Tralieve 80 mg chewable tablets for dogs
Tralieve 80 mg chewable tablets for dogs
Authorised
- Tramadol hydrochloride
Product identification
Medicine name:
Tralieve 80 mg chewable tablets for dogs
Tralieve 80 mg Kauwtablet
Tralieve 80 mg Comprimé à croquer
Tralieve 80 mg Kautablette
Active substance:
- Tramadol hydrochloride
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Tramadol hydrochloride80.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Chewable tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN02AX02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
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:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V531884
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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Labelling
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