Veterinary Medicines

Roxacin, 100 mg/mL, otopina za injekciju, za goveda i svinje

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Roxacin, 100 mg/mL, otopina za injekciju, za goveda i svinje
Active substance:
  • Enrofloxacin
Target species:
  • Cattle
  • Pig
Route of administration:
  • Subcutaneous use
  • Intravenous use
  • Intramuscular 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:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        12
        day
      • Milk
        4
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        5
        day
      • Milk
        3
        day
  • Intramuscular use
    • Pig
      • Meat and offal
        13
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) 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:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/21-01/63
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Croatian (PDF)
Published on: 23/06/2023
Updated on: 27/06/2023
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