Sedadex

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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) for Sedadex. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Sedadex.

For practical information about using Sedadex, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This EPAR was last updated on 27/11/2017

Authorisation details

Product details
Name
Sedadex
Agency product number
EMEA/V/C/004202
Active substance
dexmedetomidine hydrochloride
International non-proprietary name (INN) or common name
dexmedetomidine
Anatomical therapeutic chemical veterinary (ATCvet) codes
QN05CM18
Publication details
Marketing-authorisation holder
Le Vet Beheer B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
12/08/2016
Contact address
Wilgenweg 7
3421 TV
Oudewater
Netherlands

Product information

19/10/2017 Sedadex - EMEA/V/C/004202 - IAIN/0002

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
  • HYPNOTICS AND SEDATIVES

Therapeutic indication

Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats. Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures. Premedication in dogs and cats before induction and maintenance of general anaesthesia.

Assessment history

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