Veterinary Medicine Information website

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 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:
  • Slovenia
Package description:
  • Glass vial of hydrolytic class I 1 x 10 doses
  • Glass vials of hydrolytic class II 1 x 50 doses
  • Glass vials of hydrolytic class II 1 x 100 doses
  • HDPE vial 1 x 10 doses
  • HDPE vial 1 x 50 doses
  • HDPE vial 1 x 100 doses
  • Glass vial 10 x 10 doses
  • HDPE vial 10 x 10 doses

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:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0830/001
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

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 21/10/2025
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Labelling

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Slovenian (PDF)
Published on: 21/10/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 21/10/2025
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