Veterinary Medicines

Vetroxy LA 200 mg/ml solution for injection for cattle, sheep and pigs

Authorised
  • Oxytetracycline dihydrate
Download as PDF

Product identification

Medicine name:
Vetroxy LA 200 mg/ml solution for injection for cattle, sheep and pigs
Vetroxy LA 200 mg/ml Roztwór do wstrzykiwań
Active substance:
  • Oxytetracycline dihydrate
Target species:
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Oxytetracycline dihydrate
    216.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        10
        day
      • Meat and offal
        31
        day
    • Sheep
      • Milk
        7
        day
      • Meat and offal
        9
        day
    • Pig
      • Meat and offal
        18
        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:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Bimeda Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma B.V.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2786
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0253/001
Concerned member states:
  • Estonia
  • Greece
  • Hungary
  • Latvia
  • Poland
  • Sweden
  • United Kingdom (Northern Ireland)

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
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: 4/02/2022
Download

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

Combined File of all Documents

English (PDF)
Published on: 1/12/2023
Download

PuAR Vetroxy LA NLV0253001_UKV0611001_04112023.pdf

English (PDF)
Published on: 1/12/2023
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."