Veterinary Medicines

Rompun 2% 20 mg/ml Oplossing voor injectie

Authorised
  • Xylazine hydrochloride
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Product identification

Medicine name:
Rompun 2% 20 mg/ml Oplossing voor injectie
Rompun 2% 20 mg/ml Solution injectable
Rompun 2% 20 mg/ml Injektionslösung
Active substance:
  • Xylazine hydrochloride
Target species:
  • Cat
  • Cattle
  • Dog
  • 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
    • Cat
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
    • Dog
  • Intravenous use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        no withdrawal period
    • Horse
      • Meat and offal
        1
        day
      • Milk
        no withdrawal period
    • Dog
    • Cat
  • 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:
  • Belgium
Available in:
  • Belgium
Package description:
  • Rompun 2% 25 ml Vial Solution for injection

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 8(3) of Directive No 2001/83/EC)
Marketing authorisation holder:
  • Elanco Animal Health GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • KVP Pharma+Veterinaer Produkte GmbH
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V041815
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 5/01/2024
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French (PDF)
Published on: 5/01/2024
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Package Leaflet

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Dutch (PDF)
Published on: 22/01/2024
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French (PDF)
Published on: 22/01/2024
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German (PDF)
Published on: 22/01/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 5/01/2024
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French (PDF)
Published on: 5/01/2024
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German (PDF)
Published on: 5/01/2024
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