Veterinary Medicines Information website

Rompun TS - 500 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Tiere

Not authorised
  • Xylazine hydrochloride
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Product identification

Medicine name:
Rompun TS - 500 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Tiere
Active substance:
  • Xylazine hydrochloride
Target species:
  • Horse
  • Zoo animals
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Xylazine hydrochloride
    583.00
    milligram(s)
    /
    1.00
    Vial
Pharmaceutical form:
  • Powder and solvent for solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Horse
      • Meat and offal
        1
        day
      • Milk
        24
        hour
  • Intravenous use
    • Horse
      • Meat and offal
        1
        day
      • Milk
        24
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM92
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Austria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Elanco Animal Health GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • KVP Pharma+Veterinaer Produkte GmbH
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 15751
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.
German (PDF)
Published on: 20/05/2020
Updated on: 24/09/2025
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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.
German (PDF)
Published on: 17/09/2020
Updated on: 24/09/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 20/05/2020
Updated on: 24/09/2025
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