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 |
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
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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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.