Veterinary Medicines

Oxytet L.A. 200 mg/ml Roztwór do wstrzykiwań

Authorised
  • Oxytetracycline
Download as PDF

Product identification

Medicine name:
Oxytet L.A. 200 mg/ml Roztwór do wstrzykiwań
Active substance:
  • Oxytetracycline
Target species:
  • Sheep
  • Pig
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Oxytetracycline
    216.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Sheep
      • Milk
        6
        day
      • Meat and offal
        20
        day
    • Pig
      • Meat and offal
        20
        day
    • Cattle
      • Milk
        8
        day
      • Meat and offal
        35
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01AA06
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:
  • Scanvet Poland Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 0085
Date of authorisation status change:

Documents

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
Download

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: 1/02/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 1/02/2023
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."