Veterinary Medicines

BOFLOX 100 mg/ml

Authorised
  • Marbofloxacin
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Product identification

Medicine name:
BOFLOX 100 mg/ml
Boflox 100 mg/ml инжекционен разтвор за говеда и свине
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
    • Pig (sow)
      • Meat and offal
        4
        day
    • Cattle
      • Milk
        no withdrawal period
  • Intravenous use
    • Cattle
      • Meat and offal
        no withdrawal period
    • Cattle
      • Milk
        no withdrawal period
  • Subcutaneous use
    • Cattle
      • Meat and offal
        no withdrawal period
    • Cattle
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA93
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
Package description:
  • cardboard box containing 12 vials of 250 ml
  • cardboard box containing 12 vials of 100 ml
  • cardboard box containing 10 vials of 250 ml
  • cardboard box containing 10 vials of 100 ml
  • cardboard box containing 6 vials of 250 ml
  • cardboard box containing 6 vials of 100 ml
  • 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:
  • Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
  • KELA Kempisch Laboratorium Kela Laboratoria
  • aniMedica GmbH
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-1944
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0190/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/04/2023
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Bulgarian (PDF)
Published on: 8/03/2022
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Package Leaflet

English (PDF)
Published on: 6/04/2023
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Bulgarian (PDF)
Published on: 8/03/2022
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Labelling

English (PDF)
Published on: 6/04/2023
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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