Veterinary Medicines

Nuflor Minidose 450 mg/ml solution for injection for cattle

Not authorised
  • Florfenicol
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Product identification

Medicine name:
Nuflor Minidose 450 mg/ml solution for injection for cattle
Nuflor Minidose 450 mg/ml Oplossing voor injectie
Nuflor Minidose 450 mg/ml Solution injectable
Nuflor Minidose 450 mg/ml Injektionslösung
Active substance:
  • Florfenicol
Target species:
  • Cattle
Route of administration:
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Florfenicol
    450.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        64
        day
  • Intramuscular use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        37
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01BA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Belgium
Package description:
  • (ID3) 250 millilitre(s): unspecified outer container with 1 Vial (Glass) with 250 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID2) 100 millilitre(s): unspecified outer container with 1 Vial (Glass) with 100 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID1) 50 millilitre(s): unspecified outer container with 1 Vial (Glass) with 50 millilitre(s), closed with Stopper (bromobutyl rubber`)

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:
  • Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International GmbH
  • Trirx Segre
  • Vet Pharma Friesoythe GmbH
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V321964
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0122/001

Documents

Summary of Product Characteristics

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Dutch (PDF)
Published on: 13/04/2023
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French (PDF)
Published on: 13/04/2023
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Package Leaflet

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Dutch (PDF)
Published on: 13/04/2023
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French (PDF)
Published on: 13/04/2023
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German (PDF)
Published on: 13/04/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 13/04/2023
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French (PDF)
Published on: 13/04/2023
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German (PDF)
Published on: 13/04/2023
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