Nobilis OR Inac

Withdrawn

This medicine's authorisation has been withdrawn

adjuvanted inactivated vaccine against Ornithobacterium rhinotracheale serotype A

Overview

The marketing authorisation for this product has been withdrawn at the request of the marketing authorisation holder.

Nobilis OR Inac : EPAR - Summary for the public

Product information

Nobilis OR inac : EPAR - Product Information

Nobilis OR inac : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Nobilis OR Inac
• 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) code:
  QI01AB07

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.

Authorisation details

• EMA product number:
  EMEA/V/C/000062
• Marketing authorisation holder:
  Intervet International BV

  Wim de Körverstraat 35; 5831 AN Boxmeer; The Netherlands

• Marketing authorisation issued:
  24/01/2003
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

Nobilis OR inac : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Nobilis OR inac : EPAR - Scientific Discussion

Nobilis OR inac : EPAR - Procedural steps taken before authorisation