Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Nobivac L4   
Auth. number : EU/2/12/143
Active substance : Canine leptospirosis vaccine (inactivated)
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI07 - Immunologicals for canidae
Pharmacological subgroup: QI07A - Dog
Chemical subgroup: QI07AB - Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Chemical substance: QI07AB01 - leptospira
(See WHO ATCvet Index)
Indication: For active immunisation of dogs against:
- L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion
- L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion
- L. interrogans serogroup Australis serovar Bratislava to reduce infection
- L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion
Marketing Authorisation Holder: Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland
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
18/07/2012 Centralised - Authorisation EMEA/V/C/2010 (2012)5092 of 16/07/2012
07/05/2015 Centralised - Variation EMEA/V/C/2010/II/3
Updated with Decision(2016)3564 of 03/06/2016
07/06/2016 Centralised - Yearly update (2016)3564 of 03/06/2016
12/08/2016 Centralised - Variation EMEA/V/C/2010/IB/5
Updated with Decision(2017)1778 of 13/03/2017
15/03/2017 Centralised - Renewal EMEA/V/C/2010/R/7 (2017)1778 of 13/03/2017
13/07/2017 Centralised - Variation EMEA/V/C/2010/IB/8/G