Veterinary Medicines

BioBos BTV 3 suspension for injection for sheep and cattle

Authorised
  • Bluetongue virus, serotype 3, strain Bio-93:BTV3, Inactivated
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Product identification

Medicine name:
BioBos BTV 3, Injekční suspenze
BioBos BTV 3 suspension for injection for sheep and cattle
Active substance:
  • Bluetongue virus, serotype 3, strain Bio-93:BTV3, Inactivated
Target species:
  • Sheep
  • Cattle
Route of administration:
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Bluetongue virus, serotype 3, strain Bio-93:BTV3, Inactivated
    320.00
    enzyme-linked immunosorbent assay unit
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
  • Intramuscular use
    • Cattle
      • Milk
        0
        hour
      • 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:
  • Czechia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Applications in exceptional circumstances (Article 25 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta, a.s.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/053/24-C
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0212/001
Concerned member states:
  • Bulgaria
  • Estonia
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Slovakia
  • Slovenia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/09/2025
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Czech (PDF)
Published on: 24/09/2025
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Package Leaflet

English (PDF)
Published on: 24/09/2025
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Czech (PDF)
Published on: 24/09/2025
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Labelling

English (PDF)
Published on: 24/09/2025
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Czech (PDF)
Published on: 24/09/2025
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eu-puar-czv0212001-mr-biobos_btv_3-en.pdf

English (PDF)
Published on: 24/09/2025
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