Dexdor

RSS

dexmedetomidine

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 05/11/2018

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
9
Date of issue of marketing authorisation valid throughout the European Union
15/09/2011
Contact address
Orionintie 1
FI-02200 Espoo
Finland

Product information

09/10/2018 Dexdor - EMEA/H/C/002268 - N/0029

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

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).

Assessment history

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