Veterinary Medicines

COLDOSTIN 4 800 000 UI/G POWDER FOR ADMINISTRATION IN DRINKING WATER/MILK

Authorised
  • COLISTIN SULFATE
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Product identification

Medicine name:
COLDOSTIN 4 800 000 UI/G POWDER FOR ADMINISTRATION IN DRINKING WATER/MILK
Coldostin 4800000 IU/g Poeder voor toediening in het drinkwater/in de melk
Coldostin 4800000 IU/g Poudre pour administration dans le lait ou l'eau de boisson
Coldostin 4800000 IU/g Pulver zum Eingeben über das Trinkwasser/die Milch
Active substance:
  • COLISTIN SULFATE
Target species:
  • Turkey
  • Pig
  • Sheep (lamb)
  • Cattle (calf)
  • Chicken
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • COLISTIN SULFATE
    4800000.00
    international unit(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water/milk
Withdrawal period by route of administration:
  • Oral use
    • Turkey
      • Meat and offal
        1
        day
    • Pig
      • Meat and offal
        1
        day
    • Sheep (lamb)
      • Meat and offal
        1
        day
    • Cattle (calf)
      • 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:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • Composite can of 1 kg containing a measuring spoon (3 g)
  • Securitainer of 1 kg
  • Securitainer of 100 g
  • Bucket of 1 kg

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:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0299/001
Concerned member states:
  • Belgium
  • Denmark
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • 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.
Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
Download
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