Prevexxion RN+HVT+IBD

Infectious bursal disease and Marek's disease vaccine (live recombinant)

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 marketing authorisation for the veterinary medicinal product Prevexxion RN+HVT+IBD, concentrate and solvent for suspension for injection, intended for chickens. The applicant for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.

Prevexxion RN+HVT+IBD is an immunological veterinary medicinal product containing live recombinant turkey herpesvirus, strain vHVT013-69 and live recombinant Marek's disease (MD) virus, serotype 1, strain RN1250, live (ATCvet code QI01AD) as active substances.

The benefit of Prevexxion RN+HVT+IBD is the stimulation of active immunity in one-day-old chicks in order to prevent mortality and clinical signs and reduce lesions caused by MD virus (including very virulent MD virus); and to prevent mortality and clinical signs and lesions caused by infectious bursal disease (Gumboro disease) virus.

For MD, the onset of immunity is 5 days after vaccination and the duration of immunity covers the entire risk period. For infectious bursal disease, the onset of immunity is 14 days after vaccination and the duration of immunity is 10 weeks after vaccination.
Prevexxion RN+HVT+IBD is generally well tolerated at the recommended dose, adverse reactions (limited and transient effect on growth) are only seen at overdoses.

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 Prevexxion RN+HVT+IBD 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.

Key facts

Name
Prevexxion RN+HVT+IBD
Agency product number
EMEA/V/C/005057
International non-proprietary name (INN) or common name
  • Infectious bursal disease and Marek's disease vaccine (live recombinant)
Species
Chicken
Active substance
  • live recombinant turkey herpesvirus, strain vHVT013-69
  • live recombinant Marek's disease (MD) virus, serotype 1, strain RN1250, live
Date opinion adopted
20/05/2020
Company name
Boehringer Ingelheim Vetmedica GmbH
Status
Positive
Application type
Initial authorisation

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