Veterinary Medicine Information website

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

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • Cardboard box with 1 amber Type II 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 I glass bottle of 100 ml with a grey bromobutyl rubber stopper and aluminiumcap.
  • Cardboard box with 1 amber Type I glass bottle of 50 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:
  • TAD Pharma GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
  • TAD Pharma GmbH
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 400998.00.00
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

Combined File of all Documents

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German (PDF)
Published on: 9/10/2024
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