Veterinary Medicines

Labiprofen 150 mg/ml solution for injection

Authorised
  • Ketoprofen
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Product identification

Medicine name:
Labiprofen 150 mg/ml solution for injection
Labiprofen 150 mg/ml oldatos injekció szarvasmarhák, sertések és lovak részére A.U.V.
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:
  • Hungary
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:
  • National Food Chain Safety Office
Authorisation number:
  • 4229/X/21 NÉBIH ÁTI
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

Labelling

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

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
Download
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