Veterinary Medicines

Otisan 3 mg/ml + 10 mg/ml + 1 mg/ml ear drops, suspension for dogs

Authorised
  • Marbofloxacin
  • Clotrimazole
  • Dexamethasone acetate
Download as PDF

Product identification

Medicine name:
Otisan 3 mg/ml + 10 mg/ml + 1 mg/ml ear drops, suspension for dogs
Otisan, 3/10/1mg/ml, Ušní kapky, suspenze
Active substance:
  • Marbofloxacin
  • Clotrimazole
  • Dexamethasone acetate
Target species:
  • Dog
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Marbofloxacin
    3.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Clotrimazole
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Dexamethasone acetate
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear drops, suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Available in:
  • Czechia
Package description:
  • Cardboard box with 1 bottle of 15 ml
  • Cardboard box with 1 bottle of 25 ml.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Przedsiebiorstwo Wielobranzowe Vet-Agro Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Przedsiebiorstwo Wielobranzowe Vet-Agro Sp. z o.o.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/006/24-C
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0425/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Greece
  • Ireland
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 27/06/2024
Download
Czech (PDF)
Published on: 14/05/2024
Download

Package Leaflet

English (PDF)
Published on: 27/06/2024
Download
Czech (PDF)
Published on: 24/09/2024
Download

Labelling

English (PDF)
Published on: 27/06/2024
Download
Czech (PDF)
Published on: 14/05/2024
Download