Veterinary Medicine Information website

TOLFELAB 40 mg/ml SOLUTION FOR INJECTION FOR CATTLE PIGS CATS AND DOGS

Authorised
  • Tolfenamic acid
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Product identification

Medicine name:
TOLFELAB 40 mg/ml SOLUTION FOR INJECTION FOR CATTLE PIGS CATS AND DOGS
Active substance:
  • Tolfenamic acid
Target species:
  • Pig
  • Dog
  • Cattle
  • 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
    • Pig
      • Meat and offal
        16
        day
    • Cattle
      • Meat and offal
        12
        day
      • Milk
        0
        hour
  • 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:
  • Croatia
Available in:
  • Croatia
Package description:
  • Box with 1 vial of 20 ml
  • Box with 1 vial of 50 ml
  • Box with 1 vial of 100 ml
  • Box with 1 vial of 250 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:
  • Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/22-01/733
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0417/001
Concerned member states:
  • Belgium
  • Croatia
  • Estonia
  • France
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/03/2023
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Croatian (PDF)
Published on: 20/03/2023
Download

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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