Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: LETIFEND   
Auth. number : EU/2/16/195
Active substance : Recombinant Protein Q from L. infantum MON-1
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI07 - Immunologicals for canidae
Pharmacological subgroup: QI07A - Dog
Chemical subgroup: QI07AO - Inactivated parasitic vaccines
Chemical substance: QI07AO01 - Leishmania
(See WHO ATCvet Index)
Indication: For active immunisation of non-infected dogs from 6 months of age to reduce the risk of developing an active infection and/or clinical disease after exposure to Leishmania infantum.

The efficacy of the vaccine was demonstrated in a field study where dogs were naturally exposed to Leishmania infantum in zones with high infection pressure over a two year period.

In laboratory studies including experimental challenge with Leishmania infantum, the vaccine reduced the severity of the disease, including clinical signs and parasite burden in spleen and lymph nodes.

Onset of immunity: 28 days after vaccination.

Duration of immunity: 1 year after vaccination.
Marketing Authorisation Holder: Laboratorios LETI, S.L.unipersonal
C/ Del Sol 5, Polígono Industrial Norte Tres Cantos, 28760 Madrid, España
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
22/04/2016 Centralised - Authorisation EMEA/V/C/3865 (2016)2487 of 20/04/2016
01/09/2016 Centralised - Variation EMEA/V/C/3865/IB/02
Updated with Decision(2017)6279 of 14/09/2017
16/05/2017 Centralised - Variation EMEA/V/C/3865/IA/05
Updated with Decision(2017)6279 of 14/09/2017
18/09/2017 Centralised - Yearly update (2017)6279 of 14/09/2017