Veterinary Medicines

KELAPROFEN 100 mg/ml

Authorised
  • Ketoprofen
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Product identification

Medicine name:
KELAPROFEN 100 mg/ml
Active substance:
  • Ketoprofen
Target species:
  • Cattle
  • Horse
  • Pig
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
    • Horse
    • Pig
  • Intravenous use
    • Cattle
    • Horse
    • Pig
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AE03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • box containing 1 vial of 50 ml
  • box containing 1 vial of 100 ml
  • box containing 1 vial of 250 ml
  • box containing 6 vials of 50 ml
  • box containing 6 vials of 100 ml
  • box containing 6 vials of 250 ml
  • box containing 10 vials of 50 ml
  • box containing 10 vials of 100 ml
  • box containing 10 vials of 250 ml
  • box containing 12 vials of 50 ml
  • box containing 12 vials of 100 ml
  • box containing 12 vials 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:
  • Kela Kempisch Laboratorium Kela Laboratoria
Marketing authorisation date:
Manufacturing sites for batch release:
  • Kela - Kempisch Laboratorium - Kela Laboratoria
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • 06126/3000
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0160/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 21/12/2023
Download

Package Leaflet

English (PDF)
Published on: 21/12/2023
Download

Labelling

English (PDF)
Published on: 21/12/2023
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eu-PUAR-esv0160001-dcp-kelaprofen--100-mg-ml-en.pdf

English (PDF)
Published on: 21/12/2023
Download
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