Veterinary Medicines

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

Authorised
  • Ceftiofur hydrochloride
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Product identification

Medicine name:
Cefavex 50 mg/ml, suspension for injection for pigs and cattle
CEFAVEX 50 mg/ml, suspensie injectabilă pentru porcine și bovine
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
        5
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        8
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01DD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Available in:
  • Romania
Package description:
  • Colourless glass type I vial of 100 ml, closed with grey coated bromobutyl rubber stopper and aluminium cap.Vial is individually packed in a carton box.One grouped as a clinical pack.
  • Colourless glass type I vial of 100 ml, closed with grey coated bromobutyl rubber stoppers and aluminium caps.Vials are individually packed in a carton box.Six vials are grouped as a clinical pack.
  • Colourless glass type I vial of 100 ml, closed with grey coated bromobutyl rubber stoppers and aluminium caps.Vials are individually packed in a carton box.Ten vials are grouped as a clinical pack.
  • Colourless glass type I vial of 100 ml, closed with grey coated bromobutyl rubber stoppers and aluminium caps.Vials are individually packed in a carton box.Twelve vials are grouped as a clinical pack.

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:
  • S P Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • S P Veterinaria S.A.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 180069
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0304/001
Concerned member states:
  • Bulgaria
  • Germany
  • Greece
  • Hungary
  • Italy
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2024
Download

Combined File of all Documents

English (PDF)
Published on: 22/12/2024
Download
Romanian (PDF)
Published on: 21/02/2025
Download
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