Tramcoat 20 mg film-coated tablets for dogs
Tramcoat 20 mg film-coated tablets for dogs
Authorised
- Tramadol hydrochloride
Product identification
Medicine name:
Tramcoat 20 mg film-coated tablets for dogs
Tramcoat 20 mg comprimate filmate pentru câini
Active substance:
- Tramadol hydrochloride
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Tramadol hydrochloride20.00milligram(s)1.00Tablet
Pharmaceutical form:
-
Film-coated tablet
Withdrawal period by route of administration:
-
Oral use
- Dog
-
All relevant tissuesno withdrawal periodNot applicable to dogs.
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN02AX02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Romania
Package description:
- Cardboard box of 1 PVC/PE/PVDC-aluminium blister, containing 10 tablets.
- Cardboard box of 2 PVC/PE/PVDC-aluminium blister, containing 10 tablets.
- Cardboard box of 3 PVC/PE/PVDC-aluminium blister, containing 10 tablets.
- Cardboard box of 4 PVC/PE/PVDC-aluminium blister, containing 10 tablets.
- Cardboard box of 5 PVC/PE/PVDC-aluminium blister, containing 10 tablets.
- Cardboard box of 6 PVC/PE/PVDC-aluminium blister, containing 10 tablets.
- Cardboard box of 7 PVC/PE/PVDC-aluminium blister, containing 10 tablets.
- Cardboard box of 8 PVC/PE/PVDC-aluminium blister, containing 10 tablets.
- Cardboard box of 9 PVC/PE/PVDC-aluminium blister, containing 10 tablets.
- Cardboard box of 10 PVC/PE/PVDC-aluminium blister, containing 10 tablets.
- Cardboard box of 12 PVC/PE/PVDC-aluminium blister, containing 10 tablets.
- Cardboard box of 25 PVC/PE/PVDC-aluminium blister, containing 10 tablets.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Lelypharma B.V.
Responsible authority:
- Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
- 240031
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0387/002
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
Combined File of all Documents
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in another language below.
Romanian (PDF)
Published on: 2/04/2024
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