Divence IBR Marker Live

Opinion

EMA has issued an opinion on this medicine

Infectious bovine rhinotracheitis virus, strain CEDDEL, gE- tk- double-gene deleted, Live

Overview

On 19 June 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion¹, recommending the granting of a marketing authorisation for the veterinary medicinal product Divence IBR Marker Live, lyophilisate and solvent for emulsion for injection, intended for cattle. The applicant for this veterinary medicinal product is Laboratorios Hipra, S.A.

Divence IBR Marker Live is a live vaccine containing bovine herpesvirus type 1 (BoHV-1), strain CEDDEL, gE- tk- double-gene deleted (ATCvet code QI02AD01) as active substance, and it stimulates active immunity against bovine herpesvirus type 1.

The benefit of DIVENCE IBR Marker Live is the active immunisation of cattle from 10 weeks of age to reduce virus shedding, hyperthermia and clinical signs of IBR (infectious bovine rhinotracheitis).

The most common side effects are injection site inflammation and elevated temperature.

Detailed conditions for the use of this product are described in the summary of product characteristics (SPC) which will be published in the Union Product Database (UPD) 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 Divence IBR Marker Live 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.

CVMP summary of positive opinion for Divence IBR Marker Live

AdoptedReference Number: EMA/CVMP/252070/2024

Product details

• Name of medicine:
  Divence IBR Marker Live
• Active substance:
  Infectious bovine rhinotracheitis virus, strain CEDDEL, gE- tk- double-gene deleted, Live
• International non-proprietary name (INN) or common name:
  Infectious bovine rhinotracheitis virus, strain CEDDEL, gE- tk- double-gene deleted, Live
• Species:
  Cattle
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI02AD01
• EMA product number:
  EMEA/V/C/006260
• Marketing authorisation applicant:
  Laboratorios Hipra S.A
• Opinion adopted:
  19/06/2024
• Opinion status:
  Positive