Veterinary Medicines

Belacol 100 % Compactate

Authorised
  • COLISTIN SULFATE
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Product identification

Medicine name:
Belacol 100 % Compactate
Belacol 1000 mg/g, κοκκία για χρήση στο πόσιμο νερό για βοοειδή, χοίρους και ορνίθια
Active substance:
  • COLISTIN SULFATE
Target species:
  • Cattle
  • Chicken
  • Pig
Route of administration:
  • In drinking water/milk use

Product details

Active substance and strength:
  • COLISTIN SULFATE
    1000.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Granules for use in drinking water
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Cattle
      • Meat and offal
        1
        day
    • Chicken
      • Meat and offal
        1
        day
    • Pig
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA07AA10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Greece
Package description:
  • 1 kg in fold-up carton with inner layer (paper/PE/Alu/PE)
  • 250 g in fold-up carton with inner layer (paper/PE/Alu/PE)
  • 2.5 kg in kard-o-seal-bag (PE/paper/PE/Alu/PE)
  • 500 g in fold-up carton with inner layer (paper/PE/Alu/PE)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Bela-Pharm GmbH & Co. KG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bela-Pharm GmbH & Co. KG
Responsible authority:
  • National Organization For Medicines
Authorisation number:
  • 105060/08-11-2021
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0199/001
Concerned member states:
  • Croatia
  • Estonia
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Slovakia

Documents

Summary of Product Characteristics

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Greek (PDF)
Published on: 25/05/2022
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