Veterinary Medicines

Domosedan 10 mg/ml solution for injection for horses and cattle

Authorised
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
Download as PDF

Product identification

Medicine name:
DOMOSEDAN 10 mg/ml Solução injetável para cavalos
Domosedan 10 mg/ml solution for injection for horses and cattle
Active substance:
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
Target species:
  • Cattle
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
    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
  • Intravenous use
    • Cattle
      • Meat and offal
        2
        day
      • Milk
        12
        hour
    • Horse
      • Meat and offal
        2
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:
  • 1 x Type I clear glass vial containing 20 ml, closed with a chlorobutyl rubber stopper and an aluminium overseal, in a cardboard box.
  • 1 x Type I clear glass vial containing 5 ml, closed with a chlorobutyl rubber stopper and an aluminium overseal, in a cardboard box.
  • 6 x Type I clear glass vials containing 5 ml, closed with a chlorobutyl rubber stopper and an aluminium overseal, in a cardboard box.
  • 10 x Type I clear glass vials containing 5 ml, closed with a chlorobutyl rubber stopper and an aluminium overseal, in a cardboard box.
  • 5 x Type I clear glass vials containing 20 ml, closed with a chlorobutyl rubber stopper and an aluminium overseal, in a cardboard box.
  • 10 x Type I clear glass vials containing 20 ml, closed with a chlorobutyl rubber stopper and an aluminium overseal, in a cardboard box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Orion Corporation
Marketing authorisation date:
Manufacturing sites for batch release:
  • Orion Corporation
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 434/01/12NFVPT
Date of authorisation status change:

Documents

Combined File of all Documents

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