Veterinary Medicines

Oxyfluke 34 mg/ml Oral Suspension for Cattle and Sheep

Authorised
  • Oxyclozanide
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Product identification

Medicine name:
Oxyfluke 34 mg/ml Oral Suspension for Cattle and Sheep
Oxyfluke 34 mg/ml peroralna suspenzija za govedo in ovce
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
        108
        hour
    • 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:
  • Slovenia
Package description:
  • White high density polyethylene backpacks (1 L) closed with white polypropylene screw caps. 1 x 1 L in a cardboard box
  • White high density polyethylene backpacks (2.5 L) closed with white polypropylene screw caps. 1 x 2.5 L in a cardboard box
  • White high density polyethylene backpacks (5 L) closed with white polypropylene screw caps. 1 x 5 L in a cardboard box
  • White high density polyethylene backpacks (5 L) closed with white polypropylene screw caps. 2 x 5 L in a cardboard box

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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Manufacturing Limited
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0596/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0601/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Hungary
  • Luxembourg
  • Netherlands
  • Portugal
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Slovenian (PDF)
Published on: 3/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 3/03/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 3/03/2022
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