Tranquiline 35 mg/ml Oral Gel for Dogs
Tranquiline 35 mg/ml Oral Gel for Dogs
Authorised
- Acepromazine maleate
Product identification
Medicine name:
Tranquiline 35 mg/ml Oral Gel for Dogs
Active substance:
- Acepromazine maleate
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Acepromazine maleate47.50/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Oral gel
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05AA04
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Prefilled syringe:Container: White, high-density polyethylene syringe barrel. White, low-density polyethylene syringe plunger. Closure: White, high-density polyethylene, push-fit cap. Fill volume: 10 ml Dosing device: The product is presented in an oral dosing syringe which is graduated at 1 ml intervals.
- Glass bottleContainer: Amber Type III glass bottle of 10 ml volume. Closure: high-density polyethylene/low-density polyethylene child resistant closure Extractable volume 9.8 ml of Tranquiline gel can be withdrawn from each 10 ml amber glass bottle Dosing device: 1.0 ml polypropylene oral dosing syringe, graduated at 0.05 ml intervals, is supplied with the 10 ml amber glass bottle.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Floris Holding B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Floris Veterinaire Producten B.V.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0278/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Cyprus
-
Denmark
-
France
-
Germany
-
Greece
-
Italy
-
Netherlands
-
Norway
-
Poland
-
Romania
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Labelling
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Combined File of all Documents
English (PDF)
Download Published on: 18/01/2026
