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, ausų lašai ir odos suspensija šunims, katėms ir jūrų kiaulytėms
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Lithuania
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:
  • State Food And Veterinary Service
Authorisation number:
  • LT/2/24/2822/001
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Lithuanian (PDF)
Published on: 11/07/2024
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7014442-paren-20240508.pdf

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