Veterinary Medicines

DISTOCUR 34 MG/ML ORAL SUSPENSION FOR CATTLE AND SHEEP

Authorised
  • Oxyclozanide
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Product identification

Medicine name:
DISTOCUR 34 MG/ML ORAL SUSPENSION FOR CATTLE AND SHEEP
Distocur Vet. 34 mg/ml oral suspension
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:
  • Denmark
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 Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma France
  • Dopharma B.V.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 57702
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.
Danish (, ORAL SUSPENSION 34 MG-ML)
Published on: 18/12/2023
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eu-puar-frv0312001-mr-rpe515-en.pdf

English (PDF)
Published on: 7/01/2026
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