Veterinary Medicines

Syvazul BTV BTV 4+8 - Suspension for injection

Authorised
  • Bluetongue virus, Serotype 4, strain SPA-1/2004, Inactivated
  • Bluetongue virus, Serotype 8, strain BTV-8/BEL2006/02, Inactivated
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Product identification

Medicine name:
Syvazul BTV BTV 4+8 - Suspension for injection
Active substance:
  • Bluetongue virus, Serotype 4, strain SPA-1/2004, Inactivated
  • Bluetongue virus, Serotype 8, strain BTV-8/BEL2006/02, Inactivated
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Bluetongue virus, Serotype 4, strain SPA-1/2004, Inactivated
    Presentation_strength:RP ≥ 1 Reference:Hse Index:0
  • Bluetongue virus, Serotype 8, strain BTV-8/BEL2006/02, Inactivated
    Presentation_strength:RP ≥ 1 Reference:Hse Index:1
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Not applicable
        0
        day
    • Sheep
      • Not applicable
        0
        day
  • Subcutaneous use
    • Cattle
      • Not applicable
        0
        day
    • Sheep
      • Not applicable
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI04AA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Available in:
  • Austria
  • Belgium
  • France
  • Germany
  • Spain
Package description:
  • Packaging:Vial (PP), Package_size:1 vial, Content:80 ml (40 sheep doses or 20 cattle doses)
  • Packaging:Vial (PP), Package_size:1 vial, Content:200 ml (100 sheep doses or 50 cattle doses)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.
Responsible authority:
  • European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Combined File of all Documents

English (PDF)
Published on: 20/06/2024
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Bulgarian (PDF)
Published on: 20/06/2024
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Croatian (PDF)
Published on: 20/06/2024
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Czech (PDF)
Published on: 20/06/2024
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Danish (PDF)
Published on: 20/06/2024
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Dutch (PDF)
Published on: 20/06/2024
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Estonian (PDF)
Published on: 20/06/2024
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Finnish (PDF)
Published on: 20/06/2024
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French (PDF)
Published on: 20/06/2024
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German (PDF)
Published on: 20/06/2024
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Greek (PDF)
Published on: 20/06/2024
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Hungarian (PDF)
Published on: 20/06/2024
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Icelandic (PDF)
Published on: 20/06/2024
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Italian (PDF)
Published on: 20/06/2024
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Latvian (PDF)
Published on: 20/06/2024
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Lithuanian (PDF)
Published on: 20/06/2024
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Maltese (PDF)
Published on: 20/06/2024
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Norwegian (PDF)
Published on: 20/06/2024
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Polish (PDF)
Published on: 20/06/2024
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Portuguese (PDF)
Published on: 20/06/2024
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Romanian (PDF)
Published on: 20/06/2024
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Slovak (PDF)
Published on: 20/06/2024
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Slovenian (PDF)
Published on: 20/06/2024
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Spanish (PDF)
Published on: 20/06/2024
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Swedish (PDF)
Published on: 20/06/2024
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ema-puar-syvazul-btv-v-4611-par-en.pdf

English (PDF)
Published on: 16/03/2023
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