Veterinary Medicine Information website

Enroxil Max 100 mg/ml solution for injection for cattle

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Enroxil Max 100 mg/ml solution for injection for cattle
Active substance:
  • Enrofloxacin
Target species:
  • Cattle
Route of administration:
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Enrofloxacin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        72
        hour
  • Subcutaneous use
    • Cattle
      • Meat and offal
        14
        day
      • Milk
        84
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • Amber glass Type 2 multi-dose vial of 100 ml with bromobutyl rubber stopper

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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 160065
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0424/001
Concerned member states:
  • Czechia
  • Italy
  • Latvia
  • Lithuania
  • Romania
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
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Romanian (PDF)
Published on: 4/03/2022
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