Veterinary Medicines

Vetoryl 20 mg hard capsules for dogs

Authorised
  • Trilostane
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Product identification

Medicine name:
Vetoryl 20 mg hard capsules for dogs
Vetoryl 20 mg hårda kapslar till hund
Active substance:
  • Trilostane
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Trilostane
    20.00
    milligram(s)
    /
    1.00
    Capsule
Pharmaceutical form:
  • Capsule, hard
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Sweden
Package description:
  • PVC-PVdc/aluminium foil blisters in a cardboard box. Each blister contains 10 capsules.Pack size: 30 capsules

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - known active substance (Article 8 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • GENERA d.d.
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 66063
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0514/010/DX/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 13/04/2025
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Swedish (PDF)
Published on: 8/04/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 8/04/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 8/04/2025
Download

Combined File of all Documents

English (PDF)
Published on: 13/04/2025
Download

ie-puar-mr-iev0514010dx001-vetoryl-20-mg-hard-capsules-for-dogs-en.pdf

English (PDF)
Published on: 13/04/2025
Download
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