Nobivac LeuFel

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On 7 September 2017, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product Nobivac LeuFel, suspension for injection, intended for active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease. The applicant for this veterinary medicinal product is Virbac.

Nobivac LeuFel is an inactivated viral vaccine for cats against feline leukaemia (ATCvet code QI06AA01). It contains the purified recombinant p45 FeLV-envelope antigen that was derived from the gp70 surface glycoprotein of the FeLV subgroup A and is expressed in Escherichia coli as active substance.

The benefits of Nobivac LeuFel are the active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease. The onset of immunity of the vaccine is 3 weeks after the primary vaccination and the duration of immunity is one year after the primary vaccination. The most common side effects are moderate and transient local swelling, an oedema or a nodule (<2 cm) after the first injection. These local reactions resolve spontaneously within from 3 to 4 weeks at the most. After the second injection, and subsequent administrations, this reaction is markedly reduced. In rare cases, pain at palpation, sneezing or conjunctivitis may be noted, that resolves without any treatment. The transient common signs following vaccination may also be observed, such as: hyperthermia (lasting 1 to 4 days), apathy, digestive disturbances. In very rare cases, anaphylactic reactions have been reported.

Detailed conditions for the use of this product will be described in the summary of product characteristics (SPC) which will be published in the European public assessment report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Nobivac LeuFel and therefore recommends the granting of the marketing authorisation.


1 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.

Name Language First published Last updated
CVMP summary of positive opinion for Nobivac LeuFel (English only) 2017-09-08  

Key facts

Product details for Nobivac LeuFel
NameNobivac LeuFel
INN or common namepurified Rp-45 FeLV-envelope antigen
Active substance

purified Rp-45 FeLV-envelope antigen

Date opinion adopted07/09/2017
Company name

Virbac

StatusPositive
Application typeInitial authorisation