Veterinary Medicines

Oxytocinum Biowet Puławy 10 j.m./ml Roztwór do wstrzykiwań

Authorised
  • Oxytocin
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Product identification

Medicine name:
Oxytocinum Biowet Puławy 10 j.m./ml Roztwór do wstrzykiwań
Active substance:
  • Oxytocin
Target species:
  • Cattle
  • Sheep
  • Horse
  • Cat
  • Pig
  • Dog
Route of administration:
  • Subcutaneous use
  • Intravenous use
  • Intramuscular 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:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Sheep
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Horse
      • Meat and offal
        0
        day
    • Cat
    • Pig
      • Meat and offal
        0
        day
    • Dog
  • Intravenous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        0
        day
    • Cat
    • Pig
      • Meat and offal
        0
        day
    • Dog
  • Intramuscular use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Sheep
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Horse
      • Meat and offal
        0
        day
    • Cat
    • Pig
      • Meat and offal
        0
        day
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01BB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Biowet Pulawy Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Biowet Pulawy Sp. z o.o.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 0045
Date of authorisation status change:

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 26/04/2022
Download
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