Zulvac 8 Ovis

inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02

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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 Zulvac 8 Ovis?

Zulvac 8 Ovis is a vaccine that contains inactivated (killed) bluetongue serotype 8 virus as the active substance. It is available as a suspension for injection.

What is Zulvac 8 Ovis used for?

Zulvac 8 Ovis is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. The virus exists in several forms (serotypes) throughout the world; the type used in Zulvac 8 Ovis is serotype 8. The vaccine is used to prevent viraemia (the presence of the virus in the blood) in sheep from one and a half months of age.

The vaccine is given to animals as an injection under the skin. The first injection is given from one and a half months of age and the second injection is given three weeks later. Protection starts 25 days after the last injection and lasts for at least a year.

How does Zulvac 8 Ovis work?

Zulvac 8 Ovis is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Zulvac 8 Ovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease. When it is given to sheep, theimmune system recognises the viruses as ‘foreign’ and makes antibodies against them. In the future, if the animals are exposed to the bluetongue virus, the immune system will be able to produce antibodies more quickly. This will help them to protect against the disease.

The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) to enhance the immune response.

How has Zulvac 8 Ovis been studied?

The safety of the vaccine was studied in laboratory safety studies carried out with Zulvac 8 Ovis in sheep. Results from a series of laboratory safety trials performed with vaccines of similar composition but containing different serotypes of the virus were also presented.

The effectiveness of the vaccine in preventing viraemia in sheep was studied in a laboratory trial using the vaccine in sheep from one month of age. The company also presented results from a series of studies with other vaccines that contain other serotypes of the bluetongue virus, as well as preliminary results from a study in sheep investigating how long the immunity produced by the vaccine lasted after vaccination.

What benefit has Zulvac 8 Ovis shown during the studies?

The studies showed that the vaccine is safe for sheep and that it prevents viraemia in animals from one and a half months of age that are infected with bluetongue virus serotype 8.

The studies also showed that the vaccine can be used in pregnant sheep.

What is the risk associated with Zulvac 8 Ovis?

Sheep may show a temporary increase in body temperature, no more than 1.2°C, in the 24 hours after vaccination. There may also be a local reaction at the injection site, such as swelling (generally lasting less than a week) or ‘nodules’ (hardening under the skin) that may last for more than 6 or 7 weeks.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or milk used for human consumption. The withdrawal period for Zulvac 8 Ovis for meat and milk is zero days.

Why has Zulvac 8 Ovis been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zulvac 8 Ovis exceed the risks in the prevention of viraemia caused by the bluetongue virus serotype 8 in sheep from one and a half months of age. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Zulvac 8 Ovis was initially authorised under ‘exceptional circumstances’. This means that it was not possible to obtain complete information about Zulvac 8 Ovis at the time of the initial authorisation. The European Medicines Agency (EMA) reviewed additional information submitted according to an agreed timetable on the quality, safety and efficacy of the vaccine. In 2013 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 8 Ovis to convert to a normal status.

Other information about Zulvac 8 Ovis

The European Commission granted a marketing authorisation valid throughout the EU for Zulvac 8 Ovis on 15 January 2010. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Zulvac 8 Ovis : EPAR - Summary for the public BG = bălgarski 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public ES = español 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public CS = čeština 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public DA = dansk 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public DE = Deutsch 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public ET = eesti keel 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public EL = elliniká 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public EN = English 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public FR = français 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public IT = italiano 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public LV = latviešu valoda 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public LT = lietuvių kalba 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public HU = magyar 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public MT = Malti 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public NL = Nederlands 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public PL = polski 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public PT = português 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public RO = română 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public SK = slovenčina 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public SL = slovenščina 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public FI = suomi 2010-01-21 2014-05-06
Zulvac 8 Ovis : EPAR - Summary for the public SV = svenska 2010-01-21 2014-05-06

This EPAR was last updated on 11/04/2017 .

Authorisation details

Product details

Product details for Zulvac 8 Ovis
NameZulvac 8 Ovis
Agency product numberEMEA/V/C/000147
Active substance

inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02

International non-proprietary name (INN) or common name

inactivated bluetongue virus, serotype 8

Species Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codes QI04AA02






Publication details

Publication details for Zulvac 8 Ovis
Marketing-authorisation holder

Zoetis Belgium SA

Revision8
Date of issue of marketing authorisation valid throughout the European Union15/01/2010

Contact address:

Zoetis Belgium SA
Rue Laid Burniat 1
1348
Louvain-la-Neuve
Belgium

Product information

Product information

23/03/2017  Zulvac 8 Ovis -EMEA/V/C/000147 -IG/0747

Name Language First published Last updated
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11
Zulvac 8 Ovis : EPAR - Product Information SV = svenska 2010-01-21 2017-04-11

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
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  
Zulvac 8 Ovis : EPAR - All Authorised presentations SV = svenska 2010-01-21  

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of sheep from 1.5 months of age for the prevention of viraemia caused by bluetongue virus, serotype 8.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Authorised

This medicine is approved for use in the European Union

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