Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Dexdor   
Auth. number : EU/1/11/718
Active substance : dexmedetomidine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05C - Hypnotics and sedatives
Chemical subgroup: N05CM - Other hypnotics and sedatives
Chemical substance: N05CM18 - dexmedetomidine
(See WHO ATC Index)
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).
Marketing Authorisation Holder: Orion Corporation
Orionintie 1, 02200 Espoo, Suomi
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
21/09/2011 Centralised - Authorisation EMEA/H/C/2268 (2011)6587 of 16/09/2011
10/02/2012 Centralised - Notification EMEA/H/C/2268/N/1
Updated with Decision(2013)9738 of 18/12/2013
10/08/2012 Centralised - Notification EMEA/H/C/2268/N/2
Updated with Decision(2013)9738 of 18/12/2013
13/12/2012 Centralised - Variation EMEA/H/C/2268/II/3
Updated with Decision(2013)9738 of 18/12/2013
21/03/2013 Centralised - Variation EMEA/H/C/2268/II/4/G
Updated with Decision(2013)9738 of 18/12/2013
04/12/2013 Centralised - Notification EMEA/H/C/2268/N/6
Updated with Decision(2013)9738 of 18/12/2013
23/12/2013 Centralised - Yearly update (2013)9738 of 18/12/2013
20/11/2014 Centralised - Variation EMEA/H/C/2268/II/9
Updated with Decision(2015)7733 of 03/11/2015
25/06/2015 Centralised - Variation EMEA/H/C/2268/II/11/G
Updated with Decision(2015)7733 of 03/11/2015
05/11/2015 Centralised - Yearly update (2015)7733 of 03/11/2015
30/05/2016 Centralised - Renewal EMEA/H/C/2268/R/19 (2016)3296 of 26/05/2016
19/05/2017 Corrigendum (2011)6587 of 16/09/2011
12/12/2017 PSUSA - Modification EMEA/H/C/2268/PSUSA/998/201703 (2017)8599 of 08/12/2017