Dexmedetomidine Accord
dexmedetomidine
Table of contents
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.
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List item
Dexmedetomidine Accord : EPAR - Medicine overview (PDF/169.24 KB)
First published: 19/02/2020
EMA/681137/2019 -
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Dexmedetomidine Accord : EPAR - Risk-management-plan summary (PDF/147.48 KB)
First published: 19/02/2020
Last updated: 02/12/2022
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
|
Generic |
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 | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
|
Revision |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
13/02/2020
|
Contact address |
Accord Healthcare S.L.U. |
Product information
24/01/2023 Dexmedetomidine Accord - EMEA/H/C/005152 - IB/0011
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 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.