Ultifend ND IBD

Authorised

This medicine is authorised for use in the European Union

Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)

Overview

On 17 February 2021, 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 Ultifend ND IBD, concentrate and solvent for suspension for injection, intended for chickens and chicken embryonated eggs. The applicant for this veterinary medicinal product is Ceva-Phylaxia Veterinary Biologicals Co. Ltd.

Ultifend ND IBD is an immunological veterinary medicinal product containing cell-associated live recombinant turkey herpesvirus (rHVT-ND-IBD) expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, as active substance.

The benefit of Ultifend ND IBD is the stimulation of active immunity in one-day-old chicks or 18-day-old chicken embryonated eggs in order to reduce mortality, clinical signs and lesions caused by Newcastle disease virus (NDV) and to reduce virus shedding; to reduce mortality, clinical signs and bursa lesions caused by very virulent infectious bursal disease virus (IBDV); and to reduce mortality, clinical signs and lesions caused by classical Marek’s disease virus (MDV).

Ultifend ND IBD is generally well tolerated at the recommended dose. No adverse reactions were observed after the administration of the recommended dose or a 10-fold overdose.

Detailed conditions for the use of this product are 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 Ultifend ND IBD and therefore recommends the granting of the marketing authorisation.

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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.

Ultifend ND IBD : EPAR - Medicine overview

Reference Number: EMA/145332/2021

Product information

Ultifend ND IBD : EPAR - Product information

20/04/2021

Ultifend ND IBD : EPAR - All authorised presentations

Product details

• Name of medicine:
  Ultifend ND IBD
• Active substance:
  Turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant
• International non-proprietary name (INN) or common name:
  Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)
• Species:
  • Embryonated chicken eggs
  • Chicken
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI01AD16

Pharmacotherapeutic group

Immunologicals for aves

Therapeutic indication

For the active immunisation of one-day-old chicks or 18-day-old chicken embryonated eggs to reduce mortality, clinical signs and lesions caused by Newcastle disease virus (NDV) and to reduce virus shedding; to reduce mortality, clinical signs and bursa lesions caused by very virulent infectious bursal disease virus (IBDV); to reduce mortality, clinical signs and lesions caused by classical Marek’s disease virus (MDV).

Authorisation details

• EMA product number:
  EMEA/V/C/005347
• Marketing authorisation holder:
  CEVA-Phylaxia Zrt.

  Szállás Utca 5 ; 1107 Budapest ; Hungary

• Opinion adopted:
  17/02/2021
• Opinion status:
  Positive
• Marketing authorisation issued:
  20/04/2021

Assessment history

Initial marketing authorisation documents

Ultifend ND IBD : EPAR - Public assessment report

AdoptedReference Number: EMA/160757/2021