Adrestan 60 mg hard capsules
Adrestan 60 mg hard capsules
Authorised
- Trilostane
Product identification
Medicine name:
Adrestan 60 mg hard capsules
ADRESTAN 60 mg capsule dure
Active substance:
- Trilostane
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Trilostane60.00/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:
-
Valid
Authorised in:
-
Italy
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:
- Dales Pharmaceuticals Limited
- GENERA d.d.
Responsible authority:
- Ministry Of Health
Authorisation number:
- 104909
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0503/003
Concerned member states:
-
Belgium
-
France
-
Italy
-
Netherlands
-
Portugal
-
Spain
-
United Kingdom (Northern Ireland)
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
Combined File of all Documents
This document does not exist in this language (English). You can find it
in another language below.
Italian (PDF)
Published on: 11/04/2022
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