Veterinary Medicines

Tralieve 80 mg chewable tablets for dogs

Authorised
  • Tramadol hydrochloride
Download as PDF

Product identification

Medicine name:
Tralieve 80 mg chewable tablets for dogs
Tralieve vet 80 mg košļājamās tabletes suņiem
Active substance:
  • Tramadol hydrochloride
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Tramadol hydrochloride
    80.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral 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:
  • Latvia
Package description:
  • Cardboard box of 10 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 1 Aluminium - PVC/PE/PVDC blister of 10 tablets.
  • Cardboard box containing 10 separate cardboard boxes, each containing 3 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 3 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 2 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 9 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 8 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 7 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 6 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 5 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 4 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 25 Aluminium - PVC/PE/PVDC blisters of 10 tablets.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
  • Genera d.d.
Responsible authority:
  • Food And Veterinary Service
Authorisation number:
  • V/DCP/18/0025
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0231/002
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Latvian (PDF)
Published on: 27/11/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."