Veterinary Medicines

DISTOCUR 34 MG/ML ORAL SUSPENSION FOR CATTLE AND SHEEP

Authorised
  • Oxyclozanide
Download as PDF

Product identification

Medicine name:
DISTOCUR 34 MG/ML ORAL SUSPENSION FOR CATTLE AND SHEEP
DISTOCUR 34 MG/ML SUSPENSION BUVABLE POUR BOVINS ET OVINS
Active substance:
  • Oxyclozanide
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Oxyclozanide
    34.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Cattle
      • Meat and offal
        13
        day
      • Milk
        5
        day
    • Sheep
      • Meat and offal
        14
        day
      • Milk
        7
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AG06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dopharma France S.A.S.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma France S.A.S.
  • Dopharma B.V.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/6031466 0/2015
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0312/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Denmark
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovenia
  • Sweden
  • 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: 24/01/2024
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 7/02/2025
Download

Combined File of all Documents

English (PDF)
Published on: 7/02/2025
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."