Veterinary Medicine Information website

TILMIPRIL 300 mg/ml Solution for injection for cattle

Authorised
  • Tilmicosin
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Product identification

Medicine name:
TILMIPRIL 300 mg/ml Solution for injection for cattle
Active substance:
  • Tilmicosin
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Tilmicosin
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        70
        day
      • Milk
        no withdrawal period
    • Sheep
      • Meat and offal
        42
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • box containing 12 vials of 250 ml
  • box containing 10 vials of 250 ml
  • box containing 6 vials of 250 ml
  • box containing 12 vials of 100 ml
  • box containing 10 vials of 100 ml
  • box containing 6 vials of 100 ml
  • box containing 12 vials of 50 ml
  • box containing 10 vials of 50 ml
  • box containing 6 vials of 50 ml
  • 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
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Vetpharma Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1958
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0140/001
Concerned member states:
  • Czechia
  • Italy
  • Poland
  • Portugal

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 21/02/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 21/02/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 21/02/2025
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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eu-PUAR-esv0140001-dcp-tilmipril-300-mg-ml-solution-for-injection-for-cattle-en.pdf

English (PDF)
Published on: 22/12/2023
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