Veterinary Medicines

APSALIQ COLISTINA 3.000.000 UI/ml

Authorised
  • COLISTIN SULFATE
Download as PDF

Product identification

Medicine name:
APSALIQ COLISTINA 3.000.000 UI/ml
APSALIQ COLISTIN 3 000 000 UI/ml soluție pentru utilizare în apa de băut/lapte pentru porcine, bovine, ovine, pui de găină și curci
Active substance:
  • COLISTIN SULFATE
Target species:
  • Pig
  • Turkey
  • Chicken
  • Cattle (calf)
  • Sheep (lamb)
Route of administration:
  • In drinking water/milk use

Product details

Active substance and strength:
  • COLISTIN SULFATE
    3000000.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water/milk
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Pig
      • Meat and offal
        1
        day
    • Turkey
      • Meat and offal
        1
        day
      • Eggs
        0
        day
    • Chicken
      • Meat and offal
        1
        day
      • Eggs
        0
        day
    • Cattle (calf)
      • Meat and offal
        1
        day
      • Milk
        no withdrawal period
    • Sheep (lamb)
      • Meat and offal
        1
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA07AA10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • bottle of 5 L
  • bottle of 1 L

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:
  • Andres Pintaluba S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Andres Pintaluba S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 220032
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0270/001
Concerned member states:
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Greece
  • Hungary
  • Italy
  • Poland
  • Portugal
  • Romania
  • Slovakia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
Download
Romanian (PDF)
Published on: 22/03/2022
Download

Package Leaflet

English (PDF)
Published on: 22/12/2023
Download

Labelling

English (PDF)
Published on: 22/12/2023
Download

eu-PUAR-esv0270001-dcp-apsaliq-colistina-3.000.000-ui-ml-en.pdf

English (PDF)
Published on: 22/12/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."