Leucofeligen FeLV/RCP

feline calicivirosis, feline viral rhinotrachieitis, feline infectious enteritis (feline panleucopenia) vaccine (live), feline leukaemia vaccine (inactivated)

Table of contents

Opinion

On 20 May 2020, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Leucofeligen FeLV/RCP. The marketing authorisation holder for this veterinary medicinal product is Virbac S.A.

Leucofeligen FeLV/RCP is currently authorised as lyophilisate and suspension for suspension for injection. The variation concerns to change the onset of immunity for the calicivirus component of the vaccine from 4 weeks after primary vaccination to 3 weeks after first vaccine injection of primary vaccination.

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 revised European public assessment report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.


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.

Key facts

Name
Leucofeligen FeLV/RCP
Agency product number
EMEA/V/C/000143
International non-proprietary name (INN) or common name
  • feline calicivirosis, feline viral rhinotrachieitis, feline infectious enteritis (feline panleucopenia) vaccine (live), feline leukaemia vaccine (inactivated)
Species
Cats
Active substance
  • live feline calicivirus (strain F9) / live feline viral rhinotracheitis virus (strain F2) / live feline panleucopenia virus
  • purified p45 feline leukaemia virus envelope antigen
Date opinion adopted
25/05/2020
Company name
Virbac S.A.
Status
Positive
Application type
Post-authorisation

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