Veterinary Medicines

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
Norfenicol 300 mg/ml Injektionslösung für Rinder und Schweine
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:
  • Germany
Package description:
  • 500 ml clear type I glass vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box or a protective sleeve.
  • 250 ml clear type I glass vial with bromobutyl rubber bung and aluminium presented in a cardboard box or a protective sleeve.
  • 100 ml clear type I glass vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box or a protective sleeve.
  • 50 ml clear type I glass vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box.
  • 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 or a protective sleeve.
  • 250 ml HDPE plastic vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box or a protective sleeve.
  • 500 ml HDPE plastic vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box or a protective sleeve.

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 Laboratories Limited
  • Norbrook Manufacturing Limited
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401549.00.00
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
  • Spain
  • United Kingdom (Northern Ireland)
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