Not authorised

Product identification

Medicine name:
Adrestan 30 mg hard capsules
ADRESTAN 30 mg CAPSULAS DURAS PARA PERROS
Active substance:
  • Trilostane
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Trilostane
    30.00
    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
Authorisation status:
  • Surrendered
Authorised in:
  • Spain
Package description:
  • Three PVC-PVdc/aluminium foil blister strips each containing 10 capsules.

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 3376 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0503/002

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
Spanish (PDF)
Published on: 16/03/2023

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/03/2023

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/03/2023

Source URL: https://medicines.health.europa.eu/veterinary/600000049163