Veterinary Medicines

Xylexx 20 mg/ml solution for injection for cattle, horses, dogs and cats

Authorised
  • Xylazine
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Product identification

Medicine name:
Xylexx 20 mg/ml solution for injection for cattle, horses, dogs and cats
Xylexx 20 mg/ml Oplossing voor injectie
Xylexx 20 mg/ml Solution injectable
Xylexx 20 mg/ml Injektionslösung
Active substance:
  • Xylazine
Target species:
  • Cat
  • Cattle
  • Dog
  • Horse
Route of administration:
  • Subcutaneous use
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Xylazine
    20.00
    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
  • Intravenous use
    • Horse
      • Meat and offal
        1
        day
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        no withdrawal period
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:
  • Cardboard box containing 1 vial of 30 ml
  • Cardboard box containing 5 vials of 30 ml
  • Polystyrene box containing 24 vials of 30 ml

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:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V660898
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0366/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 28/11/2022
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Package Leaflet

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Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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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.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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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: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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