Veterinary Medicines

Tilkomay 300 mg/ml + 90 mg/ml solution for injection

Authorised
  • Tilmicosin
  • Ketoprofen

Product identification

Medicine name:
Tilkomay 300 mg/ml + 90 mg/ml solution for injection
TILKOMAY 300 mg/ml + 90 mg/ml SOLUCION INYECTABLE
Active substance:
  • Tilmicosin
  • Ketoprofen
Target species:
  • Cattle (calf)
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Tilmicosin
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Ketoprofen
    90.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle (calf)
      • Meat and offal
        93
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA99
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • box containing 1 vial of 250 ml
  • box containing 1 vial of 100 ml
  • box containing 1 vial of 50 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Laboratorios Maymo S.A.U.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Maymo S.A.U.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3734 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0279/001
Concerned member states:
  • Hungary
  • Italy
  • Poland
  • Portugal
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
Download
Spanish (PDF)
Published on: 4/06/2024

Package Leaflet

English (PDF)
Published on: 12/04/2023
Download
Spanish (PDF)
Published on: 4/06/2024

Labelling

English (PDF)
Published on: 12/04/2023
Download
Spanish (PDF)
Published on: 4/06/2024

eu-PUAR-tilkomay-300-mg-ml-+-90-mg-ml-solution-for-injection-en.pdf

English (PDF)
Published on: 12/04/2023
Download

es-puar-tilkomay-300-mg-ml-+-90-mg-ml-solution-for-injection-es.pdf

Spanish (PDF)
Published on: 17/03/2023
Download