Veterinary Medicines

Oxytocine Prodivet 10 IU/ml Oplossing voor injectie

Authorised
  • Oxytocin
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Product identification

Medicine name:
Oxytocine Prodivet 10 IU/ml Oplossing voor injectie
Oxytocine Prodivet 10 IU/ml Solution injectable
Oxytocine Prodivet 10 IU/ml Injektionslösung
Active substance:
  • Oxytocin
Target species:
  • Sheep
  • Horse
  • Cattle
  • Goat
  • Dog
  • Cat
  • Pig
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Oxytocin
    10.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Sheep
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Horse
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Goat
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        no withdrawal period
  • Intravenous use
    • Sheep
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Horse
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Cattle
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        no withdrawal period
    • Goat
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01BB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • Oxytocine Prodivet 100 ml Vial Solution for injection
  • Oxytocine Prodivet 50 ml Vial Solution for injection
  • Oxytocine Prodivet 20 ml Vial Solution for injection
  • Oxytocine Prodivet 10 ml Vial Solution for injection

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Prodivet Pharmaceuticals
Marketing authorisation date:
Manufacturing sites for batch release:
  • Prodivet Pharmaceuticals
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V106881
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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Package Leaflet

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Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Labelling

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Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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