Nobivac L4 - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

canine leptospirosis vaccine (inactivated)

Opinion

On 12 June 2025 the Committee for Veterinary Medicinal Products (CVMP) adopted an opinion*, recommending the change to the terms of the marketing authorisations for the veterinary medicinal products Nobivac L4 and Nobivac LoVo L4, following worksharing procedure for a group of variations. The marketing authorisation holder for this veterinary medicinal product is Intervet International B.V..

Nobivac L4 and Nobivac LoVo L4 are currently authorised for the 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/Liangguang to reduce infection and urinary    excretion.

The proposed variation is to add a new therapeutic indication or modification of an approved one for 2 new Leptospira serovars, existing Leptospira serovars, addition of efficacy against serovar Australis and associated non-mixed use with Nobivac Rabies (Nationally registered). A consequential name update from L4 to L6 is also proposed.

Detailed conditions for the use of this product are described in the updated summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

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*Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.

CVMP post-authorisation summary of positive opinion for Nobivac L4 (VRA0000184065)

AdoptedReference Number: EMADOC-1700519818-2188844

Key facts

• Name of medicine:
  Nobivac L4
• EMA 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:
  canine leptospirosis vaccine (inactivated)
• Date of opinion:
  12/06/2025
• Status:
  Positive