Veterinary Medicines

Labiprofen 150 mg/ml solution for injection

Authorised
  • Ketoprofen
Download as PDF

Product identification

Medicine name:
Labiprofen 150 mg/ml solution for injection
Labiprofen 150 mg/ml Oplossing voor injectie
Labiprofen 150 mg/ml Solution injectable
Labiprofen 150 mg/ml Injektionslösung
Active substance:
  • Ketoprofen
Target species:
  • Cattle
  • Pig
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Ketoprofen
    150.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
    • Pig
    • Horse
  • Intravenous use
    • Cattle
    • Pig
    • Horse
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AE03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • box containing 10 vials of 250 ml
  • box containing 10 vials of 100 ml
  • box containing 12 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:
  • Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V587546
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0388/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Portugal
  • Romania
  • Slovenia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

English (PDF)
Published on: 24/03/2023
Download
Dutch (PDF)
Published on: 3/10/2023
Download
French (PDF)
Published on: 3/10/2023
Download
German (PDF)
Published on: 3/10/2023
Download

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
Download
Dutch (PDF)
Published on: 3/10/2023
Download
French (PDF)
Published on: 3/10/2023
Download
German (PDF)
Published on: 3/10/2023
Download

Labelling

English (PDF)
Published on: 24/03/2023
Download
Dutch (PDF)
Published on: 3/10/2023
Download
French (PDF)
Published on: 3/10/2023
Download
German (PDF)
Published on: 3/10/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."