Veterinary Medicines Information website

BLUEVAC-4

Authorised
  • Bluetongue virus, Serotype 4, strain SPA-1/2004, Inactivated
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Product identification

Medicine name:
BLUEVAC-4
Active substance:
  • Bluetongue virus, Serotype 4, strain SPA-1/2004, Inactivated
Target species:
  • Sheep
  • Cattle
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Bluetongue virus, Serotype 4, strain SPA-1/2004, Inactivated
    316228000.00
    50% cell culture infectious dose
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
      • Meat and offal
        0
        day
    • Cattle
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AA08
  • QI04AA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • CZ Vaccines S.A.U.
Marketing authorisation date:
Manufacturing sites for batch release:
  • CZ Vaccines S.A.U.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 1704 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0268/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Greece
  • Portugal
  • Romania
  • Slovenia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
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Spanish (PDF)
Published on: 17/03/2023
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Package Leaflet

English (PDF)
Published on: 22/12/2023
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Spanish (PDF)
Published on: 17/03/2023
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Labelling

English (PDF)
Published on: 22/12/2023
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Spanish (PDF)
Published on: 17/03/2023
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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eu-PUAR-esv0268001-mrp-bluevac-4-en.pdf

English (PDF)
Published on: 22/12/2023
Download