Veterinary Medicines

MARBOCOLI 100 mg/ml solution for injection

Authorised
  • Marbofloxacin
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Product identification

Medicine name:
MARBOCOLI 100 mg/ml solution for injection
MARBOCOLI 100 mg/ml, soluție injectabilă pentru bovine și porcine
Active substance:
  • Marbofloxacin
Target species:
  • Cattle
  • Pig (sow)
  • Pigs (for fattening)
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
    • Pigs (for fattening)
      • 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
    • Pigs (for fattening)
      • 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
    • Pigs (for fattening)
      • 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:
  • Romania
Available in:
  • Romania
Package description:
  • box containing 10 PP vials of 250 ml
  • box containing 10 PP vials of 100 ml
  • box containing 1 PP vial of 250 ml
  • box containing 1 PP vial of 100 ml
  • box containing 10 glass vials of 250 ml
  • box containing 1 glass vial of 250 ml
  • box containing 10 glass vials of 100 ml
  • box containing 1 glass vial of 100 ml
  • box containing 10 glass vials of 50 ml
  • box containing 1 glass 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:
  • S P Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • S P Veterinaria S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 200061
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0217/001
Concerned member states:
  • Malta
  • Poland
  • Portugal
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/04/2023
Download
Romanian (PDF)
Published on: 17/11/2022
Download

eu-PUAR-marbocoli-100-mg-ml-solution-for-injection-en.pdf

English (PDF)
Published on: 11/04/2023
Download
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