Bluevac BTV (previously known as Bluevac BTV8)

RSS
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-Torneiros
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

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

News

How useful was this page?

Add your rating