Veterinary Medicines

SEDAXYLAN

Authorised
  • Xylazine hydrochloride
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Product identification

Medicine name:
SEDAXYLAN
Sedaxylan 20 mg/ml Oplossing voor injectie
Sedaxylan 20 mg/ml Solution injectable
Sedaxylan 20 mg/ml Injektionslösung
Active substance:
  • Xylazine hydrochloride
Target species:
  • Cattle
  • Horse
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Xylazine hydrochloride
    23.30
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
    • Horse
      • Meat and offal
        1
        day
    • Dog
    • Cat
  • Intravenous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
    • Horse
      • Meat and offal
        1
        day
    • Dog
    • Cat
  • Subcutaneous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
    • Horse
      • Meat and offal
        1
        day
    • Dog
    • 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
Package description:
  • Vial of 50 ml volume contents 50 ml. Glass type II, amber coloured. Bromobutyl rubber stopper type I secured with aluminium cap.
  • Vial of 30 ml volume contents 25 ml. Glass type II, amber coloured. Bromobutyl rubber stopper type I secured with aluminium cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Bibliographic application (Article 22 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V254834
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0106/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

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: 23/04/2025
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French (PDF)
Published on: 23/04/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 23/04/2025
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French (PDF)
Published on: 23/04/2025
Download
German (PDF)
Published on: 23/04/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 23/04/2025
Download
French (PDF)
Published on: 23/04/2025
Download
German (PDF)
Published on: 23/04/2025
Download
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