Adrestan 30 mg hard capsules
Adrestan 30 mg hard capsules
Not authorised
- Trilostane
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:
-
Trilostane30.00/milligram(s)1.00Capsule
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:
-
Surrendered
Authorised in:
-
Spain
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 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
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 3/05/2024
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
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