FOI – Reports received on Nobivac L4
Published 19 November 2025
© Crown copyright 2025
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/vmd-foieir-requests-august-2025/foi-reports-received-on-nobivac-l4
ATI1112 Request
Reports received on dermatological skin reactions following patients receiving Nobivac L4 for the first time.
Our reply
Nobivac L4 Suspension for Injection for Dogs is a veterinary medicinal product (VMP) used 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/Liangguang to reduce infection and urinary excretion.
Please be aware that the data we have provided below are not subject to independent verification and the Veterinary Medicines Directorate (VMD) does not guarantee their accuracy. We have included all adverse event reports. This includes reports where more than one product was used, reports when the product was used off-label, that is using a medicine in a way that is not specified on the product’s label, or reports where, on further evaluation, there may have been other reasons for the adverse event occurring.
The data provided below relates to adverse events occurring in the United Kingdom. For adverse events relating to European countries, data is available here: European database of suspected adverse drug reaction reports.
We are able to provide the number of adverse events reports coded to Preferred Term (PT) level as per VeDDRA (VeDDRA (Veterinary Dictionary for Drug Regulatory Activities)). All adverse events submitted to the VMD directly or from Marketing Authorisation Holders have their clinical signs coded using this standardised approach. Specifics of adverse events submitted are provided within a narrative section of the submission and the codes used may not exactly correlate verbatim with the detail provided in the narrative. Based on the dermatological skin reactions provided in your enquiry, we have searched for all adverse event reports containing Nobivac L4 Suspension for Injection for Dogs and any of the following PT level VeDDRA terms in dogs: ‘Alopecia’, ‘Dermatitis and eczema’, ‘Erythema’, ‘Injection site erythema’, ‘Injection site hair change’ or ‘Pruritus’.
The search criteria above returned a total of 1,253 case reports containing these terms. We have provided an overview of the breakdown of dermatological skin reactions by PT level. Please be aware that one animal may have more than one clinical sign belonging to the same PT, and each adverse event report may contain more than one animal. Therefore, the total number of reports does not equal the total number of animals reacted.
| VeDDRA Preferred Term | Number of reports |
|---|---|
| Alopecia | 101 |
| Dermatitis and eczema | 282 |
| Erythema | 232 |
| Injection site erythema | 36 |
| Injection site hair change | 20 |
| Pruritus | 582 |
We are unable to filter the number of adverse event reports above for reports where Nobivac L4 Suspension for Injection for Dogs was received for the first time. Treatment details such as whether a product was administered to an animal previously are not mandatory fields in the VICH adverse event report format, and therefore this information is not available for every adverse event report and the VMD does not hold this data in an easily retrievable format.
Any confirmed information regarding warnings and precautions for specific groups of animals is located on the SPC, if any specific trends regarding at risk animals are identified then the SPC would be updated. SPCs can be accessed on https://www.vmd.defra.gov.uk/ProductInformationDatabase/. The SPC for Nobivac L4 Suspension for Injection for Dogs states ‘hypersensitivity reaction’ as ‘very rare (Leptospira vaccination in dogs - GOV.UK)