Veterinary Medicine Information website

PRACETAM 400 MG/ML SOLUTION FOR USE IN DRINKING WATER FOR PIGS

Authorised
  • Paracetamol
Download as PDF

Product identification

Medicine name:
PRACETAM 400 MG/ML SOLUTION FOR USE IN DRINKING WATER FOR PIGS
Active substance:
  • Paracetamol
Target species:
  • Pig
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Paracetamol
    400.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Concentrate for oral solution
Withdrawal period by route of administration:
  • Oral use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02BE01
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • 500 ml bottle
  • 5 litre bottle
  • 2.5 litre bottle
  • 1 litre bottle

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • Ceva Sante Animale
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V498853
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0181/002
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download
Dutch (PDF)
Published on: 18/08/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download
Dutch (PDF)
Published on: 18/08/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download
Dutch (PDF)
Published on: 18/08/2025
Download