Veterinary Medicines

Tranquiline 35 mg/ml Oral Gel for Dogs

Authorised
  • Acepromazine maleate
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Product identification

Medicine name:
Tranquiline 35 mg/ml Oral Gel for Dogs
Sedanine 35 mg/ml gel orale per cani
Active substance:
  • Acepromazine maleate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Acepromazine maleate
    47.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral gel
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • 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polyethylene/low-density polyethylene child resistant closure Extractable volume 9.8 ml of Tranquiline gel can be withdrawn from each 10 ml amber glass bottle Dosing device: 1.0 ml polypropylene oral dosing syringe, graduated at 0.05 ml intervals, is supplied with the 10 ml amber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.
  • 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.

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 Produkten B.V.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 105513
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)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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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: 23/03/2022
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