Veterinary Medicines

Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats

Authorised
  • Oxytocin
Download as PDF

Product identification

Medicine name:
Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats
Oxytobel 10 NE/ml oldatos injekció lovak, szarvasmarhák, sertések, juhok, kecskék, kutyák és macskák részére
Active substance:
  • Oxytocin
Target species:
  • Cattle
  • Dog
  • Goat
  • Sheep
  • Horse
  • Cat
  • Pig
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous 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
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Dog
    • Goat
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Cat
    • Pig
      • Meat and offal
        0
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Goat
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Dog
    • Goat
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Cat
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01BB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Hungary
Available in:
  • Hungary
Package description:
  • Type I (10 ml) brown glass vial closed with bromobutyl rubber stopper and sealed with aluminium cap.1 x 10 ml in a cardboard box
  • Type I (10 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.5 x 10 ml in a cardboard box
  • Type I (10 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.12 x 10 ml in a cardboard box
  • Type I (25 ml) brown glass vial closed with bromobutyl rubber stopper and sealed with aluminium cap.1 x 25 ml in a cardboard box
  • Type I (25 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.10 x 25 ml in a cardboard box
  • Type II (50 ml) brown glass vial closed with bromobutyl rubber stopper and sealed with aluminium cap.1 x 50 ml in a cardboard box
  • Type II (50 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.12 x 50 ml in a cardboard box
  • Type II (50 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.6 x (1 x 50 ml) wrapped with clear foil (multipack)
  • Type II (100 ml) brown glass vial closed with bromobutyl rubber stopper and sealed with aluminium cap.1 x 100 ml in a cardboard box
  • Type II (100 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.12 x 100 ml in a cardboard box
  • Type II (100 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.6 x (1 x 100 ml) wrapped with clear foil (multipack)

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:
  • Bela-Pharm GmbH & Co. KG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bela-Pharm GmbH & Co. KG
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 3613/X/14 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0313/001
Concerned member states:
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Hungary
  • Iceland
  • Norway
  • Poland
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."