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Pharmaceuticals - Community Register
Community register of veterinary medicinal products
|Auth. number :||EU/2/11/121|
|Active substance :||Leishmania infantum Excreted Secreted Proteins (ESP)|
|ATC:||Anatomical main group: QI - Immunologicals|
Therapeutic subgroup: QI07 - Immunologicals for canidae
Pharmacological subgroup: QI07A - Dog
Chemical subgroup: QI07AO - Inactivated parasitic vaccines
Chemical substance: QI07AO - Inactivated parasitic vaccines
(See WHO ATCvet Index)
|Indication:||For the active immunization of Leishmania negative dogs from 6 months of age to reduce the risk to|
develop an active infection and clinical disease after contact with Leishmania infantum.
The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure
in zones with high infection pressure.
Onset of immunity: 4 weeks after the primary vaccination course.
Duration of immunity: 1 year after the last (re-)vaccination.
|Marketing Authorisation Holder:||VIRBAC S.A.
1ère Avenue - 2065 m - L.I.D., F-06516 Carros CEDEX, France
|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|
|17/03/2011||Centralised - Authorisation||EMEA/V/C/232||(2011)1787 of 14/03/2011|
|10/01/2013||Centralised - Variation||EMEA/V/C/232/IB/2|
|Updated with Decision(2014)1244 of 20/02/2014|
|24/02/2014||Centralised - Yearly update||(2014)1244 of 20/02/2014|
|11/01/2016||Centralised - Renewal||EMEA/V/C/232/R/4||(2016)80 of 07/01/2016|