Veterinary Medicines

DETOSEDAN SOLUTION INJECTABLE POUR CHEVAUX ET BOVINS

Authorised
  • Medetomidine hydrochloride
Download as PDF

Product identification

Medicine name:
DETOSEDAN SOLUTION INJECTABLE POUR CHEVAUX ET BOVINS
DETOSEDAN 10 mg/ml SOLUCION INYECTABLE PARA CABALLOS Y BOVINO
Active substance:
  • Medetomidine hydrochloride
Target species:
  • Cattle
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Medetomidine hydrochloride
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        2
        day
      • Milk
        12
        hour
    • Horse
      • Meat and offal
        2
        day
      • Milk
        12
        hour
  • Intravenous use
    • Cattle
      • Meat and offal
        2
        day
      • Milk
        12
        hour
    • Horse
      • Meat and offal
        2
        day
      • Milk
        12
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:

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:
  • Vetpharma Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chemical Iberica Productos Veterinarios S.L.
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2399 ESP
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0227/001
Concerned member states:
  • Austria
  • Germany
  • Hungary
  • Italy
  • Portugal
  • Spain

Documents

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: 16/02/2023
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."