Veterinary Medicines

Vetoryl 5 mg hard capsules for dogs

Authorised
  • Trilostane
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Product identification

Medicine name:
Vetoryl 5 mg hard capsules for dogs
Vetoryl 5 mg kapsel, hard, til hund
Active substance:
  • Trilostane
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Trilostane
    5.00
    milligram(s)
    /
    1.00
    Capsule
Pharmaceutical form:
  • Capsule, hard
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Package description:
  • 30 capsules, contained in three PVC-PVdc/aluminium foil blisters with 10 capsules/blister.

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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 19-13227
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0514/005
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 26/08/2024
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Norwegian (PDF)
Published on: 10/10/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 10/10/2024
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