Veterinary Medicines

Tranquigel 35 mg/g oral gel for dogs and horses

Authorised
  • Acepromazine maleate
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Product identification

Medicine name:
Tranquigel 35 mg/g oral gel for dogs and horses
Tranquigel vet 35 mg/g Oral gel
Active substance:
  • Acepromazine maleate
Target species:
  • Dog
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Acepromazine maleate
    47.52
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral gel
Withdrawal period by route of administration:
  • Oral use
    • Dog
    • Horse
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Sweden
Package description:
  • Multi-pack with 12 cardboard boxes each containing 1 white LLDPE (linear low-density polyethylene) pre-filled oral syringe of 8 ml containing 6 gram. The syringes are closed with a LLDPE cap
  • Multi-pack with 12 cardboard boxes each containing 1 white LLDPE (linear low-density polyethylene) pre-filled oral syringe of 4 ml containing 3 gram. The syringes are closed with a LLDPE cap
  • Multi-pack with 12 cardboard boxes each containing 1 white LLDPE (linear low-density polyethylene) pre-filled oral syringe of 14 ml containing 12 gram. The syringes are closed with a LLDPE cap
  • Multi-pack with 12 cardboard boxes each containing 1 white LLDPE (linear low-density polyethylene) pre-filled oral syringe of 14 ml containing 10 gram. The syringes are closed with a LLDPE cap
  • Cardboard box with 1 white LLDPE (linear low-density polyethylene) pre-filled oral syringe of 8 ml containing 6 gram. The syringes are closed with a LLDPE cap.
  • Cardboard box with 1 white LLDPE (linear low-density polyethylene) pre-filled oral syringe of 4 ml containing 3 gram. The syringes are closed with a LLDPE cap
  • Cardboard box with 1 white LLDPE (linear low-density polyethylene) pre-filled oral syringe of 14 ml containing 12 gram. The syringes are closed with a LLDPE cap
  • Cardboard box with 1 white LLDPE (linear low-density polyethylene) pre-filled oral syringe of 14 ml containing 10 gram. The syringes are closed with a LLDPE cap

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:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 54964
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0215/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 15/04/2025
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 15/04/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 15/04/2025
Download

Combined File of all Documents

English (PDF)
Published on: 22/05/2025
Download
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