Veterinary Medicines

Unisol 25 mg/ml oral solution for calves

Not authorised
  • Enrofloxacin
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Product identification

Medicine name:
Unisol 25 mg/ml oral solution for calves
Doraflox 25 mg/ml Drank
Doraflox 25 mg/ml Solution buvable
Doraflox 25 mg/ml Lösung zum Einnehmen
Active substance:
  • Enrofloxacin
Target species:
  • Cattle
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Enrofloxacin
    25.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Cattle
      • Meat and offal
        11
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Belgium
Package description:
  • Container Material: High density polyethylene bottles Container Closure: Polyethylene screw cap Container Colour: White Container Volume: 250 ml Dosing Device: For containers of 250 ml a 20 ml measuring device of polypropylene is included.
  • Container Material: High density polyethylene bottles Container Closure: Polyethylene screw cap Container Colour: White Container Volume: 500 ml Dosing Device: For containers of 500 ml a 20 ml measuring device of polypropylene is included.
  • Container Material: High density polyethylene bottles Container Closure: Polyethylene screw cap Container Colour: White Container Volume: 1 litre Dosing Device: For containers of 1 L a 75 ml measuring device of polypropylene is included.

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:
  • Vetpharma Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Karizoo S.A.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V402595
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0216/002

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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German (PDF)
Published on: 22/03/2022
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