Authorised

Product identification

Medicine name:
Easotic 1.11 mg/ml + 1505 IU/ml + 15.1 mg/ml - Ear drops, suspension
Active substance:
  • Hydrocortisone aceponate
  • Miconazole nitrate
  • Gentamicin sulfate
Target species:
  • Dog
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Hydrocortisone aceponate
    Presentation_strength:1.11 mg Reference:Hse Index:0
  • Miconazole nitrate
    Presentation_strength:15.1 mg Reference:Ph Eur Index:1
  • Gentamicin sulfate
    Presentation_strength:1505 IU Reference:Ph Eur Index:2
Pharmaceutical form:
  • Ear drops, suspension
Withdrawal period by route of administration:
  • Auricular use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02CA03
Authorisation status:
  • Valid
Authorised in:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Package description:
  • Packaging:Pipette (HDPE), Package_size:200 pipettes, Content:1 ml
  • Packaging:Pipette (HDPE), Package_size:100 pipettes, Content:1 ml
  • Packaging:Pipette (HDPE), Package_size:50 pipettes, Content:1 ml
  • Packaging:Pipette (HDPE), Package_size:10 pipettes, Content:1 ml
  • Packaging:Pipette (HDPE), Package_size:5 pipettes, Content:1 ml
  • Packaging:Container (PP), Package_size:1 container, Content:10 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Virbac S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • VIRBAC
Responsible authority:
  • European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Combined File of all Documents

English (PDF)
Published on: 6/03/2024
Download
Bulgarian (PDF)
Published on: 6/03/2024
Croatian (PDF)
Published on: 6/03/2024
Czech (PDF)
Published on: 6/03/2024
Danish (PDF)
Published on: 6/03/2024
Dutch (PDF)
Published on: 6/03/2024
Estonian (PDF)
Published on: 6/03/2024
Finnish (PDF)
Published on: 6/03/2024
French (PDF)
Published on: 6/03/2024
German (PDF)
Published on: 6/03/2024
Greek (PDF)
Published on: 6/03/2024
Hungarian (PDF)
Published on: 6/03/2024
Icelandic (PDF)
Published on: 6/03/2024
Italian (PDF)
Published on: 6/03/2024
Latvian (PDF)
Published on: 6/03/2024
Lithuanian (PDF)
Published on: 6/03/2024
Maltese (PDF)
Published on: 6/03/2024
Norwegian (PDF)
Published on: 6/03/2024
Polish (PDF)
Published on: 6/03/2024
Portuguese (PDF)
Published on: 6/03/2024
Romanian (PDF)
Published on: 6/03/2024
Slovak (PDF)
Published on: 6/03/2024
Slovenian (PDF)
Published on: 6/03/2024
Spanish (PDF)
Published on: 6/03/2024
Swedish (PDF)
Published on: 6/03/2024

ema-puar-easotic-v-140-par-en.pdf

English (PDF)
Published on: 17/03/2023
Download

Source URL: https://medicines.health.europa.eu/veterinary/600000004091