Innovax-ND-IBD

Authorised

This medicine is authorised for use in the European Union

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

Overview

Up-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website.

Innovax-ND-IBD : EPAR - Medicine overview

Reference Number: EMA/391280/2017

Product information

Innovax-ND-IBD : EPAR - Product Information

Innovax-ND-IBD : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Innovax-ND-IBD
• Active substance:
  cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of ND virus and the VP2 protein of IBD virus
• International non-proprietary name (INN) or common name:
  • Newcastle disease
  • infectious bursal disease
  • Marek's disease vaccine (live recombinant)

Pharmacotherapeutic group

• Immunologicals for aves
• Domestic fowl
• Live viral vaccines

Authorisation details

• EMA product number:
  EMEA/V/C/004422

Assessment history

Changes since initial authorisation of medicine

Innovax-ND-IBD : EPAR - Procedural steps taken and scientific information after the authorisation

Innovax-ND-IBD-V-C-4422-II-0004 : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/193705/2019

CVMP post-authorisation summary of positive opinion for Innovax-ND-IBD (II/0004)

Adopted Reference Number: EMA/CVMP/507630/2020

Innovax-ND-IBD-V-C-4422-X-0001 : EPAR - Assessment report - Extension

Adopted Reference Number: EMA/193705/2019

CVMP post-authorisation summary of positive opinion for Innovax-ND-IBD (X-001)

Adopted Reference Number: EMA/CVMP/153784/201

Initial marketing authorisation documents

Innovax-ND-IBD : EPAR - Public assessment report

Reference Number: EMA/377164/2017

CVMP summary of positive opinion for Innovax-ND-IBD

Adopted Reference Number: EMA/CVMP/290079/2017