Veterinary Medicines

KELACYL 100 mg/ml solution for injection for cattle and pigs

Authorised
  • Marbofloxacin
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Product identification

Medicine name:
KELACYL 100 mg/ml solution for injection for cattle and pigs
Kelbomar 100 mg/ml Oplossing voor injectie voor runderen en varkens
Kelbomar 100 mg/ml Solution injectable pour bovins et porcins
Kelbomar 100 mg/ml Injektionslösung für Rinder und Schweine
Active substance:
  • Marbofloxacin
Target species:
  • Cattle
  • Pig (sow)
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Marbofloxacin
    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
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig (sow)
      • Meat and offal
        4
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig (sow)
      • Meat and offal
        4
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig (sow)
      • Meat and offal
        4
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA93
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • box containing 12 vials of 250 ml individually packed in a carton box
  • box containing 12 vials of 100 ml individually packed in a carton box
  • box containing 10 vials of 250 ml individually packed in a carton box
  • box containing 10 vials of 100 ml individually packed in a carton box
  • box containing 6 vials of 250 ml individually packed in a carton box
  • box containing 6 vials of 100 ml individually packed in a carton box
  • cardboard box containing 1 vial of 250 ml
  • cardboard box containing 1 vial of 100 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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V442355
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0189/001
Concerned member states:
  • Belgium
  • Germany
  • Luxembourg
  • Poland
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
Download
Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
Download

Package Leaflet

English (PDF)
Published on: 22/12/2023
Download
Dutch (PDF)
Published on: 22/03/2022
Download
French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
Download

Labelling

English (PDF)
Published on: 22/12/2023
Download

eu-PUAR-esv0189001-dcp-kelacyl-100-mg-ml-en.pdf

English (PDF)
Published on: 22/12/2023
Download
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