Syvazul BTV

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Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)

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

Overview

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

The vaccine contains inactivated (killed) bluetongue viruses. The variety (serotype) of the virus in the vaccine is selected depending on which serotypes are circulating and causing disease at the time of manufacture, so it may contain serotype 1, 4 or 8 or a combination of any two of these.

This EPAR was last updated on 19/09/2019

Authorisation details

Product details
Name
Syvazul BTV
Agency product number
EMEA/V/C/004611
Active substance
  • Inactivated bluetongue virus, serotype 1, strain ALG2006/01 E1
  • Inactivated bluetongue virus, serotype 4, strain BTV-4/SPA-1/2004
  • Inactivated bluetongue virus, serotype 8, strain BEL2006/01
International non-proprietary name (INN) or common name
Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)
Species
  • Cattle
  • Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI04AA02
Publication details
Marketing-authorisation holder
LABORATORIOS SYVA, S.A.U.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
09/01/2019
Contact address

Avda. Parroco Pablo Diez 49-57
24010 Leon
Spain

Product information

02/07/2019 Syvazul BTV - EMEA/V/C/004611 - IAIN/0001

Contents

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Pharmacotherapeutic group

Inactivated viral vaccines

Therapeutic indication

For active immunisation of sheep to prevent viraemia and reduce clinical signs and lesions caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* and clinical signs and lesions caused by bluetongue virus serotype 4

For active immunisation of cattle to prevent viraemia caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* caused by bluetongue virus serotype 4.

Assessment history

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