Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: CaniLeish   
Auth. number : EU/2/11/121
INN : 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.ia negative dogs from 6 months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum.
Marketing Authorisation Holder: VIRBAC S.A.
1ère Avenue - 2065 m - L.I.D., F-06516 Carros CEDEX, 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
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 - Variation (2014)1244 of 20/02/2014