Nobilis IB Primo QX

live avian infectious bronchitis virus, strain D388

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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).

What is Nobilis IB Primo QX?

Nobilis IB Primo QX is a veterinary vaccine that contains live attenuated (weakened) avian infectious bronchitis virus strain D388. Nobilis IB Primo QX is available as a lyophilisate (freeze-dried powder) which may be supplied with a solvent. The vaccine is to be made up into a suspension for use.

What is Nobilis IB Primo QX used for?

Nobilis IB Primo QX is used to protect chickens against viral infectious bronchitis caused by strains of infectious bronchitis virus known as QX-like variants, such as strain D388. The vaccine is given to chickens from 1 day of age or older by spraying onto the chickens or by applying drops into the eyes or nostrils. The period of protection is 8 weeks.

How does Nobilis IB Primo QX work?

Nobilis IB Primo QX is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The avian infection bronchitis virus in Nobilis IB Primo QX has been attenuated (weakened) so that it does not cause disease. When Nobilis IB Primo QX 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 Nobilis IB Primo QX been studied?

The effectiveness of the vaccine was first studied in a number of laboratory studies in chickens. The purpose of the studies was to establish how long it took for chickens to be fully protected, the length of time protection lasts against infectious bronchitis due to QX-like variants, as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine.

The effectiveness of Nobilis IB Primo QX was investigated in two field studies.

In the first study broiler chickens (chickens bred for meat) were spray vaccinated with both Nobilis IB Primo QX and Nobilis IB Ma5, a vaccine against a Massachusetts strain of infectious bronchitis virus. Two groups of 28 birds were challenged with the virus 3 weeks after vaccination, one group with a QX strain and the second group with another strain called M41. Control groups of birds were unvaccinated to show the effectiveness of the challenge.

In a second study 42 broiler chickens were spray vaccinated at 1 day old and challenged 3 weeks after vaccination with a QX strain of the virus. Unvaccinated chicks were retained as controls to show the effectiveness of the challenge.

What benefit has Nobilis IB Primo QX shown during the studies?

The laboratory studies showed that the vaccine had its full effect by three weeks and that protection lasted for eight weeks; protection was not affected by antibodies transmitted from the mother.

In the first field study 100% of the birds vaccinated with Nobilis IB Primo QX mixed with Nobilis IB Ma5 were protected from the QX strain and 90% were protected from M41, compared with none of the unvaccinated birds.

The second field study showed 93% of the Nobilis IB Primo QX vaccinated birds and none of the unvaccinated birds to be protected from the challenge.

What is the risk associated with Nobilis IB Primo QX?

Nobilis IB Primo QX must not be given to birds which are laying eggs or within 4 weeks before the start of the laying period.

After vaccination a mild short lived reaction in the airways, including a nasal discharge, may occur for at least 10 days. These reactions are very rare (affecting less than 1 bird in 10,000).

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

If vaccinating by spray masks with eye protection should be worn when handling the product. Hands and equipment should be washed and disinfected after vaccination to avoid spread of the virus.

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 or eggs or milk used for human consumption. The withdrawal period for Nobilis IB Primo QX for chickens is zero days.

Why has Nobilis IB Primo QX been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobilis IB Primo QX exceed the risks for the approved indication and recommended that Nobilis IB Primo QX be given a marketing authorisation. The Committee recommended that a further overdose study should be submitted. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Other information about Nobilis IB Primo QX

The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis IB Primo QX on 4 September 2014. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Nobilis IB Primo QX : EPAR - Summary for the public BG = bălgarski 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public ES = español 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public CS = čeština 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public DA = dansk 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public DE = Deutsch 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public ET = eesti keel 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public EL = elliniká 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public EN = English 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public FR = français 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public IT = italiano 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public LV = latviešu valoda 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public LT = lietuvių kalba 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public HU = magyar 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public MT = Malti 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public NL = Nederlands 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public PL = polski 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public PT = português 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public RO = română 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public SK = slovenčina 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public SL = slovenščina 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public FI = suomi 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public SV = svenska 2014-11-04  
Nobilis IB Primo QX : EPAR - Summary for the public HR = Hrvatski 2014-11-04  

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

Authorisation details

Product details

Product details for Nobilis IB Primo QX
NameNobilis IB Primo QX
Agency product numberEMEA/V/C/002802
Active substance

live avian infectious bronchitis virus, strain D388

International non-proprietary name (INN) or common name

avian infectious bronchitis vaccine (live)

Species Chicken
Anatomical therapeutic chemical veterinary (ATCvet) codeQI01AD07

Publication details

Publication details for Nobilis IB Primo QX
Marketing-authorisation holder

Intervet International B.V.

Revision1
Date of issue of marketing authorisation valid throughout the European Union04/09/2014

Contact address:

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

Product information

Product information

15/07/2016  Nobilis IB Primo QX -EMEA/V/C/002802 -IB/0001

Name Language First published Last updated
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 2016-07-20
Nobilis IB Primo QX : EPAR - Product Information HR = Hrvatski 2014-11-04 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 Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  
Nobilis IB Primo QX : EPAR - All Authorised presentations HR = Hrvatski 2014-11-04  

Pharmacotherapeutic group

Immunologicals for domestic fowl; live viral vaccines

Therapeutic indication

For active immunisation of chickens in order to reduce respiratory signs of avian infectious bronchitis caused by QX-like variants of infectious bronchitis virus.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nobilis IB Primo QX : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-07-20  

Initial marketing-authorisation documents

Name Language First published Last updated
Nobilis IB Primo QX : EPAR - Public assessment report HR = Hrvatski 2014-11-04  
CVMP summary of positive opinion for Nobilis IB Primo QX HR = Hrvatski 2014-07-11