Veterinary Medicines

Bravoxin 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 C, beta toxoid
  • Clostridium perfringens, type B, beta toxoid
  • Clostridium perfringens, type A, alpha toxoid
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Product identification

Medicine name:
Bravoxin 10 suspension for injection for cattle and sheep
BRAVOXIN 10
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 C, beta toxoid
  • Clostridium perfringens, type B, 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
    unit(s)
    /
    1.00
    millilitre(s)
  • Clostridium sordellii, toxoid
    4.40
    international unit(s)
    /
    1.00
    millilitre(s)
  • Tetanus toxoid adsorbed
    4.90
    international unit(s)
    /
    1.00
    millilitre(s)
  • Clostridium septicum, toxoid
    4.60
    international unit(s)
    /
    1.00
    millilitre(s)
  • Clostridium novyi, toxoid
    3.80
    international unit(s)
    /
    1.00
    millilitre(s)
  • Clostridium chauvoei, Inactivated
    90.00
    percentage protection
    /
    1.00
    millilitre(s)
  • Clostridium perfringens, type D, epsilon toxoid
    5.30
    international unit(s)
    /
    1.00
    millilitre(s)
  • Clostridium perfringens, type C, beta toxoid
    18.20
    international unit(s)
    /
    1.00
    millilitre(s)
  • Clostridium perfringens, type B, beta toxoid
    18.20
    international unit(s)
    /
    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
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Sheep
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AB01
  • QI04AB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • (ID1): 1 Box with 1 Bottle (Low Density PolyEthylene) with 20 millilitre(s) (20 millilitre(s))
  • (ID2): 1 Box with 1 Bottle (Low Density PolyEthylene) with 50 millilitre(s) (50 millilitre(s))
  • (ID3): 1 Box with 1 Bottle (Low Density PolyEthylene) with 100 millilitre(s) (100 millilitre(s))

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
Marketing authorisation holder:
  • MSD Animal Health S.r.l.
Marketing authorisation date:
Manufacturing sites for batch release:
  • MSD Animal Health UK Limited
  • INTERVET INTERNATIONAL B.V.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 104043
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0279/001
Concerned member states:
  • Belgium
  • France
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 14/05/2022
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Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 3/06/2022
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