File downloaded on 2026-04-06
Source URL: https://medicines.health.europa.eu/veterinary/en/600000016939
Authorised

Product identification

Medicine name:
Nefotek 100 mg/ml Solution for Injection
Active substance:
  • Ketoprofen
Target species:
  • Cattle
  • Pig
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Ketoprofen
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        4
        day
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        0
        hour
  • Intravenous use
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        4
        day
      • Milk
        no withdrawal period
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        4
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AE03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Hungary
Available in:
  • Hungary
Package description:
  • cardboard box containing 1 vial of 100 ml
  • cardboard box containing 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:
  • Vetpharma Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 3092/X/12 MgSzH ÁTI
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0176/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Slovakia
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 1/02/2024
Download
Hungarian (PDF)
Published on: 9/03/2022
Download

Package Leaflet

English (PDF)
Published on: 1/02/2024
Download

Labelling

English (PDF)
Published on: 1/02/2024
Download

Combined File of all Documents

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