- Application under evaluation
- CVMP opinion
- European Commission decision
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The marketing authorisation for this product has been withdrawn at the request of the marketing authorisation holder.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
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Product information
Nobilis OR inac : EPAR - Product Information
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Nobilis OR inac : EPAR - All Authorised presentations
English (EN) (159.4 KB - PDF)
български (BG) (240.59 KB - PDF)
español (ES) (159.57 KB - PDF)
čeština (CS) (235.61 KB - PDF)
dansk (DA) (159.42 KB - PDF)
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eesti keel (ET) (159.2 KB - PDF)
ελληνικά (EL) (82.3 KB - PDF)
français (FR) (159.37 KB - PDF)
italiano (IT) (159.39 KB - PDF)
latviešu valoda (LV) (234.13 KB - PDF)
lietuvių kalba (LT) (227.96 KB - PDF)
magyar (HU) (234.71 KB - PDF)
Malti (MT) (238.27 KB - PDF)
Nederlands (NL) (159.27 KB - PDF)
polski (PL) (234.03 KB - PDF)
português (PT) (159.39 KB - PDF)
română (RO) (224.27 KB - PDF)
slovenčina (SK) (234.38 KB - PDF)
slovenščina (SL) (230.29 KB - PDF)
Suomi (FI) (159.17 KB - PDF)
svenska (SV) (159.85 KB - PDF)
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 avesTherapeutic 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
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands - Marketing authorisation issued
- 24/01/2003
- Revision
- 7
Assessment history
Nobilis OR inac : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (164.85 KB - PDF)