Nobivac L4

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Vaccine to prevent Leptospira infections in dogs

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 11/11/2021

Authorisation details

Product details
Name
Nobivac L4
Agency product number
EMEA/V/C/002010
Active substance
  • Leptospira interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
  • L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
  • L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
  • L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
International non-proprietary name (INN) or common name
Vaccine to prevent Leptospira infections in dogs
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI07AB01
Publication details
Marketing-authorisation holder
Intervet International BV
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
16/07/2012
Contact address
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

07/10/2021 Nobivac L4 - EMEA/V/C/002010 - WS/2058/0012

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

For active immunisation of dogs against:

  • Leptospira 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.

Assessment history

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