Veterinary Medicines Information website

Norfenicol 300 mg/ml Solution for Injection for Cattle and Pigs

Authorised
  • Florfenicol
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Product identification

Medicine name:
Norfenicol 300 mg/ml Solution for Injection for Cattle and Pigs
Active substance:
  • Florfenicol
Target species:
  • Cattle
  • Pig
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
        39
        day
    • Pig
      • Meat and offal
        22
        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:
  • Romania
Package description:
  • 50 ml clear type I glass vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box.
  • 100 ml clear type I glass vial with bromobutyl rubber bung and aluminium seal accompanied by a protective sleeve.
  • 250 ml clear type I glass vial with bromobutyl rubber bung and aluminium accompanied by a protective sleeve.
  • 500 ml clear type I glass vial with bromobutyl rubber bung and aluminium seal accompanied by a protective sleeve.
  • 50 ml HDPE plastic vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box.
  • 100 ml HDPE plastic vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box.
  • 250 ml HDPE plastic vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box.
  • 500 ml HDPE plastic vial with bromobutyl rubber bung and aluminium seal presented 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:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 190105
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0282/001
Concerned member states:
  • Belgium
  • Czechia
  • Denmark
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Romania
  • Slovakia
  • Slovenia
  • 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.
Romanian (PDF)
Published on: 25/11/2025
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Summary of Product Characteristics

English (PDF)
Published on: 16/01/2026
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