Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Equip WNV   
Auth. number : EU/2/08/086
Active substance : West Nile fever vaccine (inactivated recombinant)
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI05 - Immunologicals for equidae
Pharmacological subgroup: QI05A - Horse
Chemical subgroup: QI05AA - Inactivated viral vaccines
Chemical substance: QI05AA10 - West nile virus
(See WHO ATCvet Index)
Indication: For the active immunisation of horses of 6 months of age or older against West Nile virus (WNV) disease by reducing the number of viraemic horses after infection with WNV lineage 1 or 2 strains and to reduce duration and severity of clinical signs against WNV of lineage 2 strains.
Onset of immunity: 3 weeks after primary vaccination course.
Duration of immunity: 12 months after primary vaccination course for WNV lineage 1 strains. For WNV lineage 2 strains the duration of immunity has not been established.
Marketing Authorisation Holder: Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique
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
25/11/2008 Centralised - Authorisation EMEA/V/C/137 (2008)7465 of 21/11/2008
21/09/2009 Centralised - Notification EMEA/V/C/137/N/1
Updated with Decision(2011)189 of 13/01/2011
20/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/137/IB/2
27/09/2010 Centralised - Variation EMEA/V/C/137/IA/3G
Updated with Decision(2011)189 of 13/01/2011
19/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/137/IB/5
18/01/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/137/T/4 (2011)189 of 13/01/2011
25/05/2012 Centralised - Variation EMEA/V/C/137/IAin/9
Updated with Decision(2012)3456 of 22/05/2012
25/05/2012 Centralised - Variation EMEA/V/C/137/II/6 (2012)3456 of 22/05/2012
08/11/2012 Centralised - Variation EMEA/V/C/137/II/10
Updated with Decision(2013)3217 of 27/05/2013
29/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/137/T/13 (2013)3217 of 27/05/2013
05/09/2013 Centralised - Variation EMEA/V/C/137/IA/15
Updated with Decision(2013)6864 of 11/10/2013
16/09/2013 Centralised - Renewal EMEA/V/C/137/R/14 (2013)5929 of 12/09/2013
15/10/2013 Centralised - 2-Monthly update EMEA/V/C/137/II/12 (2013)6864 of 11/10/2013
11/12/2014 Centralised - Variation EMEA/V/C/137/II/18
Updated with Decision(2015)9749 of 18/12/2015
26/06/2015 Centralised - Variation EMEA/V/C/137/IA/21
Updated with Decision(2015)9749 of 18/12/2015
04/12/2015 Centralised - Variation EMEA/V/C/137/IB/22
Updated with Decision(2015)9749 of 18/12/2015
21/12/2015 Centralised - Yearly update (2015)9749 of 18/12/2015
12/02/2016 Centralised - Variation EMEA/V/C/137/IB/23