Sedadex
dexmedetomidine
Table of contents
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.
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 |
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
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PSYCHOLEPTICS
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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.