Veterinary Medicines

Florgane 300 mg/ml Suspension for Injection for Cattle and Pigs

Authorised
  • Florfenicol
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Product identification

Medicine name:
Florgane 300 mg/ml Suspension for Injection for Cattle and Pigs
Florgane 300 mg/ml Injektionssuspension für Rinder und Schweine
Active substance:
  • Florfenicol
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Florfenicol
    300.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        37
        day
    • Pig
      • Meat and offal
        22
        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:
  • (ID8) 6000 millilitre(s): unspecified outer container with 12 Bottle (PolyPropylene) each with 500 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID7) 500 millilitre(s): unspecified outer container with 1 Bottle (PolyPropylene) with 500 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID6) 3000 millilitre(s): unspecified outer container with 12 Bottle (PolyPropylene) each with 250 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID5) 250 millilitre(s): unspecified outer container with 1 Bottle (PolyPropylene) with 250 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID4) 1200 millilitre(s): unspecified outer container with 12 Bottle (PolyPropylene) each with 100 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID3) 100 millilitre(s): unspecified outer container with 1 Bottle (PolyPropylene) with 100 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID2) 600 millilitre(s): unspecified outer container with 12 Bottle (PolyPropylene) each with 50 millilitre(s), closed with Stopper (bromobutyl rubber`)
  • (ID1) 50 millilitre(s): unspecified outer container with 1 Bottle (PolyPropylene) with 50 millilitre(s), closed with Stopper (bromobutyl rubber`)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Emdoka
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401497.00.00
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0132/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 3/02/2025
Download
German (PDF)
Published on: 3/02/2025
Download

2401497-paren-20130711.pdf

English (PDF)
Published on: 3/02/2025
Download
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