Zulvac BTV Ovis

One of the following inactivated bluetongue virus strains:

Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1

Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02

Inactivated bluetongue virus, serotype 4, strain SPA-1/2004

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This is a summary of the European public assessment report (EPAR) for Zulvac BTV Ovis. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Zulvac BTV Ovis.

For practical information about using Zulvac BTV Ovis, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Zulvac BTV Ovis and what is it used for?

Zulvac BTV Ovis is a vaccine used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.

The vaccine contains inactivated (killed) bluetongue virus. It can contain one of the following three varieties: BTV serotype 1, BTV serotype 4 and BTV serotype 8. The serotype to be used in the vaccine is selected before manufacture depending on which type is most commonly circulating and causing disease at the time. The vaccine can prevent the presence of serotypes 1 or 8 in the blood and reduce levels of serotype 4.

How is Zulvac BTV Ovis used?

The vaccine is available as a suspension for injection and can only be obtained with a prescription.

The vaccine is given to sheep as two injections under the skin. The first injection is given from 6 weeks of age and a second injection is given three weeks later. For booster vaccination against serotype 1 or 8 a single injection is given every 12 months, whilst for booster vaccination against serotype 4 two injections are given three weeks apart every 12 months. Protection starts 3 weeks after the initial course of two injections and lasts for one year.

How does Zulvac BTV Ovis work?

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

Zulvac BTV Ovis contains bluetongue virus of one type selected from serotypes 1, 4 and 8. The vaccine also contains ‘adjuvants’ (aluminium hydroxide and Quil-A) that enhance the response of the immune system.

What benefits of Zulvac BTV Ovis have been shown in studies?

Laboratory studies were conducted with the individual serotypes 1, 4 and 8 as well as with the combination of 1 and 8 in sheep which showed that protection starts three weeks after completion of the initial course of two injections for each serotype. Further laboratory studies showed protection lasts for one year for each serotype. A laboratory study with lambs vaccinated with serotype 4 showed the vaccine to reduce levels of serotype 4 in the blood for at least 12 months whilst studies with serotype 1 and 8 showed absence of the respective serotypes after one year. Data on the effectiveness under field conditions of other bluetongue virus vaccines containing the individual serotypes or a combination of two serotypes were also taken into account.

What are the risks associated with Zulvac BTV Ovis?

The most common side effects with Zulvac BTV Ovis (which may affect more than 1 in 10 animals) are a short-lived increase in body temperature, up to 1.6˚C, during the 2 days after vaccination and local reactions at the injection site. In most cases the reactions are diffuse swellings at the injection site which last no longer than one week. They may also be nodules that can be felt under the skin of up to 60 cm2 in size which reduce with time but may persist for more than 50 days.

For the full list of restrictions, see the package leaflet.

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

None

What is the withdrawal period in food-producing animals?

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

The withdrawal period for meat and milk from sheep treated with Zulvac BTV Ovis is ‘zero’ days, which means there is no mandatory waiting time.

Why is Zulvac BTV Ovis approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zulvac BTV Ovis’ benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Zulvac BTV Ovis?

The European Commission granted a marketing authorisation valid throughout the EU for Zulvac BTV Ovis on 25 April 2017.

The full EPAR for Zulvac BTV Ovis can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. For more information about treatment with Zulvac BTV Ovis, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Zulvac BTV Ovis : EPAR - Summary for the public BG = bălgarski 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public ES = español 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public CS = čeština 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public DA = dansk 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public DE = Deutsch 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public ET = eesti keel 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public EL = elliniká 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public EN = English 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public FR = français 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public IT = italiano 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public LV = latviešu valoda 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public LT = lietuvių kalba 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public HU = magyar 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public MT = Malti 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public NL = Nederlands 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public PL = polski 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public PT = português 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public RO = română 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public SK = slovenčina 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public SL = slovenščina 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public FI = suomi 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public SV = svenska 2017-05-12  
Zulvac BTV Ovis : EPAR - Summary for the public HR = Hrvatski 2017-05-12  

This EPAR was last updated on 12/05/2017 .

Authorisation details

Product details

Product details for Zulvac BTV Ovis
NameZulvac BTV Ovis
Agency product numberEMEA/V/C/004185
Active substance

One of the following inactivated bluetongue virus strains:

Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1

Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02

Inactivated bluetongue virus, serotype 4, strain SPA-1/2004

International non-proprietary name (INN) or common name

bluetongue vaccine (inactivated)

Species Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codes QI04AA02



Publication details

Publication details for Zulvac BTV Ovis
Marketing-authorisation holder

Zoetis Belgium SA

Revision0
Date of issue of marketing authorisation valid throughout the European Union25/04/2017

Contact address:

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

Product information

Product information

25/04/2017  Zulvac BTV Ovis -EMEA/V/C/004185

Name Language First published Last updated
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - Product Information HR = Hrvatski 2017-05-12  

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 BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  
Zulvac BTV Ovis : EPAR - All Authorised presentations HR = Hrvatski 2017-05-12  

Pharmacotherapeutic group

Immunologicals, inactivated viral vaccines for sheep

Therapeutic indication

Active immunisation of sheep from 6 weeks of age for the prevention of viraemia caused by bluetongue virus, serotypes 1 and 8, and for the reduction of viraemia caused by bluetongue virus, serotype 4.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Zulvac BTV Ovis : EPAR - Public assessment report HR = Hrvatski 2017-05-12  
CVMP summary of positive opinion for Zulvac BTV Ovis HR = Hrvatski 2017-02-17  

Authorised

This medicine is approved for use in the European Union