File downloaded on 2025-12-02
Source URL: https://medicines.health.europa.eu/veterinary/en/600000049139
Not authorised

Product identification

Medicine name:
Adrestan 10 mg hard capsules for dogs
Adrestan 10 mg Hard Capsules for Dogs
Active substance:
  • Trilostane
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Trilostane
    10.00
    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:
  • Expired
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • Three PVC-PVdc/aluminium foil blister strips each containing 10 capsules.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent application (Article 13c of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • VM 10434/4087
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0503/001

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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