Veterinary Medicines Information website

Enroxil 100 mg/ml solution for injection for cattle and pigs

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Enroxil 100 mg/ml solution for injection for cattle and pigs
Active substance:
  • Enrofloxacin
Target species:
  • Pig
  • Cattle
Route of administration:
  • Intramuscular use
  • 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:
  • Intramuscular use
    • Pig
      • Meat and offal
        13
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        5
        day
      • Milk
        3
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        12
        day
      • Milk
        4
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • 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.
  • Cardboard box with 1 amber Type II glass bottle of 50 ml with a grey bromobutyl rubber stopper and aluminiumcap.
  • 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:
  • KRKA tovarna zdravil d.d. Novo mesto
  • TAD Pharma GmbH
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 10488
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0422/002
Concerned member states:
  • Austria
  • Germany
  • Netherlands
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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