Nobilis IB 4-91

live attenuated avian infectious bronchitis virus variant strain 4-91

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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).

What is Nobilis IB 4-91?

Nobilis IB 4-91 is a veterinary vaccine that contains live attenuated (weakened) avian infectious bronchitis virus. Nobilis IB 4-91 is available as a lyophilisate (freeze-dried powder) which is to be made up into a suspension.

What is Nobilis IB 4-91 used for?

Nobilis IB 4-91 is used to immunise chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91, which causes infectious bronchitis in chickens.

Nobilis IB 4-91 can be given to one-day-old chicks and older chickens by coarse spray or by intranasal (breathed in through the nose) or ocular (absorbed by the eyes) administration. The vaccine can be given to seven-day and older chickens in their drinking water.

The vaccine can be administered to future layers and breeders from day old onwards via intranasal / ocular route or coarse spray. The vaccine can be administered to seven-day and older chickens by drinking water. For prolonged immunity, chickens should be revaccinated every six weeks after the initial administration.

How does Nobilis IB 4-91 work?

Nobilis IB 4-91 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The avian infectious bronchitis virus in Nobilis IB 4-91 has been attenuated (weakened) so that it does not cause disease. When Nobilis IB 4-91 is given to chickens the animals’ immune system recognises the virus as ‘foreign’ and makes antibodies against it. In the future if the animals are exposed to the virus the immune system will be able to respond more quickly. This will help protect them against infectious bronchitis.

How has the effectiveness of Nobilis IB 4-91 been studied?

The Nobilis IB 4-91 vaccine has been studied in various vaccination schedules in a number of trials. The vaccine was given by coarse spray to chicken of various ages. The main measures of effectiveness included the development of antibodies to the IB 4-91 virus, the overall death rate of the chickens and the percentage of chicken rejected because of disease. Nobilis IB 4-91 vaccine has also been compared with controls, i.e. chickens that were not vaccinated.

What benefit has Nobilis IB 4-91 shown during the studies?

There was a clear immune response to Nobilis IB 4-91. In one trial, after three weeks 100% of chickens had developed antibodies to the IB 4-91 virus compared with 17% for the controls.

What are the side effects of Nobilis IB 4-91?

Nobilis IB 4-91 can cause mild respiratory signs of disease which may last for a few days depending on the health and condition of the chickens.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

There are no precautions for the person, but it is recommended to wash and disinfect hands and equipment after vaccinating to avoid spread of the virus.

The vaccine virus may spread from vaccinated to non-vaccinated chickens, so care should be taken to separate vaccinated from non-vaccinated chickens.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption. It is also the time allowed after administration of the medicine before eggs may be used for human consumption.

The withdrawal period for Nobilis IB 4-91 for chickens is zero days.

Why has Nobilis IB 4-91 been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Nobilis IB 4-91 exceed the risks for the approved indication and recommended that Nobilis IB 4-91 should be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Nobilis IB 4-91

The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis IB 4-91 on 9 June 1998. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Nobilis IB 4-91 : EPAR - Summary for the public BG = bălgarski 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public ES = español 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public CS = čeština 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public DA = dansk 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public DE = Deutsch 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public ET = eesti keel 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public EL = elliniká 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public EN = English 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public FR = français 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public IT = italiano 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public LV = latviešu valoda 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public LT = lietuvių kalba 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public HU = magyar 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public MT = Malti 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public NL = Nederlands 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public PL = polski 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public PT = português 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public RO = română 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public SK = slovenčina 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public SL = slovenščina 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public FI = suomi 2007-05-02 2015-07-08
Nobilis IB 4-91 : EPAR - Summary for the public SV = svenska 2007-05-02 2015-07-08

This EPAR was last updated on 20/07/2016 .

Authorisation details

Product details

Product details for Nobilis IB 4-91
NameNobilis IB 4-91
Agency product numberEMEA/V/C/000036
Active substance

live attenuated avian infectious bronchitis virus variant strain 4-91

International non-proprietary name (INN) or common name

live attenuated vaccine against avian infectious bronchitis

Species Chicken
Anatomical therapeutic chemical veterinary (ATCvet) codeQI01AD07

Publication details

Publication details for Nobilis IB 4-91
Marketing-authorisation holder

Intervet International BV

Revision11
Date of issue of marketing authorisation valid throughout the European Union09/06/1998

Contact address:

Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

Product information

15/07/2016  Nobilis IB 4-91 -EMEA/V/C/000036 -II/0022/G

Name Language First published Last updated
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20
Nobilis IB 4-91 : EPAR - Product Information SV = svenska 2008-06-03 2016-07-20

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.


Name Language First published Last updated
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17
Nobilis IB 4-91 : EPAR - All Authorised presentations SV = svenska 2008-06-03 2016-05-17

Pharmacotherapeutic group

Immunologicals For aves

Therapeutic indication

Active immunisation of chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nobilis IB 4-91 : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2008-06-03 2016-07-20

Initial marketing-authorisation documents

Name Language First published Last updated
Nobilis IB 4-91 : EPAR - Procedural steps taken before authorisation SV = svenska 2006-08-29  
Nobilis IB 4-91 : EPAR - Scientific Discussion SV = svenska 2006-08-29