Veterinary Medicines

Bultavo 3, Suspension for injection

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

Medicine name:
Bultavo 3, Suspension for injection
BULTAVO 3
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
        day
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        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:
  • Germany
Package description:
  • Glass Vial 10 x 10.0 millilitre(s)
  • Glass Vial 1 x 10.0 millilitre(s)
  • Glass Vial 1 x 50.0 millilitre(s)
  • Glass Vial 1 x 100.0 millilitre(s)
  • Plastic (HDPE) Vial 10 x 10.0 millilitre(s)
  • Plastic (HDPE) Vial 1 x 10.0 millilitre(s)
  • Plastic (HDPE) Vial 1 x 50.0 millilitre(s)
  • Plastic (HDPE) Vial 1 x 100.0 millilitre(s)

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:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Paul-Ehrlich-Institut
Authorisation number:
  • PEI.V.12244.01.1
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0207/001
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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German (PDF)
Published on: 23/05/2025
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