Veterinary Medicines

Trilotab 10 mg chewable tablets for dogs

Authorised
  • Trilostane
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Product identification

Medicine name:
Trilotab 10 mg chewable tablets for dogs
Trilotab Vet. 10 mg tyggetabletter
Active substance:
  • Trilostane
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Trilostane
    10.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • Aluminium-PVC/Aluminium/oPA blisters, containing 10 tablets. Cardboard box of 30 tablets
  • Aluminium-PVC/Aluminium/oPA blisters, containing 10 tablets. Cardboard box 100 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:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 67346
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0373/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

PuAR Trilotab NL_V_0373_001-005_DC 2023-08.pdf

English (PDF)
Published on: 25/08/2023
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