Veterinary Medicines

NUFLOR 300 mg/ml solution for injection for cattle and sheep

Authorised
  • Florfenicol
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Product identification

Medicine name:
NUFLOR 300 mg/ml solution for injection for cattle and sheep
NUFLOR 300 mg/ml SOLUCION INYECTABLE PARA BOVINO Y OVINO
Active substance:
  • Florfenicol
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Florfenicol
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        30
        day
    • Sheep
      • Meat and offal
        39
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        44
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01BA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • 50 ml colourless Type I glass vial closed with bromobutyl rubber stopper with aluminium seal.
  • 100 ml colourless Type I glass vial closed with bromobutyl rubber stopper with aluminium seal.
  • 250 ml colourless Type I glass vial closed with bromobutyl rubber stopper with aluminium seal.

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:
  • Merck Sharp & Dohme Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Trirx Segre
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2706 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0269/001
Concerned member states:
  • Belgium
  • Denmark
  • France
  • Greece
  • Italy
  • Luxembourg
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 30/03/2025
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Spanish (PDF)
Published on: 15/04/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 15/04/2025
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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: 19/12/2024
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Combined File of all Documents

English (PDF)
Published on: 29/12/2024
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