Veterinary Medicines

Otomicol ear drops and cutaneous suspension for dogs, cats and guinea pigs

Authorised
  • Miconazole nitrate
  • Prednisolone acetate
  • POLYMYXIN B SULFATE
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Product identification

Medicine name:
Otomicol ear drops and cutaneous suspension for dogs, cats and guinea pigs
Otomicol капки за уши и суспензия за кожа за кучета, котки и морски свинчета
Active substance:
  • Miconazole nitrate
  • Prednisolone acetate
  • POLYMYXIN B SULFATE
Target species:
  • Cat
  • Dog
  • Guinea pig
Route of administration:
  • Auricular use
  • Cutaneous use

Product details

Active substance and strength:
  • Miconazole nitrate
    23.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Prednisolone acetate
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • POLYMYXIN B SULFATE
    5500.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear drops, suspension
Withdrawal period by route of administration:
  • Auricular use
    • Cat
    • Dog
  • Cutaneous use
    • Guinea pig
    • Cat
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Package description:
  • (ID1) 15 millilitre(s): Box (Cardboard) with 1 Bottle (Low Density PolyEthylene) with 15 millilitre(s), closed with Tropfer and Verschluss mit Originalitätssicherung (Low Density PolyEthylene, High Density PolyEthylene)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-3255
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0342/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 15/07/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 15/07/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 15/07/2024
Download

7014442-paren-20240508.pdf

English (PDF)
Published on: 21/08/2024
Download
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