FOI release

FOI ATI1142 - Nobivac (FeLV/Tricat vaccine) adverse reaction reports

Published 5 February 2026

1. ATI1142 Request

Possible adverse reaction reports on Nobivac (FeLV/Tricat vaccine) regarding acute submandibular lymph node enlargement.

2. Our reply

Nobivac Tricat Trio, lyophilisate and solvent for suspension for injection for cats is a veterinary medicinal product (VMP) used for active immunisation of cats:

• to reduce the clinical signs caused by infection with feline calicivirus (FCV) and rhinotracheitis virus (FVR)
• to prevent the clinical signs, leucopenia and virus excretion caused by infection with feline panleucopenia virus (FPLV)

Nobivac FeLV Suspension for Injection for Cats is a VMP used for active immunisation of cats:

• for active immunisation of healthy cats to prevent persistent feline leukaemia-virus viraemia and any associated clinical signs of the feline leucosis

If you or someone else involved with the case has not yet reported this adverse event to the relevant Marketing Authorisation Holder (MAH, pharmaceutical company) then please do so. MAH contact details can be found within the product information that comes packaged with a medicine, on the MAH’s website, or by searching for the product on the Product information Database, which contains details of all authorised VMPs. The MAH distributor for Nobivac Tricat Trio and Nobivac FeLV suspension for injection for cats is MSD Animal Health and their adverse event reporting form can be found here.

MAHs have a legal obligation to report all adverse event reports they receive to the VMD within 30 days of awareness, as per paragraph 57 of The Veterinary Medicines Regulations 2013 and the accompanying guidance in Guideline III Adverse event reporting - GOV.UK.

All adverse events submitted to the VMD have their clinical signs coded using the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA). We have provided you below with the number of adverse event reports for Nobivac FeLV and Nobivac Tricat for lymphadenopathy by preferred term (PT), which is one of the hierarchical levels of VeDDRA. Currently, there is no VeDDRA term that specifically denotes submandibular lymphadenopathy. Further information regarding VeDDRA can be located on the European Medicines Agency website, including the VeDDRA list of clinical terms for reporting suspected adverse events and the Guidance notes on the use of VeDDRA terminology.

Your request pertained to submandibular lymph node enlargement, specifically questioning if this has been encountered before following administration of Nobivac Tricat Trio and Nobivac FeLV. In our database, there are 72 cases for Nobivac Tricat Trio that include the PT lymphadenopathy in the United Kingdom. There are 93 cases for Nobivac FeLV that include the PT lymphadenopathy in the United Kingdom. Nobivac Tricat Trio and Nobivac FeLV vaccines are frequently administered concurrently, and therefore the numbers given above will include reports where both vaccines were given.

Please be aware the data are not subject to independent verification and the VMD does not guarantee their accuracy. The figures are based on adverse events submitted to the VMD for the purposes of pharmacovigilance.

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.

Evaluation is dependent on the accuracy and quality of data received from veterinary professionals and animal owners, and reporting frequency can vary over time (reporting frequency may be affected by a product being new to the market or social media interest, for example).

Although adverse event report information can be useful to provide a general overview of a VMP, it is important for any clinical decisions regarding the use of a VMP to be based on a risk-benefit discussion specific to the animal or group of animals being administered the VMP. An overall frequency of an adverse event occurring for a VMP does not reflect the actual risk for an individual animal, as there are many individual factors that may contribute to the likelihood of an adverse event occurring.

The VMD does not give individual clinical advice, as the specific treatment of an animal is best determined by the veterinary professional under whose care they fall. For advice on specific cases, general product advice or when considering off-label use, we advise veterinary professionals to contact the Marketing Authorisation Holder (pharmaceutical company).

All medicines whether for human or animal use come with risk, and the benefits of use in wider populations need to outweigh the potential risks. Information on adverse events that have been known to occur following administration of a particular product are summarised in sections 3.6/4.6 of the Summary of Product Characteristics (SPC). The SPC is a document describing the properties and the officially approved conditions of use of a medicine. The SPC and associated product information are updated as new information is available, and the latest version of an SPC can be found on our publicly available Product Information Database. We continually assess and update our findings relating to products used within the United Kingdom and should there be sufficient data to suggest that an SPC requires alteration or that another appropriate action is required, this will be carried out within the required timeframe, as set out by the current legislation surrounding that veterinary medicinal product or region.

Pharmacovigilance updates are published on gov.uk at https://www.gov.uk/guidance/urgent-safety-updates-for-veterinary-medicines; this also includes any updates involving non-veterinary medicines used in animals. To receive these pharmacovigilance updates via email, please click on the ‘Get emails about this page’ button.