Veterinary Medicines

Defixopzyl

Authorised
  • IRON(III)-HYDROXIDE DEXTRAN COMPLEX
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Product identification

Medicine name:
Defixopzyl
Defixopzyl 200 mg/ml, soluzione iniettabile per suini (suinetti) e bovini (vitelli)
Active substance:
  • IRON(III)-HYDROXIDE DEXTRAN COMPLEX
Target species:
  • Pig (piglet)
  • Cattle (calf)
Route of administration:
  • Subcutaneous use
  • Intramuscular use
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • IRON(III)-HYDROXIDE DEXTRAN COMPLEX
    519.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Pig (piglet)
      • All relevant tissues
        0
        day
    • Cattle (calf)
  • Intramuscular use
    • Pig (piglet)
      • All relevant tissues
        0
        day
    • Cattle (calf)
  • Subcutaneous use
    • Pig (piglet)
      • All relevant tissues
        0
        day
    • Cattle (calf)
  • Intramuscular use
    • Pig (piglet)
      • All relevant tissues
        0
        day
    • Cattle (calf)
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QB03AC
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Complete application (stand-alone) - Directive No 2001/82/EC
Marketing authorisation holder:
  • Pharmacosmos A/S
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pharmacosmos A/S
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 105750
Date of authorisation status change:
Reference member state:
  • Sweden
Procedure number:
  • SE/V/0124/001
Concerned member states:
  • Belgium
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 18/10/2023
Download

Package Leaflet

English (PDF)
Published on: 18/10/2023
Download

Labelling

English (PDF)
Published on: 18/10/2023
Download

eu-puar-sev0124001-mr-defixopzyl-solution-for-injection-en.pdf

English (PDF)
Published on: 18/10/2023
Download
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