Veterinary Medicines

OTIMIX, Ušní kapky, suspenze

Not authorised
  • Prednisolone acetate
  • POLYMYXIN B SULFATE
  • Miconazole nitrate
Download as PDF

Product identification

Medicine name:
OTIMIX, Ušní kapky, suspenze
Active substance:
  • Prednisolone acetate
  • POLYMYXIN B SULFATE
  • Miconazole nitrate
Target species:
  • Dog
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Prednisolone acetate
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • POLYMYXIN B SULFATE
    5500.00
    international unit(s)
    /
    1.00
    millilitre(s)
  • Miconazole nitrate
    23.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear drops, suspension
Withdrawal period by route of administration:
  • Auricular use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Czechia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/028/15-C
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
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."