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Community register of veterinary medicinal products


Product information

Invented name: Suvaxyn PCV   
Auth. number : EU/2/09/099
Active substance : Porcine circovirus recombinant virus (cpcv) 1-2, inactivated
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI09 - Immunologicals for suidae
Pharmacological subgroup: QI09A - Pig
Chemical subgroup: QI09AA - Inactivated viral vaccines
Chemical substance: QI09AA07 - porcine circovirus
(See WHO ATCvet Index)
Indication: Active immunisation of pigs over the age of 3 weeks against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Onset of immunity: from 3 weeks post-vaccination.
Duration of immunity: 19 weeks post-vaccination.
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
30/07/2009 Centralised - Authorisation EMEA/V/C/149 (2009)6045 of 24/07/2009
25/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/149/II/1
28/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/149/IA/2
1/10/2010 Centralised - Suspension of martketing authorisation EMEA/V/C/149/A-45/65 (2010)6747 of 27/09/2010
25/05/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/149/T/4 (2011)3711 of 23/05/2011
23/07/2012 Centralised - Variation EMEA/V/C/149/IA/6
Updated with Decision(2012)7892 of 29/10/2012
12/10/2012 Centralised - Lift of suspension EMEA/V/C/149/Z/7 (2012)7205 of 10/10/2012
1/11/2012 Centralised - Variation (2012)7892 of 29/10/2012
22/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/149/T/9 (2013)2987 of 16/05/2013
18/07/2013 Centralised - Variation (rejected) EMEA/V/C/149/II/8
5/09/2013 Centralised - Variation EMEA/V/C/149/IA/12/G
Updated with Decision(2014)560 of 29/01/2014
10/10/2013 Centralised - Variation EMEA/V/C/149/II/11/G
Updated with Decision(2014)560 of 29/01/2014
31/01/2014 Centralised - Modification EMEA/V/C/149/Art.45/10 (2014)560 of 29/01/2014
11/06/2014 Centralised - Renewal EMEA/V/C/149/R/16 (2014)3946 of 6/06/2014
24/04/2015 Centralised - Variation EMEA/V/C/149/IB/20/G
Updated with Decision(2016)2867 of 03/05/2016
24/04/2015 Centralised - Variation EMEA/V/C/149/IG/544/21
Updated with Decision(2016)2867 of 03/05/2016
26/06/2015 Centralised - Variation EMEA/V/C/149/IB/543
Updated with Decision(2016)2867 of 03/05/2016
20/05/2016 Centralised - Yearly update (2016)2867 of 3/05/2016
23/03/2017 Centralised - Variation EMEA/V/C/149/IG/747
Updated with Decision(2018)1927 of 22/03/2018
26/03/2018 Centralised - Yearly update (2018)1927 of 22/03/2018