Veterinary Medicines

CUBOLAC POLICLOSTRIDIAL 7/11, SUSPENSION INYECTABLE PARA BOVINO, OVINO Y CAPRINO

Authorised
  • Clostridium chauvoei, Inactivated
  • Clostridium sordellii, toxoid
  • Clostridium novyi, type B, alpha toxoid
  • Clostridium septicum, toxoid
  • Clostridium perfringens, type D, epsilon toxoid
  • Clostridium perfringens, type A, alpha toxoid
  • Clostridium perfringens, type C, beta1 toxoid
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Product identification

Medicine name:
CUBOLAC POLICLOSTRIDIAL 7/11, SUSPENSION INYECTABLE PARA BOVINO, OVINO Y CAPRINO
Active substance:
  • Clostridium chauvoei, Inactivated
  • Clostridium sordellii, toxoid
  • Clostridium novyi, type B, alpha toxoid
  • Clostridium septicum, toxoid
  • Clostridium perfringens, type D, epsilon toxoid
  • Clostridium perfringens, type A, alpha toxoid
  • Clostridium perfringens, type C, beta1 toxoid
Target species:
  • Cattle
  • Sheep
  • Goat
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Clostridium chauvoei, Inactivated
    100.00
    percentage protection
    /
    1.00
    Dose
  • Clostridium sordellii, toxoid
    100.00
    percentage protection
    /
    1.00
    Dose
  • Clostridium novyi, type B, alpha toxoid
    3.50
    Toxicity unit(s)
    /
    1.00
    Dose
  • Clostridium septicum, toxoid
    2.50
    Toxicity unit(s)
    /
    1.00
    Dose
  • Clostridium perfringens, type D, epsilon toxoid
    5.00
    Toxicity unit(s)
    /
    1.00
    Dose
  • Clostridium perfringens, type A, alpha toxoid
    0.30
    Toxicity unit(s)
    /
    1.00
    Dose
  • Clostridium perfringens, type C, beta1 toxoid
    10.00
    Toxicity unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Goat
      • Meat and offal
        0
        day
      • Milk
        0
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Goat
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AB01
  • QI03AB
  • QI04AB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • CZ Vaccines S.A.U.
Marketing authorisation date:
Manufacturing sites for batch release:
  • CZ Vaccines S.A.U.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 1187 ESP
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Spanish (PDF)
Published on: 4/06/2024
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Package Leaflet

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Spanish (PDF)
Published on: 4/06/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 4/06/2024
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