Veterinary Medicines

Tralieve 80 mg chewable tablets for dogs

Authorised
  • Tramadol hydrochloride
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Product identification

Medicine name:
Tralieve 80 mg chewable tablets for dogs
Tralieve Vet. 80 mg tyggetabletter
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:
  • Denmark
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:
  • Danish Medicines Agency
Authorisation number:
  • 59304
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

Summary of Product Characteristics

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Danish (, TYGGETABLETTER 80 MG)
Published on: 2/12/2024
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