Veterinary Medicines

GIRAXA, 50 mg (1,2 mil. i.j.)/g, prašak za oralnu otopinu, telad, prasad i kokoši

Authorised
  • COLISTIN SULFATE
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Product identification

Medicine name:
GIRAXA, 50 mg (1,2 mil. i.j.)/g, prašak za oralnu otopinu, telad, prasad i kokoši
Active substance:
  • COLISTIN SULFATE
Target species:
  • Cattle (calf)
  • Pig (piglet)
  • Chicken
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • COLISTIN SULFATE
    50.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for oral solution
Withdrawal period by route of administration:
  • Oral use
    • Cattle (calf)
      • Meat and offal
        1
        day
    • Pig (piglet)
      • Meat and offal
        1
        day
    • Chicken
      • Meat and offal
        1
        day
      • Egg
        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:
  • Croatia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Krka-Farma d.o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Krka d.d. Novo Mesto
  • Krka d.d. Novo Mesto
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/17-01/290
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Croatian (PDF)
Published on: 13/02/2022
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