Veterinary Medicine Information website

Cortotic 0.584 mg/ml ear spray, solution for dogs

Authorised
  • Hydrocortisone aceponate
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Product identification

Medicine name:
Cortotic 0.584 mg/ml ear spray, solution for dogs
Active substance:
  • Hydrocortisone aceponate
Target species:
  • Dog
Route of administration:
  • Auricular use

Product details

Active substance and strength:
  • Hydrocortisone aceponate
    0.58
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Ear spray, solution
Withdrawal period by route of administration:
  • Auricular use
    • Dog
      • Not applicable
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QS02BA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • Box with 1 high density polyethylene (HDPE) bottle of 20 ml filled with 16 ml of solution, closed with an HDPE screw cap and an HDPE spray pump.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
  • Virbac
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V661027
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0370/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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