Veterinary Medicines

Tramcoat 20 mg film-coated tablets for dogs

Authorised
  • Tramadol hydrochloride
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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 hydrochloride
    20.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Film-coated tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
      • All relevant tissues
        no withdrawal period
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)

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 2/04/2024
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