Veterinary Medicines

ENROXIL 50 mg/ml solution for injection for calves, pigs and dogs

Authorised
  • Enrofloxacin
Download as PDF

Product identification

Medicine name:
ENROXIL 50 mg/ml solution for injection for calves, pigs and dogs
ENROXIL 50 mg/ml solution for injection for calves, pigs and dogs
Active substance:
  • Enrofloxacin
Target species:
  • Pig
  • Cattle
  • Dog
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Enrofloxacin
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        13
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        5
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        12
        day
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Cardboard box with 1 amber Type I glass bottle of 50 ml with a grey bromobutyl rubber stopper and aluminiumcap.
  • Cardboard box with 1 amber Type I glass bottle of 100 ml with a grey bromobutyl rubber stopper and aluminiumcap.
  • Cardboard box with 1 amber Type II glass bottle of 50 ml with a grey bromobutyl rubber stopper and aluminium cap.
  • Cardboard box with 1 amber Type II glass bottle of 100 ml with a grey bromobutyl rubber stopper and aluminiumcap.

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:
  • TAD Pharma GmbH
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10774/002/002
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0422/001
Concerned member states:
  • Austria
  • Germany
  • Netherlands
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
How useful was this page?:
Average: 5 (3 votes)
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."