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 28/01/2022

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
5
Date of issue of marketing authorisation valid throughout the European Union
12/08/2016
Contact address
Wilgenweg 7
3421 TV
Oudewater
Netherlands

Product information

27/01/2022 Sedadex - EMEA/V/C/004202 - IG1436

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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