Dexdomitor

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dexmedetomidine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 17/05/2018

Authorisation details

Product details
Name
Dexdomitor
Agency product number
EMEA/V/C/000070
Active substance
dexmedetomidine hydrochloride
International non-proprietary name (INN) or common name
dexmedetomidine
Species
  • Dogs
  • Cats
Anatomical therapeutic chemical veterinary (ATCvet) codes
QN05CM18
Publication details
Marketing-authorisation holder
Orion Corporation
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
29/08/2002
Contact address
Orionintie 1
FIN-02200 Espoo
Finland

Product information

03/05/2018 Dexdomitor - EMEA/V/C/000070 - IAIN/0037

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

PSYCHOLEPTICS

Therapeutic indication

Noninvasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.

Premedication in cats before induction and maintenance of general anaesthesia with ketamine.

Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.

Premedication in dogs before induction and maintenance of general anaesthesia.

Assessment history

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