Veterinary Medicines

Dexacortone 0,5 mg tablets for dogs and cats

Authorised
  • Dexamethasone
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Product identification

Medicine name:
Dexacortone 0,5 mg tablets for dogs and cats
Dexacortone 0.5 mg Kauwtablet
Dexacortone 0.5 mg Comprimé à croquer
Dexacortone 0.5 mg Kautablette
Active substance:
  • Dexamethasone
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Dexamethasone
    0.50
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Aluminium - PVC-PE-PVDC blister. Cardboard box of 2 blisters of 10 tablets.
  • Aluminium - PVC-PE-PVDC blister. Cardboard box of 6 blisters of 10 tablets.
  • Aluminium - PVC-PE-PVDC blister. Cardboard box of 5 blisters of 10 tablets.
  • Aluminium - PVC-PE-PVDC blister. Cardboard box of 1 blister of 10 tablets.
  • Aluminium - PVC-PE-PVDC blister. Cardboard box of 9 blisters of 10 tablets.
  • Aluminium - PVC-PE-PVDC blister. Cardboard box of 4 blisters of 10 tablets.
  • Aluminium - PVC-PE-PVDC blister. Cardboard box of 10 blisters of 10 tablets.
  • Aluminium - PVC-PE-PVDC blister. Cardboard box of 3 blisters of 10 tablets.
  • Aluminium - PVC-PE-PVDC blister. Cardboard box of 8 blisters of 10 tablets.
  • Aluminium - PVC-PE-PVDC blister. Cardboard box of 7 blisters of 10 tablets.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V525840
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0219/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • 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.
Dutch (PDF)
Published on: 6/11/2024
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French (PDF)
Published on: 6/11/2024
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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: 6/11/2024
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French (PDF)
Published on: 6/11/2024
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German (PDF)
Published on: 6/11/2024
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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: 6/11/2024
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French (PDF)
Published on: 6/11/2024
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German (PDF)
Published on: 6/11/2024
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