Dexmedetomidine Accord

dexmedetomidine

Table of contents

Opinion

On 12 December 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dexmedetomidine Accord, intended for the induction of light to moderate sedation of adults in intensive care unit. The applicant for this medicinal product is Accord Healthcare S.L.U.

Dexmedetomidine Accord will be available as a concentrate for solution for infusion (100 µg/ml). The active substance of Dexmedetomidine Accord is dexmedetomidine, a sedative agent (ATC code: N05CM18) acting as a selective alpha-2 receptor agonist with a broad range of pharmacological properties. The sedative effects are mediated through decreased firing of locus coeruleus, the predominant noradrenergic nucleus situated in the brainstem. Dexmedetomidine has shown some analgesic and anaesthetic/analgesic-sparing effects.

Dexmedetomidine Accord is a generic of Dexdor, which has been authorised in the EU. Since Dexmedetomidine Accord is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Dexdor was not required.

“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.”

It is proposed that Dexmedetomidine Accord is for hospital use only. Dexmedetomidine Accord should be administered by healthcare professionals skilled in the management of patients requiring intensive care.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Dexmedetomidine Accord
Agency product number
EMEA/H/C/005152
International non-proprietary name (INN) or common name
  • dexmedetomidine
Active substance
  • dexmedetomidine hydrochloride
Therapeutic area
Premedication
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.

Date opinion adopted
12/12/2019
Company name
Accord Healthcare S.L.U.
Status
Positive
Application type
Initial authorisation

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