Veterinary Medicines

ROLAXIN 100 mg/ml SOLUCION INYECTABLE PARA BOVINO OVINO CAPRINO Y PORCINO

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
ROLAXIN 100 mg/ml SOLUCION INYECTABLE PARA BOVINO OVINO CAPRINO Y PORCINO
Active substance:
  • Enrofloxacin
Target species:
  • Cattle
  • Sheep
  • Goat
  • 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
        no withdrawal period
    • Sheep
      • Meat and offal
        4
        day
    • Goat
      • Meat and offal
        6
        day
    • Cattle
      • Milk
        no withdrawal period
    • Sheep
      • Milk
        3
        day
    • Goat
      • Milk
        4
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        no withdrawal period
    • Cattle
      • Milk
        no withdrawal period
  • 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:
  • Spain
Available in:
  • Spain
Package description:

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:
  • Mevet S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Mevet S.A.
Responsible authority:
  • Spanish Agency For Medicines And Health Products
Authorisation number:
  • 3656 ESP
Date of authorisation status change:

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 9/01/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 9/01/2025
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 9/01/2025
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es-puar-rolaxin-100-mg-ml-solucion-inyectable-para-bovino-ovino-caprino-y-porcino-es.pdf

Spanish (PDF)
Published on: 9/11/2022
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