Nobilis OR Inac

RSS

adjuvanted inactivated vaccine against Ornithobacterium rhinotracheale serotype A

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

Overview

This is a summary of the European Public Assessment Report. 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 02/10/2008

Authorisation details

Product details
Name
Nobilis OR Inac
Agency product number
EMEA/V/C/000062
Active substance
inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A, strain B3263/91
International non-proprietary name (INN) or common name
adjuvanted inactivated vaccine against Ornithobacterium rhinotracheale serotype A
Species
Chicken
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI01AB07
Publication details
Marketing-authorisation holder
Intervet International BV
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
24/01/2003
Contact address
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

10/01/2008 Nobilis OR Inac - EMEA/V/C/000062 - R/0005

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 passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved.

Under field conditions passive immunity is transferred during lay for 43 weeks after the last vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14 days after hatching.

Assessment history

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