Veterinary Medicines

Giraxa, 50mg/g, Powder for oral solution

Authorised
  • Colistin
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Product identification

Medicine name:
Giraxa, 50mg/g, Powder for oral solution
Giraxa 50 mg/g prašek za peroralno raztopino za teleta, pujske in piščance
Active substance:
  • Colistin
Target species:
  • Chicken (broiler)
  • Cattle (calf)
  • Pig (piglet)
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Colistin
    1200000.00
    international unit(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for oral solution
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken (broiler)
      • Meat and offal
        1
        day
      • Egg
        no withdrawal period
    • Cattle (calf)
      • Meat and offal
        1
        day
    • Pig (piglet)
      • 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:
  • Slovenia
Package description:
  • Plastic Sachet 1 x 100.0 gram(s)
  • Plastic Sachet 1 x 1000.0 gram(s)
  • Plastic Vial 1 x 100.0 gram(s)
  • Plastic Vial 1 x 1000.0 gram(s)

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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • Krka d.d. Novo Mesto
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0160/001
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0103/001
Concerned member states:
  • Latvia
  • Lithuania
  • Poland
  • Slovenia

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 2/03/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 2/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 2/03/2022
Download
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