Veterinary Medicines

Xylamidor 20 mg/ml Injektionslösung für Tiere

Authorised
  • Xylazine hydrochloride
Download as PDF

Product identification

Medicine name:
Xylamidor 20 mg/ml Injektionslösung für Tiere
Xylamidor 20 mg/ml Injektionslösung für Tiere
Active substance:
  • Xylazine hydrochloride
Target species:
  • Cattle
  • Dog
  • Cat
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Xylazine hydrochloride
    23.32
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        0
        hour
    • Dog
    • Cat
  • Intravenous use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        0
        hour
    • Dog
    • Horse
      • Meat and offal
        1
        day
      • Milk
        0
        hour
  • Subcutaneous use
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM92
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
Available in:
  • Austria
Package description:
  • Clear glass vial type I with 5 x 10 ml solution for injection with a coated bromobutyl rubber stopper, type I and aluminium cap in a cardboard box.
  • Clear glass vial type II with 25 ml solution for injection with a coated bromobutyl rubber stopper, type I and aluminium cap.
  • Clear glass vial type II with 50 ml solution for injection with a coated bromobutyl rubber stopper, type I and aluminium cap.
  • Clear glass vial type I with 10 ml solution for injection with a coated bromobutyl rubber stopper, type I and aluminium cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Vetviva Richter GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetviva Richter GmbH
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 841754
Date of authorisation status change:
Reference member state:
  • Austria
Procedure number:
  • AT/V/0029/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Cyprus
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Latvia
  • Netherlands
  • Norway
  • Poland
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 10/07/2023
Updated on: 3/05/2024
Download

Summary of Product Characteristics

English (PDF)
Published on: 11/08/2023
Updated on: 3/05/2024
Download
German (PDF)
Published on: 10/07/2023
Updated on: 3/05/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 10/07/2023
Updated on: 3/05/2024
Download

at-puar-atv0029001-mr-xylaemidoer-en.pdf

English (PDF)
Published on: 8/08/2023
Updated on: 3/05/2024
Download

at-puar-atv0029001-mr-xylaemidoer-de.pdf

German (PDF)
Published on: 8/08/2023
Updated 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."