Veterinary Medicines

Florfenikel 300 mg/ml solution for injection for cattle and pigs

Authorised
  • Florfenicol
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Product identification

Medicine name:
Florfenikel 300 mg/ml solution for injection for cattle and pigs
Kelaflor 300 mg/ml injektionsvæske, opløsning
Active substance:
  • Florfenicol
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Florfenicol
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        34
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        18
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01BA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 250 ml (PP)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 100 ml (PP)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 12 x 250 ml (PP)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 10 x 250 ml (PP)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 6 x 250 ml (PP)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 12 x 100 ml (PP)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 10 x 100 ml (PP)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 6 x 100 ml (PP)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 6 x 250 ml (glass)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 6 x 100 ml (glass)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 12 x 250 ml (glass)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 10 x 250 ml (glass)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 250 ml (glass)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 12 x 100 ml (glass)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 10 x 100 ml (glass)
  • Florfenikel 300 mg/ml inj. sol. i.m. vial 100 ml (glass)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • KELA Kempisch Laboratorium Kela Laboratoria
Marketing authorisation date:
Manufacturing sites for batch release:
  • S P Veterinaria S.A.
  • KELA Kempisch Laboratorium Kela Laboratoria
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 47459
Date of authorisation status change:
Reference member state:
  • Belgium
Procedure number:
  • BE/V/0038/001
Concerned member states:
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)
Generic of:

Documents

Combined File of all Documents

English (PDF)
Published on: 18/04/2024
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Summary of Product Characteristics

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Danish (PDF)
Published on: 9/12/2025
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