Vaxxitek HVT+IBD

RSS

live vaccine against infectious bursal disease and Marek's disease

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 09/04/2018

Authorisation details

Product details
Name
Vaxxitek HVT+IBD
Agency product number
EMEA/V/C/000065
Active substance
live vHVT013-69 recombinant virus
International non-proprietary name (INN) or common name
live vaccine against infectious bursal disease and Marek's disease
Species
  • Embryonated eggs
  • Chicken
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI01AD15
Publication details
Marketing-authorisation holder
Merial
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
09/08/2002
Contact address
29 avenue Tony Garnier
69007 Lyon
France

Product information

15/02/2018 Vaxxitek HVT+IBD - EMEA/V/C/000065 - WS/1209/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

IMMUNOLOGICALS FOR AVES

Therapeutic indication

For active immunisation of chickens:

  • to prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.
    The onset of protection is from 2 weeks and the protection extends to 9 weeks;
  • to reduce mortality, clinical signs and lesions of Marek’s disease.
    The onset of protection is from 4 days. A single vaccination is sufficient to provide protection during the risk period.

Assessment history

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