Bluevac BTV (previously known as Bluevac BTV8)

Table of contents

Opinion

On 18 June 2020, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Bluevac BTV8. The marketing authorisation holder for this veterinary medicinal product is CZ Veterinaria S.A.

Bluevac BTV8 is currently authorised as suspension for injection. The variation concerns the conversion of the Bluevac BTV8 dossier into a multi-strain dossier (Bluevac BTV), and the addition of the strains BTV1 and BTV4 into the multi-strain dossier. Additionally, the MAH takes the opportunity to amend its address together with the address of the manufacturer of the biological active substance and the address of the manufacturer responsible for batch release.

Detailed conditions for the use of this product are described in the updated summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the revised European public assessment report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.


1Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.

Key facts

Name
Bluevac BTV (previously known as Bluevac BTV8)
Agency product number
EMEA/V/C/000156
Species
Sheep
Cattle
Active substance
  • bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated]
Accelerated 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.

Date opinion adopted
18/06/2020
Company name
CZ Veterinaria S.A.
Status
Positive
Application type
Post-authorisation

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