Products

Date: 2018-06-28

Type of information: Positive opinion for the granting of a Market Authorisation in the EU

Product name: Dexdor®

Compound: dexmedetomidine

Therapeutic area: CNS diseases

Action mechanism:

• Dexmedetomidine is a relatively selective alpha2-agonist which acts on the central nervous system to produce sedation.

Company: Orion Corporation (Finland)

Disease:

• sedation of adult intensive care unit (ICU) patients

Latest news:

• • On September 21, 2011, Orion Corporation announced that the European Commission has granted centralised marketing authorisation for dexdor® (dexmedetomidine) indicated for sedation of adult intensive care unit (ICU) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale [RASS] 0 to -3). The authorisation covers all 27 European Union countries.
• The active substance of dexdor® is dexmedetomidine, a sedative agent originated by Orion's pharmaceutical R&D. Dexmedetomidine is available with the brand name Precedex® in more than 30 countries outside Europe, including the USA (since 2000) and Japan (since 2004). The distributor for the product outside Europe is Hospira under Orion's license.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization: 2011-09-21

Favourable opinion UE: 2011-07-21

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

• • On June 28, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for Dexdor®.  The CHMP adopted a new indication as follows: "For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation."
• The full indications for Dexdor will be as follows: "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."

Is general: Yes