Bluevac BTV (previously known as Bluevac BTV8)

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

Overview

Bluevac BTV is a vaccine used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges. Signs of the disease include fever and skin ulceration, as well as swelling and occasionally blueish discolouration of the tongue mainly seen in sheep. The vaccine is used to prevent viraemia (presence of viruses in the blood) caused by bluetongue virus serotypes 1, 4 or 8 in sheep and cattle and to reduce clinical signs caused by serotype 8 in sheep. The vaccine contains inactivated (killed) bluetongue virus serotypes 1, 4 or 8.

This EPAR was last updated on 27/10/2020

Authorisation details

Product details
Name
Bluevac BTV (previously known as Bluevac BTV8)
Agency product number
EMEA/V/C/000156
Active substance
bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated]
Species
  • Sheep
  • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI04AA02
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
CZ Veterinaria S.A.
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
14/04/2011
Contact address
La Relva s/n
36400 Porriño (Pontevedra)
Spain

Product information

20/08/2020 Bluevac BTV (previously known as Bluevac BTV8) - EMEA/V/C/000156 - II/0010/G

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.

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Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Sheep

Active immunisation against bluetongue virus serotype 8 to prevent viraemia and to reduce clinical signs.

Onset of immunity: 20 days after second dose.

Duration of immunity: 1 year after second dose.

Cattle

Active immunisation against bluetongue virus serotype 8 to prevent viraemia.

Onset of immunity: 31 days after second dose.

Duration of immunity: 1 year after second dose.

Assessment history

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