Veterinary Medicines

Tribovax 10 suspension for injection for cattle and sheep

Authorised
  • Clostridium novyi, type D, toxoid
  • Clostridium sordellii, toxoid
  • Tetanus toxoid adsorbed
  • Clostridium septicum, toxoid
  • Clostridium novyi, toxoid
  • Clostridium chauvoei, Inactivated
  • Clostridium perfringens, type D, epsilon toxoid
  • Clostridium perfringens, type B and C, beta toxoid
  • Clostridium perfringens, type A, alpha toxoid
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Product identification

Medicine name:
Bravoxin
Tribovax 10 suspension for injection for cattle and sheep
Active substance:
  • Clostridium novyi, type D, toxoid
  • Clostridium sordellii, toxoid
  • Tetanus toxoid adsorbed
  • Clostridium septicum, toxoid
  • Clostridium novyi, toxoid
  • Clostridium chauvoei, Inactivated
  • Clostridium perfringens, type D, epsilon toxoid
  • Clostridium perfringens, type B and C, beta toxoid
  • Clostridium perfringens, type A, alpha toxoid
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Clostridium novyi, type D, toxoid
    17.40
    enzyme-linked immunosorbent assay unit
    /
    1.00
    millilitre(s)
  • Clostridium sordellii, toxoid
    4.40
    enzyme-linked immunosorbent assay unit
    /
    1.00
    millilitre(s)
  • Tetanus toxoid adsorbed
    4.90
    enzyme-linked immunosorbent assay unit
    /
    1.00
    millilitre(s)
  • Clostridium septicum, toxoid
    4.60
    enzyme-linked immunosorbent assay unit
    /
    1.00
    millilitre(s)
  • Clostridium novyi, toxoid
    3.80
    enzyme-linked immunosorbent assay unit
    /
    1.00
    millilitre(s)
  • Clostridium chauvoei, Inactivated
    90.00
    percentage protection
    /
    1.00
    millilitre(s)
  • Clostridium perfringens, type D, epsilon toxoid
    5.30
    enzyme-linked immunosorbent assay unit
    /
    1.00
    millilitre(s)
  • Clostridium perfringens, type B and C, beta toxoid
    18.20
    enzyme-linked immunosorbent assay unit
    /
    1.00
    millilitre(s)
  • Clostridium perfringens, type A, alpha toxoid
    0.50
    enzyme-linked immunosorbent assay unit
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AB01
  • QI04AB01
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • (ID3): 1 Box with 1 Bottle (Low Density PolyEthylene) with 100 millilitre(s) (100.0 millilitre(s))
  • (ID2): 1 Box with 1 Bottle (Low Density PolyEthylene) with 50 millilitre(s) (50.0 millilitre(s))

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Intervet (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10996/286/001
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0289/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 1/11/2024
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