Veterinary Medicines

GESTAVET OXYTOCIN 10 IU/ml Synthetic Oxytocin, solution for injection

Authorised
  • OXYTOCIN SYNTHETIC
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Product identification

Medicine name:
HIPRACIN 10IU/ML ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ
GESTAVET OXYTOCIN 10 IU/ml Synthetic Oxytocin, solution for injection
Active substance:
  • OXYTOCIN SYNTHETIC
Target species:
  • Cattle
  • Dog
  • Sheep
  • Cat
  • Pig
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • OXYTOCIN SYNTHETIC
    10.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        12
        hour
      • Milk
        12
        hour
    • Dog
    • Sheep
      • Meat and offal
        12
        hour
      • Milk
        12
        hour
    • Cat
    • Pig
      • Meat and offal
        12
        hour
  • Intravenous use
    • Cattle
      • Meat and offal
        12
        hour
      • Milk
        12
        hour
    • Dog
    • Sheep
      • Meat and offal
        12
        hour
      • Milk
        12
        hour
    • Cat
    • Pig
      • Meat and offal
        12
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01BB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Greece
Package description:
  • The veterinary medicinal product is bottled in sterile 10 ml, colourless Type I glass vial, closed with Type II basic polymeric elastomer closure with anodised aluminium cap. Two 10 ml vials are available in a cardboard box.
  • The veterinary medicinal product is bottled in sterile 50 ml colourless Type II glass vial, closed with Type II basic polymeric elastomer closure with anodised aluminium cap. One vial of 50 ml is available in a cardboard box.
  • The veterinary medicinal product is bottled in sterile 10 ml, colourless Type I glass vial closed with Type II basic polymeric elastomer closure with anodised aluminium cap. Clinical presentation: 25 x 10
  • The veterinary medicinal product is bottled in sterile 10 ml, colourless Type I glass vial closed with Type II basic polymeric elastomer closure with anodised aluminium cap. Clinical presentation: 20 x 10

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Biogenesis Global S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • National Organization For Medicines
Authorisation number:
  • 72709/08-11-2007/K-0144701
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0134/001
Concerned member states:
  • Austria
  • Greece
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
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