Veterinary Medicines

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

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
ROXACIN 100 mg/ml solution for injection for cattle and pigs
Roxacin 100 mg/ml oplossing voor injectie voor runderen en varkens
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:
  • Type II Amber glass vial of 250 ml capacity closed with pink bromobutyl rubber stopper and aluminium flip-off seal. One vial of 250 ml is available in a cardboard box.
  • Type II Amber glass vial of 100 ml capacity closed with grey bromobutyl rubber stopper and aluminium flip-off seal. One vial of 100 ml is available in a cardboard box.

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:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 107005
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0256/001
Concerned member states:
  • Belgium
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 26/01/2022
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Summary of Product Characteristics

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