Dexmedetomidine Accord

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dexmedetomidine

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

Overview

Dexmedetomidine Accord is a medicine used to sedate (calm or make sleepy) adults 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).

Dexmedetomidine Accord contains the active substance dexmedetomidine.

Dexmedetomidine Accord is a ‘generic medicine’. This means that Dexmedetomidine Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Dexdor.

This EPAR was last updated on 21/07/2020

Authorisation details

Product details
Name
Dexmedetomidine Accord
Agency product number
EMEA/H/C/005152
Active substance
dexmedetomidine
International non-proprietary name (INN) or common name
dexmedetomidine
Therapeutic area (MeSH)
Premedication
Anatomical therapeutic chemical (ATC) code
N05CM18
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
13/02/2020
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

29/06/2020 Dexmedetomidine Accord - EMEA/H/C/005152 - IAIN/0001

Contents

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Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

For sedation of adult ICU (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).

For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.

Assessment history

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