Veterinary Medicines

Nipoxyme 200 mg/g oral suspension

Authorised
  • COLISTIN SULFATE
Download as PDF

Product identification

Medicine name:
Nipoxyme 200 mg/g oral suspension
Nipoxyme 200 mg/g suspensão para administração na água de bebida
Active substance:
  • COLISTIN SULFATE
Target species:
  • Pig
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • COLISTIN SULFATE
    6.00
    million international units
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Suspension for use in drinking water
Withdrawal period by route of administration:
  • Oral 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:
  • Portugal
Package description:
  • 1 kg bottles of high-density polyethylene (HDPE). Closure with screw cap and aluminium induction heat seal liner. The bottle includes a polypropylene measuring device.
  • 500 g bottles of high-density polyethylene (HDPE). Closure with screw cap and aluminium induction heat seal liner. The bottle includes a polypropylene measuring device.

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.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Maymo S.A.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 184/01/09DFVPT
Date of authorisation status change:
Reference member state:
  • Portugal
Procedure number:
  • PT/V/0127/001
Concerned member states:
  • Hungary
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 23/11/2021
Download

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 13/07/2022
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."