Veterinary Medicines

Tralieve 50 mg/ml solution for injection for dogs

Authorised
  • Tramadol hydrochloride
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Product identification

Medicine name:
Tralieve 50 mg/ml solution for injection for dogs
Tralieve Vet. 50 mg/ml injektionsvæske, opløsning
Active substance:
  • Tramadol hydrochloride
Target species:
  • Dog
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Tramadol hydrochloride
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
  • Intravenous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AX02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Multi-pack with 10 boxes each containing 1 vial of 10 ml
  • Multi-pack with 6 boxes each containing 1 vial of 10 ml
  • Multi-pack with 10 boxes each containing 1 vial of 50 ml
  • Multi-pack with 10 boxes each containing 1 vial of 20 ml
  • Box with 1 vial of 50 ml
  • Box with 1 vial of 20 ml
  • Box with 1 vial of 10 ml
  • Multi-pack with 6 boxes each containing 1 vial of 50 ml
  • Multi-pack with 6 boxes each containing 1 vial of 20 ml

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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 58919
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0226/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Danish (, INJEKTIONSVÆSKE, OPLØSNING 50 MG-ML)
Published on: 7/04/2025
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