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 suspensie voor oraal gebruik voor runderen en schapen
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:
  • Netherlands
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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 119808
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 26/01/2022
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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