Veterinary Medicines

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

Authorised
  • Xylazine hydrochloride
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Product identification

Medicine name:
Xylasol 20 mg/ml, solution for injection for cattle, horses, dogs and cats
Xylasol 20 mg/ml, oplossing voor injectie voor runderen, paarden, honden en katten
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
    23.31
    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
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
  • Intravenous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
    • Horse
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
  • Subcutaneous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
    • Horse
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM92
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • Cardboard box containing 1 vial (uncoloured glass type II, closed with bromobutyl rubber stopper, secured with aluminium cap) filled with 50 ml
  • Cardboard box containing 1 vial (uncoloured glass type II, closed with bromobutyl rubber stopper, secured with aluminium cap) filled with 25 ml
  • Cardboard box containing 1 vial (uncoloured glass type II, closed with bromobutyl rubber stopper, secured with aluminium cap) filled with 10 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:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 108964
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0158/001
Concerned member states:
  • Austria
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Norway
  • Spain
  • Sweden

Documents

Combined File of all Documents

English (PDF)
Published on: 21/06/2022
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Dutch (PDF)
Published on: 25/01/2022
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108964 - par.pdf

English (PDF)
Published on: 21/06/2022
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