Veterinary Medicines

APSALIQ COLISTINA 3.000.000 UI/ml

Authorised
  • COLISTIN SULFATE
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Product identification

Medicine name:
APSALIQ COLISTINA 3.000.000 UI/ml
APSALIQ COLISTINA 3.000.000 UI/ml SOLUCION PARA ADMINISTRACION EN AGUA DE BEBIDA Y LECHE PARA PORCINO, BOVINO, OVINO, POLLOS Y PAVOS
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:
  • Spain
Package description:

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:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3525 ESP
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
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Spanish (PDF)
Published on: 17/03/2023
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Package Leaflet

English (PDF)
Published on: 22/12/2023
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Spanish (PDF)
Published on: 17/03/2023
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Labelling

English (PDF)
Published on: 22/12/2023
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Spanish (PDF)
Published on: 17/03/2023
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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eu-PUAR-esv0270001-dcp-apsaliq-colistina-3.000.000-ui-ml-en.pdf

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

es-puar-apsaliq-colistina-3.000.000-ui-ml-es.pdf

Spanish (PDF)
Published on: 17/03/2023
Download