Trilorale 50 mg/ml - Oral suspension
Trilorale 50 mg/ml - Oral suspension
Authorised
- Trilostane
Product identification
Medicine name:
Trilorale 50 mg/ml - Oral suspension
Active substance:
- Trilostane
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Trilostane50.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Oral suspension
Withdrawal period by route of administration:
-
Oral use
-
Dog
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QH02CA01
Legal status of supply:
-
Medicinal product subject to medical prescription
Authorisation status:
-
Valid
Authorised in:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Liechtenstein
-
Lithuania
-
Luxembourg
-
Malta
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
Available in:
-
France
Package description:
- Packaging:Bottle with 1 ml and 5 ml PP syringe (HDPE), Package_size:1 bottle, Content:50 ml
- Packaging:Bottle with 1 ml and 5 ml PP syringe (HDPE), Package_size:1 bottle, Content:100 ml
- Packaging:Bottle with 1 ml and 5 ml PP syringe (HDPE), Package_size:1 bottle, Content:25 ml
- Packaging:Bottle with 1 ml and 5 ml PP syringe (HDPE), Package_size:1 bottle, Content:10 ml
- Packaging:Bottle with 1 ml and 5 ml PP syringe (HDPE), Package_size:1 bottle, Content:72 ml
- Packaging:Bottle with 1 ml and 5 ml PP syringe (HDPE), Package_size:1 bottle, Content:36 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application – change in pharmaceutical form (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
- AXIENCE
Marketing authorisation date:
Manufacturing sites for batch release:
- Lelypharma B.V.
Responsible authority:
- European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 18/02/2025
Bulgarian (PDF)
Published on: 18/02/2025
Croatian (PDF)
Published on: 18/02/2025
Czech (PDF)
Published on: 18/02/2025
Danish (PDF)
Published on: 18/02/2025
Dutch (PDF)
Published on: 18/02/2025
Estonian (PDF)
Published on: 18/02/2025
Finnish (PDF)
Published on: 18/02/2025
French (PDF)
Published on: 18/02/2025
German (PDF)
Published on: 18/02/2025
Greek (PDF)
Published on: 18/02/2025
Hungarian (PDF)
Published on: 18/02/2025
Icelandic (PDF)
Published on: 18/02/2025
Italian (PDF)
Published on: 18/02/2025
Latvian (PDF)
Published on: 18/02/2025
Lithuanian (PDF)
Published on: 18/02/2025
Maltese (PDF)
Published on: 18/02/2025
Norwegian (PDF)
Published on: 18/02/2025
Polish (PDF)
Published on: 18/02/2025
Portuguese (PDF)
Published on: 18/02/2025
Romanian (PDF)
Published on: 18/02/2025
Slovak (PDF)
Published on: 18/02/2025
Slovenian (PDF)
Published on: 18/02/2025
Spanish (PDF)
Published on: 18/02/2025
Swedish (PDF)
Published on: 18/02/2025
ema-puar-v6124-trilorale-en.pdf
English (PDF)
Download Published on: 16/10/2024
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