Nobilis OR Inac

RSS

adjuvanted inactivated vaccine against Ornithobacterium rhinotracheale serotype A

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for this product has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 03/10/2022

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
7
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

29/08/2022 Nobilis OR Inac - EMEA/V/C/000062 - R/0005

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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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