Veterinary Medicines

NIPOXYME 22.500.000 IU/g POWDER FOR USE IN DRINKING WATER

Authorised
  • COLISTIN SULFATE
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Product identification

Medicine name:
NIPOXYME 22.500.000 IU/g POWDER FOR USE IN DRINKING WATER
NIPOXIME 22.500.000 UI/g pulbere pentru utilizare în apa de băut
Active substance:
  • COLISTIN SULFATE
Target species:
  • Pig
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • COLISTIN SULFATE
    22500000.00
    international unit(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • 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:
  • Romania
Package description:
  • bag containing 250g
  • box containing 1 Kg
  • box containing 500 g
  • box containing 250 g

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Andersen S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Maymo S.A.U.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 150164
Date of authorisation status change:
Reference member state:
  • Poland
Procedure number:
  • PL/V/0111/001
Concerned member states:
  • Romania
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 18/12/2025
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Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Romanian (PDF)
Published on: 15/07/2025
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Package Leaflet and Labelling

English (PDF)
Published on: 18/12/2025
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