Veterinary Medicine Information website

Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle

Authorised
  • Ceftiofur hydrochloride
Download as PDF

Product identification

Medicine name:
Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle
Active substance:
  • Ceftiofur hydrochloride
Target species:
  • Pig
  • Cattle
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Ceftiofur hydrochloride
    53.48
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        8
        day
  • Subcutaneous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        8
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01DD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Carton box containing one glass vial, type II 100 ml, sealed with a bromobutyl rubber stopper and aluminium overseal.
  • Polystyrene box containing 6 glass vials, type II 250 ml, sealed with bromobutyl rubber stopper and aluminium overseal.
  • Polystyrene box containing 12 glass vials, type II 100 ml, sealed with a bromobutyl rubber stopper and aluminium overseal.
  • Carton box containing one glass vial, type II 50 ml, sealed with a bromobutyl rubber stopper and aluminium overseal.
  • Polystyrene box containing 15 glass vials, type II 50 ml, sealed with a bromobutyl rubber stopper and aluminium overseal.
  • Carton box containing one glass vial, type II 250 ml, sealed with a bromobutyl rubber stopper and aluminium overseal.

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:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 46584
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0148/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 16/06/2022
Download
Danish (PDF)
Published on: 29/06/2023
Download

107101 - PAR.pdf

English (PDF)
Published on: 16/06/2022
Download