Veterinary Medicine Information website

TOLFEDOL, 40 mg/ml, solution for injection for cattle, pigs, cats and dogs

Authorised
  • Tolfenamic acid
Download as PDF

Product identification

Medicine name:
TOLFEDOL, 40 mg/ml, solution for injection for cattle, pigs, cats and dogs
Active substance:
  • Tolfenamic acid
Target species:
  • Cattle
  • Dog
  • Pig
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Tolfenamic acid
    40.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        12
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        16
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        24
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AG02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Amber polypropylene vial of 250 ml provided with a pink bromobutyl stopper and aluminium seal with a flip-off sealing.Each vial is packaged in an outer carton.
  • Amber polypropylene vial of 100 ml provided with a grey bromobutyl stopper and aluminium seal with a flip-off sealing.Each vial is packaged in an outer carton.
  • Amber polypropylene vial of 50 ml provided with a grey bromobutyl stopper and aluminium seal with a flip-off sealing.Each vial is packaged in an outer carton.
  • Amber polypropylene vial of 20 ml provided with a grey bromobutyl stopper and aluminium seal with a flip-off sealing.Each vial is packaged in an outer carton.

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:
  • S P Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • S P Veterinaria S.A.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/6409545 3/2015
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0344/001
Concerned member states:
  • France
  • Germany
  • Portugal
  • Romania
  • Slovakia
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 25/09/2024
Download
French (PDF)
Published on: 26/09/2024
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 15/10/2025
Download

Combined File of all Documents

English (PDF)
Published on: 25/09/2024
Download