Veterinary Medicines

Xylasol 100 mg/ml, solution for injection for cattle and horses

Authorised
  • Xylazine hydrochloride
Download as PDF

Product identification

Medicine name:
Xylasol 100 mg/ml, solution for injection for cattle and horses
XYLASOL 100 mg/ml SOLUCION INYECTABLE PARA BOVINO Y CABALLOS
Active substance:
  • Xylazine hydrochloride
Target species:
  • Cattle
  • Horse
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Xylazine hydrochloride
    116.55
    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
    • Dog
    • Cat
  • Intravenous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
    • Horse
      • Milk
        no withdrawal period
      • 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:
  • Spain
Package description:
  • 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
  • Cardboard box containing 1 vial (uncoloured glass type II, closed with bromobutyl rubber stopper, secured with aluminium cap) filled with 50 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) 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:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2559 ESP
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0158/002
Concerned member states:
  • Germany
  • Hungary
  • Spain

Documents

Combined File of all Documents

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

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/02/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/02/2023
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 15/03/2023
Download

108965 par.pdf

English (PDF)
Published on: 21/06/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."