Leucogen (purified p45 FeLV-envelope antigen) - QI06AA01

Updated on site: 21-Sep-2017

Medication name: Leucogen
Substance: purified p45 FeLV-envelope antigen
Manufacturer: Virbac S.A.

How has Leucogen been studied?

Because Leucogen has been available in the European Union (EU) since 1988, and is also used as part of a multivalent vaccine called Leucofeligen FeLV/RCP, the company used data from studies carried out with these vaccines to support the use of Leucogen.

Two main ‘field’ studies involved kittens aged eight to nine weeks, the first using Leucogen and the second using Leucofeligen FeLV/RCP. The main measure of effectiveness was the presence of antibodies against FeLV in the vaccinated kittens’ blood. Further studies were carried out under laboratory conditions to show that vaccination prevented FeLV from remaining in the blood.

What benefit has Leucogen shown during the studies?

The studies showed that Leucogen provided protection against FeLV infection. Vaccination on two occasions with three to four weeks between injections prevented FeLV from remaining in the blood and prevented the signs of FeLV infection.

What is the risk associated with Leucogen?

A temporary small nodule (hard swelling) may appear at the site of injection. This usually resolves on its own within three to four weeks. This reaction is reduced after subsequent injections. In rare cases, there may be pain on being touched, sneezing or conjunctivitis (eye inflammation). These resolve without any treatment. The temporary usual signs following vaccination, such as increased temperature, apathy (listlessness) and digestive problems such as abdominal discomfort may also be seen following vaccination. For a full list of all side effects reported with Leucogen, see the Package Leaflet. Leucogen should not be used in pregnant cats. Its use is not recommended in cats nursing kittens.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

In case of accidental self-injection, seek medical advice immediately and show the Package Leaflet or the label to the doctor.

Why has Leucogen been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Leucogen exceed the risks for the active immunisation of cats from eight weeks of age against feline leukaemia, and recommended that Leucogen be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Leucogen:

The European Commission granted a marketing authorisation valid throughout the EU for Leucogen to Virbac S.A. on 17 June 2009. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated on 17 June 2009.