralised - Variation (2011)8848 of 24/11/2011
27/12/2011 Corrigendum (2011)8848 of 22/12/2011
14/12/2012 Centralised - Annual reassessment EMEA/V/C/155/S/3 (2012)9391 of 06/12/2012
12/09/2013 Centralised - Annual reassessment EMEA/V/C/155/S/5