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Pharmaceuticals - Community Register
Community register of veterinary medicinal products
|Auth. number :||EU/2/07/075|
|Active substance :||Not available|
|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:||Piglets: Active immunisation of piglets to reduce faecal excretion of PCV2 and virus load in blood, and as an aid to reduce PCV2 linked clinical signs, including wasting, weight loss and mortality as well as to reduce virus load and lesions in lymphoid tissues associated with PCV2 infection.|
Onset of immunity: 2 weeks.
Duration of immunity: at least 14 weeks after vaccination.
Sows and gilts: Passive immunisation of piglets via the colostrum, after active immunisation of sows and gilts, to reduce lesions in lymphoid tissues associated with PCV2 infection and as an aid to reduce PCV2-linked mortality.
Duration of immunity: up to 5 weeks after transfer of passive antibodies through colostrum intake.
|Marketing Authorisation Holder:||Ceva-Phylaxia Zrt.
Szállás u. 5, 1107 Budapest, Magyarország
|EPAR and active 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.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|25/06/2007||Centralised - Authorisation||EMEA/V/C/114||(2007)3140 of 21/06/2007|
|27/08/2008||Centralised - Variation||EMEA/V/C/114/II/1||(2008)4674 of 25/08/2008|
|19/11/2008||Centralised - Variation||EMEA/V/C/114/IB/2|
|Updated with Decision(2009)4583 of 08/06/2009|
|10/06/2009||Centralised - Variation||(2009)4583 of 8/06/2009|
|24/07/2009||Centralised - Variation (no change in Commission Decision)||EMEA/V/C/114/II/3|
|24/09/2009||Centralised - Variation (no change in Commission Decision)||EMEA/V/C/114/II/4|
|3/12/2010||Centralised - Variation||EMEA/V/C/114/II/5||(2010)8649 of 29/11/2010|
|10/05/2011||Centralised - Variation||EMEA/V/C/114/IB/6/G|
|Updated with Decision(2011)9183 of 05/12/2011|
|7/12/2011||Centralised - Variation||(2011)9183 of 5/12/2011|
|14/05/2012||Centralised - Renewal||EMEA/V/C/114/R/7||(2012)3217 of 10/05/2012|
|16/05/2013||Centralised - Variation||EMEA/V/C/114/II/8|
|Updated with Decision(2014)3417 of 16/05/2014|
|20/05/2014||Centralised - Yearly update||(2014)3417 of 16/05/2014|
|22/02/2017||Centralised - Variation||EMEA/V/C/114/IA/13/G|
|Updated with Decision(2017)7893 of 21/11/2017|
|15/06/2017||Centralised - Transfer Marketing Authorisation Holder||EMEA/V/C/114/T/14||(2017)4203 of 13/06/2017|
|23/11/2017||Centralised - Transfer Marketing Authorisation Holder||EMEA/V/C/114/T/14||(2017)7893 of 21/11/2017|