Zulvac 1+8 Bovis

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inactivated bluetongue virus, serotypes 1 and 8

Authorised
This medicine is authorised for use in the European Union.

Overview

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).

This EPAR was last updated on 23/10/2019

Authorisation details

Product details
Name
Zulvac 1+8 Bovis
Agency product number
EMEA/V/C/002473
Active substance
  • inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP
  • inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02
International non-proprietary name (INN) or common name
inactivated bluetongue virus, serotypes 1 and 8
Species
Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI02AA08
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Publication details
Marketing-authorisation holder
Zoetis Belgium SA
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
08/03/2012
Contact address

Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium

Product information

21/06/2019 Zulvac 1+8 Bovis - EMEA/V/C/002473 - IB/00016

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.

Pharmacotherapeutic group

  • Immunologicals
  • Immunologicals for bovidae
  • CATTLE
  • Inactivated viral vaccines
  • bluetongue virus

Therapeutic indication

Active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotypes 1 and 8.

*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).

Assessment history

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