Veterinary Medicines

COLFIVE 5.000.000 UI/ML

Not authorised
  • COLISTIN SULFATE
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Product identification

Medicine name:
COLFIVE 5.000.000 UI/ML
Pluscolan 5000000 IU/ml Concentraat voor drank
Pluscolan 5000000 IU/ml Solution à diluer pour solution buvable
Pluscolan 5000000 IU/ml Konzentrat zur Herstellung einer Lösung zum Einnehmen
Active substance:
  • COLISTIN SULFATE
Target species:
  • Pig
  • Turkey
  • Cattle (calf)
  • Sheep (lamb)
  • Chicken
Route of administration:
  • In drinking water/milk use
  • Oral use

Product details

Active substance and strength:
  • COLISTIN SULFATE
    5000000.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Concentrate for oral solution
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Pig
      • Meat and offal
        1
        day
    • Turkey
      • Meat and offal
        1
        day
      • Eggs
        0
        day
    • Cattle (calf)
      • Meat and offal
        1
        day
    • Sheep (lamb)
      • Meat and offal
        1
        day
    • Chicken
      • Meat and offal
        1
        day
      • Eggs
        0
        day
  • Oral use
    • Pig
      • Meat and offal
        1
        day
    • Turkey
      • Meat and offal
        1
        day
      • Eggs
        0
        day
    • Cattle (calf)
      • Meat and offal
        1
        day
    • Sheep (lamb)
      • Meat and offal
        1
        day
    • Chicken
      • Meat and offal
        1
        day
      • Eggs
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA07AA10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Belgium
Package description:
  • bottle of 5 l
  • bottle of 1 l
  • box containing 1 bottle of 100 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
  • aniMedica GmbH
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V515324
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0221/001

Documents

Summary of Product Characteristics

English (PDF)
Published on: 20/10/2025
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Package Leaflet

English (PDF)
Published on: 20/10/2025
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Dutch (PDF)
Published on: 17/08/2025
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Labelling

English (PDF)
Published on: 20/10/2025
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Dutch (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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