Zulvac 1 Bovis

inactivated bluetongue virus, serotype 1

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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 Zulvac 1 Bovis?

Zulvac 1 Bovis is a vaccine that is available as a suspension for injection. It contains inactivated (killed) bluetongue serotype-1 virus.

What is Zulvac 1 Bovis used for?

Zulvac 1 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. The vaccine is used to prevent viraemia (the presence of the viruses in the blood) in cattle from two and a half months of age.

The vaccine is given to young animals as two injections into the muscle. The first injection is given from two and a half months of age and the second injection is given three weeks later. Protection starts two weeks after the last injection and lasts for a year.

How does Zulvac 1 Bovis work?

Zulvac 1 Bovis is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Zulvac 1 Bovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease. When it is given to cattle, the immune system recognises the viruses as ‘foreign’ and makes antibodies against them. In the future, if the animals are exposed to the bluetongue virus, their immune systems will be able to produce antibodies more quickly. This will help to protect them against the disease.

Zulvac 1 Bovis contains bluetongue virus of one serotype (serotype 1). The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) to enhance the immune response.

How has Zulvac 1 Bovis been studied?

The safety of the vaccine was studied in two main laboratory safety studies and a field safety study carried out in cattle, as well as two studies carried out in pregnant cows.

The effectiveness of the vaccine was studied in three main laboratory studies in calves where animals were challenged with bluetongue virus serotype 1, after receiving Zulvac 1 Bovis vaccine containing different amounts of virus. The studies aim was to establish the smallest dose of vaccine that prevented viraemia as well as the duration of protection for Zulvac 1 Bovis.

What benefit has Zulvac 1 Bovis shown during the studies?

The studies showed the vaccine prevents viraemia in cattle and offers protection for one year.The vaccine is safe for cattle from two and a half months of age onwards and in pregnant cows.

The vaccine was also generally well tolerated and shown to be safe.

What is the risk associated with Zulvac 1 Bovis?

Cattle may have a slightly raised body temperature following vaccination.

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 1 Bovis for meat and milk is zero days.

Why has Zulvac 1 Bovis been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zulvac 1 Bovis exceed the risks in the prevention of viraemia caused by bluetongue virus, serotype 1 in cattle from two and a half months of age. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Zulvac 1 Bovis was initially authorised under ‘exceptional circumstances’. This means that it was not possible to obtain complete information about Zulvac 1 Bovis at the time of the initial authorisation. The European Medicines Agency reviewed additional information submitted according to an agreed timetable on the quality and safety of the vaccine. In 2012, the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1 Bovis to convert to normal.

Other information about Zulvac 1 Bovis

The European Commission granted a marketing authorisation valid throughout the European Union, for Zulvac 1 Bovis on 5 August 2011. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Zulvac 1 Bovis : EPAR - Summary for the public BG = bălgarski 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public ES = español 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public CS = čeština 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public DA = dansk 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public DE = Deutsch 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public ET = eesti keel 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public EL = elliniká 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public EN = English 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public FR = français 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public IT = italiano 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public LV = latviešu valoda 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public LT = lietuvių kalba 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public HU = magyar 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public MT = Malti 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public NL = Nederlands 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public PL = polski 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public PT = português 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public RO = română 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public SK = slovenčina 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public SL = slovenščina 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public FI = suomi 2011-10-10 2013-06-04
Zulvac 1 Bovis : EPAR - Summary for the public SV = svenska 2011-10-10 2013-06-04

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

Authorisation details

Product details

Product details for Zulvac 1 Bovis
NameZulvac 1 Bovis
Agency product numberEMEA/V/C/002334
Active substance

inactivated bluetongue virus, serotype 1

International non-proprietary name (INN) or common name

inactivated bluetongue virus, serotype 1

Species Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes QI02AA08



Accelerated procedure

Accelerated procedures are intended to speed up access to new medicines of major public-health interest. Eligible products must either responds to unmet medical needs or constitute a significant improvement over the available methods of prevention, diagnosis or treatment of a condition.

Publication details

Publication details for Zulvac 1 Bovis
Marketing-authorisation holder

Zoetis Belgium SA

Revision6
Date of issue of marketing authorisation valid throughout the European Union05/08/2011

Contact address:

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

Product information

Product information

23/03/2017  Zulvac 1 Bovis -EMEA/V/C/002334 -IG/0747

Name Language First published Last updated
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 2017-04-11
Zulvac 1 Bovis : EPAR - Product information SV = svenska 2011-10-10 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 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17
Zulvac 1 Bovis : EPAR - All authorised presentations SV = svenska 2011-10-10 2011-01-17

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of cattle from 2½ months of age for the prevention of viraemia caused by bluetongue virus, serotype 1.

Onset of immunity: 15 days after completion of the primary vaccination course.

Duration of immunity: 12 months.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Zulvac 1 Bovis : EPAR - Scientific discussion SV = svenska 2011-10-10  
CVMP summary of positive opinion for Zulvac 1 Bovis SV = svenska 2011-06-10