Veterinary Medicines

Unisol 5 mg/ml oral solution for piglets

Not authorised
  • Enrofloxacin
Download as PDF

Product identification

Medicine name:
Unisol 5 mg/ml oral solution for piglets
UNISOL 5 mg/ml SOLUCION ORAL PARA LECHONES
Active substance:
  • Enrofloxacin
Target species:
  • Pig
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Enrofloxacin
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Pig
      • Meat and offal
        10
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Spain
Package description:
  • Container Material: High density polyethylene bottles Container Closure: Polypropylene screw cap Container Colour: White Container Volume: 250 ml Dosing Device: Polypropylene/polyethylene/stainless steel pump dispensing 1 ml

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:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2047 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0216/001

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
Download
Spanish (PDF)
Published on: 22/02/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 22/02/2023
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 22/02/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."