Veterinary Medicines

Nuflor Minidose 450 mg/ml solution for injection for cattle

Authorised
  • Florfenicol
Download as PDF

Product identification

Medicine name:
Nuflor Minidose 450 mg/ml solution for injection for cattle
Nuflor Minidose 450 mg/ml solutie injectabila pentru bovine
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:
  • Valid
Authorised in:
  • Romania
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:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 150118
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0122/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Portugal
  • Romania
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 26/02/2024
Download
Romanian (PDF)
Published on: 23/03/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."