Dexdor
dexmedetomidine
Table of contents
Overview
Dexdoris a medicine used to sedate (calm or make sleepy) adult patients in the following settings:
- in hospital intensive care units to bring about a light level of sedation in which the patient can still respond to verbal stimulation (corresponding to a score of between 0 and -3 on the Richmond Agitation-Sedation Scale);
- before or during diagnostic or surgical procedures where the patient remains awake (awake sedation).
Dexdor contains the active substance dexmedetomidine.
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List item
Dexdor : EPAR - Medicine overview (PDF/91.24 KB)
First published: 04/10/2011
Last updated: 01/10/2018
EMA/648646/2011 -
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List item
Dexdor : EPAR - Risk Management Plan (PDF/695.47 KB)
First published: 20/06/2023
Authorisation details
Product details | |
---|---|
Name |
Dexdor
|
Agency product number |
EMEA/H/C/002268
|
Active substance |
Dexmedetomidine hydrochloride
|
International non-proprietary name (INN) or common name |
dexmedetomidine
|
Therapeutic area (MeSH) |
Conscious Sedation
|
Anatomical therapeutic chemical (ATC) code |
N05CM18
|
Publication details | |
---|---|
Marketing-authorisation holder |
Orion Corporation
|
Revision |
16
|
Date of issue of marketing authorisation valid throughout the European Union |
15/09/2011
|
Contact address |
Orionintie 1 |
Product information
08/07/2022 Dexdor - EMEA/H/C/002268 - II/0035
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
Psycholeptics
Therapeutic indication
For sedation of adult intensive care unit patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3).