Veterinary Medicines

HIDROCOL, 4000000 IU/ML SOLUTION FOR USE IN DRINKING WATER/MILK

Authorised
  • COLISTIN SULFATE
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Product identification

Medicine name:
HIDROCOL, 4000000 IU/ML SOLUTION FOR USE IN DRINKING WATER/MILK
HIDROCOL, 4000000 UI/ml soluție pentru utilizare în apa de băut/lapte
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
    4000000.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water/milk
Withdrawal period by route of administration:
  • Oral use
    • Turkey
      • Meat and offal
        1
        day
      • Eggs
        0
        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:
  • Romania
Available in:
  • Romania
Package description:
  • 1 L white high density polyethylene bottles sealed by induction and closed by a high density polyethylene screw cap.
  • 5 L white high density polyethylene barrels sealed by induction and closed by a high density polyethylene screw cap.

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:
  • S P Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • S P Veterinaria S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 210136
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0294/001
Concerned member states:
  • Bulgaria
  • Cyprus
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Malta
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 27/11/2025
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