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 34 mg/ml Suspensie voor oraal gebruik
Distocur 34 mg/ml Suspension buvable
Distocur 34 mg/ml Suspension zum Einnehmen
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:
  • Belgium
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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V521031
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

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Dutch (PDF)
Published on: 15/03/2024
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French (PDF)
Published on: 15/03/2024
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Package Leaflet

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Dutch (PDF)
Published on: 15/03/2024
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French (PDF)
Published on: 15/03/2024
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German (PDF)
Published on: 15/03/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 15/03/2024
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French (PDF)
Published on: 15/03/2024
Download
German (PDF)
Published on: 15/03/2024
Download
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